Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is also an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

This article was updated on Jan. 3, 2022.

Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is also an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

This article was updated on Jan. 3, 2022.

Vedolizumab does not seem to increase the risk of Clostridioides difficile infection (CDI), compared with anti–tumor necrosis factor (TNF) therapies in biologic-naive patients with ulcerative colitis (UC), despite concerns that the gut-selective monoclonal antibody treatment may increase gastrointestinal infections at a greater rate than other biologics in this patient population.

Perturbations of the gut microbiota that occur in IBD predispose patients to CDI. Given that treatment with monoclonal antibody vedolizumab exerts an inhibitory action on lymphocyte trafficking to the intestines, questions have been raised on whether this action could increase the risk of CDI in an already vulnerable population.

In patients with UC, the incidence of CDI typically confers a higher risk of adverse outcomes. Unfortunately, CDI is a common complication associated with inflammatory bowel disease (IBD) that can lead to disease flares, further adding to the physical and psychological burden associated with the condition, according to recent studies.

These concerns, however, may not be warranted in patients with UC, according to findings from a retrospective study presented at the annual Advances in Inflammatory Bowel Diseases conference by Rahul Dalal, MD, a gastroenterology fellow at Brigham and Women’s Hospital in Boston.

In the study, Dr. Dalal and colleagues retrospectively analyzed electronic medical records of adult patients with UC who initiated infliximab, adalimumab, or vedolizumab between June 2014 and December 2020. Patients in this retrospective cohort were followed until there was a documented occurrence of CDI, colectomy, or biologic discontinuation/switch, or until the last recorded gastroenterology encounter.

The researchers analyzed the time from biologic initiation to first CDI, which was characterized by a positive stool for C. difficile toxin or toxigenic C. difficile polymerase chain reaction with CDI-specific antibiotic prescriptions. Additionally, the investigators evaluated rates of CDI-related hospitalization, colectomy, or death within a 30-day period of CDI. The primary analysis compared patients with UC who initiated vedolizumab (n = 195) versus anti-TNF therapy (n = 610).

Compared with those treated with anti-TNF agents, patients who initiated vedolizumab were older and less frequently received systemic corticosteroids or had UC-related hospitalization within 12 months prior to starting biologics.

Over 1,436 patient-years’ worth of follow-up, the investigators observed 43 CDIs. Patients treated with vedolizumab less frequently had CDI (1.0% vs. 6.7%; P =.001) and CDI hospitalization (1.0% vs. 3.8%; P =.042), compared with those treated with anti-TNF therapies. The investigators reported no significant differences in the rates of colectomies or deaths or rates of exposure to antibiotics/corticosteroids during the follow-up period or within 30 days prior to CDI onset.

In the unadjusted Cox model, the researchers reported that vedolizumab featured a lower hazard of CDI, compared with anti-TNF (hazard ratio, 0.17; 95% confidence interval, 0.04-0.71). The multivariable Cox model found no significant difference in hazard of CDI for vedolizumab when compared with anti-TNF therapy (HR, 0.33; 95% CI, 0.05-2.03) or immunomodulator exposure (HR, 1.01; 95% CI, 0.41-2.40). The incidence of CDI prior to biologic initiation was associated with an increased hazard of subsequent CDI (HR, 5.95; 95% CI, 2.93-12.09). In the subgroup of patients who experienced a CDI, approximately 39.5% had CDI before biologic initiation at a median of 227 days preceding the subsequent event.

“Vedolizumab is one of the safest biologics that we have in the clinic,” said Jean-Frederic Colombel, MD, who was asked to comment on the study. Dr. Colombel, who wasn’t involved in the study, is a gastroenterologist and serves as director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai, both in New York. “Findings from this study reinforce the safety profile of vedolizumab” despite the potential concerns regarding gastroenterological infection with the agent, he added.
 

Recurrence worries

Recurrent CDI is also an issue in patients with IBD, many of whom are considered at high risk for initial and recurrent infection. During a session on CDI and recurrence at the AIBD meeting, Sahil Khanna, MBBS, of the Mayo Clinic, explained that there are three different treatment guidelines to manage initial CDI in patients with IBD.

Predominantly, these guidelines also suggest human monoclonal antibody bezlotoxumab could be used for prevention of CDI recurrence in patients at high risk of recurrence, including those who had experienced severe CDI. “One can argue that anyone with IBD who has C. difficile can be a severe CDI patient because of the bad outcomes we can see,” he explained.

“We do know that IBD is a state of chronic microbial dysbiosis compared to our patients without IBD who get C. difficile because of antibiotic exposure, and that’s why these patients have a high risk of recurrence, compared with non-IBD patients,” said Dr. Khanna. He noted that the bezlotoxumab studies showed numerically lower CDI recurrence rates compared with other treatments in patients with IBD who were initially treated with the monoclonal antibody, but this difference was not statistically significant. “But again, this agent has been shown to be safe in this patient population.”

Dr. Dalal reported having no relevant conflicts of interest. Dr. Colombel has consulted for Takeda, which markets Entyvio for UC. Dr. Khanna has research grants from Rebiotix, as well as consulting fees from Shire Plc, Premier, Facile Therapeutics, and ProbioTech.

This article was updated on Jan. 3, 2022.

Real-world practice data show that less than 10% of patients with inflammatory bowel disease (IBD) receive early treatment with monoclonal antibody vedolizumab, despite better outcomes with earlier initiation. That said, earlier initiation of vedolizumab appears to be more common in younger patients and women, according to the study findings.

Previous research supports the early use of biologics in the management of IBD, given findings that show earlier treatment is associated with increased likelihood of response and remission compared with delayed management. In actual clinical practice, biologic agents are often delayed, potentially contributing to suboptimal outcomes and increased risks of IBD-associated adverse effects.

In a real-world study presented during the 2021 Advances in Inflammatory Bowel Diseases (AIBD) meeting by Maja Kuharic, a PhD candidate at the University of Illinois at Chicago, researchers assessed administrative datasets to gauge the timing of vedolizumab utilization in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).

Data from the 2017 to 2019 MarketScan commercial and Medicare claims databases were examined in the study. Patients with continuous enrollment in the same health plan for 12 months or longer both before and after their initial IBD diagnosis were included. Additionally, the analysis included patients with 1 or more vedolizumab claim following the index IBD diagnosis.

A total of five treatment pathways were predefined for the study. First, early vedolizumab use was defined as treatment with the monoclonal antibody therapy within 30 days of the first IBD diagnostic claim. A “delayed vedolizumab 1” initiation group was defined as initial treatment with immunomodulators followed by switching to vedolizumab. Additionally, “delayed vedolizumab 2” was defined by initial utilization of corticosteroids with immunomodulators prior to vedolizumab initiation. “Delayed vedolizumab 3” was characterized by the initial use of 5-aminosalicylic acid (5-ASA) with corticosteroids before vedolizumab. Finally, “delayed vedolizumab 4” was defined by the use of 5-ASA with corticosteroids and immunomodulators before vedolizumab.

The real-world cohort study included 1,342 patients with UC (median age, 43 years; 51.0% male) and 964 patients with CD (median age, 45 years; 43.6% male) who received vedolizumab. Early vedolizumab initiation was observed in 6.6% of patients with UC and 9.6% of patients with CD. In the UC population, the proportions of patients classified in the delayed vedolizumab 1, 2, 3, and 4 groups were 7.5%, 14.8%, 37.6%, and 33.4%, respectively. Among the CD group, the proportions of patients in each delayed vedolizumab arms were 19.0%, 36.8%, 19.0%, and 15.6%, respectively.

In the UC cohort, patients who experienced early vedolizumab initiation had a median younger age than those in the delayed groups (40 vs. 44 years, respectively). Additionally, the proportion of men was lower in the early vedolizumab cohort (46.1% vs. 51.4%). Similar findings were observed in the CD group: those who initiated vedolizumab earlier had a lower median age (43 vs. 45 years) and were less frequently men (39.8%% vs. 43.9%).

Across both treatment indications, there were no clinically meaningful differences between treatment groups in terms of geographic location, payer type (that is, commercial vs. Medicare), or year of diagnosis.

According to Jean-Frederic Colombel, MD, who was asked to comment on the study, a limitation of the findings is the lack of explanation as to why early initiation of vedolizumab is higher in younger patients and women. “Rather, it just reflects clinical practice in the real world with no justification,” said Dr. Colombel, a gastroenterologist and director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai in New York, who wasn’t involved in the study.

“[The findings] may look surprising since the drug, because of its safety, could be considered first-line in elderly fragile patients with higher risk of infection,” added Dr. Colombel. He noted that what is missing from the study is the longitudinal assessment of early treatment in terms of disease modification. In particular, he asked, what needs to be further explored is the “long-term impact of early vedolizumab initiation on the risk of surgery and complications.”

During another session at the AIBD 2021 meeting on the positioning of therapies in IBD, Anita Afzali, MD, of the Ohio State University Wexner Medical Center in Hilliard, Ohio, noted that for newly diagnosed patients, early initiation of vedolizumab may be most appropriate for patients with unfavorable pharmacokinetics. For instance, Dr. Afzali said, vedolizumab or ustekinumab could be the biologics of choice for an older woman with ileocolonic CD and the HLA-DQA1*04 genotype in whom clinicians would want to avoid an immunomodulator.

“When you look at different factors, whether you’re discussing the drug itself or the patient, there’s different considerations” for selecting a therapy in IBD, explained Dr. Afzali. These considerations, she stated, include those related to drug efficacy and safety as well as disease and individual characteristics such as age, comorbidities, preferences, and costs.

Ms. Kuharic is a PhD candidate and is also a Health Economics and Outcomes Research Fellow at Takeda. Dr. Colombel has consulted for Takeda, which markets vedolizumab for CD and UC. Dr. Afzali has reported relationships with several pharmaceutical companies, including BMS, Eli Lilly, Gilead, Pfizer, IBD Horizons, AbbVie, Takeda, and Janssen.

Real-world practice data show that less than 10% of patients with inflammatory bowel disease (IBD) receive early treatment with monoclonal antibody vedolizumab, despite better outcomes with earlier initiation. That said, earlier initiation of vedolizumab appears to be more common in younger patients and women, according to the study findings.

Previous research supports the early use of biologics in the management of IBD, given findings that show earlier treatment is associated with increased likelihood of response and remission compared with delayed management. In actual clinical practice, biologic agents are often delayed, potentially contributing to suboptimal outcomes and increased risks of IBD-associated adverse effects.

In a real-world study presented during the 2021 Advances in Inflammatory Bowel Diseases (AIBD) meeting by Maja Kuharic, a PhD candidate at the University of Illinois at Chicago, researchers assessed administrative datasets to gauge the timing of vedolizumab utilization in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).

Data from the 2017 to 2019 MarketScan commercial and Medicare claims databases were examined in the study. Patients with continuous enrollment in the same health plan for 12 months or longer both before and after their initial IBD diagnosis were included. Additionally, the analysis included patients with 1 or more vedolizumab claim following the index IBD diagnosis.

A total of five treatment pathways were predefined for the study. First, early vedolizumab use was defined as treatment with the monoclonal antibody therapy within 30 days of the first IBD diagnostic claim. A “delayed vedolizumab 1” initiation group was defined as initial treatment with immunomodulators followed by switching to vedolizumab. Additionally, “delayed vedolizumab 2” was defined by initial utilization of corticosteroids with immunomodulators prior to vedolizumab initiation. “Delayed vedolizumab 3” was characterized by the initial use of 5-aminosalicylic acid (5-ASA) with corticosteroids before vedolizumab. Finally, “delayed vedolizumab 4” was defined by the use of 5-ASA with corticosteroids and immunomodulators before vedolizumab.

The real-world cohort study included 1,342 patients with UC (median age, 43 years; 51.0% male) and 964 patients with CD (median age, 45 years; 43.6% male) who received vedolizumab. Early vedolizumab initiation was observed in 6.6% of patients with UC and 9.6% of patients with CD. In the UC population, the proportions of patients classified in the delayed vedolizumab 1, 2, 3, and 4 groups were 7.5%, 14.8%, 37.6%, and 33.4%, respectively. Among the CD group, the proportions of patients in each delayed vedolizumab arms were 19.0%, 36.8%, 19.0%, and 15.6%, respectively.

In the UC cohort, patients who experienced early vedolizumab initiation had a median younger age than those in the delayed groups (40 vs. 44 years, respectively). Additionally, the proportion of men was lower in the early vedolizumab cohort (46.1% vs. 51.4%). Similar findings were observed in the CD group: those who initiated vedolizumab earlier had a lower median age (43 vs. 45 years) and were less frequently men (39.8%% vs. 43.9%).

Across both treatment indications, there were no clinically meaningful differences between treatment groups in terms of geographic location, payer type (that is, commercial vs. Medicare), or year of diagnosis.

According to Jean-Frederic Colombel, MD, who was asked to comment on the study, a limitation of the findings is the lack of explanation as to why early initiation of vedolizumab is higher in younger patients and women. “Rather, it just reflects clinical practice in the real world with no justification,” said Dr. Colombel, a gastroenterologist and director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai in New York, who wasn’t involved in the study.

“[The findings] may look surprising since the drug, because of its safety, could be considered first-line in elderly fragile patients with higher risk of infection,” added Dr. Colombel. He noted that what is missing from the study is the longitudinal assessment of early treatment in terms of disease modification. In particular, he asked, what needs to be further explored is the “long-term impact of early vedolizumab initiation on the risk of surgery and complications.”

During another session at the AIBD 2021 meeting on the positioning of therapies in IBD, Anita Afzali, MD, of the Ohio State University Wexner Medical Center in Hilliard, Ohio, noted that for newly diagnosed patients, early initiation of vedolizumab may be most appropriate for patients with unfavorable pharmacokinetics. For instance, Dr. Afzali said, vedolizumab or ustekinumab could be the biologics of choice for an older woman with ileocolonic CD and the HLA-DQA1*04 genotype in whom clinicians would want to avoid an immunomodulator.

“When you look at different factors, whether you’re discussing the drug itself or the patient, there’s different considerations” for selecting a therapy in IBD, explained Dr. Afzali. These considerations, she stated, include those related to drug efficacy and safety as well as disease and individual characteristics such as age, comorbidities, preferences, and costs.

Ms. Kuharic is a PhD candidate and is also a Health Economics and Outcomes Research Fellow at Takeda. Dr. Colombel has consulted for Takeda, which markets vedolizumab for CD and UC. Dr. Afzali has reported relationships with several pharmaceutical companies, including BMS, Eli Lilly, Gilead, Pfizer, IBD Horizons, AbbVie, Takeda, and Janssen.

Real-world practice data show that less than 10% of patients with inflammatory bowel disease (IBD) receive early treatment with monoclonal antibody vedolizumab, despite better outcomes with earlier initiation. That said, earlier initiation of vedolizumab appears to be more common in younger patients and women, according to the study findings.

Previous research supports the early use of biologics in the management of IBD, given findings that show earlier treatment is associated with increased likelihood of response and remission compared with delayed management. In actual clinical practice, biologic agents are often delayed, potentially contributing to suboptimal outcomes and increased risks of IBD-associated adverse effects.

In a real-world study presented during the 2021 Advances in Inflammatory Bowel Diseases (AIBD) meeting by Maja Kuharic, a PhD candidate at the University of Illinois at Chicago, researchers assessed administrative datasets to gauge the timing of vedolizumab utilization in adult patients with Crohn’s disease (CD) or ulcerative colitis (UC).

Data from the 2017 to 2019 MarketScan commercial and Medicare claims databases were examined in the study. Patients with continuous enrollment in the same health plan for 12 months or longer both before and after their initial IBD diagnosis were included. Additionally, the analysis included patients with 1 or more vedolizumab claim following the index IBD diagnosis.

A total of five treatment pathways were predefined for the study. First, early vedolizumab use was defined as treatment with the monoclonal antibody therapy within 30 days of the first IBD diagnostic claim. A “delayed vedolizumab 1” initiation group was defined as initial treatment with immunomodulators followed by switching to vedolizumab. Additionally, “delayed vedolizumab 2” was defined by initial utilization of corticosteroids with immunomodulators prior to vedolizumab initiation. “Delayed vedolizumab 3” was characterized by the initial use of 5-aminosalicylic acid (5-ASA) with corticosteroids before vedolizumab. Finally, “delayed vedolizumab 4” was defined by the use of 5-ASA with corticosteroids and immunomodulators before vedolizumab.

The real-world cohort study included 1,342 patients with UC (median age, 43 years; 51.0% male) and 964 patients with CD (median age, 45 years; 43.6% male) who received vedolizumab. Early vedolizumab initiation was observed in 6.6% of patients with UC and 9.6% of patients with CD. In the UC population, the proportions of patients classified in the delayed vedolizumab 1, 2, 3, and 4 groups were 7.5%, 14.8%, 37.6%, and 33.4%, respectively. Among the CD group, the proportions of patients in each delayed vedolizumab arms were 19.0%, 36.8%, 19.0%, and 15.6%, respectively.

In the UC cohort, patients who experienced early vedolizumab initiation had a median younger age than those in the delayed groups (40 vs. 44 years, respectively). Additionally, the proportion of men was lower in the early vedolizumab cohort (46.1% vs. 51.4%). Similar findings were observed in the CD group: those who initiated vedolizumab earlier had a lower median age (43 vs. 45 years) and were less frequently men (39.8%% vs. 43.9%).

Across both treatment indications, there were no clinically meaningful differences between treatment groups in terms of geographic location, payer type (that is, commercial vs. Medicare), or year of diagnosis.

According to Jean-Frederic Colombel, MD, who was asked to comment on the study, a limitation of the findings is the lack of explanation as to why early initiation of vedolizumab is higher in younger patients and women. “Rather, it just reflects clinical practice in the real world with no justification,” said Dr. Colombel, a gastroenterologist and director of the Feinstein IBD Center at Mount Sinai Hospital and professor of medicine (division of gastroenterology) at the Icahn School of Medicine at Mount Sinai in New York, who wasn’t involved in the study.

“[The findings] may look surprising since the drug, because of its safety, could be considered first-line in elderly fragile patients with higher risk of infection,” added Dr. Colombel. He noted that what is missing from the study is the longitudinal assessment of early treatment in terms of disease modification. In particular, he asked, what needs to be further explored is the “long-term impact of early vedolizumab initiation on the risk of surgery and complications.”

During another session at the AIBD 2021 meeting on the positioning of therapies in IBD, Anita Afzali, MD, of the Ohio State University Wexner Medical Center in Hilliard, Ohio, noted that for newly diagnosed patients, early initiation of vedolizumab may be most appropriate for patients with unfavorable pharmacokinetics. For instance, Dr. Afzali said, vedolizumab or ustekinumab could be the biologics of choice for an older woman with ileocolonic CD and the HLA-DQA1*04 genotype in whom clinicians would want to avoid an immunomodulator.

“When you look at different factors, whether you’re discussing the drug itself or the patient, there’s different considerations” for selecting a therapy in IBD, explained Dr. Afzali. These considerations, she stated, include those related to drug efficacy and safety as well as disease and individual characteristics such as age, comorbidities, preferences, and costs.

Ms. Kuharic is a PhD candidate and is also a Health Economics and Outcomes Research Fellow at Takeda. Dr. Colombel has consulted for Takeda, which markets vedolizumab for CD and UC. Dr. Afzali has reported relationships with several pharmaceutical companies, including BMS, Eli Lilly, Gilead, Pfizer, IBD Horizons, AbbVie, Takeda, and Janssen.

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

In the November 2021 issue of Pediatric News are two stories that on the surface present viewpoints that couldn’t be more divergent. On page 1 under the headline “Gender dysphoria” you will read about a position statement by the Royal Australian and New Zealand College of Psychiatrists (RANZCP) in which they strongly recommend a mental health evaluation for any child or adolescent with gender dysphoria “before any firm decisions are made on whether to prescribe hormonal treatments to transition, or perform surgeries.”

On page 6 is another story titled “Gender-affirming care ‘can save lives’ new research shows” that reports on a research study in which transgender and binary young people who received a year of gender-affirming care experienced less depression and fewer suicidal thoughts. Dr. David J. Inwards-Breland, chief of adolescent and young adult medicine at Rady Children’s Hospital in San Diego and one of the authors of the study is quoted as saying “The younger we can provide gender-affirming care, the less likely [our patients are] to have depression and then negative outcomes.” One can’t avoid the impression that he is in favor of moving ahead without delay in prescribing gender-affirming care.

Where does the new recommendation by the RANZCP fit in with this sense of urgency? Does requiring a mental health evaluation constitute a delay in the institution of gender-affirming care that could increase the risk of negative mental health outcomes for gender dysphoric patients?

In one of the final paragraphs in the Pediatric News article one learns that Dr. Inwards-Breland would agree with the folks of RANZCP. He acknowledges that his study relied on screening and not diagnostic testing and says that “future studies should look at a mental health evaluation and diagnosis by a mental health provider.”

When we drill into the details there are two issues that demand clarification. First, what kind of time course are we talking about for a mental health evaluation? Are we talking weeks, or months, hopefully not years? This of course depends on the availability of mental health services for the specific patient and the depth of the evaluation required. How long a delay is acceptable?

Second, will the evaluation be performed by a provider free of bias? Can it be performed without creating the impression that the patient needs to see a mental health provider because there is something wrong with being trans and we can fix it? One would hope these evaluations would be performed in the spirit of wanting to learn more about the patient with the goal of making the process go more smoothly.

Listening to neighborhood discussions around the fire pit I find that the RANZCP plea for a broader and deeper look at each gender-dysphoric child strikes a chord with the general population. More and more people are realizing that gender-dysphoria happens and that for too long it was closeted with unfortunate consequences. However, there is a feeling, in fact one in which I share, that the rapid rise in its prevalence contains an element of social contagion. And, some irreversible decisions are being made without sufficient consideration. This may or not be a valid concern but it seems to me a thorough and sensitively done mental health evaluation might minimize the collateral damage from some gender-affirming care and at least help those patients for whom it is prescribed transition more smoothly.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

An artificial intelligence (AI) system called “ENDOANGEL” was effective for real-time monitoring of endoscopic “blind spots” and improved detection of early gastric cancer (EGC) during esophagogastroduodenoscopy (EGD), according to research published recently.

Science Photo Library/SCIEPRO/Brand X Pictures

While EGD is widely used to examine lesions found in the upper gastrointestinal tract, there is considerable variability among endoscopists regarding performance, resulting in a substantial miss rate for EGC. But in a study published in the journal Endoscopy, researchers suggest a more objective assessment of lesions with AI technology could improve detection rates in real time, thus improving the chances of establishing an early diagnosis and initiating prompt treatment of gastric cancer.

The researchers updated a developed AI system called WISENSE, which previously demonstrated an ability to monitor gastric areas overlooked during EGD (termed “blind spots”). The investigators integrated a trained real-time EGC detection model into the WISENSE system and changed the name of the updated system to ENDOANGEL.

Researchers from the Renmin Hospital of Wuhan (China) University used deep convolutional neural networks and deep reinforcement learning to develop the ENDOANGEL. A total of 1,050 patients from five hospitals in China who were undergoing EGD were randomized to either an ENDOANGEL-assisted protocol (n = 498) or a control group (n = 504) that did not use the ENDOANGEL system. Examination consisted of white-light imaging observation, magnifying image-enhanced endoscopy observation, and biopsy of suspicious lesions.

The investigators compared the groups in terms of the number of blind spots after the intervention. They assessed the performance of the AI-based ENDOANGEL system in its ability to predict EGC in a real-world clinical setting.

Patients assigned to ENDOANGEL had a significantly fewer mean number of blind spots compared with patients assigned to control (5.38 vs. 9.82, respectively; P < .001). Despite this advantage, patients in the ENDOANGEL group had significantly longer inspection time (5.40 minutes vs. 4.38 minutes; P < .001).

There were 819 lesions reported by endoscopists in the ENDOANGEL group, which included 196 gastric lesions with pathological results. According to the investigators, the ENDOANGEL system correctly predicted all three EGCs, including one mucosal carcinoma and two high grade neoplasias, as well as two advanced gastric cancers. The per-lesion accuracy was 84.7 %, while the sensitivity and specificity rates for detecting gastric cancer were 100% and 84.3%, respectively.

The authors noted limitations of the analysis itself and those stemming from the short follow-up, as well as possible bias introduced by unblinded statisticians. Further research is warranted, they wrote.

“In conclusion, ENDOANGEL, a system for improving endoscopy quality based on deep learning, achieved real-time monitoring of endoscopic blind spots, timing, and EGC detection during EGD,” according to the authors. “ENDOANGEL greatly improved the quality of EGD in this multicenter study, and showed potential for detecting EGC in real clinical settings.”
 

Spotting the blind spots

An AI-based system such as ENDOANGEL could overcome some of the natural weaknesses to standard diagnostic testing, thereby improving rates of EGC testing, David Hoffman, MD, a gastroenterology oncologist and medical director of Cedars-Sinai Cancer Beverly Hills, said in an interview. “I think that there are ethical questions that we’re going to have to grapple with respect to accessibility and data mining and what that really means,” said Dr. Hoffman, who wasn’t involved in the study. “But I think that in the optimistic view, using AI with machine learning and deep learning has tremendous potential for public health and for cancer medicine in particular.”

Dr. Hoffman added that beyond early detection of cancer, AI systems may hold additional benefits, particularly in regard to assisting decisions for personalized medicine and assisting in real-time surgical interventions. “Using AI with machine learning and deep learning has tremendous potential and I think it sort of is a natural offshoot into what we’re seeing in ... algorithmic approaches to use of big data, so it’s sort of a natural evolution in terms of medical applications,” he explained.

Anuj Patel, MD, a medical oncology specialist at the Dana-Farber Cancer Institute, Boston, who wasn’t involved in the new research, explained that any strategy that helps detect gastric cancer at earlier stages could have a visible global impact. “We have a lower incidence of gastric cancer in the United States, but the training of and clinical volume of early gastric cancers seen by different providers can vary,” Dr. Patel said in an interview. “AI systems could provide a second layer of evaluation during procedures where an endoscopist might otherwise miss the subtle features associated with some early gastric cancers.”

While the findings from the ENDOANGEL study appear promising, Dr. Patel noted that the most important long-term question is whether this reduction of endoscopic blind spots as a result of implementing the system will translate to meaningful improvements in patient outcomes. “More broadly, I think that we will need to see how well these techniques can be applied across different populations,” he added. “Because AI models such as these need to be trained, it will be important to see if they need to be retrained when used in countries where gastric cancer might present differently or with distinctive endoscopic equipment and techniques.”

The study authors, as well as Dr. Patel and Dr. Hoffman, had no conflicts of interest to disclose.

An artificial intelligence (AI) system called “ENDOANGEL” was effective for real-time monitoring of endoscopic “blind spots” and improved detection of early gastric cancer (EGC) during esophagogastroduodenoscopy (EGD), according to research published recently.

Science Photo Library/SCIEPRO/Brand X Pictures

While EGD is widely used to examine lesions found in the upper gastrointestinal tract, there is considerable variability among endoscopists regarding performance, resulting in a substantial miss rate for EGC. But in a study published in the journal Endoscopy, researchers suggest a more objective assessment of lesions with AI technology could improve detection rates in real time, thus improving the chances of establishing an early diagnosis and initiating prompt treatment of gastric cancer.

The researchers updated a developed AI system called WISENSE, which previously demonstrated an ability to monitor gastric areas overlooked during EGD (termed “blind spots”). The investigators integrated a trained real-time EGC detection model into the WISENSE system and changed the name of the updated system to ENDOANGEL.

Researchers from the Renmin Hospital of Wuhan (China) University used deep convolutional neural networks and deep reinforcement learning to develop the ENDOANGEL. A total of 1,050 patients from five hospitals in China who were undergoing EGD were randomized to either an ENDOANGEL-assisted protocol (n = 498) or a control group (n = 504) that did not use the ENDOANGEL system. Examination consisted of white-light imaging observation, magnifying image-enhanced endoscopy observation, and biopsy of suspicious lesions.

The investigators compared the groups in terms of the number of blind spots after the intervention. They assessed the performance of the AI-based ENDOANGEL system in its ability to predict EGC in a real-world clinical setting.

Patients assigned to ENDOANGEL had a significantly fewer mean number of blind spots compared with patients assigned to control (5.38 vs. 9.82, respectively; P < .001). Despite this advantage, patients in the ENDOANGEL group had significantly longer inspection time (5.40 minutes vs. 4.38 minutes; P < .001).

There were 819 lesions reported by endoscopists in the ENDOANGEL group, which included 196 gastric lesions with pathological results. According to the investigators, the ENDOANGEL system correctly predicted all three EGCs, including one mucosal carcinoma and two high grade neoplasias, as well as two advanced gastric cancers. The per-lesion accuracy was 84.7 %, while the sensitivity and specificity rates for detecting gastric cancer were 100% and 84.3%, respectively.

The authors noted limitations of the analysis itself and those stemming from the short follow-up, as well as possible bias introduced by unblinded statisticians. Further research is warranted, they wrote.

“In conclusion, ENDOANGEL, a system for improving endoscopy quality based on deep learning, achieved real-time monitoring of endoscopic blind spots, timing, and EGC detection during EGD,” according to the authors. “ENDOANGEL greatly improved the quality of EGD in this multicenter study, and showed potential for detecting EGC in real clinical settings.”
 

Spotting the blind spots

An AI-based system such as ENDOANGEL could overcome some of the natural weaknesses to standard diagnostic testing, thereby improving rates of EGC testing, David Hoffman, MD, a gastroenterology oncologist and medical director of Cedars-Sinai Cancer Beverly Hills, said in an interview. “I think that there are ethical questions that we’re going to have to grapple with respect to accessibility and data mining and what that really means,” said Dr. Hoffman, who wasn’t involved in the study. “But I think that in the optimistic view, using AI with machine learning and deep learning has tremendous potential for public health and for cancer medicine in particular.”

Dr. Hoffman added that beyond early detection of cancer, AI systems may hold additional benefits, particularly in regard to assisting decisions for personalized medicine and assisting in real-time surgical interventions. “Using AI with machine learning and deep learning has tremendous potential and I think it sort of is a natural offshoot into what we’re seeing in ... algorithmic approaches to use of big data, so it’s sort of a natural evolution in terms of medical applications,” he explained.

Anuj Patel, MD, a medical oncology specialist at the Dana-Farber Cancer Institute, Boston, who wasn’t involved in the new research, explained that any strategy that helps detect gastric cancer at earlier stages could have a visible global impact. “We have a lower incidence of gastric cancer in the United States, but the training of and clinical volume of early gastric cancers seen by different providers can vary,” Dr. Patel said in an interview. “AI systems could provide a second layer of evaluation during procedures where an endoscopist might otherwise miss the subtle features associated with some early gastric cancers.”

While the findings from the ENDOANGEL study appear promising, Dr. Patel noted that the most important long-term question is whether this reduction of endoscopic blind spots as a result of implementing the system will translate to meaningful improvements in patient outcomes. “More broadly, I think that we will need to see how well these techniques can be applied across different populations,” he added. “Because AI models such as these need to be trained, it will be important to see if they need to be retrained when used in countries where gastric cancer might present differently or with distinctive endoscopic equipment and techniques.”

The study authors, as well as Dr. Patel and Dr. Hoffman, had no conflicts of interest to disclose.

An artificial intelligence (AI) system called “ENDOANGEL” was effective for real-time monitoring of endoscopic “blind spots” and improved detection of early gastric cancer (EGC) during esophagogastroduodenoscopy (EGD), according to research published recently.

Science Photo Library/SCIEPRO/Brand X Pictures

While EGD is widely used to examine lesions found in the upper gastrointestinal tract, there is considerable variability among endoscopists regarding performance, resulting in a substantial miss rate for EGC. But in a study published in the journal Endoscopy, researchers suggest a more objective assessment of lesions with AI technology could improve detection rates in real time, thus improving the chances of establishing an early diagnosis and initiating prompt treatment of gastric cancer.

The researchers updated a developed AI system called WISENSE, which previously demonstrated an ability to monitor gastric areas overlooked during EGD (termed “blind spots”). The investigators integrated a trained real-time EGC detection model into the WISENSE system and changed the name of the updated system to ENDOANGEL.

Researchers from the Renmin Hospital of Wuhan (China) University used deep convolutional neural networks and deep reinforcement learning to develop the ENDOANGEL. A total of 1,050 patients from five hospitals in China who were undergoing EGD were randomized to either an ENDOANGEL-assisted protocol (n = 498) or a control group (n = 504) that did not use the ENDOANGEL system. Examination consisted of white-light imaging observation, magnifying image-enhanced endoscopy observation, and biopsy of suspicious lesions.

The investigators compared the groups in terms of the number of blind spots after the intervention. They assessed the performance of the AI-based ENDOANGEL system in its ability to predict EGC in a real-world clinical setting.

Patients assigned to ENDOANGEL had a significantly fewer mean number of blind spots compared with patients assigned to control (5.38 vs. 9.82, respectively; P < .001). Despite this advantage, patients in the ENDOANGEL group had significantly longer inspection time (5.40 minutes vs. 4.38 minutes; P < .001).

There were 819 lesions reported by endoscopists in the ENDOANGEL group, which included 196 gastric lesions with pathological results. According to the investigators, the ENDOANGEL system correctly predicted all three EGCs, including one mucosal carcinoma and two high grade neoplasias, as well as two advanced gastric cancers. The per-lesion accuracy was 84.7 %, while the sensitivity and specificity rates for detecting gastric cancer were 100% and 84.3%, respectively.

The authors noted limitations of the analysis itself and those stemming from the short follow-up, as well as possible bias introduced by unblinded statisticians. Further research is warranted, they wrote.

“In conclusion, ENDOANGEL, a system for improving endoscopy quality based on deep learning, achieved real-time monitoring of endoscopic blind spots, timing, and EGC detection during EGD,” according to the authors. “ENDOANGEL greatly improved the quality of EGD in this multicenter study, and showed potential for detecting EGC in real clinical settings.”
 

Spotting the blind spots

An AI-based system such as ENDOANGEL could overcome some of the natural weaknesses to standard diagnostic testing, thereby improving rates of EGC testing, David Hoffman, MD, a gastroenterology oncologist and medical director of Cedars-Sinai Cancer Beverly Hills, said in an interview. “I think that there are ethical questions that we’re going to have to grapple with respect to accessibility and data mining and what that really means,” said Dr. Hoffman, who wasn’t involved in the study. “But I think that in the optimistic view, using AI with machine learning and deep learning has tremendous potential for public health and for cancer medicine in particular.”

Dr. Hoffman added that beyond early detection of cancer, AI systems may hold additional benefits, particularly in regard to assisting decisions for personalized medicine and assisting in real-time surgical interventions. “Using AI with machine learning and deep learning has tremendous potential and I think it sort of is a natural offshoot into what we’re seeing in ... algorithmic approaches to use of big data, so it’s sort of a natural evolution in terms of medical applications,” he explained.

Anuj Patel, MD, a medical oncology specialist at the Dana-Farber Cancer Institute, Boston, who wasn’t involved in the new research, explained that any strategy that helps detect gastric cancer at earlier stages could have a visible global impact. “We have a lower incidence of gastric cancer in the United States, but the training of and clinical volume of early gastric cancers seen by different providers can vary,” Dr. Patel said in an interview. “AI systems could provide a second layer of evaluation during procedures where an endoscopist might otherwise miss the subtle features associated with some early gastric cancers.”

While the findings from the ENDOANGEL study appear promising, Dr. Patel noted that the most important long-term question is whether this reduction of endoscopic blind spots as a result of implementing the system will translate to meaningful improvements in patient outcomes. “More broadly, I think that we will need to see how well these techniques can be applied across different populations,” he added. “Because AI models such as these need to be trained, it will be important to see if they need to be retrained when used in countries where gastric cancer might present differently or with distinctive endoscopic equipment and techniques.”

The study authors, as well as Dr. Patel and Dr. Hoffman, had no conflicts of interest to disclose.

Key clinical point: Circulating biomarkers for inflammation, abnormal extracellular matrix remodeling, congestion, and myocardial injury were associated with alterations in cardiac structure and function that affected prognosis in patients with rheumatoid arthritis (RA).

Major finding: Left ventricular mass index (LVMi), left atrial volume index (LAVi), and diastolic function (E/e′) were associated with biomarkers of inflammation (tumor necrosis factor receptor superfamily member 11a, bone morphogenetic protein 9, and pentraxin-related protein 3), extracellular matrix remodeling (placental growth factor), congestion (N-terminal probrain natriuretic peptide and adrenomedullin), and myocardial injury (troponin; all P < .05). Higher LVMi (adjusted hazard ratio [aHR] 1.03; P < .001) and E/e¢ (aHR 1.06; P = .042) were associated with poor prognosis.

Study details: This study included 355 adult patients with RA from the RA Porto cohort.

Disclosures: No information on funding was provided. The authors declared no conflict of interests.

Source: Kobayashi M et al. Front Cardiovasc Med. 2021;8:754784 (Nov 18). Doi: 10.3389/fcvm.2021.754784.

Key clinical point: Circulating biomarkers for inflammation, abnormal extracellular matrix remodeling, congestion, and myocardial injury were associated with alterations in cardiac structure and function that affected prognosis in patients with rheumatoid arthritis (RA).

Major finding: Left ventricular mass index (LVMi), left atrial volume index (LAVi), and diastolic function (E/e′) were associated with biomarkers of inflammation (tumor necrosis factor receptor superfamily member 11a, bone morphogenetic protein 9, and pentraxin-related protein 3), extracellular matrix remodeling (placental growth factor), congestion (N-terminal probrain natriuretic peptide and adrenomedullin), and myocardial injury (troponin; all P < .05). Higher LVMi (adjusted hazard ratio [aHR] 1.03; P < .001) and E/e¢ (aHR 1.06; P = .042) were associated with poor prognosis.

Study details: This study included 355 adult patients with RA from the RA Porto cohort.

Disclosures: No information on funding was provided. The authors declared no conflict of interests.

Source: Kobayashi M et al. Front Cardiovasc Med. 2021;8:754784 (Nov 18). Doi: 10.3389/fcvm.2021.754784.

Key clinical point: Circulating biomarkers for inflammation, abnormal extracellular matrix remodeling, congestion, and myocardial injury were associated with alterations in cardiac structure and function that affected prognosis in patients with rheumatoid arthritis (RA).

Major finding: Left ventricular mass index (LVMi), left atrial volume index (LAVi), and diastolic function (E/e′) were associated with biomarkers of inflammation (tumor necrosis factor receptor superfamily member 11a, bone morphogenetic protein 9, and pentraxin-related protein 3), extracellular matrix remodeling (placental growth factor), congestion (N-terminal probrain natriuretic peptide and adrenomedullin), and myocardial injury (troponin; all P < .05). Higher LVMi (adjusted hazard ratio [aHR] 1.03; P < .001) and E/e¢ (aHR 1.06; P = .042) were associated with poor prognosis.

Study details: This study included 355 adult patients with RA from the RA Porto cohort.

Disclosures: No information on funding was provided. The authors declared no conflict of interests.

Source: Kobayashi M et al. Front Cardiovasc Med. 2021;8:754784 (Nov 18). Doi: 10.3389/fcvm.2021.754784.

Key clinical point: Herpes zoster (HZ) events occur in tofacitinib-treated patients with rheumatoid arthritis (RA), but most of them are nonserious, mild, or moderate with HZ events resolving in most patients.

Major finding: Overall, 11.1% and 8.0% of patients with RA experienced at least 1 or recurring HZ events, respectively. Most events were nonserious, mild, or moderate in severity, with the majority of the first (97.6%) and second (96.8%) HZ events resolved in most patients. Tofacitinib treatment remained unchanged in 47.3% of patients with the first HZ event and was temporarily or permanently discontinued in 42.8% and 9.1% of patients, respectively.

Study details: The data come from a post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) clinical studies involving 7,061 and 783 tofacitinib-treated patients with RA and PsA, respectively.

Disclosures: These studies were sponsored by Pfizer Inc. T Hirose, J L Rivas, and K Kwok reported being employees and shareholders of Pfizer Inc. Other authors reported receiving grant/research support and speaker/consultancy fees from various companies including Pfizer.

Source: Winthrop KL et al. Rheumatol Ther. 2021 (Dec 6). Doi: 10.1007/s40744-021-00390-0.

Key clinical point: Herpes zoster (HZ) events occur in tofacitinib-treated patients with rheumatoid arthritis (RA), but most of them are nonserious, mild, or moderate with HZ events resolving in most patients.

Major finding: Overall, 11.1% and 8.0% of patients with RA experienced at least 1 or recurring HZ events, respectively. Most events were nonserious, mild, or moderate in severity, with the majority of the first (97.6%) and second (96.8%) HZ events resolved in most patients. Tofacitinib treatment remained unchanged in 47.3% of patients with the first HZ event and was temporarily or permanently discontinued in 42.8% and 9.1% of patients, respectively.

Study details: The data come from a post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) clinical studies involving 7,061 and 783 tofacitinib-treated patients with RA and PsA, respectively.

Disclosures: These studies were sponsored by Pfizer Inc. T Hirose, J L Rivas, and K Kwok reported being employees and shareholders of Pfizer Inc. Other authors reported receiving grant/research support and speaker/consultancy fees from various companies including Pfizer.

Source: Winthrop KL et al. Rheumatol Ther. 2021 (Dec 6). Doi: 10.1007/s40744-021-00390-0.

Key clinical point: Herpes zoster (HZ) events occur in tofacitinib-treated patients with rheumatoid arthritis (RA), but most of them are nonserious, mild, or moderate with HZ events resolving in most patients.

Major finding: Overall, 11.1% and 8.0% of patients with RA experienced at least 1 or recurring HZ events, respectively. Most events were nonserious, mild, or moderate in severity, with the majority of the first (97.6%) and second (96.8%) HZ events resolved in most patients. Tofacitinib treatment remained unchanged in 47.3% of patients with the first HZ event and was temporarily or permanently discontinued in 42.8% and 9.1% of patients, respectively.

Study details: The data come from a post hoc analysis of pooled data from 21 RA and 3 psoriatic arthritis (PsA) clinical studies involving 7,061 and 783 tofacitinib-treated patients with RA and PsA, respectively.

Disclosures: These studies were sponsored by Pfizer Inc. T Hirose, J L Rivas, and K Kwok reported being employees and shareholders of Pfizer Inc. Other authors reported receiving grant/research support and speaker/consultancy fees from various companies including Pfizer.

Source: Winthrop KL et al. Rheumatol Ther. 2021 (Dec 6). Doi: 10.1007/s40744-021-00390-0.

Key clinical point: Consumption of flaxseed for 12 weeks improved disease activity and reduced pain, morning stiffness, and disease feeling in patients with rheumatoid arthritis (RA).

Major finding: Disease Activity Score 28-joints-erythrocyte sedimentation rate improved significantly in patients receiving flaxseed plus regular diet (RF; P = .001), but not in patients receiving flaxseed plus anti-inflammatory diet (AIF; P = .057) and roasted wheat plus regular diet (RW; P = .110). Significant reductions in pain severity (P ≤ .001), morning stiffness (P < .05), and disease feeling (P < .01) were observed in the AIF and RF groups.

Study details: This randomized controlled trial included 120 patients with RA who were randomly assigned to 12-week intervention with AIF, RF, or RW diet groups.

Disclosures: This study was funded by the Shiraz University of Medical Sciences, Shiraz, Iran. No disclosures were reported.

Source: Ghaseminasab-Parizi M et al. Eur J Nutr. 2021 (Nov 27). Doi: 10.1007/s00394-021-02707-9.

Key clinical point: Consumption of flaxseed for 12 weeks improved disease activity and reduced pain, morning stiffness, and disease feeling in patients with rheumatoid arthritis (RA).

Major finding: Disease Activity Score 28-joints-erythrocyte sedimentation rate improved significantly in patients receiving flaxseed plus regular diet (RF; P = .001), but not in patients receiving flaxseed plus anti-inflammatory diet (AIF; P = .057) and roasted wheat plus regular diet (RW; P = .110). Significant reductions in pain severity (P ≤ .001), morning stiffness (P < .05), and disease feeling (P < .01) were observed in the AIF and RF groups.

Study details: This randomized controlled trial included 120 patients with RA who were randomly assigned to 12-week intervention with AIF, RF, or RW diet groups.

Disclosures: This study was funded by the Shiraz University of Medical Sciences, Shiraz, Iran. No disclosures were reported.

Source: Ghaseminasab-Parizi M et al. Eur J Nutr. 2021 (Nov 27). Doi: 10.1007/s00394-021-02707-9.

Key clinical point: Consumption of flaxseed for 12 weeks improved disease activity and reduced pain, morning stiffness, and disease feeling in patients with rheumatoid arthritis (RA).

Major finding: Disease Activity Score 28-joints-erythrocyte sedimentation rate improved significantly in patients receiving flaxseed plus regular diet (RF; P = .001), but not in patients receiving flaxseed plus anti-inflammatory diet (AIF; P = .057) and roasted wheat plus regular diet (RW; P = .110). Significant reductions in pain severity (P ≤ .001), morning stiffness (P < .05), and disease feeling (P < .01) were observed in the AIF and RF groups.

Study details: This randomized controlled trial included 120 patients with RA who were randomly assigned to 12-week intervention with AIF, RF, or RW diet groups.

Disclosures: This study was funded by the Shiraz University of Medical Sciences, Shiraz, Iran. No disclosures were reported.

Source: Ghaseminasab-Parizi M et al. Eur J Nutr. 2021 (Nov 27). Doi: 10.1007/s00394-021-02707-9.

Key clinical point: Patients with rheumatoid arthritis (RA) do not exhibit an elevated risk for acute or 1-year postoperative surgical site infection following total knee arthroplasty (TKA) compared with patients with osteoarthritis.

Major finding: The risk for surgical site infection at 90 days (adjusted odds ratio [aOR] 0.81; P = .598) and 1 year (aOR 0.463; P = .26) post-TKA was not significantly different between patients with RA and osteoarthritis.

Study details: This retrospective cohort study included patients with RA (n = 1,126) and osteoarthritis (n = 63,215) who underwent primary TKA.

Disclosures: No external funding was received for this study. The authors declared no conflict of interests.

Source: Chung HK et al. Sci Rep. 2021;11:22704 (Nov 22). Doi: 10.1038/s41598-021-02153-x.

Key clinical point: Patients with rheumatoid arthritis (RA) do not exhibit an elevated risk for acute or 1-year postoperative surgical site infection following total knee arthroplasty (TKA) compared with patients with osteoarthritis.

Major finding: The risk for surgical site infection at 90 days (adjusted odds ratio [aOR] 0.81; P = .598) and 1 year (aOR 0.463; P = .26) post-TKA was not significantly different between patients with RA and osteoarthritis.

Study details: This retrospective cohort study included patients with RA (n = 1,126) and osteoarthritis (n = 63,215) who underwent primary TKA.

Disclosures: No external funding was received for this study. The authors declared no conflict of interests.

Source: Chung HK et al. Sci Rep. 2021;11:22704 (Nov 22). Doi: 10.1038/s41598-021-02153-x.

Key clinical point: Patients with rheumatoid arthritis (RA) do not exhibit an elevated risk for acute or 1-year postoperative surgical site infection following total knee arthroplasty (TKA) compared with patients with osteoarthritis.

Major finding: The risk for surgical site infection at 90 days (adjusted odds ratio [aOR] 0.81; P = .598) and 1 year (aOR 0.463; P = .26) post-TKA was not significantly different between patients with RA and osteoarthritis.

Study details: This retrospective cohort study included patients with RA (n = 1,126) and osteoarthritis (n = 63,215) who underwent primary TKA.

Disclosures: No external funding was received for this study. The authors declared no conflict of interests.

Source: Chung HK et al. Sci Rep. 2021;11:22704 (Nov 22). Doi: 10.1038/s41598-021-02153-x.

Key clinical point: Positive correlations between circulating inflammatory cytokines and coinhibitory checkpoint molecules modulated by anticitrullinated peptide antibodies (ACPA) or joint damage stage existed in patients with rheumatoid arthritis (RA).

Major finding: Serum levels of interleukin-6 (IL-6) and tumor necrosis factor-a (TNF-α) were positively associated with RA disease activity and galectin-9, independent of ACPA titers (all P < .05) and with soluble T-cell immunoglobulin and mucin-domain containing-3 in patients with ACPA <200 U/mL (P < .05). Galectin-9 was positively correlated with IL-6 (P = .005) only in patients without advanced joint damage and with TNF-a (P = .001) and IL-6 (P = .02) in patients with advanced joint damage.

Study details: This retrospective analysis included 132 patients with RA.

Disclosures: The work was funded by the Japan Grant-in-Aid for Scientific Research. K Migita received grants from Chugai, Pfizer, and AbbVie. Other authors declared no conflict of interests.

Source: Matsumoto H et al. PLoS One. 2021;16(11):e0260254 (Nov 18). Doi: 10.1371/journal.pone.0260254.

Key clinical point: Positive correlations between circulating inflammatory cytokines and coinhibitory checkpoint molecules modulated by anticitrullinated peptide antibodies (ACPA) or joint damage stage existed in patients with rheumatoid arthritis (RA).

Major finding: Serum levels of interleukin-6 (IL-6) and tumor necrosis factor-a (TNF-α) were positively associated with RA disease activity and galectin-9, independent of ACPA titers (all P < .05) and with soluble T-cell immunoglobulin and mucin-domain containing-3 in patients with ACPA <200 U/mL (P < .05). Galectin-9 was positively correlated with IL-6 (P = .005) only in patients without advanced joint damage and with TNF-a (P = .001) and IL-6 (P = .02) in patients with advanced joint damage.

Study details: This retrospective analysis included 132 patients with RA.

Disclosures: The work was funded by the Japan Grant-in-Aid for Scientific Research. K Migita received grants from Chugai, Pfizer, and AbbVie. Other authors declared no conflict of interests.

Source: Matsumoto H et al. PLoS One. 2021;16(11):e0260254 (Nov 18). Doi: 10.1371/journal.pone.0260254.

Key clinical point: Positive correlations between circulating inflammatory cytokines and coinhibitory checkpoint molecules modulated by anticitrullinated peptide antibodies (ACPA) or joint damage stage existed in patients with rheumatoid arthritis (RA).

Major finding: Serum levels of interleukin-6 (IL-6) and tumor necrosis factor-a (TNF-α) were positively associated with RA disease activity and galectin-9, independent of ACPA titers (all P < .05) and with soluble T-cell immunoglobulin and mucin-domain containing-3 in patients with ACPA <200 U/mL (P < .05). Galectin-9 was positively correlated with IL-6 (P = .005) only in patients without advanced joint damage and with TNF-a (P = .001) and IL-6 (P = .02) in patients with advanced joint damage.

Study details: This retrospective analysis included 132 patients with RA.

Disclosures: The work was funded by the Japan Grant-in-Aid for Scientific Research. K Migita received grants from Chugai, Pfizer, and AbbVie. Other authors declared no conflict of interests.

Source: Matsumoto H et al. PLoS One. 2021;16(11):e0260254 (Nov 18). Doi: 10.1371/journal.pone.0260254.

Key clinical point: Complete treatment adherence has still not been achieved in rheumatoid arthritis (RA), and factors like having patient-physician agreement on the treatment and the type of treatment prescribed are significant predictors of adherence.

Major finding: The 6-month prevalence of adherence was 59.1% (95% CI 48.1%-71.8%), with treatment agreement between patient and physician (odds ratio [OR] 4.29; P = .01) and information adaptation (OR 1.54; P = .015) being significant predictors of adherence. Treatment adherence was higher with second-line conventional synthetic disease-modifying rheumatic drug (csDMARD; OR 4.72; P = .005) and biological DMARDs/targeted synthetic DMARDs (OR 3.50; P = .029) vs. first-line csDMARDs.

Study details: This was a 6-month observational longitudinal prospective cohort study involving 180 patients with RA.

Disclosures: The ADHIERA trial was supported by a grant from Roche España to the Spanish Foundation of Rheumatology. A Balsa reported receiving speaker fees from various sources including Roche. Two other authors did not receive fees or personal grants from any laboratory, although their institute works by contract for laboratories for various sources.

Source: Balsa A et al. Ann Rheum Dis. 2021 (Nov 29). Doi: 10.1136/annrheumdis-2021-221163.

Key clinical point: Complete treatment adherence has still not been achieved in rheumatoid arthritis (RA), and factors like having patient-physician agreement on the treatment and the type of treatment prescribed are significant predictors of adherence.

Major finding: The 6-month prevalence of adherence was 59.1% (95% CI 48.1%-71.8%), with treatment agreement between patient and physician (odds ratio [OR] 4.29; P = .01) and information adaptation (OR 1.54; P = .015) being significant predictors of adherence. Treatment adherence was higher with second-line conventional synthetic disease-modifying rheumatic drug (csDMARD; OR 4.72; P = .005) and biological DMARDs/targeted synthetic DMARDs (OR 3.50; P = .029) vs. first-line csDMARDs.

Study details: This was a 6-month observational longitudinal prospective cohort study involving 180 patients with RA.

Disclosures: The ADHIERA trial was supported by a grant from Roche España to the Spanish Foundation of Rheumatology. A Balsa reported receiving speaker fees from various sources including Roche. Two other authors did not receive fees or personal grants from any laboratory, although their institute works by contract for laboratories for various sources.

Source: Balsa A et al. Ann Rheum Dis. 2021 (Nov 29). Doi: 10.1136/annrheumdis-2021-221163.

Key clinical point: Complete treatment adherence has still not been achieved in rheumatoid arthritis (RA), and factors like having patient-physician agreement on the treatment and the type of treatment prescribed are significant predictors of adherence.

Major finding: The 6-month prevalence of adherence was 59.1% (95% CI 48.1%-71.8%), with treatment agreement between patient and physician (odds ratio [OR] 4.29; P = .01) and information adaptation (OR 1.54; P = .015) being significant predictors of adherence. Treatment adherence was higher with second-line conventional synthetic disease-modifying rheumatic drug (csDMARD; OR 4.72; P = .005) and biological DMARDs/targeted synthetic DMARDs (OR 3.50; P = .029) vs. first-line csDMARDs.

Study details: This was a 6-month observational longitudinal prospective cohort study involving 180 patients with RA.

Disclosures: The ADHIERA trial was supported by a grant from Roche España to the Spanish Foundation of Rheumatology. A Balsa reported receiving speaker fees from various sources including Roche. Two other authors did not receive fees or personal grants from any laboratory, although their institute works by contract for laboratories for various sources.

Source: Balsa A et al. Ann Rheum Dis. 2021 (Nov 29). Doi: 10.1136/annrheumdis-2021-221163.