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NAFLD linked to worse outcomes in IBD
Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.
Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.
IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).
Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.
Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.
“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.
“This is the largest study to date, and the signal is very clear. It really does underscore the need [to study not just how] medications and other factors influence the clinical syndrome, but how it happens mechanistically. There are a multitude of metabolic interactions going on between the gut and liver. We need to understand this better – not just at the systemic level, but at the enterohepatic circulation level,” said Dr. Ciorba.
Possible mechanisms include liver toxicity due to medication, IBD-associated inflammation, or changes to gut bacteria, according to Dr. Noorian.
The study also brings to light something that could become an emerging problem. “In the past, Crohn’s patients were oftentimes thin because their Crohn’s disease wasn’t well treated. They were taking steroids all the time, so they had fat redistribution, including to the liver. Now we see IBD patients who are obese, and most are not underweight. It has become a compounding problem at this point with both conditions contributing to morbidity,” said Dr. Ciorba.
The study had no source of funding. Dr. Noorian and Dr. Ciorba have no relevant financial disclosures.
Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.
Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.
IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).
Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.
Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.
“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.
“This is the largest study to date, and the signal is very clear. It really does underscore the need [to study not just how] medications and other factors influence the clinical syndrome, but how it happens mechanistically. There are a multitude of metabolic interactions going on between the gut and liver. We need to understand this better – not just at the systemic level, but at the enterohepatic circulation level,” said Dr. Ciorba.
Possible mechanisms include liver toxicity due to medication, IBD-associated inflammation, or changes to gut bacteria, according to Dr. Noorian.
The study also brings to light something that could become an emerging problem. “In the past, Crohn’s patients were oftentimes thin because their Crohn’s disease wasn’t well treated. They were taking steroids all the time, so they had fat redistribution, including to the liver. Now we see IBD patients who are obese, and most are not underweight. It has become a compounding problem at this point with both conditions contributing to morbidity,” said Dr. Ciorba.
The study had no source of funding. Dr. Noorian and Dr. Ciorba have no relevant financial disclosures.
Nonalcoholic fatty liver disease (NAFLD) in patients with inflammatory bowel disease (IBD) is associated with worse outcomes, and that relationship may be influenced by nonmetabolic factors. That is the conclusion of a new nationwide database analysis. NAFLD is common in IBD, with an estimated prevalence of 27%-32%.
Previous, smaller studies showed possible links between NAFLD and a history of IBD surgery, IBD disease activity, and metabolic factors, “but none of the studies looked at it on the scale that we did, and our study was more focused on outcomes than simply examining factors associated with both NAFLD and IBD,” Shaya Noorian, MD, of UCLA Medical Center in Los Angeles, said in an interview. Dr. Noorian presented the research at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Noorian and colleagues found higher rates of hospital readmission, longer hospitalization, and higher costs, but not higher rates of death among patients with both Crohn’s disease or ulcerative colitis and NAFLD. The researchers analyzed data from patients in the Nationwide Readmissions Database (2016-2017), using ICD-10 codes to identify patients with IBD and NAFLD, along with propensity-matched controls. The study included 3,655 with Crohn’s disease and NAFLD and 7,482 without, and there were 2,026 with ulcerative colitis and NAFLD 4,094 without.
IBD hospital readmission rates were higher with comorbid NAFLD in Crohn’s disease (hazard ratio, 1.98; 95% confidence interval, 1.8-2.17; P < .001) and ulcerative colitis (HR, 1.97; 95% CI, 1.67-2.32; P < .001). Comorbid NAFLD was associated with additional length of stay Crohn’s disease (0.74 days; 95% CI, 0.29-1.18; P < .01) and ulcerative colitis (0.84 days; 0.32-1.35, respectively; P < .01), and there was additional cost of care with both Crohn’s disease ($7,766; 95% CI, $2,693-$12,839; P < .01) and ulcerative colitis ($11,496; 95% CI, $4,361-$18,631; P < .01).
Kaplan Meier curves for IBD readmission-free survival versus days since discharge showed clear separation in both Crohn’s disease and ulcerative colitis among patients with versus those without NAFLD.
Although evidence points to nonmetabolic factors being involved, metabolic factors such as obesity and diabetes are likely important as well. “We still do recognize that it’s very likely that these metabolic factors play a role in developing NAFLD in IBD. I think the fact that there are worse outcomes in patients with NAFLD supports the fact that we should do our best to control the metabolic factors like diabetes, obesity, et cetera. We don’t want to minimize that aspect of it. But I think the fact that there were still worse outcomes after adjusting for metabolic factors emphasizes the importance of researching these factors further to see which ones are the main contributors. If we can find the main contributor, whether that’s medication, IBD disease burden, or history of surgery, perhaps we can use that information to prevent development or progression of NAFLD,” said Dr. Noorian.
“Historical reports have examined the relationship between Crohn’s disease and NAFLD. The currently study included both Crohn’s and ulcerative colitis, thus impressively demonstrating the importance of this interaction across IBD,” said Matthew Ciorba, MD, director of the IBD Center at Washington University in St. Louis, who attended the session.
“This is the largest study to date, and the signal is very clear. It really does underscore the need [to study not just how] medications and other factors influence the clinical syndrome, but how it happens mechanistically. There are a multitude of metabolic interactions going on between the gut and liver. We need to understand this better – not just at the systemic level, but at the enterohepatic circulation level,” said Dr. Ciorba.
Possible mechanisms include liver toxicity due to medication, IBD-associated inflammation, or changes to gut bacteria, according to Dr. Noorian.
The study also brings to light something that could become an emerging problem. “In the past, Crohn’s patients were oftentimes thin because their Crohn’s disease wasn’t well treated. They were taking steroids all the time, so they had fat redistribution, including to the liver. Now we see IBD patients who are obese, and most are not underweight. It has become a compounding problem at this point with both conditions contributing to morbidity,” said Dr. Ciorba.
The study had no source of funding. Dr. Noorian and Dr. Ciorba have no relevant financial disclosures.
FROM THE CROHN’S & COLITIS CONGRESS
Racial, social inequities persist in IBD
Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.
Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.
An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode.
Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.
Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.
Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.
Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.
But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.
Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).
Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.
She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.
Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.
Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.
Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.
Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.
The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.
Updated Feb. 17, 2021.
Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.
Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.
An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode.
Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.
Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.
Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.
Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.
But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.
Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).
Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.
She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.
Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.
Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.
Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.
Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.
The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.
Updated Feb. 17, 2021.
Although inflammatory bowel disease (IBD) affects primarily White patients, about one-quarter of cases are found in non-White racial and ethnic groups. Various factors have combined to lead to disparities in treatment and outcomes for non-Whites with IBD.
Ethnic and racial disparities, along with socioeconomic factors, were the subject of a presentation by Ruby Greywoode, MD, at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
“Historical and present-day realities of racial inequity and factors that contribute to socioeconomic status [include] educational and housing policies, employment practices, and generational wealth. Addressing health disparities requires acknowledging these systemic factors,” said Dr. Greywoode, who is with Montefiore Medical Center in New York.
An important concept in discussing health disparity is social determinants of health, which refers to nonbiological factors that affect health and health outcomes. These are “the conditions in which people live, work, learn, and play that affect their health and their quality of life,” said Dr. Greywoode.
Dr. Greywoode shared examples of social determinants that affect economic stability and financial worry. One study found that one in six IBD patients reported not taking their medications because of cost considerations. A survey of about 900 adults showed that 1 in 4 delayed medical care – half of those because of cost; patients who delayed care were 2.5 times more likely to report an IBD flare in the previous year.
Another important issue is food insecurity. Other presenters at the session emphasized the importance of high-quality nutrition in IBD, and Dr. Greywoode presented one survey showing that only 9% of patients who had both food security and social support reported cost-related medication nonadherence. Among those that had either food insecurity or poor social support, 12% reported cost-related medication nonadherence, but the proportion jumped to 57% among patients who had both food insecurity and lack of social support.
Session comoderator Kelly Issokson noted that socioeconomic factors often interfere with adoption of healthy diets. Whole foods and plant-based foods are expensive, and the financial pressures of the COVID-19 epidemic have made that worse. “Millions of people are slipping into poverty and food insecurity. This is one of the things she highlighted as factors in medication nonadherence,” said Ms. Issokson, who is the clinical nutritional coordinator at the digestive disease clinic at Cedars-Sinai Medical Center in Los Angeles.
Dr. Greywoode also described studies that looked at race, socioeconomic status, and IBD outcomes. A review from 2013 showed disparities among Whites, African Americans, and Hispanics with respect to undergoing ulcerative colitis–related colectomy and Crohn’s disease–related bowel resection. Ulcerative colitis patients on Medicaid had 230% greater in-patient mortality, compared with patients with private insurance, even after adjustment for multiple confounders.
But inequities are not static. “Since this publication, we have numerous other studies drawing conclusions that sometimes agree with and sometimes conflict with it. My belief is that health disparities in IBD will continue to be an active area of research. We know that it takes vigilance to identify, track, and address any disparities when they do arise,” said Dr. Greywoode.
Dr. Greywoode also noted that phenotypic differences based on race and ethnicity influence disparities. She showed results from a meta-analysis that found a difference in the frequency of perianal Crohn’s disease by race and ethnicity; the highest frequency occurred in Black patients (31%), followed by Asians (22%), Whites (14%), and Hispanics (13%). Another study showed that African American patients with Crohn’s disease were more likely to develop a new abscess (adjusted odds ratio, 2.27; 95% confidence interval, 1.31-3.93) or anal fissure (aOR, 1.76; 95% CI, 1.01-3.07), and were also more likely to be initiated on an anti–tumor necrosis factor drug (aOR, 1.85; 95% CI, 1.09-3.14).
Those differences underscore the need to recognize that IBD is not just a disease for White patients. “As we move forward in IBD research, we recognize that individuals of European ancestry are not the only ones who have IBD. There is a growing diverse racial and ethnic population with IBD,” said Dr. Greywoode.
She noted that, in the United States, it is estimated that about one in four adult patients are non-Hispanic African American, Hispanic, Asians, or other ethnicities. Nevertheless, Whites are overrepresented among participants in IBD clinical trials. Some trials are composed of as much as 95% White patients, and sometimes race isn’t even listed. “It’s unclear if [race/ethnicity data are] not collected or not deemed important, but we know that what is not collected is not measured, and what is not measured can’t be evaluated, either to praise or constructively criticize,” said Dr. Greywoode.
Fortunately, there are efforts in place to improve representation in clinical trials. There has been a mandate for almost 3 decades that federally funded research must include racial and ethnic minorities who have been traditionally underrepresented. The Food and Drug Administration has also provided guidance to industry to improve diversity in clinical trial participation, and industry groups have developed strategies, including improved representation among investigators and related early-career development programs. At the community and independent health care practice levels, clinical trial networks encourage patient participation with regulatory and data management support to bolster practices with insufficient resources.
Underrepresentation in clinical trials resonated with comoderator Tina Aswani Omprakash, who is a patient advocate and a master’s in public health student at the Icahn School of Medicine at Mount Sinai, New York. She called for greater awareness among physicians that IBD can occur among people of all backgrounds. “[Providers] would look at me and [say]: ‘There’s no way that, as a South Asian woman, you have that kind of disease.’ There’s that lack of believability,” said Ms. Aswani Omprakash.
Greater recognition of the diversity of patients, as well as the phenotypic differences found among ethnicities, could also inform clinical trial participation and, ultimately, more personalized medicine. “We have to look at these things, observe how they’re affecting populations differently, so that we can have proper medication solutions,” said Ms. Aswani Omprakash.
Dr. Greywoode and Ms. Issokson have no relevant financial disclosures. Ms. Aswani Omprakash has consulted for Genentech, AbbVie, Janssen, and Arena.
The AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. The AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.
Updated Feb. 17, 2021.
FROM THE CROHN’S & COLITIS CONGRESS
COVID-19 risks linked to medications in IBD
Multicenter and population cohort studies suggest that patients with inflammatory bowel disease (IBD) are not at unique risk of contracting COVID-19 or experiencing worse outcomes, with the exception of a few risk factors such as corticosteroid use and combination therapy that appear tied to greater risk of hospitalization and mortality. The findings line up well with previous experience with infectious disease and are reassuring, but they also underscore the need to taper steroids and de-escalate from combination therapy, when possible.
“There is not a clear increased risk of getting COVID-19 among IBD patients compared to the general population, and that seems to hold even if you look at certain medication types, [even] if patients are on immunosuppressives like thiopurines or anti-TNF [anti–tumor necrosis factor] drugs,” Ryan C. Ungaro, MD, said in an interview. Dr. Ungaro, who is with the Icahn School of Medicine at Mount Sinai, New York, discussed IBD and COVID-19 risks at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
A systematic review showed that 0.3% of IBD patients contracted COVID-19 during study periods, compared with 0.2%-4.0% of the general population, and a matched-cohort analysis of a national Veterans Affairs database showed an infection prevalence of 0.23% among patients with IBD versus 0.20% among those without (P = .29). The analysis also showed use of anti-TNF therapies or thiopurines was not associated with an increased risk.
Studies show that patients with IBD in general do not appear to be at greater risk of severe disease outcomes such as hospitalization or 30-day mortality. For example, a U.S. national database study of more than 40 million patients compared 232 patients with IBD who were diagnosed with COVID-19 with 19,776 non-IBD patients and found that, after propensity matching, there were no significant association between IBD and worse outcomes (risk ratio, 0.93; 95% confidence interval, 0.68-1.27; P = .86) or hospitalizations (RR, 1.10; 95% CI, 0.74-1.40; P = .91)).
However, some risk factors could be red flags. Data from the international SECURE-IBD registry showed an association between combined endpoint of ICU, requiring a ventilator, or death and advanced age (adjusted odds ratio, 1.04; 95% CI, 1.01-1.06; P < .01) and two or more comorbidities (aOR, 2.87; 95% CI, 1.05-7.85; P < .04). More specifically to IBD, severe COVID-19 was associated with use of corticosteroids (aOR, 6.87; 95% CI, 2.30-20.51; P < .001). In terms of other therapies, another study found a similar effect with thiopurines (compared with TNF monotherapy; aOR, 4.08; 95% CI, 1.65-9.78; Bonferroni adjusted P = .008), and combined use of anti-TNF drugs and a thiopurine (compared with TNF monotherapy; aOR, 4.01; 95% CI, 1.73-9.61; Bonferroni adjusted P = .013), but anti-TNF therapies alone trended toward a protective effect (compared with no anti-TNF therapy; aOR, 0.69; Bonferroni adjusted P = .52). That study found no significant association between severe outcomes and anti-IL 12/23 (compared with anti-TNF monotherapy; aOR, 0.98; 95% CI, 0.12-8.06; P = .98) or anti-integrin biologics (compared with anti-TNF monotherapy; aOR, 2.42; 95% CI, 0.59-9.96; P = .22).
Overall, the data are “generally consistent with prior data on infections and IBD: That steroids and combination therapy increase the risk of infection and bad outcomes and that interestingly biologic monotherapy may actually confer a little bit of protection against emergent outcomes and at a minimum appears to be neutral,” said Dr. Ungaro.
He noted that the recommendations from the IOIBD COVID-19 Task Force were based on expert opinion, but the new data have largely supported them overall. He did suggest some potential modifications, including reducing thiopurine use among patients on combination therapy. According to Dr. Ungaro, the recommendations do call for withholding all IBD therapy for 10 days after positive SARS-CoV-2 tests, whether the patient is symptomatic or not. “I think the recent data is reassuring that potentially in asymptomatic and maybe even mild cases, the monotherapy biologics – we can consider not delaying administering those. I think we need more data about that, but it’s reassuring that patients on those had no worse outcomes and [in fact did] slightly better,” Dr. Ungaro said during the presentation.
The data reinforced the need to consider tapering patients off corticosteroids or combination therapies, if possible. “It’s something we were doing in regular IBD care beforehand, but the COVID-19 pandemic offers another reason to limit the use of steroids and evaluate if patients are able to de-escalate from combination therapies,” said Dr. Ungaro.
On the other hand, there was concern among some patients early in the pandemic that their immunotherapy drugs may put them at risk of contracting COVID-19, which led some to discontinue medications. Ongoing studies are illustrating the problem with this, according to David T. Rubin, MD, professor of medicine at the University of Chicago and chair of the congress’s organizing committee. “The data do not in general suggest you should do that to protect yourself. In fact, being on the therapies may have a better outcome. Patients always want to come off their therapies, [but] during the pandemic that is a risk not worth taking. Getting sick from your Crohn’s disease or colitis, when there are limited health care resources and, in some places, limited hospital beds and where the rescue therapy might include steroids, is a risky proposition. It’s not the time to do this,” said Dr. Rubin.
With respect to vaccines, it appears so far that there is no increased risk of adverse events associated with IBD. Patients who are on immunosuppressive drugs may experience a lower response to immunization, which has been seen with other vaccines. “The benefits likely outweigh the risks based on our prior experience with other vaccinations. It’s an area of ongoing study, but I do think we should recommend that our IBD patients get the COVID-19 vaccine, especially if they have risk factors for severe disease,” said Dr. Ungaro.
Dr. Ungaro is on the advisory board for Bristol-Myers Squibb, Janssen, Pfizer, and Takeda. He has received funding from AbbVie, Boehringer Ingelheim, Eli Lilly, and Pfizer. He has been a speaker or received consulting fees from AbbVie and Eli Lilly. Dr. Rubin is a consultant for Janssen, Pfizer, Takeda, and AbbVie.
This article was updated Jan. 27, 2021.
Multicenter and population cohort studies suggest that patients with inflammatory bowel disease (IBD) are not at unique risk of contracting COVID-19 or experiencing worse outcomes, with the exception of a few risk factors such as corticosteroid use and combination therapy that appear tied to greater risk of hospitalization and mortality. The findings line up well with previous experience with infectious disease and are reassuring, but they also underscore the need to taper steroids and de-escalate from combination therapy, when possible.
“There is not a clear increased risk of getting COVID-19 among IBD patients compared to the general population, and that seems to hold even if you look at certain medication types, [even] if patients are on immunosuppressives like thiopurines or anti-TNF [anti–tumor necrosis factor] drugs,” Ryan C. Ungaro, MD, said in an interview. Dr. Ungaro, who is with the Icahn School of Medicine at Mount Sinai, New York, discussed IBD and COVID-19 risks at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
A systematic review showed that 0.3% of IBD patients contracted COVID-19 during study periods, compared with 0.2%-4.0% of the general population, and a matched-cohort analysis of a national Veterans Affairs database showed an infection prevalence of 0.23% among patients with IBD versus 0.20% among those without (P = .29). The analysis also showed use of anti-TNF therapies or thiopurines was not associated with an increased risk.
Studies show that patients with IBD in general do not appear to be at greater risk of severe disease outcomes such as hospitalization or 30-day mortality. For example, a U.S. national database study of more than 40 million patients compared 232 patients with IBD who were diagnosed with COVID-19 with 19,776 non-IBD patients and found that, after propensity matching, there were no significant association between IBD and worse outcomes (risk ratio, 0.93; 95% confidence interval, 0.68-1.27; P = .86) or hospitalizations (RR, 1.10; 95% CI, 0.74-1.40; P = .91)).
However, some risk factors could be red flags. Data from the international SECURE-IBD registry showed an association between combined endpoint of ICU, requiring a ventilator, or death and advanced age (adjusted odds ratio, 1.04; 95% CI, 1.01-1.06; P < .01) and two or more comorbidities (aOR, 2.87; 95% CI, 1.05-7.85; P < .04). More specifically to IBD, severe COVID-19 was associated with use of corticosteroids (aOR, 6.87; 95% CI, 2.30-20.51; P < .001). In terms of other therapies, another study found a similar effect with thiopurines (compared with TNF monotherapy; aOR, 4.08; 95% CI, 1.65-9.78; Bonferroni adjusted P = .008), and combined use of anti-TNF drugs and a thiopurine (compared with TNF monotherapy; aOR, 4.01; 95% CI, 1.73-9.61; Bonferroni adjusted P = .013), but anti-TNF therapies alone trended toward a protective effect (compared with no anti-TNF therapy; aOR, 0.69; Bonferroni adjusted P = .52). That study found no significant association between severe outcomes and anti-IL 12/23 (compared with anti-TNF monotherapy; aOR, 0.98; 95% CI, 0.12-8.06; P = .98) or anti-integrin biologics (compared with anti-TNF monotherapy; aOR, 2.42; 95% CI, 0.59-9.96; P = .22).
Overall, the data are “generally consistent with prior data on infections and IBD: That steroids and combination therapy increase the risk of infection and bad outcomes and that interestingly biologic monotherapy may actually confer a little bit of protection against emergent outcomes and at a minimum appears to be neutral,” said Dr. Ungaro.
He noted that the recommendations from the IOIBD COVID-19 Task Force were based on expert opinion, but the new data have largely supported them overall. He did suggest some potential modifications, including reducing thiopurine use among patients on combination therapy. According to Dr. Ungaro, the recommendations do call for withholding all IBD therapy for 10 days after positive SARS-CoV-2 tests, whether the patient is symptomatic or not. “I think the recent data is reassuring that potentially in asymptomatic and maybe even mild cases, the monotherapy biologics – we can consider not delaying administering those. I think we need more data about that, but it’s reassuring that patients on those had no worse outcomes and [in fact did] slightly better,” Dr. Ungaro said during the presentation.
The data reinforced the need to consider tapering patients off corticosteroids or combination therapies, if possible. “It’s something we were doing in regular IBD care beforehand, but the COVID-19 pandemic offers another reason to limit the use of steroids and evaluate if patients are able to de-escalate from combination therapies,” said Dr. Ungaro.
On the other hand, there was concern among some patients early in the pandemic that their immunotherapy drugs may put them at risk of contracting COVID-19, which led some to discontinue medications. Ongoing studies are illustrating the problem with this, according to David T. Rubin, MD, professor of medicine at the University of Chicago and chair of the congress’s organizing committee. “The data do not in general suggest you should do that to protect yourself. In fact, being on the therapies may have a better outcome. Patients always want to come off their therapies, [but] during the pandemic that is a risk not worth taking. Getting sick from your Crohn’s disease or colitis, when there are limited health care resources and, in some places, limited hospital beds and where the rescue therapy might include steroids, is a risky proposition. It’s not the time to do this,” said Dr. Rubin.
With respect to vaccines, it appears so far that there is no increased risk of adverse events associated with IBD. Patients who are on immunosuppressive drugs may experience a lower response to immunization, which has been seen with other vaccines. “The benefits likely outweigh the risks based on our prior experience with other vaccinations. It’s an area of ongoing study, but I do think we should recommend that our IBD patients get the COVID-19 vaccine, especially if they have risk factors for severe disease,” said Dr. Ungaro.
Dr. Ungaro is on the advisory board for Bristol-Myers Squibb, Janssen, Pfizer, and Takeda. He has received funding from AbbVie, Boehringer Ingelheim, Eli Lilly, and Pfizer. He has been a speaker or received consulting fees from AbbVie and Eli Lilly. Dr. Rubin is a consultant for Janssen, Pfizer, Takeda, and AbbVie.
This article was updated Jan. 27, 2021.
Multicenter and population cohort studies suggest that patients with inflammatory bowel disease (IBD) are not at unique risk of contracting COVID-19 or experiencing worse outcomes, with the exception of a few risk factors such as corticosteroid use and combination therapy that appear tied to greater risk of hospitalization and mortality. The findings line up well with previous experience with infectious disease and are reassuring, but they also underscore the need to taper steroids and de-escalate from combination therapy, when possible.
“There is not a clear increased risk of getting COVID-19 among IBD patients compared to the general population, and that seems to hold even if you look at certain medication types, [even] if patients are on immunosuppressives like thiopurines or anti-TNF [anti–tumor necrosis factor] drugs,” Ryan C. Ungaro, MD, said in an interview. Dr. Ungaro, who is with the Icahn School of Medicine at Mount Sinai, New York, discussed IBD and COVID-19 risks at the annual congress of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
A systematic review showed that 0.3% of IBD patients contracted COVID-19 during study periods, compared with 0.2%-4.0% of the general population, and a matched-cohort analysis of a national Veterans Affairs database showed an infection prevalence of 0.23% among patients with IBD versus 0.20% among those without (P = .29). The analysis also showed use of anti-TNF therapies or thiopurines was not associated with an increased risk.
Studies show that patients with IBD in general do not appear to be at greater risk of severe disease outcomes such as hospitalization or 30-day mortality. For example, a U.S. national database study of more than 40 million patients compared 232 patients with IBD who were diagnosed with COVID-19 with 19,776 non-IBD patients and found that, after propensity matching, there were no significant association between IBD and worse outcomes (risk ratio, 0.93; 95% confidence interval, 0.68-1.27; P = .86) or hospitalizations (RR, 1.10; 95% CI, 0.74-1.40; P = .91)).
However, some risk factors could be red flags. Data from the international SECURE-IBD registry showed an association between combined endpoint of ICU, requiring a ventilator, or death and advanced age (adjusted odds ratio, 1.04; 95% CI, 1.01-1.06; P < .01) and two or more comorbidities (aOR, 2.87; 95% CI, 1.05-7.85; P < .04). More specifically to IBD, severe COVID-19 was associated with use of corticosteroids (aOR, 6.87; 95% CI, 2.30-20.51; P < .001). In terms of other therapies, another study found a similar effect with thiopurines (compared with TNF monotherapy; aOR, 4.08; 95% CI, 1.65-9.78; Bonferroni adjusted P = .008), and combined use of anti-TNF drugs and a thiopurine (compared with TNF monotherapy; aOR, 4.01; 95% CI, 1.73-9.61; Bonferroni adjusted P = .013), but anti-TNF therapies alone trended toward a protective effect (compared with no anti-TNF therapy; aOR, 0.69; Bonferroni adjusted P = .52). That study found no significant association between severe outcomes and anti-IL 12/23 (compared with anti-TNF monotherapy; aOR, 0.98; 95% CI, 0.12-8.06; P = .98) or anti-integrin biologics (compared with anti-TNF monotherapy; aOR, 2.42; 95% CI, 0.59-9.96; P = .22).
Overall, the data are “generally consistent with prior data on infections and IBD: That steroids and combination therapy increase the risk of infection and bad outcomes and that interestingly biologic monotherapy may actually confer a little bit of protection against emergent outcomes and at a minimum appears to be neutral,” said Dr. Ungaro.
He noted that the recommendations from the IOIBD COVID-19 Task Force were based on expert opinion, but the new data have largely supported them overall. He did suggest some potential modifications, including reducing thiopurine use among patients on combination therapy. According to Dr. Ungaro, the recommendations do call for withholding all IBD therapy for 10 days after positive SARS-CoV-2 tests, whether the patient is symptomatic or not. “I think the recent data is reassuring that potentially in asymptomatic and maybe even mild cases, the monotherapy biologics – we can consider not delaying administering those. I think we need more data about that, but it’s reassuring that patients on those had no worse outcomes and [in fact did] slightly better,” Dr. Ungaro said during the presentation.
The data reinforced the need to consider tapering patients off corticosteroids or combination therapies, if possible. “It’s something we were doing in regular IBD care beforehand, but the COVID-19 pandemic offers another reason to limit the use of steroids and evaluate if patients are able to de-escalate from combination therapies,” said Dr. Ungaro.
On the other hand, there was concern among some patients early in the pandemic that their immunotherapy drugs may put them at risk of contracting COVID-19, which led some to discontinue medications. Ongoing studies are illustrating the problem with this, according to David T. Rubin, MD, professor of medicine at the University of Chicago and chair of the congress’s organizing committee. “The data do not in general suggest you should do that to protect yourself. In fact, being on the therapies may have a better outcome. Patients always want to come off their therapies, [but] during the pandemic that is a risk not worth taking. Getting sick from your Crohn’s disease or colitis, when there are limited health care resources and, in some places, limited hospital beds and where the rescue therapy might include steroids, is a risky proposition. It’s not the time to do this,” said Dr. Rubin.
With respect to vaccines, it appears so far that there is no increased risk of adverse events associated with IBD. Patients who are on immunosuppressive drugs may experience a lower response to immunization, which has been seen with other vaccines. “The benefits likely outweigh the risks based on our prior experience with other vaccinations. It’s an area of ongoing study, but I do think we should recommend that our IBD patients get the COVID-19 vaccine, especially if they have risk factors for severe disease,” said Dr. Ungaro.
Dr. Ungaro is on the advisory board for Bristol-Myers Squibb, Janssen, Pfizer, and Takeda. He has received funding from AbbVie, Boehringer Ingelheim, Eli Lilly, and Pfizer. He has been a speaker or received consulting fees from AbbVie and Eli Lilly. Dr. Rubin is a consultant for Janssen, Pfizer, Takeda, and AbbVie.
This article was updated Jan. 27, 2021.
FROM THE CROHN’S & COLITIS CONGRESS
AGA Clinical Practice Update: Medical management of colonic diverticulitis
A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.
For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.
“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”
The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 109 cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.
The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).
Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.
The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.
Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.
This article was updated Feb. 10, 2021.
A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.
For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.
“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”
The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 109 cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.
The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).
Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.
The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.
Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.
This article was updated Feb. 10, 2021.
A new clinical practice update from the American Gastroenterological Association seeks to provide gastroenterologists with practical and evidence-based advice for management of colonic diverticulitis.
For example, clinicians should consider lower endoscopy and CT scans of the abdomen and pelvis with oral and intravenous contrast to rule out chronic diverticular inflammation, diverticular stricture or fistula, ischemic colitis, constipation, and inflammatory bowel disease, Anne F. Peery, MD, MSCR, of the University of North Carolina, Chapel Hill, and associates wrote in Gastroenterology.
“In our practice, patients are reassured to know that ongoing symptoms are common and often attributable to visceral hypersensitivity,” they wrote. “This conversation is particularly important after a negative workup. If needed, ongoing abdominal pain can be treated with a low to modest dose of a tricyclic antidepressant.”
The update from the AGA includes 13 other recommendations, with noteworthy advice to use antibiotics selectively, rather than routinely, in cases of acute uncomplicated diverticulitis in immunocompetent patients. In a recent large meta-analysis, antibiotics did not shorten symptom duration or reduce rates of hospitalization, complications, or surgery in this setting. The clinical practice update advises using antibiotics if patients are frail or have comorbidities, vomiting or refractory symptoms, a C-reactive protein level above 140 mg/L, a baseline white blood cell count above 15 × 109 cells/L, or fluid collection or a longer segment of inflammation on CT scan. Antibiotics also are strongly advised for immunocompromised patients, who are at greater risk for complications and severe diverticulitis. Because of this risk, clinicians should have “a low threshold” for cross-sectional imaging, antibiotic treatment, and consultation with a colorectal surgeon, according to the update.
The authors recommend CT if patients have severe symptoms or have not previously been diagnosed with diverticulitis based on imaging. Clinicians also should consider imaging if patients have had multiple recurrences, are not responding to treatment, are immunocompromised, or are considering prophylactic surgery (in which case imaging is used to pinpoint areas of disease).
Colonoscopy is advised after episodes of complicated diverticulitis or after a first episode of uncomplicated diverticulitis if no high-quality colonoscopy has been performed in the past year. This colonoscopy is advised to rule out malignancy, which can be misdiagnosed as diverticulitis, and because diverticulitis (particularly complicated diverticulitis) has been associated with colon cancer in some studies, the update notes. Unless patients have “alarm symptoms” – that is, a change in stool caliber, iron deficiency anemia, bloody stools, weight loss, or abdominal pain – colonoscopy should be delayed until 6-8 weeks after the diverticulitis episode or until the acute symptoms resolve, whichever occurs later.
The decision to discuss elective segmental resection should be based on disease severity, not the prior number of episodes. Although elective surgery for diverticulitis has become increasingly common, patients should be aware that surgery often does not improve chronic gastrointestinal symptoms, such as abdominal pain, and that surgery reduces but does not eliminate the risk for recurrence. The authors recommended against surgery to prevent complicated diverticulitis in immunocompetent patients with a history of uncomplicated episodes. “In this population, complicated diverticulitis is most often the first presentation of diverticulitis and is less likely with recurrences,” the update states. For acute complicated diverticulitis that has been effectively managed without surgery, patients are at heightened risk for recurrence, but “a growing literature suggest[s] a more conservative and personalized approach” rather than the routine use of interval elective resection, the authors noted. For all patients, counseling regarding surgery should incorporate thoughtful discussions of immune status, values and preferences, and operative risks versus benefits, including effects on quality of life.
Dr. Peery and another author were supported by grants from the National Institutes of Health. The authors reported having no conflicts of interest.
SOURCE: Peery AF et al. Gastroenterology. 2020 Dec 3. doi: 10.1053/j.gastro.2020.09.059.
This article was updated Feb. 10, 2021.
FROM GASTROENTEROLOGY
IBD patients more likely to stick with vedolizumab than anti-TNF drugs
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 6, 2021.
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 6, 2021.
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 6, 2021.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
COVID-19 vaccines: Safe for immunocompromised patients?
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
Histologic remission fails to be related to UC relapse
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
Relapse in ulcerative colitis patients with endoscopic remission was unaffected by histologic remission status, based on data from a retrospective study of 269 adults.
Data from previous studies suggest that histologic remission may be the strongest predictor of prognosis of disease course, wrote Neeraj Narula, MD, of McMaster University, Hamilton, Ont., and colleagues.
“However, it is unclear if UC patients who have achieved endoscopic healing have additional benefit in clinical outcomes if they have achieved histologic remission as well compared to those with ongoing histology activity,” they said.
In a study published in Alimentary Pharmacology and Therapeutics, the researchers identified 269 adults with ulcerative colitis who had endoscopic remission. Of these, 53 had normal histology, 138 had histologically inactive colitis, and 78 had histologically active colitis.
Overall, clinical relapse occurred in 64 patients, including 12 with normal histology (22.6%), 32 with inactive colitis (23.2%), and 29 with active colitis (25.6%).
No significant difference occurred in the time to relapse in patients with inactive vs. active colitis (adjusted hazard ratio 1.17, P = .67) or in patients with normal histology vs. inactive histology (AHR 0.67, P = .39). The median time to relapse was 2.92 years, 3.0 years, and 4.0 years in the normal, inactive, and active groups, respectively. Factors associated with a shorter time to relapse included older age at colonoscopy, use of 5-aminosalicylic acid, and disease extent in cases of pancolitis and left-sided colitis.
The study findings were limited by several factors including the possibility of bias in histologic scoring, lack of objective measures of disease activity, and the lack of uniformity is histologic assessment, the researchers noted. However, the results were strengthened by the large size compared with previous studies and by the adjustments for known confounding factors, they said.
“While clinical and endoscopic remission [is the target] of therapy for patients with UC, our study does not support targeting histologic remission in patients who have already achieved endoscopic remission,” they concluded.
More research may support clinical applications
“I was rather surprised by the findings, as a majority of studies have shown that histologic healing more accurately predicts clinical relapse than endoscopic remission in UC,” Atsushi Sakuraba, MD, of the University of Chicago, said in an interview.
“Although of a good sample size, this was a retrospective study, so no firm conclusion can be made,” said Dr. Sakuraba. “Using histologic healing as a therapeutic goal is still an evolving field, and it is too early to draw a conclusion as to whether (or not) to introduce histologic healing in clinical decision making,” he emphasized.
Going forward, prospective studies are needed that match for confounders such as postendoscopy medication use, age, and disease extent, Dr. Sakuraba said.
The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
SOURCE: Narula N et al. Aliment Pharmacol Ther. 2020 Nov 1. doi: 10.1111/apt.16147.
FROM ALIMENTARY PHARMACOLOGY AND THERAPEUTICS
Key clinical point: Histologic remission had no apparent impact on time to relapse in ulcerative colitis patients with endoscopic remission.
Major finding: The median times to relapse were 2.92 years, 3.0 years, and 4.0 years in patients with normal histology, inactive colitis, and active colitis, respectively.
Study details: The data come from a retrospective, observational study of 269 adults with ulcerative colitis with endoscopic remission.
Disclosures: The study received no outside funding. Lead author Dr. Narula disclosed honoraria from Janssen, AbbVie, Takeda, Pfizer, Merck, and Ferring. Dr. Sakuraba had no financial conflicts to disclose.
Source: Narula N et al. Aliment Pharmacol Ther. 2020 Oct 20. doi: 10.1111/apt.16147.
IBD patients more likely to stick with vedolizumab than anti-TNF drugs
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 5, 2021.
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 5, 2021.
Adults with inflammatory bowel disease were more likely to continue using vedolizumab, compared with anti–tumor necrosis factor (TNF) drugs over 3 years, based on data from a retrospective study of nearly 16,000 patients.
Patient persistence with prescribed therapy is essential to managing chronic inflammatory bowel disease (IBD), but data on the persistence of patients with treatments are limited, wrote Ulf Helwig, MD, of the Practice for Internal Medicine, Oldenburg, Germany, and colleagues. “With the advent of vedolizumab, physicians for the first time had the choice between biologicals with different modes of action,” they wrote.
In a study published in the Journal of Clinical Gastroenterology, the researchers used a national prescription database to identify 15,984 adults aged 18 years and older who were treatment-naive to biologics and received prescriptions between July 2014 and March 2017. Treatment persistence was defined as continuous treatment time of at least 90 days without prescription.
A total of 2,076 vedolizumab patients were matched with 2,076 adalimumab patients; 716 vedolizumab patients were matched with 716 golimumab patients; and 2,055 vedolizumab patients were matched with 2,055 infliximab patients.
Within 3 years after the first prescription, the overall persistence rates were 35.9% for vedolizumab, 27.8% for adalimumab, 20.7% for golimumab, and 29.8% for infliximab.
In matched-pair analysis, 35.2% of vedolizumab patients were persistent, compared with 28.9% of adalimumab patients over a 3-year period; the difference was statistically significant. In addition, 30.5% of vedolizumab patients persisted, compared with 25.4% of golimumab patients, also statistically significant. A matched-pair comparison between vedolizumab and infliximab (35.7% vs. 30.2%) was not statistically significant (P = 0.119).
In addition, vedolizumab patients were significantly less likely to discontinue therapy, compared with both adalimumab and golimumab patients, with hazard ratios of 0.86 and 0.60, respectively, in the matched pair analysis; discontinuation, compared with infliximab, was not statistically significant.
“Several reasons may account for significant rates of discontinuation reported for all biological treatments in IBD,” the researchers noted. “These comprise differences in health care systems in the concerned countries, including differences in availability of biologicals, access to reimbursed drugs, or different patient care settings,” they wrote.
The study findings were limited by several factors including the lack of data on specific IBD diagnoses, IBD severity, disease course, and dose escalation, they noted.
However, the study was strengthened by the large sample size and use of a real-world setting, they said.
“Further studies are needed to identify the reasons for persistence differences between vedolizumab and anti-TNF drugs,” they concluded.
Comparisons inform choices
“There are multiple biologic options for therapy of inflammatory bowel disease, and response to therapy tends to drop off over time in many patients for a variety of reasons including development of antibodies and escape from the mechanism of the action of the drug,” said Kim L. Isaacs, MD, of the University of North Carolina at Chapel Hill, in an interview.
“Intolerance or side effects of medication also may lead to discontinuation of therapy,” said Dr. Isaacs. “This trial looks at therapy discontinuation among four biologics used for inflammatory bowel disease over a 3-year period after initiation of therapy in patients who were previous biologically naive. Reasons for discontinuation cannot be assessed with this data set,” she noted. “There are very few comparative trials with the different biologic therapies in IBD. This trial is important because it compares the two distinct biologic mechanisms of action and continuation of therapy in biologically naive patients,” she said.
Dr. Isaacs said she was not surprised by the study findings. “Discontinuation of anti-TNF therapy was more common, compared to vedolizumab and golimumab. There was no statistical difference in terms of therapy discontinuation with infliximab,” she said. “In general, vedolizumab is felt to be less systemically immunosuppressant with targeting of white blood cell trafficking to the gut, whereas anti-TNF therapy is more systemically immunosuppressant and may be associated with more systemic side effects,” she explained.
The study design does not allow for comment on comparative efficacy, “although the findings are intriguing,” said Dr. Isaacs. “If the discontinuations were caused by lack of efficacy, the findings in this study may help in positioning biologic therapy in the biologic-naive patients,” she said.
The study is “a ‘real-world’ experiment that suggests there is a difference between different biologic therapies for inflammatory bowel disease,” said Dr. Isaacs. “More controlled comparative efficacy trials are needed that can look at reasons for drug discontinuation between different populations. To date, the VARSITY trial comparing vedolizumab to adalimumab in ulcerative colitis is the only published trial to do this,” she added.
The study received no outside funding. Lead author Dr. Helwig disclosed lecture and consulting fees from AbbVie, Amgen, Biogen, Celltrion, Hexal, MSD, Ferring, Falk Foundation, Takeda, Mundipharma, Pfizer, Hospira, and Vifor Pharma. Dr. Isaacs disclosed serving on the Data and Safety Monitoring Board (DSMB) for Janssen.
Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at www.gastro.org/IBD.
SOURCE: Helwig U et al. J Clin Gastroenterol. 2021 Jan. doi: 10.1097/MCG.0000000000001323
Story updated Jan. 5, 2021.
FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY
Partnering with dietitians can bridge gaps in IBD care
Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.
Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.
Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.
Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.
The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.
Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”
Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.
The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.
Dr. Ananthakrishnan said he would check vitamin B₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.
He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.
The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.
Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.
“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.
The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.
Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”
He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.
“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.
Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.
“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.
Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”
“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.
Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.
Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.
Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.
Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.
The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.
Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”
Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.
The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.
Dr. Ananthakrishnan said he would check vitamin B₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.
He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.
The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.
Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.
“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.
The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.
Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”
He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.
“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.
Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.
“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.
Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”
“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.
Working with a registered dietitian (RD) can help ensure that changing the way patients with inflammatory bowel disease (IBD) eat won’t deprive them of the nutrients they need.
Depending on the location and resources of a medical practice, calling in a dietitian may seem like a luxury. But making those connections can be more accessible during the COVID-19 pandemic as more dietitians are working virtually.
Kelly Issokson, MS, RD, clinical nutrition coordinator for IBD at Cedars Sinai Medical Center in Los Angeles, suggested two websites that allow users to search for RDs by ZIP code or by those working virtually: the International Foundation for Gastrointestinal Disorders and eatright.org, the website for the professional body for the dietetics community, which also has a searchable database.
Ashwin N. Ananthakrishnan, MD, MPH, director of the Crohn’s and colitis center at Massachusetts General Hospital in Boston, said it’s key for gastroenterologists to communicate what exactly they want the dietitian to address and not merely refer the patient.
The provider should know what therapies exist and then have the dietitian walk the patient through the plan, he said.
Mark Mattar, MD, with MedStar Georgetown University Hospital in Washington, said that, in addition to connecting patients with dietitians, “I always refer my patient to the Crohn’s and Colitis Foundation for the most recently updated patient education materials on nutrition.”
Panelists at the Advances in Inflammatory Bowel Diseases 2020 annual meeting on Wednesday weighed in on dietary considerations for two patient scenarios posed by Maria Abreu, MD, director of the Crohn’s & Colitis Center at the University of Miami.
The first scenario involved a 54-year-old man with long-standing fibrostenotic Crohn’s disease, recently hospitalized for obstruction and discharged with a prescription for prednisone 40 mg daily. The patient had been on infliximab (Remicade), and now is taking now adalimumab (Humira) weekly. He will undergo surgery to remove an ileal stricture. Dr. Abreu asked what dietary changes the panelists would make to ensure adequate nutrition prior to surgery and prevent another obstruction.
Dr. Ananthakrishnan said he would check vitamin B₁₂, vitamin D, iron, and albumin levels to see if any micronutrients need to be replaced.
He said that, although he thinks low-fiber diets are used too often as the default for Crohn’s and ulcerative colitis, in this case he would recommend low fiber and urge the patient to avoid raw fruits, vegetables, nuts, and seeds.
The patient can remove the skins and still have shakes and smoothies to get the benefits of fiber-containing foods without the fiber component, he said.
Discussing a pediatric version of that scenario, Andrew Grossman, MD, a pediatric gastroenterologist at the Children’s Hospital of Philadelphia, said he would turn to enteral nutrition therapy.
“We would strongly encourage using a formula to try to improve nutritional status, which we know can improve surgical outcomes,” he said.
The second case was a 15-year-old girl with growth stunting. She was diagnosed at age 10 with Crohn’s disease, currently has moderate disease, and continues to have five to seven liquid bowel movements daily, along with abdominal pain after meals. She is starting adalimumab induction.
Dr. Grossman said, “first, I would not be managing this alone. I would be managing this with a dietitian and working together to improve outcomes. We need to consider aggressive therapy, and to me that would include consideration of biological therapy but also possible dietary therapy – the Crohn’s Disease Exclusion Diet or enteral nutrition therapy as possibilities.”
He pointed out that in pediatrics there must be consideration both for what the parent wants the child to do and what the child is willing to do.
“My primary focus would be on improving caloric intake, working with the dietitian to avoid foods that bother the most,” he said.
Dr. Issokson said she would recommend either exclusive enteral nutrition or a specific carbohydrate diet (SCD) for the teen.
“We see [SCD] doesn’t impair growth in our patients as long as they are being followed by a dietitian, and we’re making sure they are getting adequate nutrient intake,” she said.
Dr. Abreu said in an interview that “diet is important in patients with IBD; it is a complement to the therapies that we use and a potential opportunity to solidify a long-lived remission.”
“Although studies of diet are only now being done,” she said, “we already have some good foundational ideas about diet and its role in reducing inflammation and reducing symptoms.” And she added that treating gastroenterologists should certainly avoid telling patients that “diet does not matter.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Ananthakrishnan, Dr. Grossman, and Dr. Issokson have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.
GI physicians urge COVID-19 vaccines for all IBD patients
Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.
Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”
“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”
The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”
David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”
Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.
Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.
And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
Updates from the IBD-COVID-19 registry
Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”
He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.
Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.
The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.
“My belief is that available data are actually more reassuring than alarming,” he said.
Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.
In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.
In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.
He also advises “a high alert for COVID-19 in patients with new GI symptoms.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.
Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.
Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”
“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”
The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”
David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”
Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.
Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.
And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
Updates from the IBD-COVID-19 registry
Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”
He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.
Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.
The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.
“My belief is that available data are actually more reassuring than alarming,” he said.
Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.
In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.
In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.
He also advises “a high alert for COVID-19 in patients with new GI symptoms.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.
Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.
Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.
Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”
“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”
The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”
David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”
Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.
Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.
And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
Updates from the IBD-COVID-19 registry
Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”
He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.
Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.
The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.
“My belief is that available data are actually more reassuring than alarming,” he said.
Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.
In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.
In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.
He also advises “a high alert for COVID-19 in patients with new GI symptoms.”
Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman have disclosed no relevant financial relationships.
For the latest clinical guidance, education, research and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.
A version of this article originally appeared on Medscape.com.