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Expert shares tips for positioning biologics in IBD patient treatment
LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.
“ and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”
For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.
According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”
A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”
Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”
In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.
He went on to discuss vedolizumab, a monoclonal antibody to alpha4beta7 integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”
Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.
In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.
Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.
Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”
Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”
Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.
*This story was updated on 3/26.
LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.
“ and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”
For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.
According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”
A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”
Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”
In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.
He went on to discuss vedolizumab, a monoclonal antibody to alpha4beta7 integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”
Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.
In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.
Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.
Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”
Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”
Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.
*This story was updated on 3/26.
LAS VEGAS – In the clinical opinion of Edward V. Loftus Jr., MD, biologics for inflammatory bowel disease (IBD) patients are best positioned based on age, personal medical history, and the presence of extraintestinal manifestations.
“ and is the way to go if you’re trying to change the trajectory of illness,” Dr. Loftus said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
In general, patients who are younger at diagnosis are going to have more severe disease than patients diagnosed older, said Dr. Loftus, professor of medicine at the Mayo Clinic, Rochester, Minn. “For CD [Crohn’s disease], the presence of fistulizing disease, especially internal fistulas, and to a lesser extent perianal fistulas, and then the presence of small-bowel disease or proximal GI disease, are all harbingers of more aggressive disease,” he said. “Multiple studies show that the time interval between diagnosis and development of intestinal complications is shorter in patients with small-bowel disease relative to colonic disease. When you add up those factors, you’re talking about 70% of CD patients, if not more. Most Crohn’s patients are going to be high-risk patients.”
For ulcerative colitis (UC), being male is a risk factor for hospitalization, surgery, and for developing colon cancer. On average, males are twice as likely as females to require surgery, and they’re twice as likely to develop colon cancer. Other predictors in UC for high-risk disease include early need for hospitalization, early need for corticosteroids, and extensive colitis at diagnosis. “You’re thinking about these things because how you’re going to treat these patients is going to differ,” he said.
According to Dr. Loftus, aminosalicylate (5-ASA) drugs are the frontline drugs of choice for low-risk UC patients with mild symptoms. “If they’re having moderate symptoms, you might initially start with a corticosteroid taper,” he noted. “That can be either prednisone or budesonide MMX. In a patient with really active symptoms, they’re going to go to IV steroids or maybe directly to anti-TNF [tumor necrosis factor] therapy.” For low-risk CD patients, consider budesonide taper then observation. “If they don’t flare again, maybe monitor that patient periodically,” he advised. “For high-risk patients, consider biologic therapy with or without thiopurine or methotrexate.”
A recent analysis of Medicare and Medicaid data from 2006 to 2013 found a significantly higher rate of mortality in IBD patients treated with prolonged corticosteroids than that seen in those treated with anti-TNF therapy (Am J Gastroenterol. Jan 16, 2018. doi: 10.1038/ajg2017.479). “That should give you pause,” Dr. Loftus said. “Don’t just put your patient on prednisone because you think it’s the easiest and safest thing to do. It’s not. It’s much more dangerous and has implications [for] the patient’s life expectancy.”
Some data are beginning to emerge about the use of biosimilars in IBD, mostly from Europe. Investigators of one randomized, controlled trial of biosimilar CT-P13 vs. originator infliximab in CD presented at the 2017 Digestive Disease Week meeting; they found in their trial that at week 6 all clinical endpoints were similar between the two agents. “If you’re forced to change your patient to this particular biosimilar, I wouldn’t be too worried about it,” Dr. Loftus said. “Of course, I’m not necessarily going to switch unless my institution or a particular third-party payer mandate it.”
In a published study funded by the Norwegian government, researchers conducted a prospective trial of switching from infliximab to CT-P13 in patients with a variety of conditions (Lancet. 2017;389:2304-16). Overall, the clinical failure rate was the same for both agents. Among CD patients, the researchers observed a nonsignificant trend toward disease worsening among those on the biosimilar, “but there was essentially no difference,” Dr. Loftus said.
He went on to discuss vedolizumab, a monoclonal antibody to alpha4beta7 integrin approved in 2014 for patients with moderate to severely active UC or CD. Phase 3 data from GEMINI I in moderate to severe UC found that relevant clinical endpoints were met by week 6 and they persisted at week 52 at both doses (N Engl J Med. 2013;369[8]:699-710). “For CD, the use of vedolizumab is a bit of a mixed picture,” Dr. Loftus said. “In GEMINI II, some of the primary endpoints were met at week 6, but at least one was missed (N Engl J Med. 2013;369[8]:711-21). The same thing was seen in GEMINI III. There’s a sense here that vedolizumab takes a little bit longer to work in CD.”
Integrated safety analyses of the GEMINI trials found no signal for increased rates of serious adverse events, and no cases of progressive multifocal leukoencephalopathy have been reported (J Crohns Colitis. 2017;11[2]:185-90). “The risk factors for serious infections were prior anti-TNF failure and opioid analgesic use in UC patients and younger age, steroid use, and opioid analgesic use in CD patients,” Dr. Loftus said.
In a trial of CD patients failing anti-TNF therapy, researchers observed a robust clinical response with ustekinumab, compared with placebo, at week 6 (N Engl J Med. 2016;375:1946-60). Even greater effects were observed in UNITI-2, a trial of ustekinumab in CD patients who hadn’t failed anti-TNFs.
Dr. Loftus cautioned that elderly and immunocompromised patients face an increased risk for infections when they’re placed on anti-TNF therapy. At the same time, researchers used a French database to determine the risk of lymphoma in IBD patients stratified by medication. For patients unexposed to such therapies, the risk of lymphoma was 1:4,000. For patients on thiopurine monotherapy, the risk was about 1:2,000; it was about 1:2,500 for those on anti-TNF monotherapy and about 1:1,000 for those on combination therapy (JAMA. 2017;318:1679-86). “One of the messages in this study is we can reassure our more risk-averse patients that the absolute risk of lymphoma is very low, even among patients on combination therapy,” he said.
Dr. Loftus called for head-to-head trials comparing the individual biologic agents and shared his recommendations on how to position currently available therapies. “I would say that for the average ‘bread and butter’ Crohn’s patient, anti-TNF therapy is the way to go,” he said. “For perianal fistulizing patients, I’m going to go with anti-TNF therapy, such as infliximab or adalimumab. For a patient with active extraintestinal manifestations, such as spondyloarthropathy, uveitis, and pyoderma, anti-TNF therapy is the way to go. However, with an elderly or immunosuppressed patient, consider vedolizumab or ustekinumab. For patients with a personal history of malignancy, an anti-TNF is very reasonable, but it may be easier to convince them to consider vedolizumab or ustekinumab.”
Recommendations for UC are largely similar, he continued. “However, I think we have enough data from GEMINI I and the integrated safety data with vedolizumab to say that, for the average ‘bread and butter’ UC patient, anti-TNF therapy or vedolizumab are appropriate. For a patient with extraintestinal manifestations I would avoid vedolizumab initially and try anti-TNF therapy. For patients with acute severe colitis, we have the bulk of evidence for efficacy resting with infliximab, so I would go with that. For the elderly or immunosuppressed patient, I would go with vedolizumab. For the person with a history of malignancy, an anti-TNF agent is reasonable, but consider vedolizumab.”
Dr. Loftus disclosed that he has consulted for AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Eli Lilly, Celltrion Healthcare, Napo Pharmaceuticals. He has also received research support from AbbVie, Takeda Pharmaceutical, Janssen Pharmaceutica, UCB, Pfizer, Amgen, Genentech, Seres Pharmaceuticals, MedImmune, Allergan, and Robarts Clinical Trials.
*This story was updated on 3/26.
EXPERT ANALYSIS FROM THE CROHN’S & COLITIS CONGRESS
Study spotlights body image dissatisfaction in pediatric IBD
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
LAS VEGAS – Among current steroid use, higher body mass index percentile, and comorbid mood disorder.
The findings come from a cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort, presented by Jennifer Claytor, MS, at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Ms. Claytor, a fourth-year medical student at the University of North Carolina at Chapel Hill, and her associates asked study participants aged 5-18 years to complete surveys on demographics, disease characteristics, and the IMPACT-35 questionnaire and Patient-Reported Outcomes Measurement Information System (PROMIS) tools for assessment of psychological patient-reported outcomes. The pediatric ulcerative colitis activity index and the short Crohn’s disease activity index were used to measure disease activity.
The researchers classified body image dissatisfaction as being present if the patients selected “I look awful” or “I look bad” from the list of possible responses to the question, “How do you feel about the way you look?” Next, they performed bivariate analyses to assess associations between body image dissatisfaction and demographic, disease-related, and psychosocial factors and created logistic regression models to evaluate independent associations between selected risk factors and body image dissatisfaction. “There has been some literature which suggests that for boys, weight and not body image dissatisfaction predicts worse psychosocial outcomes,” Ms. Claytor said. “But for girls it’s body image dissatisfaction, irrespective of weight.”
Of the 664 patients, 74 (3.3%) met criteria for body image dissatisfaction. Compared with patients who did not meet criteria for body image dissatisfaction, those who did were significantly more likely to be female (69% vs. 44%, respectively; P less than .001), older (mean age of 15 vs. 13 years; P less than .001), and diagnosed with IBD an older age (median of 12 vs. 10 years; P less than .001). Ms. Claytor and her associates also found that individuals with body image dissatisfaction had a higher median BMI percentile (P = .02), higher rates of active disease (57% vs. 26%; P less than .001), higher rates of current steroid use (18% vs. 8%; P = .004), and higher rates of depression and anxiety (P less than .001).
After adjusting for age, body mass index, remission, steroid use, and other factors, the odds for developing body image dissatisfaction was highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73), female gender (OR, 2.31), and current steroid use (OR, 1.59). “I think this points to the need for enhanced counseling services and being aware of these characteristics,” Ms. Claytor said. She reported having no financial disclosures.
SOURCE: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
*This story was updated on 3/26.
REPORTING FROM CROHN’S & COLITIS CONGRESS
Key clinical point: Interventions to target modifiable risk factors for body image dissatisfaction may improve quality of life in pediatric IBD patients.
Major finding: The odds for developing body image dissatisfaction were highest among those with anxiety (odds ratio, 5.42), followed by depression (OR, 4.73) and female gender (OR, 2.31).
Study details: A cross-sectional study of 664 patients enrolled in the Crohn’s & Colitis Foundation’s Partners Kids & Teens cohort.
Disclosures: Ms. Claytor reported having no financial disclosures.
Source: Claytor J et al. Crohn’s & Colitis Congress, Poster 15.
Many drugs in the pipeline for IBD treatment
LAS VEGAS – .
“The challenge for all of us is to integrate the right drugs for the right patients,” William J. Sandborn, MD, AGAF, said at the inaugural Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Sandborn, professor and chief of the division of gastroenterology at the University of California, San Diego, began his presentation by highlighting anti-integrin therapies for inflammatory bowel disease (IBD) treatment. These leukocyte membrane glycoproteins target beta1 and beta7 subunits. They interact with endothelial ligands VCAM-1, fibronectin, and MadCAM-1, and mediate leukocyte adhesion and trafficking. Approved anti-integrin therapies to date include natalizumab and vedolizumab, while investigational therapies include etrolizumab, PF-00547,659, abrilumab, and AJM 300.
In a phase 2 study of etrolizumab as induction therapy for moderate to severe UC, Séverine Vermeire, MD, Dr. Sandborn, and associates randomized 124 patients to one of two dose levels of subcutaneous etrolizumab (100 mg at weeks 0, 4, and 8, with placebo at week 2 or a 420-mg loading dose at week 0 followed by 300 mg at weeks 2, 4, and 8), or matching placebo (The Lancet 2014 348;309-18). They found that etrolizumab was more likely to lead to clinical remission at week 10 than was placebo, especially at the 100-mg dose. Meanwhile, a more recent study of the anti-MAdCAM antibody PF-00547659 in patients with moderate to severe ulcerative colitis found that it was better than placebo for induction of remission (The Lancet 2017;390:135-144). Investigators for the trial, known as TURANDOT, found that the greatest clinical effects were observed with the 22.5-mg and 75-mg doses. “This is now being taken forward in phase 3 trials by Shire,” Dr. Sandborn said.
The anti-interleukin 12/23 antibody (p40) ustekinumab is being investigated for efficacy in UC, while anti-interleukin 23 (p19) antibodies being studied include brazikumab (MEDI2070), risankizumab (BI 6555066), geslekumab, mirikizumab (LY3074828), and tildrakizumab (MK 3222). In 2015, Janssen launched NCT02407236, with the aim of evaluating the effectiveness and safety of continuing ustekinumab as a subcutaneous (injection) maintenance therapy in patients with moderately to severely active UC who have demonstrated a clinical response to an induction treatment with intravenous ustekinumab. The estimated primary completion date is April 12, 2018. Meanwhile, a phase 2a trial of 119 patients with moderate to severe Crohn’s disease who had failed treatment with tumor necrosis factor (TNF) antagonists showed that treatment with MEDI2070 was associated with clinical improvement after 8 and 24 weeks of therapy (Gastroenterol 2017;153:77-86). The investigators also found that patients with baseline serum IL-22 concentrations above the median threshold concentration of 15.6 pg/mL treated with MEDI2070 had higher rates of clinical response and remission, compared with those with baseline concentrations below this threshold. According to Dr. Sandborn, who was not involved in the study, these results provide support for further research on the value of IL-22 serum concentrations to predict response to MEDI2070. “It’s a small study and is hypothesis generating,” he said. “This will need to be confirmed in subsequent trials.”
In a short-term study of 121 patients with active Crohn’s disease, Brian G. Feagan, MD, Dr. Sandborn, and associates found that risankizumab was more effective than placebo for inducing clinical remission, particularly at the 600-mg dose, compared with the 200-mg dose (Lancet 2017;389:1699-709). The researchers also observed significant differences in endoscopic remission among patients on the study drug, compared with those on placebo (17% vs. 3%; P = .0015) as well as endoscopic response (32% vs. 13%; P = .0104). The trial provides further evidence that selective blockade of interleukin 23 via inhibition of p19 might be a viable therapeutic approach in Crohn’s disease.
Janus kinase (JAK) inhibitors under investigation for Crohn’s disease include tofacitinib, filgotinib, upadacitinib, baricitinib, and TD-1473. In the OCTAVE Induction 1 trial led by Dr. Sandborn, 18.5% of the patients in the tofacitinib group achieved remission at 8 weeks, compared with 8.2% in the placebo group (P = .007); in the OCTAVE Induction 2 trial, remission occurred in 16.6% vs. 3.6% (P less than .001). In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5-mg tofacitinib group and 40.6% in the 10-mg tofacitinib group vs. 11.1% in the placebo group (P less than 0.001 for both comparisons with placebo; N Engl J Med. 2017;376:1723-36). “In subgroup analyses, it looks like the 10-mg dose is more effective for maintenance in patients who previously received anti-TNF therapy,” said Dr. Sandborn, who also directs the UCSD IBD Center. “All secondary outcomes were positive. You don’t see that very often. It tells you that this is a really effective therapy. It’s currently being reviewed by the FDA.”
Meanwhile, a phase 2 trial found that a higher percentage of patients with mild to moderate Crohn’s disease who received a 200-mg dose of filgotinib over 10 weeks achieved clinical remission, compared with those who received placebo (47% vs. 23%, respectively; P = .0077; The Lancet 2017;389:266-75). Serious treatment-emergent adverse effects occurred in 9% of the 152 patients treated with filgotinib and 3 of the 67 patients treated with placebo. According to Dr. Sandborn, filgotinib is currently in phase 3 development trials for both Crohn’s Disease and UC. At the same time, results from an unpublished study presented at the annual Digestive Disease Week in 2017 found that 16 weeks of treatment with the investigational agent upadacitinib led to modified clinical remission in 37% of patients on the 24-mg bid dose, compared with 30% of patients in the 6-mg bid dose. There was also a dose response for endoscopic response. “Based on these data, this drug is now in a phase 3 trial, so lots of JAK inhibitors are coming along,” he said.
Sphingosine-1–phosphate receptor 1 (S1P1) modulators currently under investigation include fingolimod (not studied in IBD), ozanimod, and etrasimod. “These modulators cause the S1P1 receptors that are expressed on the surface of positive lymphocytes to be eluded back into the cell, which leads to a reversible reduction in circulating lymphocytes in the blood,” Dr. Sandborn explained. In a phase 2 trial, he and his associates found that UC patients who received ozanimod at a daily dose of 1 mg had a slightly higher rate of clinical remission, compared with those who received placebo, but the study was not sufficiently powered to establish clinical efficacy or assess safety (N Engl J. Med 2016;374:1754-62).
Dr. Sandborn reported having consulting relationships with Takeda, Genentech, Pfizer, Shire, Amgen, and many other pharmaceutical companies.
LAS VEGAS – .
“The challenge for all of us is to integrate the right drugs for the right patients,” William J. Sandborn, MD, AGAF, said at the inaugural Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Sandborn, professor and chief of the division of gastroenterology at the University of California, San Diego, began his presentation by highlighting anti-integrin therapies for inflammatory bowel disease (IBD) treatment. These leukocyte membrane glycoproteins target beta1 and beta7 subunits. They interact with endothelial ligands VCAM-1, fibronectin, and MadCAM-1, and mediate leukocyte adhesion and trafficking. Approved anti-integrin therapies to date include natalizumab and vedolizumab, while investigational therapies include etrolizumab, PF-00547,659, abrilumab, and AJM 300.
In a phase 2 study of etrolizumab as induction therapy for moderate to severe UC, Séverine Vermeire, MD, Dr. Sandborn, and associates randomized 124 patients to one of two dose levels of subcutaneous etrolizumab (100 mg at weeks 0, 4, and 8, with placebo at week 2 or a 420-mg loading dose at week 0 followed by 300 mg at weeks 2, 4, and 8), or matching placebo (The Lancet 2014 348;309-18). They found that etrolizumab was more likely to lead to clinical remission at week 10 than was placebo, especially at the 100-mg dose. Meanwhile, a more recent study of the anti-MAdCAM antibody PF-00547659 in patients with moderate to severe ulcerative colitis found that it was better than placebo for induction of remission (The Lancet 2017;390:135-144). Investigators for the trial, known as TURANDOT, found that the greatest clinical effects were observed with the 22.5-mg and 75-mg doses. “This is now being taken forward in phase 3 trials by Shire,” Dr. Sandborn said.
The anti-interleukin 12/23 antibody (p40) ustekinumab is being investigated for efficacy in UC, while anti-interleukin 23 (p19) antibodies being studied include brazikumab (MEDI2070), risankizumab (BI 6555066), geslekumab, mirikizumab (LY3074828), and tildrakizumab (MK 3222). In 2015, Janssen launched NCT02407236, with the aim of evaluating the effectiveness and safety of continuing ustekinumab as a subcutaneous (injection) maintenance therapy in patients with moderately to severely active UC who have demonstrated a clinical response to an induction treatment with intravenous ustekinumab. The estimated primary completion date is April 12, 2018. Meanwhile, a phase 2a trial of 119 patients with moderate to severe Crohn’s disease who had failed treatment with tumor necrosis factor (TNF) antagonists showed that treatment with MEDI2070 was associated with clinical improvement after 8 and 24 weeks of therapy (Gastroenterol 2017;153:77-86). The investigators also found that patients with baseline serum IL-22 concentrations above the median threshold concentration of 15.6 pg/mL treated with MEDI2070 had higher rates of clinical response and remission, compared with those with baseline concentrations below this threshold. According to Dr. Sandborn, who was not involved in the study, these results provide support for further research on the value of IL-22 serum concentrations to predict response to MEDI2070. “It’s a small study and is hypothesis generating,” he said. “This will need to be confirmed in subsequent trials.”
In a short-term study of 121 patients with active Crohn’s disease, Brian G. Feagan, MD, Dr. Sandborn, and associates found that risankizumab was more effective than placebo for inducing clinical remission, particularly at the 600-mg dose, compared with the 200-mg dose (Lancet 2017;389:1699-709). The researchers also observed significant differences in endoscopic remission among patients on the study drug, compared with those on placebo (17% vs. 3%; P = .0015) as well as endoscopic response (32% vs. 13%; P = .0104). The trial provides further evidence that selective blockade of interleukin 23 via inhibition of p19 might be a viable therapeutic approach in Crohn’s disease.
Janus kinase (JAK) inhibitors under investigation for Crohn’s disease include tofacitinib, filgotinib, upadacitinib, baricitinib, and TD-1473. In the OCTAVE Induction 1 trial led by Dr. Sandborn, 18.5% of the patients in the tofacitinib group achieved remission at 8 weeks, compared with 8.2% in the placebo group (P = .007); in the OCTAVE Induction 2 trial, remission occurred in 16.6% vs. 3.6% (P less than .001). In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5-mg tofacitinib group and 40.6% in the 10-mg tofacitinib group vs. 11.1% in the placebo group (P less than 0.001 for both comparisons with placebo; N Engl J Med. 2017;376:1723-36). “In subgroup analyses, it looks like the 10-mg dose is more effective for maintenance in patients who previously received anti-TNF therapy,” said Dr. Sandborn, who also directs the UCSD IBD Center. “All secondary outcomes were positive. You don’t see that very often. It tells you that this is a really effective therapy. It’s currently being reviewed by the FDA.”
Meanwhile, a phase 2 trial found that a higher percentage of patients with mild to moderate Crohn’s disease who received a 200-mg dose of filgotinib over 10 weeks achieved clinical remission, compared with those who received placebo (47% vs. 23%, respectively; P = .0077; The Lancet 2017;389:266-75). Serious treatment-emergent adverse effects occurred in 9% of the 152 patients treated with filgotinib and 3 of the 67 patients treated with placebo. According to Dr. Sandborn, filgotinib is currently in phase 3 development trials for both Crohn’s Disease and UC. At the same time, results from an unpublished study presented at the annual Digestive Disease Week in 2017 found that 16 weeks of treatment with the investigational agent upadacitinib led to modified clinical remission in 37% of patients on the 24-mg bid dose, compared with 30% of patients in the 6-mg bid dose. There was also a dose response for endoscopic response. “Based on these data, this drug is now in a phase 3 trial, so lots of JAK inhibitors are coming along,” he said.
Sphingosine-1–phosphate receptor 1 (S1P1) modulators currently under investigation include fingolimod (not studied in IBD), ozanimod, and etrasimod. “These modulators cause the S1P1 receptors that are expressed on the surface of positive lymphocytes to be eluded back into the cell, which leads to a reversible reduction in circulating lymphocytes in the blood,” Dr. Sandborn explained. In a phase 2 trial, he and his associates found that UC patients who received ozanimod at a daily dose of 1 mg had a slightly higher rate of clinical remission, compared with those who received placebo, but the study was not sufficiently powered to establish clinical efficacy or assess safety (N Engl J. Med 2016;374:1754-62).
Dr. Sandborn reported having consulting relationships with Takeda, Genentech, Pfizer, Shire, Amgen, and many other pharmaceutical companies.
LAS VEGAS – .
“The challenge for all of us is to integrate the right drugs for the right patients,” William J. Sandborn, MD, AGAF, said at the inaugural Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association.
Dr. Sandborn, professor and chief of the division of gastroenterology at the University of California, San Diego, began his presentation by highlighting anti-integrin therapies for inflammatory bowel disease (IBD) treatment. These leukocyte membrane glycoproteins target beta1 and beta7 subunits. They interact with endothelial ligands VCAM-1, fibronectin, and MadCAM-1, and mediate leukocyte adhesion and trafficking. Approved anti-integrin therapies to date include natalizumab and vedolizumab, while investigational therapies include etrolizumab, PF-00547,659, abrilumab, and AJM 300.
In a phase 2 study of etrolizumab as induction therapy for moderate to severe UC, Séverine Vermeire, MD, Dr. Sandborn, and associates randomized 124 patients to one of two dose levels of subcutaneous etrolizumab (100 mg at weeks 0, 4, and 8, with placebo at week 2 or a 420-mg loading dose at week 0 followed by 300 mg at weeks 2, 4, and 8), or matching placebo (The Lancet 2014 348;309-18). They found that etrolizumab was more likely to lead to clinical remission at week 10 than was placebo, especially at the 100-mg dose. Meanwhile, a more recent study of the anti-MAdCAM antibody PF-00547659 in patients with moderate to severe ulcerative colitis found that it was better than placebo for induction of remission (The Lancet 2017;390:135-144). Investigators for the trial, known as TURANDOT, found that the greatest clinical effects were observed with the 22.5-mg and 75-mg doses. “This is now being taken forward in phase 3 trials by Shire,” Dr. Sandborn said.
The anti-interleukin 12/23 antibody (p40) ustekinumab is being investigated for efficacy in UC, while anti-interleukin 23 (p19) antibodies being studied include brazikumab (MEDI2070), risankizumab (BI 6555066), geslekumab, mirikizumab (LY3074828), and tildrakizumab (MK 3222). In 2015, Janssen launched NCT02407236, with the aim of evaluating the effectiveness and safety of continuing ustekinumab as a subcutaneous (injection) maintenance therapy in patients with moderately to severely active UC who have demonstrated a clinical response to an induction treatment with intravenous ustekinumab. The estimated primary completion date is April 12, 2018. Meanwhile, a phase 2a trial of 119 patients with moderate to severe Crohn’s disease who had failed treatment with tumor necrosis factor (TNF) antagonists showed that treatment with MEDI2070 was associated with clinical improvement after 8 and 24 weeks of therapy (Gastroenterol 2017;153:77-86). The investigators also found that patients with baseline serum IL-22 concentrations above the median threshold concentration of 15.6 pg/mL treated with MEDI2070 had higher rates of clinical response and remission, compared with those with baseline concentrations below this threshold. According to Dr. Sandborn, who was not involved in the study, these results provide support for further research on the value of IL-22 serum concentrations to predict response to MEDI2070. “It’s a small study and is hypothesis generating,” he said. “This will need to be confirmed in subsequent trials.”
In a short-term study of 121 patients with active Crohn’s disease, Brian G. Feagan, MD, Dr. Sandborn, and associates found that risankizumab was more effective than placebo for inducing clinical remission, particularly at the 600-mg dose, compared with the 200-mg dose (Lancet 2017;389:1699-709). The researchers also observed significant differences in endoscopic remission among patients on the study drug, compared with those on placebo (17% vs. 3%; P = .0015) as well as endoscopic response (32% vs. 13%; P = .0104). The trial provides further evidence that selective blockade of interleukin 23 via inhibition of p19 might be a viable therapeutic approach in Crohn’s disease.
Janus kinase (JAK) inhibitors under investigation for Crohn’s disease include tofacitinib, filgotinib, upadacitinib, baricitinib, and TD-1473. In the OCTAVE Induction 1 trial led by Dr. Sandborn, 18.5% of the patients in the tofacitinib group achieved remission at 8 weeks, compared with 8.2% in the placebo group (P = .007); in the OCTAVE Induction 2 trial, remission occurred in 16.6% vs. 3.6% (P less than .001). In the OCTAVE Sustain trial, remission at 52 weeks occurred in 34.3% of the patients in the 5-mg tofacitinib group and 40.6% in the 10-mg tofacitinib group vs. 11.1% in the placebo group (P less than 0.001 for both comparisons with placebo; N Engl J Med. 2017;376:1723-36). “In subgroup analyses, it looks like the 10-mg dose is more effective for maintenance in patients who previously received anti-TNF therapy,” said Dr. Sandborn, who also directs the UCSD IBD Center. “All secondary outcomes were positive. You don’t see that very often. It tells you that this is a really effective therapy. It’s currently being reviewed by the FDA.”
Meanwhile, a phase 2 trial found that a higher percentage of patients with mild to moderate Crohn’s disease who received a 200-mg dose of filgotinib over 10 weeks achieved clinical remission, compared with those who received placebo (47% vs. 23%, respectively; P = .0077; The Lancet 2017;389:266-75). Serious treatment-emergent adverse effects occurred in 9% of the 152 patients treated with filgotinib and 3 of the 67 patients treated with placebo. According to Dr. Sandborn, filgotinib is currently in phase 3 development trials for both Crohn’s Disease and UC. At the same time, results from an unpublished study presented at the annual Digestive Disease Week in 2017 found that 16 weeks of treatment with the investigational agent upadacitinib led to modified clinical remission in 37% of patients on the 24-mg bid dose, compared with 30% of patients in the 6-mg bid dose. There was also a dose response for endoscopic response. “Based on these data, this drug is now in a phase 3 trial, so lots of JAK inhibitors are coming along,” he said.
Sphingosine-1–phosphate receptor 1 (S1P1) modulators currently under investigation include fingolimod (not studied in IBD), ozanimod, and etrasimod. “These modulators cause the S1P1 receptors that are expressed on the surface of positive lymphocytes to be eluded back into the cell, which leads to a reversible reduction in circulating lymphocytes in the blood,” Dr. Sandborn explained. In a phase 2 trial, he and his associates found that UC patients who received ozanimod at a daily dose of 1 mg had a slightly higher rate of clinical remission, compared with those who received placebo, but the study was not sufficiently powered to establish clinical efficacy or assess safety (N Engl J. Med 2016;374:1754-62).
Dr. Sandborn reported having consulting relationships with Takeda, Genentech, Pfizer, Shire, Amgen, and many other pharmaceutical companies.
EXPERT ANALYSIS FROM THE CROHN’S & COLITIS CONGRESS
‘Smoker’s paradox’ found in study of IBD patients
Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, , a so-called “smoker’s paradox.”
“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).
Between 2002 and 2014, a higher proportion of CD patients than UC patients were smokers (25.1% vs. 17.2%; P less than .001), while CD patients who smoked were more likely to be younger than age 50 years, compared with UC patients who smoked (53.9% vs. 36.9%; P less than .001). The researchers also found that African Americans with CD were more likely than were those with UC to smoke (10% vs. 7.8%, respectively; P less than .001). On the other hand, both Hispanics and Asians with UC were more likely to be smokers than were their counterparts with CD (5% vs. 2.9% and 3.4% vs. 2.5%, respectively). From a geographical standpoint, UC patients in the Northeast and Western United States were more likely to be smokers, compared with CD patients in those regions (20.7% vs. 18.3% and 21.4% vs. 15%, respectively). Meanwhile, CD patients in the Midwest and South were more likely to be smokers, compared with UC patients in those regions (29.3% vs 26% and 37.2% vs. 31.9%, respectively).
Dr. Khan and his associates also found that a higher proportion of female CD patients were smokers, compared with female UC patients (57% vs. 47.3%; P less than .001), and that mortality among UC and CD patients with no smoking history was higher than that of their counterparts who had a smoking history (2.5% vs. 1.2% and 1.2% vs. 0.7%, respectively; P less than .001 for both associations).
“I would certainly not encourage IBD patients to smoke, but maybe we need to so some more prospective studies to better understand this smoker’s paradox,” Dr. Khan said. He reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.
Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, , a so-called “smoker’s paradox.”
“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).
Between 2002 and 2014, a higher proportion of CD patients than UC patients were smokers (25.1% vs. 17.2%; P less than .001), while CD patients who smoked were more likely to be younger than age 50 years, compared with UC patients who smoked (53.9% vs. 36.9%; P less than .001). The researchers also found that African Americans with CD were more likely than were those with UC to smoke (10% vs. 7.8%, respectively; P less than .001). On the other hand, both Hispanics and Asians with UC were more likely to be smokers than were their counterparts with CD (5% vs. 2.9% and 3.4% vs. 2.5%, respectively). From a geographical standpoint, UC patients in the Northeast and Western United States were more likely to be smokers, compared with CD patients in those regions (20.7% vs. 18.3% and 21.4% vs. 15%, respectively). Meanwhile, CD patients in the Midwest and South were more likely to be smokers, compared with UC patients in those regions (29.3% vs 26% and 37.2% vs. 31.9%, respectively).
Dr. Khan and his associates also found that a higher proportion of female CD patients were smokers, compared with female UC patients (57% vs. 47.3%; P less than .001), and that mortality among UC and CD patients with no smoking history was higher than that of their counterparts who had a smoking history (2.5% vs. 1.2% and 1.2% vs. 0.7%, respectively; P less than .001 for both associations).
“I would certainly not encourage IBD patients to smoke, but maybe we need to so some more prospective studies to better understand this smoker’s paradox,” Dr. Khan said. He reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.
Las Vegas – Smoking is more prevalent in Crohn’s disease (CD) patients than in patients with ulcerative colitis (UC), results from a retrospective analysis of national data showed. In addition, , a so-called “smoker’s paradox.”
“This paradox seems to be real, because we know that it has been shown in some heart diseases, that the patients who were smokers had better outcomes,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. In fact, a recent analysis of a nationwide cohort of patients who underwent primary percutaneous coronary intervention for ST-segment elevation myocardial infarction found that smokers had significantly lower risk‐adjusted in‐hospital mortality, compared with nonsmokers (J Am Heart Assoc. 2016 Apr 22;5:e003370. doi: 10.1161/JAHA.116.003370).
Between 2002 and 2014, a higher proportion of CD patients than UC patients were smokers (25.1% vs. 17.2%; P less than .001), while CD patients who smoked were more likely to be younger than age 50 years, compared with UC patients who smoked (53.9% vs. 36.9%; P less than .001). The researchers also found that African Americans with CD were more likely than were those with UC to smoke (10% vs. 7.8%, respectively; P less than .001). On the other hand, both Hispanics and Asians with UC were more likely to be smokers than were their counterparts with CD (5% vs. 2.9% and 3.4% vs. 2.5%, respectively). From a geographical standpoint, UC patients in the Northeast and Western United States were more likely to be smokers, compared with CD patients in those regions (20.7% vs. 18.3% and 21.4% vs. 15%, respectively). Meanwhile, CD patients in the Midwest and South were more likely to be smokers, compared with UC patients in those regions (29.3% vs 26% and 37.2% vs. 31.9%, respectively).
Dr. Khan and his associates also found that a higher proportion of female CD patients were smokers, compared with female UC patients (57% vs. 47.3%; P less than .001), and that mortality among UC and CD patients with no smoking history was higher than that of their counterparts who had a smoking history (2.5% vs. 1.2% and 1.2% vs. 0.7%, respectively; P less than .001 for both associations).
“I would certainly not encourage IBD patients to smoke, but maybe we need to so some more prospective studies to better understand this smoker’s paradox,” Dr. Khan said. He reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan et al. Crohn’s & Colitis Congress, Poster 213.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: In IBD patients, smoker status was paradoxically associated with mortality and other outcomes.
Major finding: Mortality among UC and CD patients with no smoking history was higher than that of their counterparts who had a smoking history (2.5% vs. 1.2% and 1.2% vs. 0.7%, respectively; P less than .001 for both associations).
Study details: An analysis of 22,620 patients with a primary or secondary discharge diagnosis of IBD during 2002-2014.
Disclosures: Dr. Khan reported having no financial disclosures.
Source: Khan et al. Crohn’s & Colitis Congress, Poster 213.
Higher BMI linked to problems for IBD patients
LAS VEGAS – Higher body mass index among inflammatory bowel disease patients is independently associated with an increased risk of treatment failure and IBD-related surgery or hospitalization, a single-center, retrospective cohort study demonstrated.
“The problem of IBD and obesity is on the rise,” Soumya Kurnool said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Today, 15%-40% of IBD patients are obese. This is significant because there is a decreased prevalence of remission and an increased risk of relapse in obese IBD patients. These patients also have a higher annual burden of hospitalization.”
She and her associates set out to evaluate the effect of obesity on response to biologic therapy in patients with ulcerative colitis (UC). They conducted a single-center, retrospective cohort study of biologic-treated adults with UC who started therapy during 2011-2016. The researchers excluded patients who had undergone a prior colectomy, as well as those who were underweight at the time of starting a biologic agent and those who had fewer than 6 months of follow-up data.
The primary outcome was time to treatment failure, defined as a composite of IBD-related surgery, hospitalization, and/or treatment modification. Secondary outcomes were time to IBD-related surgery and/or hospitalization and whether the patient achieved endoscopic remission within 1 year of starting biologic therapy. They conducted multivariate Cox proportional hazard analyses after adjusting for key confounders.
Ms. Kurnool reported results from 160 patients with a median age of 36 years. Half were male, and the mean follow-up was 24 months. The median BMI of the cohort was 24.3 kg/m2; 26% were overweight and 18% were obese. More than half of patients (55%) were on infliximab with weight-based dosing and 45% were on other fixed-dosing regimens, including 19% on vedolizumab. In terms of outcomes, 68% of patients experienced treatment failure. All who failed treatment underwent treatment modifications; 15% had IBD-related surgery, and 19% had IBD-related hospitalization.
After adjusting for age, sex, disease duration, prior hospitalization, prior anti-TNF therapy, steroid use, and albumin level, Ms. Kurnool and her associates found that every 1-kg/m2 increase in BMI was associated with a 4% higher risk of treatment failure (adjusted hazard ratio, 1.04), an 8% higher risk of surgery or hospitalization (adjusted HR, 1.08), and a 6% lower risk of achieving endoscopic remission (adjusted HR, 0.94).
“This increase in the risk of treatment failure and IBD-related surgery or hospitalization was consistent across strata of patients treated with infliximab and fixed-dosing regimens,” she said. “Based on these findings, physicians should consider proactive monitoring in obese patients treated with biologic agents.”
Ms. Kurnool reported having received a National Institutes of Health Short Term Training Grant from the University of California, San Diego.
*This story was updated on 3/26.
SOURCE: Kurnool S et al. Crohn’s & Colitis Congress, Clinical Abstract 24.
LAS VEGAS – Higher body mass index among inflammatory bowel disease patients is independently associated with an increased risk of treatment failure and IBD-related surgery or hospitalization, a single-center, retrospective cohort study demonstrated.
“The problem of IBD and obesity is on the rise,” Soumya Kurnool said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Today, 15%-40% of IBD patients are obese. This is significant because there is a decreased prevalence of remission and an increased risk of relapse in obese IBD patients. These patients also have a higher annual burden of hospitalization.”
She and her associates set out to evaluate the effect of obesity on response to biologic therapy in patients with ulcerative colitis (UC). They conducted a single-center, retrospective cohort study of biologic-treated adults with UC who started therapy during 2011-2016. The researchers excluded patients who had undergone a prior colectomy, as well as those who were underweight at the time of starting a biologic agent and those who had fewer than 6 months of follow-up data.
The primary outcome was time to treatment failure, defined as a composite of IBD-related surgery, hospitalization, and/or treatment modification. Secondary outcomes were time to IBD-related surgery and/or hospitalization and whether the patient achieved endoscopic remission within 1 year of starting biologic therapy. They conducted multivariate Cox proportional hazard analyses after adjusting for key confounders.
Ms. Kurnool reported results from 160 patients with a median age of 36 years. Half were male, and the mean follow-up was 24 months. The median BMI of the cohort was 24.3 kg/m2; 26% were overweight and 18% were obese. More than half of patients (55%) were on infliximab with weight-based dosing and 45% were on other fixed-dosing regimens, including 19% on vedolizumab. In terms of outcomes, 68% of patients experienced treatment failure. All who failed treatment underwent treatment modifications; 15% had IBD-related surgery, and 19% had IBD-related hospitalization.
After adjusting for age, sex, disease duration, prior hospitalization, prior anti-TNF therapy, steroid use, and albumin level, Ms. Kurnool and her associates found that every 1-kg/m2 increase in BMI was associated with a 4% higher risk of treatment failure (adjusted hazard ratio, 1.04), an 8% higher risk of surgery or hospitalization (adjusted HR, 1.08), and a 6% lower risk of achieving endoscopic remission (adjusted HR, 0.94).
“This increase in the risk of treatment failure and IBD-related surgery or hospitalization was consistent across strata of patients treated with infliximab and fixed-dosing regimens,” she said. “Based on these findings, physicians should consider proactive monitoring in obese patients treated with biologic agents.”
Ms. Kurnool reported having received a National Institutes of Health Short Term Training Grant from the University of California, San Diego.
*This story was updated on 3/26.
SOURCE: Kurnool S et al. Crohn’s & Colitis Congress, Clinical Abstract 24.
LAS VEGAS – Higher body mass index among inflammatory bowel disease patients is independently associated with an increased risk of treatment failure and IBD-related surgery or hospitalization, a single-center, retrospective cohort study demonstrated.
“The problem of IBD and obesity is on the rise,” Soumya Kurnool said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Today, 15%-40% of IBD patients are obese. This is significant because there is a decreased prevalence of remission and an increased risk of relapse in obese IBD patients. These patients also have a higher annual burden of hospitalization.”
She and her associates set out to evaluate the effect of obesity on response to biologic therapy in patients with ulcerative colitis (UC). They conducted a single-center, retrospective cohort study of biologic-treated adults with UC who started therapy during 2011-2016. The researchers excluded patients who had undergone a prior colectomy, as well as those who were underweight at the time of starting a biologic agent and those who had fewer than 6 months of follow-up data.
The primary outcome was time to treatment failure, defined as a composite of IBD-related surgery, hospitalization, and/or treatment modification. Secondary outcomes were time to IBD-related surgery and/or hospitalization and whether the patient achieved endoscopic remission within 1 year of starting biologic therapy. They conducted multivariate Cox proportional hazard analyses after adjusting for key confounders.
Ms. Kurnool reported results from 160 patients with a median age of 36 years. Half were male, and the mean follow-up was 24 months. The median BMI of the cohort was 24.3 kg/m2; 26% were overweight and 18% were obese. More than half of patients (55%) were on infliximab with weight-based dosing and 45% were on other fixed-dosing regimens, including 19% on vedolizumab. In terms of outcomes, 68% of patients experienced treatment failure. All who failed treatment underwent treatment modifications; 15% had IBD-related surgery, and 19% had IBD-related hospitalization.
After adjusting for age, sex, disease duration, prior hospitalization, prior anti-TNF therapy, steroid use, and albumin level, Ms. Kurnool and her associates found that every 1-kg/m2 increase in BMI was associated with a 4% higher risk of treatment failure (adjusted hazard ratio, 1.04), an 8% higher risk of surgery or hospitalization (adjusted HR, 1.08), and a 6% lower risk of achieving endoscopic remission (adjusted HR, 0.94).
“This increase in the risk of treatment failure and IBD-related surgery or hospitalization was consistent across strata of patients treated with infliximab and fixed-dosing regimens,” she said. “Based on these findings, physicians should consider proactive monitoring in obese patients treated with biologic agents.”
Ms. Kurnool reported having received a National Institutes of Health Short Term Training Grant from the University of California, San Diego.
*This story was updated on 3/26.
SOURCE: Kurnool S et al. Crohn’s & Colitis Congress, Clinical Abstract 24.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: Consider proactive monitoring in obese patients treated with biologic agents.
Major finding: Every 1-kg/m2 increase in BMI was associated with a 4% higher risk of treatment failure (adjusted HR, 1.04).
Study details: A single-center retrospective analysis of 160 IBD patients.
Disclosures: Ms. Kurnool reported having received a National Institutes of Health Short-Term Training Grant from the University of California, San Diego.
Source: Kurnool S et al. Crohn’s & Colitis Congress, Clinical Abstract 24.
Delayed ileal pouch anal anastomosis creation linked to lower 30-day adverse events
LAS VEGAS – compared with creating the pouch at the time of initial surgery, results from an analysis of national data demonstrated.
“More than 600,000 Americans have UC, and 20%-30% of them require surgical management,” Bharati Kochar, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “The surgical procedure of choice for many UC patients is total proctocolectomy with ileal pouch anal anastomosis creation.”
According to Dr. Kochar, an advanced fellow in inflammatory bowel diseases at the University of North Carolina at Chapel Hill, existing American medical literature regarding ileal pouch anal anastomosis (IPAA) comes mostly from quaternary care centers and compares one-stage procedures with multistage procedures.
“The risks between two- to three-stage procedures are not described, and there are no prospective national reports of postoperative adverse events after IPAA creation,” she said.
Using data from the National Surgical Quality Improvement Program, Dr. Kochar and her associates conducted an observational cohort analysis of 2,390 adult patients with a postoperative diagnosis of UC who underwent IPAA procedures between 2011 and 2015. Their aims were to evaluate adverse events within 30 days after an IPAA creation and to compare adverse events between pouch creation at the time of colectomy and delayed pouch creation.
They also performed a subanalysis of total abdominal colectomy with ileostomy (TAC), the first stage in the delayed pouch procedures, versus pouch creation at the time of colectomy. Multivariable modified Poisson regression models were used to estimate risk ratios adjusted for age, sex, race, body mass index, smoking status, diabetes, preoperative albumin, and American Society of Anesthesiologists class.
Of the 2,390 patients, 1,571 had pouches created at the time of colectomy (group A), and 819 had delayed pouch creation (group B).
Compared with patients in group B, those in group A were older (a median age of 40 years vs. 37 years, respectively; P less than .01), were more likely to be on an immunosuppressant (51% vs. 15%; P less than .01), have a lower median preoperative albumin level (3.9 vs. 4.2; P less than .01), and a longer median length of stay (6 days vs. 5 days; P less than .01).
On unadjusted analyses, the researchers also observed that, at 30 days, patients in group A had significantly more major complications, such as mortality and cardiac arrest (12.4% vs. 8.7%; P less than .01); minor complications, such as superficial surgical site infections and pneumonia (11.8% vs. 6.1%; P less than .01); unplanned readmissions (statistically similar at 23.3% vs. 21.3%), and unplanned reoperations (7.7% vs. 3.8%; P less than .01).
After controlling for confounders, patients in group B were significantly less likely to have major complications (relative risk, 0.72), minor complications (RR, 0.48), unplanned readmissions (RR, 0.95), and unplanned reoperations (RR, 0.42).
In the subgroup analysis, Dr. Kochar and her associates observed that patients who underwent TAC were significantly older, compared with patients in group A (a median of 46 years vs. 40 years, respectively; P less than .01), and a higher proportion were on immunosuppressants (69% vs. 51%; P less than .01). “Despite these factors, the risk of adverse events after TAC was lower,” Dr. Kochar said.
She acknowledged certain limitations of the study, including the inability to accurately determine the risk of linked surgeries together and the inability to assess institution and operator factors. Also, data were not collected for the purposes of studying inflammatory bowel disease.
“This is the first prospective assessment of morbidity following IPAA creation in UC patients from a national database,” Dr. Kochar concluded. “Delayed pouch procedures are associated with a lower risk of unplanned reoperations and major and minor complications. Immunosuppression at the time of pouch creation may result in an increased risk of adverse events postoperatively. The findings can be valuable for preoperative risk assessment and postoperative management.”
Dr. Kochar reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Kochar et al. Crohn’s & Colitis Congress 2018 Clinical Abstract 11.
LAS VEGAS – compared with creating the pouch at the time of initial surgery, results from an analysis of national data demonstrated.
“More than 600,000 Americans have UC, and 20%-30% of them require surgical management,” Bharati Kochar, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “The surgical procedure of choice for many UC patients is total proctocolectomy with ileal pouch anal anastomosis creation.”
According to Dr. Kochar, an advanced fellow in inflammatory bowel diseases at the University of North Carolina at Chapel Hill, existing American medical literature regarding ileal pouch anal anastomosis (IPAA) comes mostly from quaternary care centers and compares one-stage procedures with multistage procedures.
“The risks between two- to three-stage procedures are not described, and there are no prospective national reports of postoperative adverse events after IPAA creation,” she said.
Using data from the National Surgical Quality Improvement Program, Dr. Kochar and her associates conducted an observational cohort analysis of 2,390 adult patients with a postoperative diagnosis of UC who underwent IPAA procedures between 2011 and 2015. Their aims were to evaluate adverse events within 30 days after an IPAA creation and to compare adverse events between pouch creation at the time of colectomy and delayed pouch creation.
They also performed a subanalysis of total abdominal colectomy with ileostomy (TAC), the first stage in the delayed pouch procedures, versus pouch creation at the time of colectomy. Multivariable modified Poisson regression models were used to estimate risk ratios adjusted for age, sex, race, body mass index, smoking status, diabetes, preoperative albumin, and American Society of Anesthesiologists class.
Of the 2,390 patients, 1,571 had pouches created at the time of colectomy (group A), and 819 had delayed pouch creation (group B).
Compared with patients in group B, those in group A were older (a median age of 40 years vs. 37 years, respectively; P less than .01), were more likely to be on an immunosuppressant (51% vs. 15%; P less than .01), have a lower median preoperative albumin level (3.9 vs. 4.2; P less than .01), and a longer median length of stay (6 days vs. 5 days; P less than .01).
On unadjusted analyses, the researchers also observed that, at 30 days, patients in group A had significantly more major complications, such as mortality and cardiac arrest (12.4% vs. 8.7%; P less than .01); minor complications, such as superficial surgical site infections and pneumonia (11.8% vs. 6.1%; P less than .01); unplanned readmissions (statistically similar at 23.3% vs. 21.3%), and unplanned reoperations (7.7% vs. 3.8%; P less than .01).
After controlling for confounders, patients in group B were significantly less likely to have major complications (relative risk, 0.72), minor complications (RR, 0.48), unplanned readmissions (RR, 0.95), and unplanned reoperations (RR, 0.42).
In the subgroup analysis, Dr. Kochar and her associates observed that patients who underwent TAC were significantly older, compared with patients in group A (a median of 46 years vs. 40 years, respectively; P less than .01), and a higher proportion were on immunosuppressants (69% vs. 51%; P less than .01). “Despite these factors, the risk of adverse events after TAC was lower,” Dr. Kochar said.
She acknowledged certain limitations of the study, including the inability to accurately determine the risk of linked surgeries together and the inability to assess institution and operator factors. Also, data were not collected for the purposes of studying inflammatory bowel disease.
“This is the first prospective assessment of morbidity following IPAA creation in UC patients from a national database,” Dr. Kochar concluded. “Delayed pouch procedures are associated with a lower risk of unplanned reoperations and major and minor complications. Immunosuppression at the time of pouch creation may result in an increased risk of adverse events postoperatively. The findings can be valuable for preoperative risk assessment and postoperative management.”
Dr. Kochar reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Kochar et al. Crohn’s & Colitis Congress 2018 Clinical Abstract 11.
LAS VEGAS – compared with creating the pouch at the time of initial surgery, results from an analysis of national data demonstrated.
“More than 600,000 Americans have UC, and 20%-30% of them require surgical management,” Bharati Kochar, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “The surgical procedure of choice for many UC patients is total proctocolectomy with ileal pouch anal anastomosis creation.”
According to Dr. Kochar, an advanced fellow in inflammatory bowel diseases at the University of North Carolina at Chapel Hill, existing American medical literature regarding ileal pouch anal anastomosis (IPAA) comes mostly from quaternary care centers and compares one-stage procedures with multistage procedures.
“The risks between two- to three-stage procedures are not described, and there are no prospective national reports of postoperative adverse events after IPAA creation,” she said.
Using data from the National Surgical Quality Improvement Program, Dr. Kochar and her associates conducted an observational cohort analysis of 2,390 adult patients with a postoperative diagnosis of UC who underwent IPAA procedures between 2011 and 2015. Their aims were to evaluate adverse events within 30 days after an IPAA creation and to compare adverse events between pouch creation at the time of colectomy and delayed pouch creation.
They also performed a subanalysis of total abdominal colectomy with ileostomy (TAC), the first stage in the delayed pouch procedures, versus pouch creation at the time of colectomy. Multivariable modified Poisson regression models were used to estimate risk ratios adjusted for age, sex, race, body mass index, smoking status, diabetes, preoperative albumin, and American Society of Anesthesiologists class.
Of the 2,390 patients, 1,571 had pouches created at the time of colectomy (group A), and 819 had delayed pouch creation (group B).
Compared with patients in group B, those in group A were older (a median age of 40 years vs. 37 years, respectively; P less than .01), were more likely to be on an immunosuppressant (51% vs. 15%; P less than .01), have a lower median preoperative albumin level (3.9 vs. 4.2; P less than .01), and a longer median length of stay (6 days vs. 5 days; P less than .01).
On unadjusted analyses, the researchers also observed that, at 30 days, patients in group A had significantly more major complications, such as mortality and cardiac arrest (12.4% vs. 8.7%; P less than .01); minor complications, such as superficial surgical site infections and pneumonia (11.8% vs. 6.1%; P less than .01); unplanned readmissions (statistically similar at 23.3% vs. 21.3%), and unplanned reoperations (7.7% vs. 3.8%; P less than .01).
After controlling for confounders, patients in group B were significantly less likely to have major complications (relative risk, 0.72), minor complications (RR, 0.48), unplanned readmissions (RR, 0.95), and unplanned reoperations (RR, 0.42).
In the subgroup analysis, Dr. Kochar and her associates observed that patients who underwent TAC were significantly older, compared with patients in group A (a median of 46 years vs. 40 years, respectively; P less than .01), and a higher proportion were on immunosuppressants (69% vs. 51%; P less than .01). “Despite these factors, the risk of adverse events after TAC was lower,” Dr. Kochar said.
She acknowledged certain limitations of the study, including the inability to accurately determine the risk of linked surgeries together and the inability to assess institution and operator factors. Also, data were not collected for the purposes of studying inflammatory bowel disease.
“This is the first prospective assessment of morbidity following IPAA creation in UC patients from a national database,” Dr. Kochar concluded. “Delayed pouch procedures are associated with a lower risk of unplanned reoperations and major and minor complications. Immunosuppression at the time of pouch creation may result in an increased risk of adverse events postoperatively. The findings can be valuable for preoperative risk assessment and postoperative management.”
Dr. Kochar reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Kochar et al. Crohn’s & Colitis Congress 2018 Clinical Abstract 11.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: Delayed ileal pouch anal anastomosis procedures are associated with a lower 30-day adverse-event rate.
Major finding: After controlling for confounders, patients who underwent delayed IPAA procedures were significantly less likely to have major complications (relative risk, 0.72), minor complications (RR, 0.48), unplanned readmissions (RR, 0.95), and unplanned reoperations (RR, 0.42) at 30 days, compared with those who underwent pouch creation at the time of initial surgery.
Study details: An observational cohort analysis of 2,390 adult patients with a postoperative diagnosis of UC.
Disclosures: Dr. Kochar reported having no financial disclosures.
Source: Kochar et al. Crohn’s & Colitis Congress 2018 Clinical Abstract 11. Gastroenterology. 2018;154(1)Suppl:S1-S114.
Emergent colectomies for ulcerative colitis declining
LAS VEGAS – , a large database analysis has shown.
“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.
In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.
They also observed disparities in IPAA surgery rates based on race and insurance type. Specifically, whites had higher rates of elective IPAA during the study period, compared with black or Hispanic patients (P less than .01), while patients with private insurance had higher rates of elective IPAA, compared with those insured by Medicare or Medicaid (P less than .01). Dr. Ungaro acknowledged certain limitations of the study, including the fact that the Nationwide Inpatient Sample relies on administrative codes, “which may increase risk of misclassification bias,” he said. They were also unable to track individual patients across time and lacked data on medication use and disease severity.
“There has been a significant decline in emergency colectomy for ulcerative colitis in the United States,” Dr. Ungaro concluded. “We expect that this is due to more effective inpatient care. However, the overall need for surgery in UC appears to be stable given unchanged IPAA rates. This suggests a limited impact on overall surgery rates with a shift from emergent to elective procedures.” He reported having no relevant financial disclosures.
*This story was updated on 3/26.
SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.
LAS VEGAS – , a large database analysis has shown.
“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.
In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.
They also observed disparities in IPAA surgery rates based on race and insurance type. Specifically, whites had higher rates of elective IPAA during the study period, compared with black or Hispanic patients (P less than .01), while patients with private insurance had higher rates of elective IPAA, compared with those insured by Medicare or Medicaid (P less than .01). Dr. Ungaro acknowledged certain limitations of the study, including the fact that the Nationwide Inpatient Sample relies on administrative codes, “which may increase risk of misclassification bias,” he said. They were also unable to track individual patients across time and lacked data on medication use and disease severity.
“There has been a significant decline in emergency colectomy for ulcerative colitis in the United States,” Dr. Ungaro concluded. “We expect that this is due to more effective inpatient care. However, the overall need for surgery in UC appears to be stable given unchanged IPAA rates. This suggests a limited impact on overall surgery rates with a shift from emergent to elective procedures.” He reported having no relevant financial disclosures.
*This story was updated on 3/26.
SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.
LAS VEGAS – , a large database analysis has shown.
“Despite advances in medical therapy for ulcerative colitis (UC), many patients still need surgery,” Ryan C. Ungaro, MD, said at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Prior epidemiologic studies have demonstrated a decline in colectomy rates over time, particularly comparing the pre- and postbiologic eras, but less is known about rates of emergent colectomy over time,” he said. In particular, he continued, data on UC colectomy and ileal pouch anal anastomosis (IPAA) surgery rates in the United States are limited.
In an effort to examine UC emergent colectomy rates and IPAA over time, Dr. Ungaro, of the division of gastroenterology at the Icahn School of Medicine at Mount Sinai, New York, and his associates analyzed data from the U.S. Nationwide Inpatient Sample from 2000 through 2014. They defined emergent colectomy cases as admission through the emergency department and used the ICD-9-CM code for subtotal colectomy (45.8) as the outcome variable, and defined a second cohort of UC patients admitted electively with an outcome variable of ICD-9-CM code for IPAA (45.95). To evaluate temporal trends of colectomy and IPAA, the researchers used joinpoint regression analysis with calculation of annual percentage change.
They also observed disparities in IPAA surgery rates based on race and insurance type. Specifically, whites had higher rates of elective IPAA during the study period, compared with black or Hispanic patients (P less than .01), while patients with private insurance had higher rates of elective IPAA, compared with those insured by Medicare or Medicaid (P less than .01). Dr. Ungaro acknowledged certain limitations of the study, including the fact that the Nationwide Inpatient Sample relies on administrative codes, “which may increase risk of misclassification bias,” he said. They were also unable to track individual patients across time and lacked data on medication use and disease severity.
“There has been a significant decline in emergency colectomy for ulcerative colitis in the United States,” Dr. Ungaro concluded. “We expect that this is due to more effective inpatient care. However, the overall need for surgery in UC appears to be stable given unchanged IPAA rates. This suggests a limited impact on overall surgery rates with a shift from emergent to elective procedures.” He reported having no relevant financial disclosures.
*This story was updated on 3/26.
SOURCE: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: There has been a significant decline in emergent ulcerative colitis colectomies in the United States.
Major finding: Between 2000 and 2014, the colectomy rate among patients emergently admitted to the hospital declined more than 7% annually (P less than .05).
Study details: An analysis of 470,720 hospital admissions from the Nationwide Inpatient Sample.
Disclosures: Dr. Ungaro reported having no financial disclosures.
Source: Ungaro RC et al. Crohn’s & Colitis Congress, Clinical Abstract 23.
Study IDs predictors of nonmelanoma skin cancer in IBD
LAS VEGAS – , a large national analysis showed.
“Some studies have shown that patients with IBD may be at increased risk for nonmelanoma skin cancer (NMSC) because of the immunomodulators that they take for the management of their disease,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “But these are mostly small, single-center studies.” In an effort to determine the epidemiology of NMSC in patients hospitalized with IBD, Dr. Khan, associate chief resident in the internal medicine department at the University of Toledo (Ohio) Medical Center and his associates analyzed the National Inpatient Sample (NIS) database for all subjects who had a primary or secondary discharge diagnosis of IBD during 2002-2014. Next, they used ICD-9 codes to identify the rate of NMSC in this population.
Compared with IBD patients without NMSC, most of the IBD patients with NMSC were males (54% vs. 42%; P less than 0.001), covered by Medicare (65% vs. 37%), were white (96% vs. 81%; P less than .001), lived in the Midwest or Western United States (27% and 26% vs. 22% and 17%), were admitted to urban teaching hospitals (57% vs. 51%; P less than .001), were discharged to skilled nursing facilities (16% vs. 10%; P less than .001), required home health care (17% vs. 11%), and were admitted electively (27% vs. 20%). The researchers observed no significant difference in mortality among IBD patients with and without NMSC (1.61% vs. 1.53%; P = .22).
Multivariate analysis revealed that the following factors were predictive of NMSC in IBD: comorbid diagnosis of rheumatoid arthritis, collagen vasculature diseases, male sex, and white race. “Patients with those risk factors should be made more aware of their risk for developing NMSC,” Dr. Khan said. “They shouldn’t be taken lightly.”
Dr. Khan reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan Z et al. Crohn’s & Colitis Congress, Poster 209.
LAS VEGAS – , a large national analysis showed.
“Some studies have shown that patients with IBD may be at increased risk for nonmelanoma skin cancer (NMSC) because of the immunomodulators that they take for the management of their disease,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “But these are mostly small, single-center studies.” In an effort to determine the epidemiology of NMSC in patients hospitalized with IBD, Dr. Khan, associate chief resident in the internal medicine department at the University of Toledo (Ohio) Medical Center and his associates analyzed the National Inpatient Sample (NIS) database for all subjects who had a primary or secondary discharge diagnosis of IBD during 2002-2014. Next, they used ICD-9 codes to identify the rate of NMSC in this population.
Compared with IBD patients without NMSC, most of the IBD patients with NMSC were males (54% vs. 42%; P less than 0.001), covered by Medicare (65% vs. 37%), were white (96% vs. 81%; P less than .001), lived in the Midwest or Western United States (27% and 26% vs. 22% and 17%), were admitted to urban teaching hospitals (57% vs. 51%; P less than .001), were discharged to skilled nursing facilities (16% vs. 10%; P less than .001), required home health care (17% vs. 11%), and were admitted electively (27% vs. 20%). The researchers observed no significant difference in mortality among IBD patients with and without NMSC (1.61% vs. 1.53%; P = .22).
Multivariate analysis revealed that the following factors were predictive of NMSC in IBD: comorbid diagnosis of rheumatoid arthritis, collagen vasculature diseases, male sex, and white race. “Patients with those risk factors should be made more aware of their risk for developing NMSC,” Dr. Khan said. “They shouldn’t be taken lightly.”
Dr. Khan reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan Z et al. Crohn’s & Colitis Congress, Poster 209.
LAS VEGAS – , a large national analysis showed.
“Some studies have shown that patients with IBD may be at increased risk for nonmelanoma skin cancer (NMSC) because of the immunomodulators that they take for the management of their disease,” Zubair Khan, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “But these are mostly small, single-center studies.” In an effort to determine the epidemiology of NMSC in patients hospitalized with IBD, Dr. Khan, associate chief resident in the internal medicine department at the University of Toledo (Ohio) Medical Center and his associates analyzed the National Inpatient Sample (NIS) database for all subjects who had a primary or secondary discharge diagnosis of IBD during 2002-2014. Next, they used ICD-9 codes to identify the rate of NMSC in this population.
Compared with IBD patients without NMSC, most of the IBD patients with NMSC were males (54% vs. 42%; P less than 0.001), covered by Medicare (65% vs. 37%), were white (96% vs. 81%; P less than .001), lived in the Midwest or Western United States (27% and 26% vs. 22% and 17%), were admitted to urban teaching hospitals (57% vs. 51%; P less than .001), were discharged to skilled nursing facilities (16% vs. 10%; P less than .001), required home health care (17% vs. 11%), and were admitted electively (27% vs. 20%). The researchers observed no significant difference in mortality among IBD patients with and without NMSC (1.61% vs. 1.53%; P = .22).
Multivariate analysis revealed that the following factors were predictive of NMSC in IBD: comorbid diagnosis of rheumatoid arthritis, collagen vasculature diseases, male sex, and white race. “Patients with those risk factors should be made more aware of their risk for developing NMSC,” Dr. Khan said. “They shouldn’t be taken lightly.”
Dr. Khan reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Khan Z et al. Crohn’s & Colitis Congress, Poster 209.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: Many factors predict which IBD patients are at risk for developing nonmelanoma skin cancer.
Major finding: Compared with IBD patients without NMSC, most of the IBD patients with NMSC were males (54% vs. 42%; P less than .001) and white (96% vs. 81%; P less than .001).
Study details: An analysis of 22,620 patients who had a primary or secondary discharge diagnosis of IBD during 2002-2014.
Disclosures: Dr. Khan reported having no financial disclosures.
Source: Khan Z et al. Crohn’s & Colitis Congress, Poster 209.
Study probes predictors of response to vedolizumab
LAS VEGAS – , a small, single-center study showed.
“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.
He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.
He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.
LAS VEGAS – , a small, single-center study showed.
“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.
He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.
He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.
LAS VEGAS – , a small, single-center study showed.
“Right now there are a variety of medications to treat Crohn’s disease, but there isn’t a set criteria [for] what [drug] works for which kind of patient,” Adam A. Dhedhi, MD, said in an interview at the Crohn’s & Colitis Congress, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “We’re trying to figure out if we can find a predictor of response to vedolizumab.” Manufactured by Millennium Pharmaceuticals, vedolizumab is a gut-selective monoclonal antibody to alpha4beta7 integrin that prevents transportation of leukocytes into gastrointestinal mucosa.
He and his associates reported that a low CRP value at time of initiation (a mean of 6.6 mg/L) was found to be a positive predictor of both response and remission (odds ratio, 0.3045; P = .001), while the mean CRP value for nonresponders was 29.9 mg/L. In addition, any smoking history was a predictor of poor response to vedolizumab (OR, 0.0008; P = .009). “That was surprising and useful information to carry forward,” Dr. Dhedhi said. “If you’re making a decision between an anti-TNF [tumor necrosis factor] agent and vedolizumab, [and] if the patient is a smoker or has a higher active disease state, that may help tip the scales one way or the other.” In their abstract, the researchers noted that cigarette smoke “has been found to be involved in beta-2 integrin activation and neutrophil migration in lung tissue and may play a similar role in the gut” (Respiratory Research 2011;12[1]:75). Dr. Dhedhi and his associates also found that more than half of patients who had previously used two or more anti-TNF therapies (58%) achieved remission, compared with 47% who had used one prior anti-TNF drug and 43% who were anti-TNF naive.
He acknowledged certain limitations of the study, including its retrospective design and small sample size. Dr. Dhedhi reported having no financial disclosures.
*This story was updated on 3/26.
SOURCE: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.
REPORTING FROM THE CROHN’S & COLITIS CONGRESS
Key clinical point: More aggressive Crohn’s disease or highly active disease is less likely to respond to vedolizumab therapy.
Major finding: A low baseline CRP level significantly predicted response and remission with vedolizumab (P = .001), while a history of smoking was a negative predictor of response and remission (P = .009).
Study details: A single-center, retrospective analysis of 45 Crohn’s patients treated with vedolizumab between 2014 and 2017.
Disclosures: Dr. Dhedhi reported having no financial disclosures.
Source: Dhedhi AA et al. Crohn’s & Colitis Congress, Poster 207.