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In Refractory IBD, Combination Therapies Appear Safe, Effective
LAS VEGAS — . The study updates a meta-analysis published in 2022, which included 13 studies. The new work included 23 studies that looked at 8 different combinations.
There is a potential concern that the high adverse event rates seen in biologics could be compounded when they are used in combination, according to Ali Osman, MD, who presented the results at a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Theoretically, you should have more side effects or more serious side effects, but interestingly we didn’t find major side effects. I think the key message is that the combinations of biologic agents are promising in terms of efficacy. In terms of adverse events, it doesn’t lead to major adverse events,” said Dr. Osman, an instructor at Washington University School of Medicine in St. Louis.
Although the study did not directly compare the combinations, it did find potential differences in efficacy. “Our most effective [combination] in terms of response and remission was a combination of ustekinumab and an anti-TNF agent with a combined rate of 81.6%. Our lowest adverse events rate were [with the combination of] tofacitinib and vedolizumab,” said Dr. Osman.
The research is a useful update, according to David T. Rubin, MD, AGAF, who was asked for comment. “This has been explored before, but this is a nice effort to describe and try to compare studies of combination biological therapies or biologicals combined with [the JAK inhibitor]. This is to further explore the efforts being made to break the therapeutic ceiling by combining mechanisms, treat IBD and extra-intestinal manifestations with multiple agents simultaneously, and to explore novel treatment strategies,” said Dr. Rubin, professor of medicine and director of the Inflammatory Bowel Disease Center at University of Chicago Medicine.
He noted that the meta-analysis is limited by heterogeneity among the studies, many of which were case series that had been re-analyzed. The update included some prospective proof-of-concept studies of interest that were not in the earlier meta-analysis, including VEGA (anti-IL13 guselkumab plus anti-TNF golimumab versus either drug alone), and EXPLORER (vedolizumab, adalimumab, methotrexate), as well as a study of infliximab combined with natalizumab.
“We await the ongoing prospective trials of dual targeted therapies and novel designs for a future that will undoubtedly include thoughtful and rational combinations,” said Dr. Rubin.
The review included 23 studies that had a minimum of two patients who were treated with a combination of two biologics or a biologic and tofacitinib. The biologics included the anti-TNF antibodies adalimumab, certolizumab pegol, golimumab, and infliximab; as well as guselkumab, natalizumab, ustekinumab, and vedolizumab. Overall, the studies included 531 patients who underwent 543 therapeutic trials, using 8 different combinations.
The highest pooled clinical response observed was 81.6% with ustekinumab combined with an anti-TNF agent (P = .04, 9 studies, 44 therapeutic trials), which also had the highest remission rate of 64.2% (P = .03).
For the treatment of Crohn’s disease, the highest pooled clinical response and remission rates were also seen with ustekinumab combined with an anti-TNF agent (8 studies, 29 therapeutic trials), at 91.6% (P = .28). In ulcerative colitis, vedolizumab plus ustekinumab had the highest pooled clinical response rate at 100.0% (P = 1.00; 4 studies, 4 treatment trials) and ustekinumab plus an anti-TNF agent F at 100.0% (P = 1.00; 4 studies, 5 treatment trials).
Tofacitinib combined with vedolizumab had the lower adverse event rate (12.5%; P = .10; 8 studies, 76 treatment trials) followed by ustekinumab and an anti-TNF agent (12.7%; P = .08; 9 studies, 43 treatment trials) and tofacitinib plus anti-TNF (13.0%; 6 studies, 27 treatment trials).
Other combinations included guselkumab plus ant-TNF (1 study; clinical response, 69.0%), natalizumab plus an anti-TNF agent (1 study, clinical response, 36.5%), tofacitinib plus an anti-TNF agent (5 studies, clinical response, 71.6%), tofacitinib plus ustekinumab (5 studies, clinical response, 70.8%), tofacitinib plus vedolizumab (8 studies, clinical response, 52.7%), vedolizumab plus an anti-TNF agent (13 studies, clinical response, 62.8%), and vedolizumab plus ustekinumab (12 studies, clinical response, 79.3%).
Dr. Osman has no relevant financial conflicts of interest. Dr. Rubin has received grant support from Takeda, and has served as a consultant for Abbvie, Bristol-Myers Squibb, Janssen Pharmaceuticals, Lilly, Pfizer, and Takeda.
LAS VEGAS — . The study updates a meta-analysis published in 2022, which included 13 studies. The new work included 23 studies that looked at 8 different combinations.
There is a potential concern that the high adverse event rates seen in biologics could be compounded when they are used in combination, according to Ali Osman, MD, who presented the results at a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Theoretically, you should have more side effects or more serious side effects, but interestingly we didn’t find major side effects. I think the key message is that the combinations of biologic agents are promising in terms of efficacy. In terms of adverse events, it doesn’t lead to major adverse events,” said Dr. Osman, an instructor at Washington University School of Medicine in St. Louis.
Although the study did not directly compare the combinations, it did find potential differences in efficacy. “Our most effective [combination] in terms of response and remission was a combination of ustekinumab and an anti-TNF agent with a combined rate of 81.6%. Our lowest adverse events rate were [with the combination of] tofacitinib and vedolizumab,” said Dr. Osman.
The research is a useful update, according to David T. Rubin, MD, AGAF, who was asked for comment. “This has been explored before, but this is a nice effort to describe and try to compare studies of combination biological therapies or biologicals combined with [the JAK inhibitor]. This is to further explore the efforts being made to break the therapeutic ceiling by combining mechanisms, treat IBD and extra-intestinal manifestations with multiple agents simultaneously, and to explore novel treatment strategies,” said Dr. Rubin, professor of medicine and director of the Inflammatory Bowel Disease Center at University of Chicago Medicine.
He noted that the meta-analysis is limited by heterogeneity among the studies, many of which were case series that had been re-analyzed. The update included some prospective proof-of-concept studies of interest that were not in the earlier meta-analysis, including VEGA (anti-IL13 guselkumab plus anti-TNF golimumab versus either drug alone), and EXPLORER (vedolizumab, adalimumab, methotrexate), as well as a study of infliximab combined with natalizumab.
“We await the ongoing prospective trials of dual targeted therapies and novel designs for a future that will undoubtedly include thoughtful and rational combinations,” said Dr. Rubin.
The review included 23 studies that had a minimum of two patients who were treated with a combination of two biologics or a biologic and tofacitinib. The biologics included the anti-TNF antibodies adalimumab, certolizumab pegol, golimumab, and infliximab; as well as guselkumab, natalizumab, ustekinumab, and vedolizumab. Overall, the studies included 531 patients who underwent 543 therapeutic trials, using 8 different combinations.
The highest pooled clinical response observed was 81.6% with ustekinumab combined with an anti-TNF agent (P = .04, 9 studies, 44 therapeutic trials), which also had the highest remission rate of 64.2% (P = .03).
For the treatment of Crohn’s disease, the highest pooled clinical response and remission rates were also seen with ustekinumab combined with an anti-TNF agent (8 studies, 29 therapeutic trials), at 91.6% (P = .28). In ulcerative colitis, vedolizumab plus ustekinumab had the highest pooled clinical response rate at 100.0% (P = 1.00; 4 studies, 4 treatment trials) and ustekinumab plus an anti-TNF agent F at 100.0% (P = 1.00; 4 studies, 5 treatment trials).
Tofacitinib combined with vedolizumab had the lower adverse event rate (12.5%; P = .10; 8 studies, 76 treatment trials) followed by ustekinumab and an anti-TNF agent (12.7%; P = .08; 9 studies, 43 treatment trials) and tofacitinib plus anti-TNF (13.0%; 6 studies, 27 treatment trials).
Other combinations included guselkumab plus ant-TNF (1 study; clinical response, 69.0%), natalizumab plus an anti-TNF agent (1 study, clinical response, 36.5%), tofacitinib plus an anti-TNF agent (5 studies, clinical response, 71.6%), tofacitinib plus ustekinumab (5 studies, clinical response, 70.8%), tofacitinib plus vedolizumab (8 studies, clinical response, 52.7%), vedolizumab plus an anti-TNF agent (13 studies, clinical response, 62.8%), and vedolizumab plus ustekinumab (12 studies, clinical response, 79.3%).
Dr. Osman has no relevant financial conflicts of interest. Dr. Rubin has received grant support from Takeda, and has served as a consultant for Abbvie, Bristol-Myers Squibb, Janssen Pharmaceuticals, Lilly, Pfizer, and Takeda.
LAS VEGAS — . The study updates a meta-analysis published in 2022, which included 13 studies. The new work included 23 studies that looked at 8 different combinations.
There is a potential concern that the high adverse event rates seen in biologics could be compounded when they are used in combination, according to Ali Osman, MD, who presented the results at a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “Theoretically, you should have more side effects or more serious side effects, but interestingly we didn’t find major side effects. I think the key message is that the combinations of biologic agents are promising in terms of efficacy. In terms of adverse events, it doesn’t lead to major adverse events,” said Dr. Osman, an instructor at Washington University School of Medicine in St. Louis.
Although the study did not directly compare the combinations, it did find potential differences in efficacy. “Our most effective [combination] in terms of response and remission was a combination of ustekinumab and an anti-TNF agent with a combined rate of 81.6%. Our lowest adverse events rate were [with the combination of] tofacitinib and vedolizumab,” said Dr. Osman.
The research is a useful update, according to David T. Rubin, MD, AGAF, who was asked for comment. “This has been explored before, but this is a nice effort to describe and try to compare studies of combination biological therapies or biologicals combined with [the JAK inhibitor]. This is to further explore the efforts being made to break the therapeutic ceiling by combining mechanisms, treat IBD and extra-intestinal manifestations with multiple agents simultaneously, and to explore novel treatment strategies,” said Dr. Rubin, professor of medicine and director of the Inflammatory Bowel Disease Center at University of Chicago Medicine.
He noted that the meta-analysis is limited by heterogeneity among the studies, many of which were case series that had been re-analyzed. The update included some prospective proof-of-concept studies of interest that were not in the earlier meta-analysis, including VEGA (anti-IL13 guselkumab plus anti-TNF golimumab versus either drug alone), and EXPLORER (vedolizumab, adalimumab, methotrexate), as well as a study of infliximab combined with natalizumab.
“We await the ongoing prospective trials of dual targeted therapies and novel designs for a future that will undoubtedly include thoughtful and rational combinations,” said Dr. Rubin.
The review included 23 studies that had a minimum of two patients who were treated with a combination of two biologics or a biologic and tofacitinib. The biologics included the anti-TNF antibodies adalimumab, certolizumab pegol, golimumab, and infliximab; as well as guselkumab, natalizumab, ustekinumab, and vedolizumab. Overall, the studies included 531 patients who underwent 543 therapeutic trials, using 8 different combinations.
The highest pooled clinical response observed was 81.6% with ustekinumab combined with an anti-TNF agent (P = .04, 9 studies, 44 therapeutic trials), which also had the highest remission rate of 64.2% (P = .03).
For the treatment of Crohn’s disease, the highest pooled clinical response and remission rates were also seen with ustekinumab combined with an anti-TNF agent (8 studies, 29 therapeutic trials), at 91.6% (P = .28). In ulcerative colitis, vedolizumab plus ustekinumab had the highest pooled clinical response rate at 100.0% (P = 1.00; 4 studies, 4 treatment trials) and ustekinumab plus an anti-TNF agent F at 100.0% (P = 1.00; 4 studies, 5 treatment trials).
Tofacitinib combined with vedolizumab had the lower adverse event rate (12.5%; P = .10; 8 studies, 76 treatment trials) followed by ustekinumab and an anti-TNF agent (12.7%; P = .08; 9 studies, 43 treatment trials) and tofacitinib plus anti-TNF (13.0%; 6 studies, 27 treatment trials).
Other combinations included guselkumab plus ant-TNF (1 study; clinical response, 69.0%), natalizumab plus an anti-TNF agent (1 study, clinical response, 36.5%), tofacitinib plus an anti-TNF agent (5 studies, clinical response, 71.6%), tofacitinib plus ustekinumab (5 studies, clinical response, 70.8%), tofacitinib plus vedolizumab (8 studies, clinical response, 52.7%), vedolizumab plus an anti-TNF agent (13 studies, clinical response, 62.8%), and vedolizumab plus ustekinumab (12 studies, clinical response, 79.3%).
Dr. Osman has no relevant financial conflicts of interest. Dr. Rubin has received grant support from Takeda, and has served as a consultant for Abbvie, Bristol-Myers Squibb, Janssen Pharmaceuticals, Lilly, Pfizer, and Takeda.
FROM CROHN’S & COLITIS CONGRESS
Telephone Best for Switching Patients to New Colonoscopy Intervals
In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:
- Telephone: 64.5%
- Secure messaging: 51.7%
- Mailed letter: 31.3%
Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).
Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.
The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).
In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.
Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).
Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.
“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”
“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.
More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.
With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
Study Details
The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.
As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”
But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
Downsides to Retroactive Changes?
Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.
“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.
Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.
Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”
While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”
As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.” Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.
The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.
The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.
In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:
- Telephone: 64.5%
- Secure messaging: 51.7%
- Mailed letter: 31.3%
Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).
Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.
The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).
In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.
Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).
Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.
“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”
“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.
More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.
With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
Study Details
The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.
As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”
But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
Downsides to Retroactive Changes?
Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.
“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.
Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.
Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”
While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”
As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.” Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.
The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.
The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.
In an article published in Clinical Gastroenterology and Hepatology, a group led by Jeffrey K. Lee, MD, MPH, a gastroenterologist at Kaiser Permanente Medical Center in San Francisco, reported the following 60-day response rates for the three contact methods in potentially transitioning more than 600 post-polypectomy patients to the new interval:
- Telephone: 64.5%
- Secure messaging: 51.7%
- Mailed letter: 31.3%
Compared with letter outreach, overall rate differences were significant for telephone (18.1%) and secure message outreach (13.1%).
Such interventions are widely used, the authors noted , but have not been compared for efficacy terms of communicating updated colonoscopy intervals.
The trial’s aim was to inform low-risk patients of the recommended interval update from 5 years — used since the 1990s — to 7-10 years. Given a choice, more patients opted to transition to the 10-year surveillance interval in the telephone (37%) and secure messaging arms (32.%) compared with mailed-letter arm (18.9%).
In addition to telephone and secure messaging outreach, factors positively associated with adoption of the 10-year interval were a positive fecal immunochemical test–based index colonoscopy and increasing age. Patients with these characteristics may be biased toward avoiding colonoscopy if not medically necessary, the authors conjectured.
Inversely associated factors included Asian or Pacific Islander race (odds ratio .58), Hispanic ethnicity (OR .40), and a higher Charlson comorbidity score of 2 vs 0 (OR .43).
Possible explanations for the race and ethnicity associations include gaps in culturally component care, lack of engagement with the English-based outreach approaches, and medical mistrust, the authors said.
“In this study, we gave all our patients an option to either extend their surveillance interval to current guideline recommendations or continue with their old interval, and some chose to do that,” Dr. Lee said in an interview. “Patients really appreciated having a choice and to be informed about the latest guideline changes.”
“A critical challenge to health systems is how to effectively de-implement outdated surveillance recommendations for low-risk patients who have a 5-year follow-up interval and potentially transition them to the recommended 7- to 10-year interval,” Dr. Lee and colleagues wrote.
More than 5 million surveillance colonoscopies are performed annually in US patients with a history of adenomas, the main precursor lesion for colorectal cancer, the authors noted.
With the recent guidelines issued in 2020 by the US Multi-Society Task Force on Colorectal Cancer lengthening the follow-up interval to 7-10 years , physicians are being advised to reevaluate low-risk patients previously scheduled with 5-year surveillance and provide an updated recommendation for follow-up.
Study Details
The three-arm pragmatic randomized trial was conducted in low-risk patients 54-70 years of age with one or two small (< 10 mm) tubular adenomas at baseline colonoscopy. Participants due for 5-year surveillance in 2022 were randomly assigned to one of three outreach arms: telephone (n = 200], secure messaging (n = 203), and mailed letter (n = 201). Stratified by age, sex, race, and ethnicity, participants could change their assigned interval to 10 years or continue with their previously scheduled 5-year interval.
As to economic considerations, the authors said that telephone may be the costliest form of outreach in terms of staffing resources. “We don’t know because we did not conduct a formal cost-effectiveness analysis,” Dr. Lee said. “However, we do know phone outreach requires a lot of personnel effort, which is why we also explored the less costly option of secure messaging/email.”
But based on the findings, telephone outreach would be a reasonable approach to update patients on post-polypectomy surveillance guideline changes if secure messaging or text messaging isn’t available, he added.
Downsides to Retroactive Changes?
Commenting on the study but not involved in it, Nabil M. Mansour, MD, an assistant professor and director of the McNair General GI Clinic at Baylor College of Medicine in Houston, noted that unlike Kaiser Permanente, his center decided against an overall effort to switch patients colonoscopied before the release of the new guidelines over to the new interval.
“Several of our physicians may have chosen to recommend a 5-year interval specifically for a variety of reasons and we felt going back, and making a blanket change to everyone’s interval retrospectively might create confusion and frustration and might actually delay the colonoscopies of some patients for which their doctors had a very good, legitimate reason to recommend a 5-year interval,” he said in an interview.
Dr. Mansour added that no difficulties were encountered in getting patients to agree to a 10-year interval. In his view telephone communication or in-person clinic visits are likely the most effective ways but both are more labor-intensive than automated patient portal messages. “I do not think traditional snail mail is effective.” His clinic uses automatic EMR reminders.
Offering another perspective on the study, Aditya Sreenivasan, MD, a gastroenterologist at Northwell Health in New York City, said his center has not reached out to correct the old intervals. “When I see a patient who previously had a colonoscopy with another physician, I always follow the previous recommendation for when the next colonoscopy should be, regardless of whether or not it technically meets guideline recommendations,” he told this news organization. “I do this because I was not there during the procedure and am not aware of any circumstances that would require a shorter interval that may not be apparent from the report.”
While he agrees with the new guidelines, Dr. Sreenivasan is “not sure if retroactively changing intervals is beneficial to patients, as the presence of guidelines may subconsciously influence the behavior of the endoscopist at the time of the procedure. For example, if a patient has a technically challenging colonoscopy and the endoscopist is running late, the endoscopist may drop their guard once they find a polyp and miss 1-2 additional small polyps that they would have spent more time looking for if they knew their next one would be in 10 years instead of 5.”
As for notification method, despite the logistical downside of taking dedicated staff time to make telephone calls, Dr. Sreenivasan said, “I think having a conversation with the patient directly is a much better way to communicate this information as it allows the patient to ask and answer questions. Things like tone of voice can provide reassurance that one cannot get via email.” Looking to the future, the study authors acknowledged that combinations of initial and reminder outreach approaches — for example, a mailed letter followed by secure message or telephone call — could potentially yield higher response rates and/or adoption rates than they observed. And a longer follow-up period with additional reminders may have produced higher yields. Additional studies are needed to optimize outreach approaches and to understand patient barriers to adopting the new guideline recommendations in different healthcare settings.
The study was supported by a Delivery Science grant from the Kaiser Permanente Northern California.
The authors disclosed no conflicts of interest. Dr. Mansour and Dr. Sreenivasan disclosed no conflicts of interest relevant to their comments.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Working together
Dear Friends,
After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.
Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.
In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.
As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.
Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.
If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
Yours truly,
Judy A. Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Dear Friends,
After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.
Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.
In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.
As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.
Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.
If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
Yours truly,
Judy A. Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Dear Friends,
After 6 months in my first faculty position, I have come to appreciate the term “multidisciplinary approach” more than ever. Not only does this facilitate optimal patient care, but I have personally learned so much from experts in other fields. This theme resonates across this issue of The New Gastroenterologist, from treating complex gallbladder disease, to caring for sexual and gender minorities, and collaborating with the tech industry to advance patient care.
Our “In Focus” feature, written by Dr. Andrew Gilman and Dr. Todd Baron, is on endoscopic management of gallbladder disease. They review endoscopic treatment options in patients with benign gallbladder disease, with emphasis on working with surgical and interventional radiology colleagues, as well as relaying endoscopic tips and techniques to achieve success in these complicated procedures.
In the “Short Clinical Reviews” section, Dr. David Chiang and Dr. Victor Chedid highlight the gaps in research and clinical care and competency for sexual and gender minorities, particularly in patients with inflammatory bowel disease. They describe the creation of the Pride in IBD clinic at Mayo Clinic in Rochester, Minn., that creates a culturally sensitive space to care for this community.
As trainees transition to early faculty, becoming a mentor is a new role that can be very rewarding and daunting at the same time. Dr. Anna Lok, recipient of the AGA’s Distinguished Mentor Award, and Dr. Vincent Chen share invaluable experiences and advice on being a mentor from senior and early-career perspectives, respectively. Similarly in the transition to early faculty, Erin Anderson, CPA, answers five common financial questions that arise to better understand and manage a significant increase in salary.
Lastly, Dr. Shifa Umar describes her unique experience as part of the AGA’s annual Tech Summit Fellows Program, a cross-section of medicine, technology, and innovation.
If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu), or Jillian Schweitzer (jschweitzer@gastro.org), managing editor of TNG.
Until next time, I leave you with a historical fun fact because we would not be where we are now without appreciating where we were: The concept of the clinicopathologic conference (CPC) was introduced by Dr. Walter B. Cannon as a medical student at Harvard Medical School.
Yours truly,
Judy A. Trieu, MD, MPH
Editor-in-Chief
Interventional Endoscopy, Division of Gastroenterology
Washington University in St. Louis
Cell-Free DNA May Inform IBD Diagnosis
LAS VEGAS —
“We think for indeterminate colitis, our assay can be quite beneficial in helping a clinician resolve or provide some additional insight and information. We have a very robust ability to predict from just the plasma microbial cell free DNA alone [whether] individuals are in remission or mild or moderate or active disease,” Shiv Kale, PhD, said during a presentation of the results at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. Dr. Kale is director of computational biomarker discovery at Karius Inc., a company whose Karius Test is also being developed as a rapid test for various infections and febrile neutropenia.
cfDNA has proved to be a useful biomarker for a range of conditions, including cancer screening, diagnosis and monitoring, prenatal testing, and organ monitoring following transplantation. The tests rely on the fact that both human and microbial cells release DNA after cell death, and it is readily detectable in plasma.
Dr. Kale described the company’s efforts to identify microbial species biomarkers and a classification scheme that he said leads to consistent performance.
The latest study included 196 patients with Crohn’s disease and 196 with ulcerative colitis, with each group including individuals in remission and with mild, moderate, and severe disease. All patients had an endoscopic assessment within 30 days of plasma measurements.
cfDNA distinguished between patients with Crohn’s disease, ulcerative colitis, and those who were asymptomatic. It distinguished between patients with IBD and those who were asymptomatic with a sensitivity of 99.5% and a specificity of 90%, which are equivalent to or better than other traditional measures to distinguish active IBD versus asymptomatic patients.
The researchers plan a follow-up study of 1,800 samples in partnership with the Crohn’s and Colitis Foundation to examine the ability of cfDNA to determine disease severity, as well as location of disease and Crohn’s disease subtypes.
An ‘Intriguing’ Method
During the Q&A session, one questioner pointed out that colorectal cancer and infections can produce microbial signatures that could be confounding the results. He asked: “Do you have a data set to compare [cfDNA findings] to serum from C. diff, norovirus, and colorectal cancer? And if you don’t, I strongly encourage you to do so.” Dr. Kale responded that the group is working on that.
Asked for comment, session moderator Dana Lukin, MD, AGAF, offered praise for the work.
“I think it’s an intriguing method that we haven’t seen used as a predictor in IBD. Using this as a biomarker of disease type is very intriguing for confirming a diagnosis. I think probably one of the most compelling points is the distinction between IBD and non-IBD. Our current serologic-based assays do not really do that very well. I think this is a big improvement on that,” said Dr. Lukin, associate professor of clinical medicine at Weill Cornell Medical College, New York.
He echoed the questioner’s comments, suggesting that a key question will be whether cfDNA can correlate with disease activity over time.
He also called for prospective studies to validate the approach.
If successful, the technology could have broad application. “Certainly in kids this might be useful or in folks that either aren’t as inclined to have invasive testing done, or for whatever logistic reasons it’s not easy,” said Dr. Lukin.
Dr. Kale is an employee of Karius. Dr. Lukin has no relevant financial disclosures..
LAS VEGAS —
“We think for indeterminate colitis, our assay can be quite beneficial in helping a clinician resolve or provide some additional insight and information. We have a very robust ability to predict from just the plasma microbial cell free DNA alone [whether] individuals are in remission or mild or moderate or active disease,” Shiv Kale, PhD, said during a presentation of the results at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. Dr. Kale is director of computational biomarker discovery at Karius Inc., a company whose Karius Test is also being developed as a rapid test for various infections and febrile neutropenia.
cfDNA has proved to be a useful biomarker for a range of conditions, including cancer screening, diagnosis and monitoring, prenatal testing, and organ monitoring following transplantation. The tests rely on the fact that both human and microbial cells release DNA after cell death, and it is readily detectable in plasma.
Dr. Kale described the company’s efforts to identify microbial species biomarkers and a classification scheme that he said leads to consistent performance.
The latest study included 196 patients with Crohn’s disease and 196 with ulcerative colitis, with each group including individuals in remission and with mild, moderate, and severe disease. All patients had an endoscopic assessment within 30 days of plasma measurements.
cfDNA distinguished between patients with Crohn’s disease, ulcerative colitis, and those who were asymptomatic. It distinguished between patients with IBD and those who were asymptomatic with a sensitivity of 99.5% and a specificity of 90%, which are equivalent to or better than other traditional measures to distinguish active IBD versus asymptomatic patients.
The researchers plan a follow-up study of 1,800 samples in partnership with the Crohn’s and Colitis Foundation to examine the ability of cfDNA to determine disease severity, as well as location of disease and Crohn’s disease subtypes.
An ‘Intriguing’ Method
During the Q&A session, one questioner pointed out that colorectal cancer and infections can produce microbial signatures that could be confounding the results. He asked: “Do you have a data set to compare [cfDNA findings] to serum from C. diff, norovirus, and colorectal cancer? And if you don’t, I strongly encourage you to do so.” Dr. Kale responded that the group is working on that.
Asked for comment, session moderator Dana Lukin, MD, AGAF, offered praise for the work.
“I think it’s an intriguing method that we haven’t seen used as a predictor in IBD. Using this as a biomarker of disease type is very intriguing for confirming a diagnosis. I think probably one of the most compelling points is the distinction between IBD and non-IBD. Our current serologic-based assays do not really do that very well. I think this is a big improvement on that,” said Dr. Lukin, associate professor of clinical medicine at Weill Cornell Medical College, New York.
He echoed the questioner’s comments, suggesting that a key question will be whether cfDNA can correlate with disease activity over time.
He also called for prospective studies to validate the approach.
If successful, the technology could have broad application. “Certainly in kids this might be useful or in folks that either aren’t as inclined to have invasive testing done, or for whatever logistic reasons it’s not easy,” said Dr. Lukin.
Dr. Kale is an employee of Karius. Dr. Lukin has no relevant financial disclosures..
LAS VEGAS —
“We think for indeterminate colitis, our assay can be quite beneficial in helping a clinician resolve or provide some additional insight and information. We have a very robust ability to predict from just the plasma microbial cell free DNA alone [whether] individuals are in remission or mild or moderate or active disease,” Shiv Kale, PhD, said during a presentation of the results at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. Dr. Kale is director of computational biomarker discovery at Karius Inc., a company whose Karius Test is also being developed as a rapid test for various infections and febrile neutropenia.
cfDNA has proved to be a useful biomarker for a range of conditions, including cancer screening, diagnosis and monitoring, prenatal testing, and organ monitoring following transplantation. The tests rely on the fact that both human and microbial cells release DNA after cell death, and it is readily detectable in plasma.
Dr. Kale described the company’s efforts to identify microbial species biomarkers and a classification scheme that he said leads to consistent performance.
The latest study included 196 patients with Crohn’s disease and 196 with ulcerative colitis, with each group including individuals in remission and with mild, moderate, and severe disease. All patients had an endoscopic assessment within 30 days of plasma measurements.
cfDNA distinguished between patients with Crohn’s disease, ulcerative colitis, and those who were asymptomatic. It distinguished between patients with IBD and those who were asymptomatic with a sensitivity of 99.5% and a specificity of 90%, which are equivalent to or better than other traditional measures to distinguish active IBD versus asymptomatic patients.
The researchers plan a follow-up study of 1,800 samples in partnership with the Crohn’s and Colitis Foundation to examine the ability of cfDNA to determine disease severity, as well as location of disease and Crohn’s disease subtypes.
An ‘Intriguing’ Method
During the Q&A session, one questioner pointed out that colorectal cancer and infections can produce microbial signatures that could be confounding the results. He asked: “Do you have a data set to compare [cfDNA findings] to serum from C. diff, norovirus, and colorectal cancer? And if you don’t, I strongly encourage you to do so.” Dr. Kale responded that the group is working on that.
Asked for comment, session moderator Dana Lukin, MD, AGAF, offered praise for the work.
“I think it’s an intriguing method that we haven’t seen used as a predictor in IBD. Using this as a biomarker of disease type is very intriguing for confirming a diagnosis. I think probably one of the most compelling points is the distinction between IBD and non-IBD. Our current serologic-based assays do not really do that very well. I think this is a big improvement on that,” said Dr. Lukin, associate professor of clinical medicine at Weill Cornell Medical College, New York.
He echoed the questioner’s comments, suggesting that a key question will be whether cfDNA can correlate with disease activity over time.
He also called for prospective studies to validate the approach.
If successful, the technology could have broad application. “Certainly in kids this might be useful or in folks that either aren’t as inclined to have invasive testing done, or for whatever logistic reasons it’s not easy,” said Dr. Lukin.
Dr. Kale is an employee of Karius. Dr. Lukin has no relevant financial disclosures..
FROM CROHN’S AND COLITIS CONGRESS
Wearable Device Tracks IBD from Sweat
LAS VEGAS —
The device, in development by EnLiSense, can rapidly detect calprotectin, C-reactive protein (CRP), and interleukin-6 (IL-6), using miniaturized versions of biochemical lab tests.
Patient monitoring relies on identifying trends, whether biomarker levels are increasing or decreasing, according to Shalini Prasad, PhD, who presented the study during a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “In a blood test you don’t get that unless you’re willing to sample every month. That’s the benefit [of the device],” said Dr. Prasad, professor of bioengineering at University of Texas at Dallas and a cofounder of EnLiSense.
The project grew out of the involvement of EnLiSense with the Biomedical Advanced Research Development Authority (BARDA). “We were tracking infections, and we were looking at inflammatory markers associated with infections: Cytokines and chemokines. We thought it was a natural pivot for us because the disease of inflammation is IBD,” said Dr. Prasad.
The device need only be worn when the physician determines the disease is in a variable state. The patient “will wear it for the duration of time as determined by the clinician,” said Dr. Prasad.
The watch face–sized device, typically worn on the forearm, absorbs sweat and performs automated biochemical analysis independently, then beams its findings to the cloud. “What you get back is concentration [of inflammatory biomarkers]. It is essentially trend line reporting of how the concentration is fluctuating over time for markers,” said Dr. Prasad.
The Crohn’s and Colitis Foundation is supporting the company through its IBD Ventures program. EnLiSense is currently conducting a study tracking patients over 4 weeks to correlate biomarker concentrations in sweat with concentrations in stool.
A key remaining question is how long the device should be worn and during what clinical periods. The technology has the potential to provide too much information. “Just figuring the balance. We’re trying to find the right spot where it makes sense for both the clinician and the patient. This is something that is a work in progress. We don’t want this to be just like any other consumer wearable which gives you something but you’re not sure what it means,” said Dr. Prasad.
The study included 33 patients with IBD who were monitored between 40 and 130 minutes. The device measured levels of CRP, IL-6, and calprotectin. Serum samples were also measured the same day.
The researchers found higher levels of calprotectin among patients with active disease in perspiration (P = .0260), serum (P = .022), and in fecal samples (P = .0411). There were no significant differences between patients who are active and those in remission with respect to CRP levels in perspiration or serum, or IL-6 in perspiration. Serum Il-6 levels were higher in those with active disease.
There was no significant difference between serum and sweat calprotectin levels among patients who were active or in remission, but the median expression of IL-6 in perspiration was higher in the active group (P = .0016). In the active group, calprotectin was elevated in sweat, serum, and stool.
Levels of calprotectin measured in perspiration correlated with levels in the serum (R2 = 0.7195), as did CRP (R2 = 0.615) and IL-6 (R2 = 0.5411).
Treating to Target
The poster caught the interest of Jeremiah Faith, PhD, who attended the session and was asked to comment. “I think patients want to know what’s happening [with their disease], and we could probably give better care if we know day to day the status of someone, especially because every time we test them we get a point in time, but the reality is probably that people are kind of wavy, and knowing the wave is much better,” he said.
He noted that there was not a strong separation between mean perspiration calprotectin values, but he said the ability to take frequent measurements could overcome that weakness. “The difference between active and remission is not as drastic as what you’d see from blood, for example. But it’s the same thing with your watch. Your watch is a really poor sensor of what your heartbeat is doing, but if you measure it every few seconds, and you average over a long period of time, it can actually more be more [accurate]. So there’s a lot of potential for this,” said Dr. Faith, associate professor of genetics and genomic sciences at the Icahn School of Medicine at Mount Sinai in New York.
If perfected, the device could help efforts at treating to target, in which therapies are adjusted to achieve minimal disease. Currently, physicians are forced to adjust doses or change therapies based on infrequent testing. “If this is accurate ... maybe at some point we will have the tools to be smarter about it,” said Dr. Faith.
Dr. Prasad is a cofounder of EnLiSense. Dr. Faith has no relevant financial disclosures.
LAS VEGAS —
The device, in development by EnLiSense, can rapidly detect calprotectin, C-reactive protein (CRP), and interleukin-6 (IL-6), using miniaturized versions of biochemical lab tests.
Patient monitoring relies on identifying trends, whether biomarker levels are increasing or decreasing, according to Shalini Prasad, PhD, who presented the study during a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “In a blood test you don’t get that unless you’re willing to sample every month. That’s the benefit [of the device],” said Dr. Prasad, professor of bioengineering at University of Texas at Dallas and a cofounder of EnLiSense.
The project grew out of the involvement of EnLiSense with the Biomedical Advanced Research Development Authority (BARDA). “We were tracking infections, and we were looking at inflammatory markers associated with infections: Cytokines and chemokines. We thought it was a natural pivot for us because the disease of inflammation is IBD,” said Dr. Prasad.
The device need only be worn when the physician determines the disease is in a variable state. The patient “will wear it for the duration of time as determined by the clinician,” said Dr. Prasad.
The watch face–sized device, typically worn on the forearm, absorbs sweat and performs automated biochemical analysis independently, then beams its findings to the cloud. “What you get back is concentration [of inflammatory biomarkers]. It is essentially trend line reporting of how the concentration is fluctuating over time for markers,” said Dr. Prasad.
The Crohn’s and Colitis Foundation is supporting the company through its IBD Ventures program. EnLiSense is currently conducting a study tracking patients over 4 weeks to correlate biomarker concentrations in sweat with concentrations in stool.
A key remaining question is how long the device should be worn and during what clinical periods. The technology has the potential to provide too much information. “Just figuring the balance. We’re trying to find the right spot where it makes sense for both the clinician and the patient. This is something that is a work in progress. We don’t want this to be just like any other consumer wearable which gives you something but you’re not sure what it means,” said Dr. Prasad.
The study included 33 patients with IBD who were monitored between 40 and 130 minutes. The device measured levels of CRP, IL-6, and calprotectin. Serum samples were also measured the same day.
The researchers found higher levels of calprotectin among patients with active disease in perspiration (P = .0260), serum (P = .022), and in fecal samples (P = .0411). There were no significant differences between patients who are active and those in remission with respect to CRP levels in perspiration or serum, or IL-6 in perspiration. Serum Il-6 levels were higher in those with active disease.
There was no significant difference between serum and sweat calprotectin levels among patients who were active or in remission, but the median expression of IL-6 in perspiration was higher in the active group (P = .0016). In the active group, calprotectin was elevated in sweat, serum, and stool.
Levels of calprotectin measured in perspiration correlated with levels in the serum (R2 = 0.7195), as did CRP (R2 = 0.615) and IL-6 (R2 = 0.5411).
Treating to Target
The poster caught the interest of Jeremiah Faith, PhD, who attended the session and was asked to comment. “I think patients want to know what’s happening [with their disease], and we could probably give better care if we know day to day the status of someone, especially because every time we test them we get a point in time, but the reality is probably that people are kind of wavy, and knowing the wave is much better,” he said.
He noted that there was not a strong separation between mean perspiration calprotectin values, but he said the ability to take frequent measurements could overcome that weakness. “The difference between active and remission is not as drastic as what you’d see from blood, for example. But it’s the same thing with your watch. Your watch is a really poor sensor of what your heartbeat is doing, but if you measure it every few seconds, and you average over a long period of time, it can actually more be more [accurate]. So there’s a lot of potential for this,” said Dr. Faith, associate professor of genetics and genomic sciences at the Icahn School of Medicine at Mount Sinai in New York.
If perfected, the device could help efforts at treating to target, in which therapies are adjusted to achieve minimal disease. Currently, physicians are forced to adjust doses or change therapies based on infrequent testing. “If this is accurate ... maybe at some point we will have the tools to be smarter about it,” said Dr. Faith.
Dr. Prasad is a cofounder of EnLiSense. Dr. Faith has no relevant financial disclosures.
LAS VEGAS —
The device, in development by EnLiSense, can rapidly detect calprotectin, C-reactive protein (CRP), and interleukin-6 (IL-6), using miniaturized versions of biochemical lab tests.
Patient monitoring relies on identifying trends, whether biomarker levels are increasing or decreasing, according to Shalini Prasad, PhD, who presented the study during a poster session at the annual Crohn’s & Colitis Congress®, a partnership of the Crohn’s & Colitis Foundation and the American Gastroenterological Association. “In a blood test you don’t get that unless you’re willing to sample every month. That’s the benefit [of the device],” said Dr. Prasad, professor of bioengineering at University of Texas at Dallas and a cofounder of EnLiSense.
The project grew out of the involvement of EnLiSense with the Biomedical Advanced Research Development Authority (BARDA). “We were tracking infections, and we were looking at inflammatory markers associated with infections: Cytokines and chemokines. We thought it was a natural pivot for us because the disease of inflammation is IBD,” said Dr. Prasad.
The device need only be worn when the physician determines the disease is in a variable state. The patient “will wear it for the duration of time as determined by the clinician,” said Dr. Prasad.
The watch face–sized device, typically worn on the forearm, absorbs sweat and performs automated biochemical analysis independently, then beams its findings to the cloud. “What you get back is concentration [of inflammatory biomarkers]. It is essentially trend line reporting of how the concentration is fluctuating over time for markers,” said Dr. Prasad.
The Crohn’s and Colitis Foundation is supporting the company through its IBD Ventures program. EnLiSense is currently conducting a study tracking patients over 4 weeks to correlate biomarker concentrations in sweat with concentrations in stool.
A key remaining question is how long the device should be worn and during what clinical periods. The technology has the potential to provide too much information. “Just figuring the balance. We’re trying to find the right spot where it makes sense for both the clinician and the patient. This is something that is a work in progress. We don’t want this to be just like any other consumer wearable which gives you something but you’re not sure what it means,” said Dr. Prasad.
The study included 33 patients with IBD who were monitored between 40 and 130 minutes. The device measured levels of CRP, IL-6, and calprotectin. Serum samples were also measured the same day.
The researchers found higher levels of calprotectin among patients with active disease in perspiration (P = .0260), serum (P = .022), and in fecal samples (P = .0411). There were no significant differences between patients who are active and those in remission with respect to CRP levels in perspiration or serum, or IL-6 in perspiration. Serum Il-6 levels were higher in those with active disease.
There was no significant difference between serum and sweat calprotectin levels among patients who were active or in remission, but the median expression of IL-6 in perspiration was higher in the active group (P = .0016). In the active group, calprotectin was elevated in sweat, serum, and stool.
Levels of calprotectin measured in perspiration correlated with levels in the serum (R2 = 0.7195), as did CRP (R2 = 0.615) and IL-6 (R2 = 0.5411).
Treating to Target
The poster caught the interest of Jeremiah Faith, PhD, who attended the session and was asked to comment. “I think patients want to know what’s happening [with their disease], and we could probably give better care if we know day to day the status of someone, especially because every time we test them we get a point in time, but the reality is probably that people are kind of wavy, and knowing the wave is much better,” he said.
He noted that there was not a strong separation between mean perspiration calprotectin values, but he said the ability to take frequent measurements could overcome that weakness. “The difference between active and remission is not as drastic as what you’d see from blood, for example. But it’s the same thing with your watch. Your watch is a really poor sensor of what your heartbeat is doing, but if you measure it every few seconds, and you average over a long period of time, it can actually more be more [accurate]. So there’s a lot of potential for this,” said Dr. Faith, associate professor of genetics and genomic sciences at the Icahn School of Medicine at Mount Sinai in New York.
If perfected, the device could help efforts at treating to target, in which therapies are adjusted to achieve minimal disease. Currently, physicians are forced to adjust doses or change therapies based on infrequent testing. “If this is accurate ... maybe at some point we will have the tools to be smarter about it,” said Dr. Faith.
Dr. Prasad is a cofounder of EnLiSense. Dr. Faith has no relevant financial disclosures.
FROM CROHN’S & COLITIS CONGRESS
Ultrasound Monitoring of IBD May Prompt Faster Treatment Change
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
, according to a small retrospective analysis.
“Current disease monitoring tools have significant limitations,” said Noa Krugliak Cleveland, MD, director of the intestinal ultrasound program at the University of Chicago. “Intestinal ultrasound is an innovative technology that enables point-of-care assessment.”
Dr. Cleveland presented the findings at the October 2023 American College of Gastroenterology’s annual scientific meeting in Vancouver, Canada.
The analysis was based on 30 patients with IBD in an ongoing real-world prospective study of upadacitinib (Rinvoq, Abbvie) who were not in clinical remission at week 8. For 11 patients, routine clinical care included IUS; the other 19 patients were monitored using a conventional approach.
In the study, both groups were almost evenly split in terms of diagnosis. In the IUS group, four patients had Crohn’s disease and five had ulcerative colitis. In the conventional management group, six had Crohn’s disease and five had ulcerative colitis.
The primary endpoint was time to treatment change.
For the secondary endpoint, the researchers defined clinical remission as a Simple Clinical Colitis Activity Index ≤ 2, or Harvey-Bradshaw Index ≤ 4, and by IUS as bowel wall thickness ≤ 3 mm in the colon or terminal ileum and no hyperemia by color Doppler signal.
The average time to treatment change in the IUS group was 1.1 days, compared with 16.6 days for the conventional management group, Dr. Cleveland reported.
The average time to clinical remission was 26.8 days for the IUS group, compared with 55.3 days for the conventional management group.
The delays in treatment change in the conventional management group were attributed to awaiting test results and endoscopy procedures, as well as communications among clinical team members.
Strength of this research project included its prospective data collection and the experienced sonographers who participated, Dr. Cleveland and colleagues said. Limitations included retrospective analysis, a small number of patients on a single therapy, and the potential for bias in patient selection. Studies of other therapies and a prospective trial are underway.
During the presentation, Dr. Cleveland commented about what kinds of treatment changes were made for patients in the study. They commonly involved extending the induction time, and, in some cases, patients were switched to another treatment, she said.
In an interview, Michael Dolinger, MD, of the Icahn School of Medicine at Mount Sinai in New York, said more research needs to be done to show whether IUS will improve outcomes.
“They’re showing that they make more changes sooner,” he said. “Does that actually affect and improve outcomes? That’s the big question.”
Dr. Dolinger said the concept for using IUS is that it helps physicians catch disease flares earlier and respond faster with changes to the treatment plan, thus preventing the buildup of chronic bowel damage.
“That’s the concept, but that concept is actually not so proven in reality” yet, he said. “But I do believe that they’re on the right path.”
In Dr. Dolinger’s view, adding ultrasound provides a more patient-centric approach to care of people with IBD. With more traditional approaches, patients often are waiting for results of tests done outside of the visit, such as MRI.
“With ultrasound, I am walking them through the results as it’s happening in real time during the clinic visit,” Dr. Dolinger said. ”I am showing them on the screen, allowing them to ask questions. They’re telling me about their symptoms, as I’m putting the probe on where it may hurt, as I’m showing them inflammation or healing. And that changes the whole conversation.”
The study received support from the Mutchnik Family Foundation. Dr. Cleveland reported financial relationships with Bristol Myers Squibb, Neurologica, and Takeda. Her coauthors reported financial relationships with multiple drug and device makers. Dr. Dolinger said he is a consultant for Samsung’s Neurologica Corp., which makes ultrasound equipment.
FROM ACG 2023
February 2024 – ICYMI
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Gastroenterology
October 2023
El-Salhy M et al. Efficacy of Fecal Microbiota Transplantation for Patients With Irritable Bowel Syndrome at 3 Years After Transplantation. Gastroenterology. 2022 Oct;163(4):982-994.e14. doi: 10.1053/j.gastro.2022.06.020. Epub 2022 Jun 14. PMID: 35709830.
Bajaj JS and Nagy LE. Natural History of Alcohol-Associated Liver Disease: Understanding the Changing Landscape of Pathophysiology and Patient Care. Gastroenterology. 2022 Oct;163(4):840-851. doi: 10.1053/j.gastro.2022.05.031. Epub 2022 May 19. PMID: 35598629; PMCID: PMC9509416.
Lo CH et al. Association of Proton Pump Inhibitor Use With All-Cause and Cause-Specific Mortality. Gastroenterology. 2022 Oct;163(4):852-861.e2. doi: 10.1053/j.gastro.2022.06.067. Epub 2022 Jul 1. PMID: 35788344; PMCID: PMC9509450.
November 2023
Khoshiwal AM et al. The Tissue Systems Pathology Test Outperforms Pathology Review in Risk Stratifying Patients With Low-Grade Dysplasia. Gastroenterology. 2023 Nov;165(5):1168-1179.e6. doi: 10.1053/j.gastro.2023.07.029. Epub 2023 Aug 30. PMID: 37657759.
Chen YI et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023 Nov;165(5):1249-1261.e5. doi: 10.1053/j.gastro.2023.07.024. Epub 2023 Aug 6. PMID: 37549753.
December 2023
Almario CV et al. Prevalence and Burden of Illness of Rome IV Irritable Bowel Syndrome in the United States: Results From a Nationwide Cross-Sectional Study. Gastroenterology. 2023 Dec;165(6):1475-1487. doi: 10.1053/j.gastro.2023.08.010. Epub 2023 Aug 16. PMID: 37595647.
Koopmann BDM et al. The Natural Disease Course of Pancreatic Cyst-Associated Neoplasia, Dysplasia, and Ductal Adenocarcinoma: Results of a Microsimulation Model. Gastroenterology. 2023 Dec;165(6):1522-1532. doi: 10.1053/j.gastro.2023.08.027. Epub 2023 Aug 24. PMID: 37633497.
Clinical Gastroenterology and Hepatology
October 2023
Jung DH et al. Comparison of a Polysaccharide Hemostatic Powder and Conventional Therapy for Peptic Ulcer Bleeding. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2844-2253.e5. doi: 10.1016/j.cgh.2023.02.031. Epub 2023 Mar 10. PMID: 36906081.
Liang PS et al. Blood Test Increases Colorectal Cancer Screening in Persons Who Declined Colonoscopy and Fecal Immunochemical Test: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2951-2957.e2. doi: 10.1016/j.cgh.2023.03.036. Epub 2023 Apr 8. PMID: 37037262; PMCID: PMC10523873.
November 2023
Li YK et al. Risk of Postcolonoscopy Thromboembolic Events: A Real-World Cohort Study. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3051-3059.e4. doi: 10.1016/j.cgh.2022.09.021. Epub 2022 Sep 24. PMID: 36167228.
Tome J et al. Bile Acid Sequestrants in Microscopic Colitis: Clinical Outcomes and Utility of Bile Acid Testing. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3125-3131.e2. doi: 10.1016/j.cgh.2023.04.031. Epub 2023 May 10. PMID: 37172800.
Berry SK et al. A Randomized Parallel-group Study of Digital Gut-directed Hypnotherapy vs Muscle Relaxation for Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2023 Nov;21(12):3152-3159.e2. doi: 10.1016/j.cgh.2023.06.015. Epub 2023 Jun 28. PMID: 37391055.
December 2023
Kanwal F et al. Risk Stratification Model for Hepatocellular Cancer in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3296-3304.e3. doi: 10.1016/j.cgh.2023.04.019. Epub 2023 Apr 30. PMID: 37390101; PMCID: PMC10661677.
Forss A et al. Patients With Microscopic Colitis Are at Higher Risk of Major Adverse Cardiovascular Events: A Matched Cohort Study. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3356-3364.e9. doi: 10.1016/j.cgh.2023.05.014. Epub 2023 May 26. PMID: 37245713.
Zheng T et al. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3405-3414.e4. doi: 10.1016/j.cgh.2023.07.008. Epub 2023 Jul 22. PMID: 37482172.
Techniques and Innovations in Gastrointestinal Endoscopy
Rengarajan A and Aadam A. Peroral Endoscopic Myotomy (POEM) and Its Use in Esophageal Dysmotility. Tech Innov Gastrointest Endosc. 2023 Dec 16. doi: 10.1016/j.tige.2023.12.004.
Wang D et al. Sphincterotomy vs Sham Procedure for Pain Relief in Sphincter of Oddi Dysfunction: Systematic Review and Meta-analysis. Tech Innov Gastrointest Endosc. 2023 Nov 7. doi: 10.1016/j.tige.2023.10.003
Gastro Hep Advances
Gregory MH et al. Short Bowel Syndrome: Transition of Pediatric Patients to Adult Gastroenterology Care. Gastro Hep Advances. 2023 Sep 8. doi: 10.1016/j.gastha.2023.09.006.
Viser AC et al. Inflammatory Bowel Disease Patients in the Ambulatory Setting Commonly Screen Positive for Malnutrition. Gastro Hep Advances. 2023 Nov 16. doi: 10.1016/j.gastha.2023.11.007.
Tenapanor Shows Response in IBS-C Within Weeks: Pooled Data Analysis
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
“Although onset of action occurs within the first week, continued therapy allows for a greater percentage of patients to achieve a meaningful response,” wrote Brian Lacy, MD, PhD, of the Mayo Clinic in Jacksonville, Florida, and co-authors in an abstract.
Dr. Lacy presented the results of this work at the annual scientific meeting of the American College of Gastroenterology (ACG) in Vancouver, Canada.
Tenapanor acts as an inhibitor of the sodium-hydrogen exchanger 3 (NHE3) and works to reduce dietary sodium absorption, which, in turn, leads to retention of fluid in the intestinal lumen, resulting in softer stool and accelerated intestinal transit, he explained.
Tenapanor is approved by the US Food and Drug Administration for adults with IBS-C.
The major goal of the analysis presented at ACG was to identify times to responses for individual symptoms, said Dr. Lacy in an email exchange with GI & Hepatology News.
Prior studies focused on global improvement in IBS-C symptoms using the FDA-approved definition of a responder: A patient who experienced at least a 30% reduction in the weekly average abdominal pain score and an increase of at least one complete spontaneous bowel movement (CSBM) in the same week for at least 6 of the first 12 treatment weeks.
“Thus, we thought it important to pool all of the data together for this post-hoc analysis, as clinicians and patients often wonder when an individual symptom will respond,” Dr. Lacy wrote in an email.
Dr. Lacy and colleagues conducted a post hoc analysis of pooled data from the phase 2b (NCT01923428) and phase 3 T3MPO-1 (NCT02621892) and T3MPO-2 (NCT02686138) studies to evaluate time to onset of tenapanor effect on bowel function and on individual and global abdominal symptoms in patients with IBS-C.
This resulted in a pooled population of 1372 intent-to-treat patients (688 placebo, 684 on the study drug), with demographics generally similar across the studies, they said.
They found that the median time to CSBM was 2 weeks, with an estimated response probability of 52.3% by week 2, 72.5% by week 8, and 76.7% by week 12.
The median time to abdominal pain response was 4 weeks; the estimated response probability was 54.6% by week 4, 67.9% by week 8, and 72.3% by week 12.
The median time to abdominal bloating response was 5 weeks; the estimated response probability was 48.1% by week 4, 61.9% by week 8, and 67.7% by week 12.
“The teaching message to patients and providers is not to give up too early; staying on this medication allowed 25% more people to improve symptoms,” Dr. Lacy wrote.
In separate interviews, two other researchers Anthony Lembo, MD, AGAF, director of research for Cleveland Clinic’s Digestive Disease & Surgery Institute, and Brooks D. Cash, MD, AGAF, chief for gastroenterology, hepatology, and nutrition at the University of Texas Health Science Center at Houston, agreed with Dr. Lacy’s message.
The study will help in counseling patients who may need to wait a bit to see a response from tenapanor, Dr. Lembo said.
“You wish patients would get better right away of course,” he said, but there can be some delay, even in cases where a drug will ultimately work for a patient.
Patients want to know if they should continue and if it is worth getting another prescription for another month if they haven’t had a significant improvement response, Dr. Lembo said.
Both Dr. Lembo and Dr. Cash said that it takes time for many drugs, not just these medications, to produce a noticeable effect for patients.
Still, “disorders of the gut-brain interaction likely do require a longer runway time to really assess their effects on multiple symptoms,” Dr. Cash said.
The tenapanor research presented at ACG will help in conveying that message to patients, Dr. Cash said.
“It also reinforces for clinicians not to be impatient,” he said.
Dr. Lacy and co-authors directed the development of the poster, and medical writing support was provided by Ashfield MedComms, an Inizio company, and funded by Ardelyx. Dr. Lacy has financial and consulting relationships with AbbVie, Ardelyx, Gernelli, Ironwood Pharmaceuticals, Salix, and Sanofi, Co-authors are employees of Ardelyx. Dr. Lembo and Dr. Cash have financial relationships with Ardelyx and other makers of IBS drugs.
FROM ACG 2023
IBS Meta-Analysis Offers Some Support for Mesalamine
Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.
Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.
Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.
According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.
“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.
Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.
Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.
Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.
A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.
Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.
Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.
“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”
Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.
One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.
Advancements in the understanding of irritable bowel syndrome (IBS) pathophysiology have led to new pharmacological agents and guidelines on the delivery of patient-specific IBS care. However, treatments targeting specific IBS mechanisms including altered immune responses, barrier dysfunction, and low-grade inflammation are lacking.
In a systematic review and meta-analysis, Goodoory et al. find that pooled results from six randomized controlled trials suggest efficacy with mesalamine, an anti-inflammatory agent, for global IBS symptoms with subgroup analyses further suggesting efficacy in IBS with diarrhea. However, results are tempered by the overall low quality of evidence and lack of benefit for abdominal pain or bowel habits. Notably, the only study rated as low risk of bias did not find mesalamine to be effective. Thus, these findings cannot yet be used to inform clinical decision-makers.
Still, further study is warranted. Such future work will benefit from including well-phenotyped patients and novel biomarkers with the ability to identify individuals in whom inflammatory mechanisms contribute to IBS symptoms.
Dr. Andrea Shin is based in the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California Los Angeles. She is a member of the editorial boards of Clinical Gastroenterology and Hepatology, and Alimentary Pharmacology & Therapeutics. She is associate clinical editor of Neurogastroenterology & Motility, and a member of the Scientific Communications Advisory Board for IBS-C. As an AGA member, she sits on the Research Awards Panel, and is a section councilor for neurogastroenterology & motility, as well as a patient education advisor. Dr. Shin has received funding from the NIH R03 Limited Competiation Small Grant Program, an ANMS Diversity Development Award, and is an NIH Loan Repayment Program Awardee. She has no other relevant disclosures.
Advancements in the understanding of irritable bowel syndrome (IBS) pathophysiology have led to new pharmacological agents and guidelines on the delivery of patient-specific IBS care. However, treatments targeting specific IBS mechanisms including altered immune responses, barrier dysfunction, and low-grade inflammation are lacking.
In a systematic review and meta-analysis, Goodoory et al. find that pooled results from six randomized controlled trials suggest efficacy with mesalamine, an anti-inflammatory agent, for global IBS symptoms with subgroup analyses further suggesting efficacy in IBS with diarrhea. However, results are tempered by the overall low quality of evidence and lack of benefit for abdominal pain or bowel habits. Notably, the only study rated as low risk of bias did not find mesalamine to be effective. Thus, these findings cannot yet be used to inform clinical decision-makers.
Still, further study is warranted. Such future work will benefit from including well-phenotyped patients and novel biomarkers with the ability to identify individuals in whom inflammatory mechanisms contribute to IBS symptoms.
Dr. Andrea Shin is based in the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California Los Angeles. She is a member of the editorial boards of Clinical Gastroenterology and Hepatology, and Alimentary Pharmacology & Therapeutics. She is associate clinical editor of Neurogastroenterology & Motility, and a member of the Scientific Communications Advisory Board for IBS-C. As an AGA member, she sits on the Research Awards Panel, and is a section councilor for neurogastroenterology & motility, as well as a patient education advisor. Dr. Shin has received funding from the NIH R03 Limited Competiation Small Grant Program, an ANMS Diversity Development Award, and is an NIH Loan Repayment Program Awardee. She has no other relevant disclosures.
Advancements in the understanding of irritable bowel syndrome (IBS) pathophysiology have led to new pharmacological agents and guidelines on the delivery of patient-specific IBS care. However, treatments targeting specific IBS mechanisms including altered immune responses, barrier dysfunction, and low-grade inflammation are lacking.
In a systematic review and meta-analysis, Goodoory et al. find that pooled results from six randomized controlled trials suggest efficacy with mesalamine, an anti-inflammatory agent, for global IBS symptoms with subgroup analyses further suggesting efficacy in IBS with diarrhea. However, results are tempered by the overall low quality of evidence and lack of benefit for abdominal pain or bowel habits. Notably, the only study rated as low risk of bias did not find mesalamine to be effective. Thus, these findings cannot yet be used to inform clinical decision-makers.
Still, further study is warranted. Such future work will benefit from including well-phenotyped patients and novel biomarkers with the ability to identify individuals in whom inflammatory mechanisms contribute to IBS symptoms.
Dr. Andrea Shin is based in the Vatche and Tamar Manoukian Division of Digestive Diseases at the University of California Los Angeles. She is a member of the editorial boards of Clinical Gastroenterology and Hepatology, and Alimentary Pharmacology & Therapeutics. She is associate clinical editor of Neurogastroenterology & Motility, and a member of the Scientific Communications Advisory Board for IBS-C. As an AGA member, she sits on the Research Awards Panel, and is a section councilor for neurogastroenterology & motility, as well as a patient education advisor. Dr. Shin has received funding from the NIH R03 Limited Competiation Small Grant Program, an ANMS Diversity Development Award, and is an NIH Loan Repayment Program Awardee. She has no other relevant disclosures.
Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.
Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.
Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.
According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.
“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.
Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.
Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.
Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.
A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.
Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.
Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.
“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”
Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.
One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.
Certain patients with irritable bowel syndrome (IBS) may benefit from treatment with mesalamine, although the quality of evidence supporting this strategy remains low, according to a recent systematic literature review and meta-analysis.
Global IBS symptoms improved significantly across the entire population, however, a subgroup analysis suggested that mesalamine may be most beneficial for patients who present with diarrhea, providing support for a large clinical trial in this patient population, reported lead author Vivek C. Goodoory, MBChB, of St. James’s University Hospital, Leeds, United Kingdom, and colleagues.
Some patients with IBS may present with low-grade inflammation in the intestine, offering theoretical grounds for prescribing mesalamine, which is typically used for treating ulcerative colitis, the investigators wrote in Clinical Gastroenterology and Hepatology. Yet previous randomized controlled trials (RCTs) evaluating mesalamine for IBS have yielded mixed results, and a meta-analysis showed that mesalamine offered no benefit.
According to Dr. Goodoory and colleagues, however, that meta-analysis fell short since it “only pooled mean symptom scores, rather than the proportion of patients in each trial experiencing an improvement in symptoms, and did not appear to include data from all available RCTs.” Furthermore, they noted that this prior study lacked subgroup analyses conducted based on IBS subtype or postinfection status.
“We, therefore, conducted a contemporaneous meta-analysis to examine the efficacy and safety of mesalamine in IBS addressing these deficits in knowledge,” the investigators wrote.
Their meta-analysis included 820 patients from 8 RCTs published between 2009 and 2022. Efficacy and safety were evaluated via dichotomous assessments of global IBS symptoms, bowel habit or stool frequency, abdominal pain, and adverse events. Two subgroup analyses were planned to evaluate responses based on post-infection status and predominant stool pattern.
Unlike the previous meta-analysis, Dr. Goodoory and colleagues detected a potential signal for efficacy.
Across all patients, mesalamine was associated with significant improvement in global IBS symptoms, compared with placebo (relative risk [RR], 0.86; 95% CI, 0.79-0.95). However, no significant improvements were detected for abdominal pain or bowel habit/stool frequency.
A subgroup analysis of patients exhibiting IBS with diarrhea showed significantly greater improvements in global IBS symptoms for mesalamine versus placebo (RR, 0.88; 95% CI, 0.79-0.99). This subgroup showed no improvements in abdominal pain or bowel habit/stool frequency.
Subgroup analyses for patients with constipation or mixed bowel habits, or based on postinfection status, revealed no significant differences, although the investigators noted that relevant data were limited.
Mesalamine appeared to be well tolerated. Across five studies reporting adverse events, 43.5% of patients receiving mesalamine reported any adverse event, compared with 41.4% of patients on placebo. The RR of experiencing an adverse event in those taking mesalamine was 1.20 (95% CI, 0.89-1.63), which was not statistically significant.
“There was no evidence of heterogeneity between studies in most of our analyses, but only one trial was at low risk of bias across all domains, and there were insufficient studies to assess for funnel plot asymmetry,” Dr. Goodoory and colleagues wrote. “Based on these limitations of the evidence,” they continued, “our confidence in the results of the meta-analysis would be low, and further large trials at low risk of bias would be informative.”
Specifically, the investigators suggested an RCT recruiting only patients with IBS with diarrhea, and reporting efficacy according to postinfection status.
One coauthor reported research funding from Tillotts Pharma and Dr Falk Pharma UK. The remaining authors reported no conflicts.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AGA Publishes New Pouchitis Management Guideline
The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.
The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).
“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”
Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.
Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
Probiotics
Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.
They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.
“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.
In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.
The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
Antibiotics
Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.
Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.
“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.
For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.
Immunosuppressive therapies
Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.
“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.
For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.
A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.
Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
Future directions
“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”
They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.
The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.
The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).
“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”
Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.
Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
Probiotics
Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.
They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.
“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.
In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.
The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
Antibiotics
Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.
Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.
“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.
For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.
Immunosuppressive therapies
Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.
“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.
For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.
A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.
Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
Future directions
“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”
They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.
The American Gastroenterological Association (AGA) has published a new clinical practice guideline on the management of pouchitis and inflammatory pouch disorders.
The guidance document, authored by Edward L. Barnes, MD, of the University of North Carolina at Chapel Hill and colleagues, includes eleven conditional recommendations that steer usage of probiotics, antibiotics, and immunosuppressive therapies in patients with these conditions, which occur most often after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC).
“Multiple strategies have been utilized in the treatment and prevention of pouchitis and inflammatory pouch conditions, including antibiotics, probiotics, corticosteroids, and advanced immunosuppressive therapies including biologics and oral small-molecule drugs,” the guideline panelists wrote on the AGA website. “However, most of the evidence base is primarily derived from retrospective observational studies or comparisons of small cohorts. Data on patients’ values and preferences for specific management decisions and treatment choices are also limited. This results in substantial practice variability.”
Still, the area is advancing. Dr. Barnes and colleagues highlighted new scoring systems for characterizing endoscopic findings and patient-reported outcomes, as well as the recent EARNEST trial (N Engl J Med. 2023 Mar 30;388(13):1191-1200), which compared vedolizumab with placebo in patients with chronic refractory pouchitis, and should be considered a “landmark study in the field,” as it could shape future trial design.
Based on all available evidence and clinical experience, the panelists issued the following recommendations, which were approved by the AGA Governing Board.
Probiotics
Because of a knowledge gap, the guideline makes no recommendation for or against use of probiotics for either the primary prevention or treatment of pouchitis.
They offered a similar explanation for the lack of guidance on using probiotics to treat pouchitis, and noted that antibiotics have demonstrated effectiveness where probiotics have not, making them the preferred treatment choice.
“There is potential that delaying therapy or using probiotics when they are not as effective as antibiotics may have significant impact on an individual patient’s quality of life,” Dr. Barnes and colleagues noted.
In contrast with the above statements, the guideline recommends usage of probiotics to prevent recurrent pouchitis in patients with recurrent, antibiotic-responsive pouchitis.
The De Simone formulation of multistrain probiotics is best supported in this scenario, the guideline notes, as this product was used in clinical trials, which collectively showed an 87% reduced risk of relapse over 12 months.
Antibiotics
Although the guideline supports antibiotics for prevention of pouchitis, the panelists noted that only one randomized controlled trial supports this recommendation, and negative effects of long-term usage need to be considered, including promotion of drug-resistant organisms and risk of Clostridioides difficile infection.
Dr. Barnes and colleagues cited more data supporting antibiotics for treatment of pouchitis, and noted that metronidazole and/or ciprofloxacin remain the preferred choices, with a typical duration of 2-4 weeks.
“An approach using a combination of antibiotics may be more effective in patients who do not respond to single-antibiotic therapy,” the panelists wrote, noting that oral vancomycin may also be considered when a patient does not respond to initial therapy.
For patients with recurrent pouchitis that relapses shortly after discontinuing antibiotics, chronic antibiotics should be considered, according to the guideline.
Immunosuppressive therapies
Advanced immunosuppressive therapies are recommended for patients with chronic antibiotic-dependent pouchitis, including those approved for treatment of UC or Crohn’s disease.
“Advanced immunosuppressive therapies may be used in lieu of chronic, continuous antibiotic therapy, particularly in patients who are intolerant to antibiotics or where patients and/or providers are concerned about risks of long-term antibiotic therapy,” the panelists wrote.
For patients with chronic antibiotic-refractory pouchitis, the guideline makes a general recommendation for advanced immunosuppressive therapies while specifically noting that vedolizumab has a greater strength of evidence in this scenario, citing the EARNEST trial.
A separate recommendation for corticosteroids is made for the same patient group, with ileal-release budesonide remaining the preferred formulation. In contrast, mesalamine is not recommended, based on a lack of supporting evidence.
Finally, the panelists recommend using corticosteroids in patients with Crohn’s-like disease of the pouch.
Future directions
“Even though pouchitis is relatively common after IPAA for UC, we observed that most of the evidence informing these guidelines was low to very low quality, derived from case series or small cohort studies, and several knowledge gaps exist,” Dr. Barnes and colleagues wrote. “Several initiatives towards improving management of inflammatory pouch disorders are already underway. However, concerted efforts in key domains are central towards improving patient care.”
They suggested that research should focus on standardizing disease entities, characterizing natural history and risk factors for inflammatory disorders of the pouch, and improving clinical trial design.The guideline was funded by the AGA Institute. The panelists disclosed relationships with Bristol-Myers Squibb, Sandoz, AbbVie, and others.
FROM THE AMERICAN GASTROENTEROLOGICAL ASSOCIATION