TBD Meeting (3042-21)

A 14-day course of hybrid therapy was as effective as 10-day bismuth quadruple therapy, but with fewer side effects, according to results of a randomized trial conducted in Taiwan.

“However, the former had fewer adverse events than the latter,” investigator Ping-I Hsu, MD, of An Nan Hospital, China Medical University, Taiwan said in a virtual presentation at the annual Digestive Disease Week® (DDW). Some patients in the trial received 14-day high-dose dual therapy, which also had a lower rate of adverse events but a lower eradication rate, compared with quadruple therapy, Dr. Hsu added.

This study confirms previous data showing that hybrid therapy has high eradication rates and a lower frequency of adverse events compared with bismuth quadruple therapy, noted Joseph Adrian L. Buensalido, MD, clinical associate professor of medicine in the division of infectious diseases at the University of the Philippines–Philippine General Hospital in Manila. “Clinicians and specialty/guideline groups may need to start looking at moving to first-line hybrid therapy as opposed to the traditional approach,” Dr. Buensalido said in an interview.
 

Current guidelines and data to date

An American College of Gastroenterology clinical guideline published in 2017 strongly recommends bismuth quadruple therapy, with a duration of 10-14 days, as a first-line treatment option. Hybrid therapy is conditionally recommended as a first-line option in the ACG guideline, while high-dose dual therapy is conditionally recommended as a salvage regimen.

In a prospective, randomized comparative study published in 2017, the eradication rates (93.9%) in patients receiving 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole) were comparable with eradication rates (92.8%) with 14-day hybrid therapy (dual therapy with pantoprazole plus amoxicillin for 7 days, followed by quadruple therapy with pantoprazole, amoxicillin, clarithromycin, and metronidazole for 7 days).

Quadruple therapy had a higher frequency of adverse events, at 55%, compared with 15.7% for hybrid therapy (P < .001). “Whether shortening the treatment duration of bismuth quadruple therapy from 14 days to 10 days can reduce the frequency of adverse effects remains unclear,” Dr. Hsu said in introductory comments to his study.
 

Comparing three approaches

In the multicenter, randomized, open-label superiority trial presented at DDW, Dr. Hsu and colleagues randomly assigned 600 Helicobacter pylori–infected participants in equal numbers to receive 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy.

The hybrid therapy regimen consisted of rabeprazole 20 mg twice a day plus amoxicillin 1 g twice a day for 14 days, with clarithromycin 500 mg and metronidazole 500 mg twice a day in the final 7 days. The high-dose dual therapy regimen consisted of rabeprazole 20 mg and amoxicillin 750 mg four times a day for 14 days. The bismuth quadruple therapy regimen consisted of rabeprazole 20 mg twice a day, tripotassium dicitrato bismuthate 300 mg four times a day, tetracycline 500 mg twice a day, and metronidazole 250 mg four times a day for 10 days.

Investigators assessed H. pylori status 6 weeks following the end of therapy. In an intention-to-treat analysis, the hybrid therapy regimen yielded an eradication rate of 96.5%, which was comparable with the 93.5% eradication rate seen with bismuth quadruple therapy and was significantly higher than the 86.0% eradication rate seen with high-dose dual therapy (P < .001), according to Dr. Hsu. Similar efficacy outcomes were seen in per-protocol analysis.

The frequency of adverse events was lowest with high-dose dual therapy, at 13.0%, according to Dr. Hsu. That was significantly lower than the 25.5% frequency of adverse events with hybrid therapy. Bismuth quadruple therapy had a rate of 34.0%.
 

Antibiotic resistance results

Antibiotic resistance was most common for metronidazole, seen in approximately 28% of the quadruple-therapy group, 34% of the hybrid group, and 37% of the high-dose therapy groups. Clarithromycin resistance occurred in about 23% of quadruple therapy recipients, 16% of hybrid recipients, and 16% of high-dose therapy recipients. Amoxicillin and tetracycline resistance was rare, occurring in approximately 0%-3% of groups.

In the quadruple therapy arm, metronidazole resistance was associated with H. pylori eradication failure, according to Dr. Hsu. The eradication rate was about 96% for those subjects with no metronidazole resistance, and 88% for those with resistance (P = .05). Amoxicillin resistance, although rare in the study, independently predicted eradication failure of high-dose dual therapy, Dr. Hsu said. The eradication rate with high-dose dual therapy was 87.6% for individuals without amoxicillin resistance, and 40.0% in individuals with resistance, according to presented data.

The authors reported no financial disclosures related to their research. Dr. Buensalido has been a speaker for Unilab, BSV Bioscience, and Philcare Pharma, and has received sponsorship from Pfizer.

A 14-day course of hybrid therapy was as effective as 10-day bismuth quadruple therapy, but with fewer side effects, according to results of a randomized trial conducted in Taiwan.

“However, the former had fewer adverse events than the latter,” investigator Ping-I Hsu, MD, of An Nan Hospital, China Medical University, Taiwan said in a virtual presentation at the annual Digestive Disease Week® (DDW). Some patients in the trial received 14-day high-dose dual therapy, which also had a lower rate of adverse events but a lower eradication rate, compared with quadruple therapy, Dr. Hsu added.

This study confirms previous data showing that hybrid therapy has high eradication rates and a lower frequency of adverse events compared with bismuth quadruple therapy, noted Joseph Adrian L. Buensalido, MD, clinical associate professor of medicine in the division of infectious diseases at the University of the Philippines–Philippine General Hospital in Manila. “Clinicians and specialty/guideline groups may need to start looking at moving to first-line hybrid therapy as opposed to the traditional approach,” Dr. Buensalido said in an interview.
 

Current guidelines and data to date

An American College of Gastroenterology clinical guideline published in 2017 strongly recommends bismuth quadruple therapy, with a duration of 10-14 days, as a first-line treatment option. Hybrid therapy is conditionally recommended as a first-line option in the ACG guideline, while high-dose dual therapy is conditionally recommended as a salvage regimen.

In a prospective, randomized comparative study published in 2017, the eradication rates (93.9%) in patients receiving 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole) were comparable with eradication rates (92.8%) with 14-day hybrid therapy (dual therapy with pantoprazole plus amoxicillin for 7 days, followed by quadruple therapy with pantoprazole, amoxicillin, clarithromycin, and metronidazole for 7 days).

Quadruple therapy had a higher frequency of adverse events, at 55%, compared with 15.7% for hybrid therapy (P < .001). “Whether shortening the treatment duration of bismuth quadruple therapy from 14 days to 10 days can reduce the frequency of adverse effects remains unclear,” Dr. Hsu said in introductory comments to his study.
 

Comparing three approaches

In the multicenter, randomized, open-label superiority trial presented at DDW, Dr. Hsu and colleagues randomly assigned 600 Helicobacter pylori–infected participants in equal numbers to receive 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy.

The hybrid therapy regimen consisted of rabeprazole 20 mg twice a day plus amoxicillin 1 g twice a day for 14 days, with clarithromycin 500 mg and metronidazole 500 mg twice a day in the final 7 days. The high-dose dual therapy regimen consisted of rabeprazole 20 mg and amoxicillin 750 mg four times a day for 14 days. The bismuth quadruple therapy regimen consisted of rabeprazole 20 mg twice a day, tripotassium dicitrato bismuthate 300 mg four times a day, tetracycline 500 mg twice a day, and metronidazole 250 mg four times a day for 10 days.

Investigators assessed H. pylori status 6 weeks following the end of therapy. In an intention-to-treat analysis, the hybrid therapy regimen yielded an eradication rate of 96.5%, which was comparable with the 93.5% eradication rate seen with bismuth quadruple therapy and was significantly higher than the 86.0% eradication rate seen with high-dose dual therapy (P < .001), according to Dr. Hsu. Similar efficacy outcomes were seen in per-protocol analysis.

The frequency of adverse events was lowest with high-dose dual therapy, at 13.0%, according to Dr. Hsu. That was significantly lower than the 25.5% frequency of adverse events with hybrid therapy. Bismuth quadruple therapy had a rate of 34.0%.
 

Antibiotic resistance results

Antibiotic resistance was most common for metronidazole, seen in approximately 28% of the quadruple-therapy group, 34% of the hybrid group, and 37% of the high-dose therapy groups. Clarithromycin resistance occurred in about 23% of quadruple therapy recipients, 16% of hybrid recipients, and 16% of high-dose therapy recipients. Amoxicillin and tetracycline resistance was rare, occurring in approximately 0%-3% of groups.

In the quadruple therapy arm, metronidazole resistance was associated with H. pylori eradication failure, according to Dr. Hsu. The eradication rate was about 96% for those subjects with no metronidazole resistance, and 88% for those with resistance (P = .05). Amoxicillin resistance, although rare in the study, independently predicted eradication failure of high-dose dual therapy, Dr. Hsu said. The eradication rate with high-dose dual therapy was 87.6% for individuals without amoxicillin resistance, and 40.0% in individuals with resistance, according to presented data.

The authors reported no financial disclosures related to their research. Dr. Buensalido has been a speaker for Unilab, BSV Bioscience, and Philcare Pharma, and has received sponsorship from Pfizer.

A 14-day course of hybrid therapy was as effective as 10-day bismuth quadruple therapy, but with fewer side effects, according to results of a randomized trial conducted in Taiwan.

“However, the former had fewer adverse events than the latter,” investigator Ping-I Hsu, MD, of An Nan Hospital, China Medical University, Taiwan said in a virtual presentation at the annual Digestive Disease Week® (DDW). Some patients in the trial received 14-day high-dose dual therapy, which also had a lower rate of adverse events but a lower eradication rate, compared with quadruple therapy, Dr. Hsu added.

This study confirms previous data showing that hybrid therapy has high eradication rates and a lower frequency of adverse events compared with bismuth quadruple therapy, noted Joseph Adrian L. Buensalido, MD, clinical associate professor of medicine in the division of infectious diseases at the University of the Philippines–Philippine General Hospital in Manila. “Clinicians and specialty/guideline groups may need to start looking at moving to first-line hybrid therapy as opposed to the traditional approach,” Dr. Buensalido said in an interview.
 

Current guidelines and data to date

An American College of Gastroenterology clinical guideline published in 2017 strongly recommends bismuth quadruple therapy, with a duration of 10-14 days, as a first-line treatment option. Hybrid therapy is conditionally recommended as a first-line option in the ACG guideline, while high-dose dual therapy is conditionally recommended as a salvage regimen.

In a prospective, randomized comparative study published in 2017, the eradication rates (93.9%) in patients receiving 14-day bismuth quadruple therapy (pantoprazole, bismuth subcitrate, tetracycline, and metronidazole) were comparable with eradication rates (92.8%) with 14-day hybrid therapy (dual therapy with pantoprazole plus amoxicillin for 7 days, followed by quadruple therapy with pantoprazole, amoxicillin, clarithromycin, and metronidazole for 7 days).

Quadruple therapy had a higher frequency of adverse events, at 55%, compared with 15.7% for hybrid therapy (P < .001). “Whether shortening the treatment duration of bismuth quadruple therapy from 14 days to 10 days can reduce the frequency of adverse effects remains unclear,” Dr. Hsu said in introductory comments to his study.
 

Comparing three approaches

In the multicenter, randomized, open-label superiority trial presented at DDW, Dr. Hsu and colleagues randomly assigned 600 Helicobacter pylori–infected participants in equal numbers to receive 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy.

The hybrid therapy regimen consisted of rabeprazole 20 mg twice a day plus amoxicillin 1 g twice a day for 14 days, with clarithromycin 500 mg and metronidazole 500 mg twice a day in the final 7 days. The high-dose dual therapy regimen consisted of rabeprazole 20 mg and amoxicillin 750 mg four times a day for 14 days. The bismuth quadruple therapy regimen consisted of rabeprazole 20 mg twice a day, tripotassium dicitrato bismuthate 300 mg four times a day, tetracycline 500 mg twice a day, and metronidazole 250 mg four times a day for 10 days.

Investigators assessed H. pylori status 6 weeks following the end of therapy. In an intention-to-treat analysis, the hybrid therapy regimen yielded an eradication rate of 96.5%, which was comparable with the 93.5% eradication rate seen with bismuth quadruple therapy and was significantly higher than the 86.0% eradication rate seen with high-dose dual therapy (P < .001), according to Dr. Hsu. Similar efficacy outcomes were seen in per-protocol analysis.

The frequency of adverse events was lowest with high-dose dual therapy, at 13.0%, according to Dr. Hsu. That was significantly lower than the 25.5% frequency of adverse events with hybrid therapy. Bismuth quadruple therapy had a rate of 34.0%.
 

Antibiotic resistance results

Antibiotic resistance was most common for metronidazole, seen in approximately 28% of the quadruple-therapy group, 34% of the hybrid group, and 37% of the high-dose therapy groups. Clarithromycin resistance occurred in about 23% of quadruple therapy recipients, 16% of hybrid recipients, and 16% of high-dose therapy recipients. Amoxicillin and tetracycline resistance was rare, occurring in approximately 0%-3% of groups.

In the quadruple therapy arm, metronidazole resistance was associated with H. pylori eradication failure, according to Dr. Hsu. The eradication rate was about 96% for those subjects with no metronidazole resistance, and 88% for those with resistance (P = .05). Amoxicillin resistance, although rare in the study, independently predicted eradication failure of high-dose dual therapy, Dr. Hsu said. The eradication rate with high-dose dual therapy was 87.6% for individuals without amoxicillin resistance, and 40.0% in individuals with resistance, according to presented data.

The authors reported no financial disclosures related to their research. Dr. Buensalido has been a speaker for Unilab, BSV Bioscience, and Philcare Pharma, and has received sponsorship from Pfizer.

For biologic-naive adults with moderate to severe Crohn’s disease, treatment with adalimumab or ustekinumab leads to similar outcomes, according to results of the head-to-head SEAVUE trial.

When lead author Bruce E. Sands, MD, of Icahn School of Medicine at Mount Sinai, New York, compared treatment arms, patients had similar rates of clinical remission at one year. All major secondary endpoints, such as endoscopic remission, were comparable, as were safety profiles, Dr. Sands reported at the annual Digestive Disease Week^® (DDW).

“From my perspective, this is an important study,” Dr. Sands wrote in a virtual chat following his presentation. “We need more head-to-head studies!”

Results from the SEAVUE trial come almost 2 years after Dr. Sands reported findings of another head-to-head IBD trial: VARSITY, which demonstrated the superiority of vedolizumab over adalimumab among patients with moderate to severe ulcerative colitis.

The multicenter, double-blinded SEAVUE trial involved 386 patients with biologic-naive Crohn’s disease who had failed corticosteroids or immunomodulators. All patients had Crohn’s Disease Activity Index (CDAI) scores ranging from 220 to 450 and had at least one ulcer detected at baseline ileocolonoscopy.

Participants were randomized in a 1:1 ratio to receive monotherapy with either subcutaneous adalimumab (citrate-free; 160 mg at baseline, 70 mg at week 2, then 40 mg every 2 weeks) or ustekinumab, which was given first intravenously at a dose of 6 mg/kg then subcutaneously at 90 mg every 8 weeks.

The primary endpoint was clinical remission at week 52, defined by a CDAI score less than 150. Major secondary endpoints included clinical response, corticosteroid-free remission, endoscopic remission, remission in patient-reported CDAI components, and clinical remission at week 16.

Results were statistically similar across all endpoints, with clinical remission at 1 year occurring in 64.9% and 61.0% of patients receiving ustekinumab and adalimumab, respectively (P = .417).

“Both treatments demonstrated rapid onset of action and robust endoscopy results,” Dr. Sands noted during his presentation; he reported comparable rates of endoscopic remission, at 28.5% and 30.7% for ustekinumab and adalimumab, respectively (P = .631).

Among secondary endpoints, ustekinumab demonstrated some superiority, with greater maintenance of clinical response at week 52 among patients with response at week 16 (88.6% vs. 78.0%; P = .016), greater reduction in liquid/soft stools in prior 7 days from baseline to week 52 (–19.9 vs. –16.2; P = .004), and greater reduction in sum number of liquid/soft stools and abdominal pain scores in prior 7 days from baseline to week 52 (–29.6 vs. –25.1; P = .013).

Safety metrics were similar between groups, and consistent with previous experience. Although the adalimumab group had a higher rate of discontinuation due to adverse events, this trend was not statistically significant (11.3% vs. 6.3%; P value not provided).
 

Don’t ignore discontinuation rates

Jordan E. Axelrad, MD, assistant professor of medicine at NYU and a clinician at the Inflammatory Bowel Disease Center at NYU Langone Health, New York, commended the SEAVUE trial for its head-to-head design, which is a first for biologics in Crohn’s disease.

“With newer drugs, there’s a critical need for head-to-head studies for us to understand where to position a lot of these agents,” he said in an interview. “[T]his was a good undifferentiated group to understand what’s the first biologic you should use in a patient with moderate-to-severe Crohn’s disease. The primary, major take-home is that [ustekinumab and adalimumab] are similarly effective.”

When asked about the slight superiority in minor secondary endpoints associated with ustekinumab, Dr. Axelrad suggested that rates of discontinuation deserve more attention.

“For me, maybe the major focus would be on the number of patients who stopped treatment,” Dr. Axelrad said, noting a higher rate of discontinuation in the adalimumab group. “Although that was just numerical, that to me is actually more important than [the minor secondary endpoints].” He also highlighted the lower injection burden associated with ustekinumab, which is given every 8 weeks, compared with every 2 weeks for adalimumab.

Ultimately, however, it’s unlikely that treatment sequencing will depend on these finer points, Dr. Axelrad suggested, and will instead come down to finances, especially with adalimumab biosimilars on the horizon, which may be the most cost-effective.

“A lot of the decision-making of where to position [ustekinumab in Crohn’s disease] is going to come down to the payer,” Dr. Axelrad said. “If there was a clear signal, providers such as myself would have a better leg to stand on, like we saw with VARSITY, where vedolizumab was clearly superior to adalimumab on multiple endpoints. We didn’t see that sort of robust signal here.”

The SEAVUE trial was supported by Janssen Scientific Affairs. Dr. Sands disclosed relationships with Janssen, AbbVie, Takeda, and others. Dr. Axelrad disclosed previous consulting fees from Janssen and research support from BioFire.

For biologic-naive adults with moderate to severe Crohn’s disease, treatment with adalimumab or ustekinumab leads to similar outcomes, according to results of the head-to-head SEAVUE trial.

When lead author Bruce E. Sands, MD, of Icahn School of Medicine at Mount Sinai, New York, compared treatment arms, patients had similar rates of clinical remission at one year. All major secondary endpoints, such as endoscopic remission, were comparable, as were safety profiles, Dr. Sands reported at the annual Digestive Disease Week^® (DDW).

“From my perspective, this is an important study,” Dr. Sands wrote in a virtual chat following his presentation. “We need more head-to-head studies!”

Results from the SEAVUE trial come almost 2 years after Dr. Sands reported findings of another head-to-head IBD trial: VARSITY, which demonstrated the superiority of vedolizumab over adalimumab among patients with moderate to severe ulcerative colitis.

The multicenter, double-blinded SEAVUE trial involved 386 patients with biologic-naive Crohn’s disease who had failed corticosteroids or immunomodulators. All patients had Crohn’s Disease Activity Index (CDAI) scores ranging from 220 to 450 and had at least one ulcer detected at baseline ileocolonoscopy.

Participants were randomized in a 1:1 ratio to receive monotherapy with either subcutaneous adalimumab (citrate-free; 160 mg at baseline, 70 mg at week 2, then 40 mg every 2 weeks) or ustekinumab, which was given first intravenously at a dose of 6 mg/kg then subcutaneously at 90 mg every 8 weeks.

The primary endpoint was clinical remission at week 52, defined by a CDAI score less than 150. Major secondary endpoints included clinical response, corticosteroid-free remission, endoscopic remission, remission in patient-reported CDAI components, and clinical remission at week 16.

Results were statistically similar across all endpoints, with clinical remission at 1 year occurring in 64.9% and 61.0% of patients receiving ustekinumab and adalimumab, respectively (P = .417).

“Both treatments demonstrated rapid onset of action and robust endoscopy results,” Dr. Sands noted during his presentation; he reported comparable rates of endoscopic remission, at 28.5% and 30.7% for ustekinumab and adalimumab, respectively (P = .631).

Among secondary endpoints, ustekinumab demonstrated some superiority, with greater maintenance of clinical response at week 52 among patients with response at week 16 (88.6% vs. 78.0%; P = .016), greater reduction in liquid/soft stools in prior 7 days from baseline to week 52 (–19.9 vs. –16.2; P = .004), and greater reduction in sum number of liquid/soft stools and abdominal pain scores in prior 7 days from baseline to week 52 (–29.6 vs. –25.1; P = .013).

Safety metrics were similar between groups, and consistent with previous experience. Although the adalimumab group had a higher rate of discontinuation due to adverse events, this trend was not statistically significant (11.3% vs. 6.3%; P value not provided).
 

Don’t ignore discontinuation rates

Jordan E. Axelrad, MD, assistant professor of medicine at NYU and a clinician at the Inflammatory Bowel Disease Center at NYU Langone Health, New York, commended the SEAVUE trial for its head-to-head design, which is a first for biologics in Crohn’s disease.

“With newer drugs, there’s a critical need for head-to-head studies for us to understand where to position a lot of these agents,” he said in an interview. “[T]his was a good undifferentiated group to understand what’s the first biologic you should use in a patient with moderate-to-severe Crohn’s disease. The primary, major take-home is that [ustekinumab and adalimumab] are similarly effective.”

When asked about the slight superiority in minor secondary endpoints associated with ustekinumab, Dr. Axelrad suggested that rates of discontinuation deserve more attention.

“For me, maybe the major focus would be on the number of patients who stopped treatment,” Dr. Axelrad said, noting a higher rate of discontinuation in the adalimumab group. “Although that was just numerical, that to me is actually more important than [the minor secondary endpoints].” He also highlighted the lower injection burden associated with ustekinumab, which is given every 8 weeks, compared with every 2 weeks for adalimumab.

Ultimately, however, it’s unlikely that treatment sequencing will depend on these finer points, Dr. Axelrad suggested, and will instead come down to finances, especially with adalimumab biosimilars on the horizon, which may be the most cost-effective.

“A lot of the decision-making of where to position [ustekinumab in Crohn’s disease] is going to come down to the payer,” Dr. Axelrad said. “If there was a clear signal, providers such as myself would have a better leg to stand on, like we saw with VARSITY, where vedolizumab was clearly superior to adalimumab on multiple endpoints. We didn’t see that sort of robust signal here.”

The SEAVUE trial was supported by Janssen Scientific Affairs. Dr. Sands disclosed relationships with Janssen, AbbVie, Takeda, and others. Dr. Axelrad disclosed previous consulting fees from Janssen and research support from BioFire.

For biologic-naive adults with moderate to severe Crohn’s disease, treatment with adalimumab or ustekinumab leads to similar outcomes, according to results of the head-to-head SEAVUE trial.

When lead author Bruce E. Sands, MD, of Icahn School of Medicine at Mount Sinai, New York, compared treatment arms, patients had similar rates of clinical remission at one year. All major secondary endpoints, such as endoscopic remission, were comparable, as were safety profiles, Dr. Sands reported at the annual Digestive Disease Week^® (DDW).

“From my perspective, this is an important study,” Dr. Sands wrote in a virtual chat following his presentation. “We need more head-to-head studies!”

Results from the SEAVUE trial come almost 2 years after Dr. Sands reported findings of another head-to-head IBD trial: VARSITY, which demonstrated the superiority of vedolizumab over adalimumab among patients with moderate to severe ulcerative colitis.

The multicenter, double-blinded SEAVUE trial involved 386 patients with biologic-naive Crohn’s disease who had failed corticosteroids or immunomodulators. All patients had Crohn’s Disease Activity Index (CDAI) scores ranging from 220 to 450 and had at least one ulcer detected at baseline ileocolonoscopy.

Participants were randomized in a 1:1 ratio to receive monotherapy with either subcutaneous adalimumab (citrate-free; 160 mg at baseline, 70 mg at week 2, then 40 mg every 2 weeks) or ustekinumab, which was given first intravenously at a dose of 6 mg/kg then subcutaneously at 90 mg every 8 weeks.

The primary endpoint was clinical remission at week 52, defined by a CDAI score less than 150. Major secondary endpoints included clinical response, corticosteroid-free remission, endoscopic remission, remission in patient-reported CDAI components, and clinical remission at week 16.

Results were statistically similar across all endpoints, with clinical remission at 1 year occurring in 64.9% and 61.0% of patients receiving ustekinumab and adalimumab, respectively (P = .417).

“Both treatments demonstrated rapid onset of action and robust endoscopy results,” Dr. Sands noted during his presentation; he reported comparable rates of endoscopic remission, at 28.5% and 30.7% for ustekinumab and adalimumab, respectively (P = .631).

Among secondary endpoints, ustekinumab demonstrated some superiority, with greater maintenance of clinical response at week 52 among patients with response at week 16 (88.6% vs. 78.0%; P = .016), greater reduction in liquid/soft stools in prior 7 days from baseline to week 52 (–19.9 vs. –16.2; P = .004), and greater reduction in sum number of liquid/soft stools and abdominal pain scores in prior 7 days from baseline to week 52 (–29.6 vs. –25.1; P = .013).

Safety metrics were similar between groups, and consistent with previous experience. Although the adalimumab group had a higher rate of discontinuation due to adverse events, this trend was not statistically significant (11.3% vs. 6.3%; P value not provided).
 

Don’t ignore discontinuation rates

Jordan E. Axelrad, MD, assistant professor of medicine at NYU and a clinician at the Inflammatory Bowel Disease Center at NYU Langone Health, New York, commended the SEAVUE trial for its head-to-head design, which is a first for biologics in Crohn’s disease.

“With newer drugs, there’s a critical need for head-to-head studies for us to understand where to position a lot of these agents,” he said in an interview. “[T]his was a good undifferentiated group to understand what’s the first biologic you should use in a patient with moderate-to-severe Crohn’s disease. The primary, major take-home is that [ustekinumab and adalimumab] are similarly effective.”

When asked about the slight superiority in minor secondary endpoints associated with ustekinumab, Dr. Axelrad suggested that rates of discontinuation deserve more attention.

“For me, maybe the major focus would be on the number of patients who stopped treatment,” Dr. Axelrad said, noting a higher rate of discontinuation in the adalimumab group. “Although that was just numerical, that to me is actually more important than [the minor secondary endpoints].” He also highlighted the lower injection burden associated with ustekinumab, which is given every 8 weeks, compared with every 2 weeks for adalimumab.

Ultimately, however, it’s unlikely that treatment sequencing will depend on these finer points, Dr. Axelrad suggested, and will instead come down to finances, especially with adalimumab biosimilars on the horizon, which may be the most cost-effective.

“A lot of the decision-making of where to position [ustekinumab in Crohn’s disease] is going to come down to the payer,” Dr. Axelrad said. “If there was a clear signal, providers such as myself would have a better leg to stand on, like we saw with VARSITY, where vedolizumab was clearly superior to adalimumab on multiple endpoints. We didn’t see that sort of robust signal here.”

The SEAVUE trial was supported by Janssen Scientific Affairs. Dr. Sands disclosed relationships with Janssen, AbbVie, Takeda, and others. Dr. Axelrad disclosed previous consulting fees from Janssen and research support from BioFire.

SER-109, an oral microbiome therapeutic, safely protects against Clostridioides difficile recurrence for up to 24 weeks, according to a recent phase 3 trial. Three days of treatment with purified Firmicutes spores reduced risk of recurrence by 54%, suggesting a sustained, clinically meaningful response, according to a multicenter study presented at this year’s Digestive Disease Week^® (DDW).

“Antibiotics targeted against C. difficile bacteria are necessary but insufficient to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome,” the investigators reported at the meeting.

“The manufacturing processes for SER-109 are designed to inactivate potential pathogens, while enriching for beneficial Firmicutes spores, which play a central role in inhibiting the cycle of C. difficile,” said Louis Y. Korman, MD, a gastroenterologist in Washington, who was lead author.
 

Extended data from ECOSPOR-III

The ECOSPOR-III trial involved 182 patients with at least three episodes of C. difficile infection in the previous 12 months. Patients underwent 10-21 days of antibiotic therapy with fidaxomicin or vancomycin to resolve symptoms before they were then randomized in a 1:1 ratio to receive either SER-109 (four capsules daily for 3 days) or placebo, with stratification by specific antibiotic and patient age (threshold of 65 years).

The primary objectives were safety and efficacy at 8 weeks. These results, which were previously reported at ACG 2020, showed a 68% relative risk reduction in the SER-109 group, and favorable safety data. The findings presented at DDW added to those earlier ones by providing safety and efficacy data extending to week 24. At this time point, patients treated with SER-109 had a 54% relative risk reduction in C. difficile recurrence. Recurrence rates were 21.3% and 47.3% for the treatment and placebo groups, respectively (P less than .001).

Patients 65 years and older benefited the most from SER-109 therapy, based on a relative risk reduction of 56% (P less than .001), versus a 49% relative risk reduction (lacking statistical significance) for patients younger than 65 years (P = .093). The specific antibiotic therapy patients received also appeared to impact outcomes. Patients treated with fidaxomicin had a 73% relative risk reduction (P = .009), compared with 48% for vancomycin (P = .006). Safety profiles were similar between study arms.

“By enriching for Firmicutes spores, SER-109 achieves high efficacy, while mitigating risk of transmitting infectious agents and represents a major paradigm shift in the clinical management of patients with recurrent C. difficile infection,” the investigators concluded, noting that “an open-label study for patients with recurrent C. difficile infection is currently enrolling.”
 

Microbiome restoration therapies

According to Sahil Khanna, MBBS, professor of medicine at Mayo Clinic, Rochester, Minn., these findings “advance the field” because they show a sustained response. “We know that microbiome restoration therapies help restore colonization resistance,” Dr. Khanna said in an interview, noting that they offer benefits comparable to fecal microbiota transplantation (FMT) without the downsides.

SER-109, an oral microbiome therapeutic, safely protects against Clostridioides difficile recurrence for up to 24 weeks, according to a recent phase 3 trial. Three days of treatment with purified Firmicutes spores reduced risk of recurrence by 54%, suggesting a sustained, clinically meaningful response, according to a multicenter study presented at this year’s Digestive Disease Week^® (DDW).

“Antibiotics targeted against C. difficile bacteria are necessary but insufficient to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome,” the investigators reported at the meeting.

“The manufacturing processes for SER-109 are designed to inactivate potential pathogens, while enriching for beneficial Firmicutes spores, which play a central role in inhibiting the cycle of C. difficile,” said Louis Y. Korman, MD, a gastroenterologist in Washington, who was lead author.
 

Extended data from ECOSPOR-III

The ECOSPOR-III trial involved 182 patients with at least three episodes of C. difficile infection in the previous 12 months. Patients underwent 10-21 days of antibiotic therapy with fidaxomicin or vancomycin to resolve symptoms before they were then randomized in a 1:1 ratio to receive either SER-109 (four capsules daily for 3 days) or placebo, with stratification by specific antibiotic and patient age (threshold of 65 years).

The primary objectives were safety and efficacy at 8 weeks. These results, which were previously reported at ACG 2020, showed a 68% relative risk reduction in the SER-109 group, and favorable safety data. The findings presented at DDW added to those earlier ones by providing safety and efficacy data extending to week 24. At this time point, patients treated with SER-109 had a 54% relative risk reduction in C. difficile recurrence. Recurrence rates were 21.3% and 47.3% for the treatment and placebo groups, respectively (P less than .001).

Patients 65 years and older benefited the most from SER-109 therapy, based on a relative risk reduction of 56% (P less than .001), versus a 49% relative risk reduction (lacking statistical significance) for patients younger than 65 years (P = .093). The specific antibiotic therapy patients received also appeared to impact outcomes. Patients treated with fidaxomicin had a 73% relative risk reduction (P = .009), compared with 48% for vancomycin (P = .006). Safety profiles were similar between study arms.

“By enriching for Firmicutes spores, SER-109 achieves high efficacy, while mitigating risk of transmitting infectious agents and represents a major paradigm shift in the clinical management of patients with recurrent C. difficile infection,” the investigators concluded, noting that “an open-label study for patients with recurrent C. difficile infection is currently enrolling.”
 

Microbiome restoration therapies

According to Sahil Khanna, MBBS, professor of medicine at Mayo Clinic, Rochester, Minn., these findings “advance the field” because they show a sustained response. “We know that microbiome restoration therapies help restore colonization resistance,” Dr. Khanna said in an interview, noting that they offer benefits comparable to fecal microbiota transplantation (FMT) without the downsides.

SER-109, an oral microbiome therapeutic, safely protects against Clostridioides difficile recurrence for up to 24 weeks, according to a recent phase 3 trial. Three days of treatment with purified Firmicutes spores reduced risk of recurrence by 54%, suggesting a sustained, clinically meaningful response, according to a multicenter study presented at this year’s Digestive Disease Week^® (DDW).

“Antibiotics targeted against C. difficile bacteria are necessary but insufficient to achieve a durable clinical response because they have no effect on C. difficile spores that germinate within a disrupted microbiome,” the investigators reported at the meeting.

“The manufacturing processes for SER-109 are designed to inactivate potential pathogens, while enriching for beneficial Firmicutes spores, which play a central role in inhibiting the cycle of C. difficile,” said Louis Y. Korman, MD, a gastroenterologist in Washington, who was lead author.
 

Extended data from ECOSPOR-III

The ECOSPOR-III trial involved 182 patients with at least three episodes of C. difficile infection in the previous 12 months. Patients underwent 10-21 days of antibiotic therapy with fidaxomicin or vancomycin to resolve symptoms before they were then randomized in a 1:1 ratio to receive either SER-109 (four capsules daily for 3 days) or placebo, with stratification by specific antibiotic and patient age (threshold of 65 years).

The primary objectives were safety and efficacy at 8 weeks. These results, which were previously reported at ACG 2020, showed a 68% relative risk reduction in the SER-109 group, and favorable safety data. The findings presented at DDW added to those earlier ones by providing safety and efficacy data extending to week 24. At this time point, patients treated with SER-109 had a 54% relative risk reduction in C. difficile recurrence. Recurrence rates were 21.3% and 47.3% for the treatment and placebo groups, respectively (P less than .001).

Patients 65 years and older benefited the most from SER-109 therapy, based on a relative risk reduction of 56% (P less than .001), versus a 49% relative risk reduction (lacking statistical significance) for patients younger than 65 years (P = .093). The specific antibiotic therapy patients received also appeared to impact outcomes. Patients treated with fidaxomicin had a 73% relative risk reduction (P = .009), compared with 48% for vancomycin (P = .006). Safety profiles were similar between study arms.

“By enriching for Firmicutes spores, SER-109 achieves high efficacy, while mitigating risk of transmitting infectious agents and represents a major paradigm shift in the clinical management of patients with recurrent C. difficile infection,” the investigators concluded, noting that “an open-label study for patients with recurrent C. difficile infection is currently enrolling.”
 

Microbiome restoration therapies

According to Sahil Khanna, MBBS, professor of medicine at Mayo Clinic, Rochester, Minn., these findings “advance the field” because they show a sustained response. “We know that microbiome restoration therapies help restore colonization resistance,” Dr. Khanna said in an interview, noting that they offer benefits comparable to fecal microbiota transplantation (FMT) without the downsides.

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.

Proton pump inhibitor (PPI) use can safely be reduced by deprescribing efforts coupled with patient and clinician education, according to a retrospective study involving more than 4 million veterans.

After 1 year, the intervention was associated with a significant reduction in PPI use without worsening of acid-related diseases, reported lead author Jacob E. Kurlander, MD, of the University of Michigan, Ann Arbor, and the VA Ann Arbor Healthcare System’s Center for Clinical Management Research.

“There’s increasing interest in interventions to reduce PPI use,” Dr. Kurlander said during his virtual presentation at the annual Digestive Disease Week® (DDW). “Many of the interventions have come in the form of patient and provider education, like the Choosing Wisely campaign put out by the American Board of Internal Medicine. However, in rigorous studies, few interventions have actually proven effective, and many of these studies lack data on clinical outcomes, so it’s difficult to ascertain the real clinical benefits, or even harms.”

In an effort to address this gap, the investigators conducted a retrospective, difference-in-difference study spanning 10 years, from 2009 to 2019. The 1-year intervention, implemented in August 2013, included refill restrictions for PPIs without documented indication for long-term use, voiding of PPI prescriptions not filled within 6 months, a quick-order option for H2-receptor antagonists, reports to identify high-dose PPI prescribing, and patient and clinician education.

The intervention group consisted of 192,607-250,349 veterans in Veteran Integrated Service Network 17, whereas the control group consisted of 3,775,978-4,360,908 veterans in other service networks (ranges in population size are due to variations across 6-month intervals of analysis). For each 6-month interval, patients were included if they had at least two primary care visits within the past 2 years, and excluded if they received primary care at three other sites that joined the intervention site after initial implementation.

The investigators analyzed three main outcomes: Proportion of veterans dispensed a PPI prescription from the VA at any dose; incidence proportion of hospitalization for upper GI diseases, including upper GI bleeding other than from esophageal varices or angiodysplasia, as well as nonbleeding acid peptic disease; and rates of primary care visits, gastroenterology visits, and esophagogastroduodenoscopies (EGDs).

The analysis was divided into a preimplementation period, lasting approximately 5 years, and a postimplementation period with a similar duration. In the postimplementation period, the intervention group had a 5.9% relative reduction in PPI prescriptions, compared with the control group (P < .001). During the same period, the intervention site did not have a significant increase in the rate of patients hospitalized for upper GI diseases, primary care visits, GI clinic visits, or EGDs.

In a subgroup analysis of patients coprescribed PPIs during time at high-risk for upper GI bleeding (that is, when they possessed at least two high-risk medications, such as warfarin), there was a 4.6% relative reduction in time with PPI gastroprotection among the intervention group, compared with the control group (P = .003). In a second sensitivity analysis, hospitalization for upper GI diseases in high-risk patients at least 65 years of age was not significantly different between groups.

“[This] multicomponent PPI deprescribing program led to sustained reductions in PPI use,” Dr. Kurlander concluded. “However, this blunt intervention also reduced appropriate use of PPIs for gastroprotection, raising some concerns about clinical quality of care, but this did not appear to cause any measurable clinical harm in terms of hospitalizations for upper GI diseases.”
 

Debate around ‘unnecessary PPI use’

According to Philip O. Katz, MD, professor of medicine and director of motility laboratories at Weill Cornell Medicine, New York, the study “makes an attempt to do what others have tried in different ways, which is to develop a mechanism to help reduce or discontinue proton pump inhibitors when people believe they’re not indicated.”

Yet this latter element – appropriate indication – drives an ongoing debate.

“This is a very controversial area,” Dr. Katz said in an interview. “The concept of using the lowest effective dose of medication needed for a symptom or a disease is not new, but the push to reducing or eliminating ‘unnecessary PPI use’ is one that I believe should be carefully discussed, and that we have a clear understanding of what constitutes unnecessary use. And quite honestly, I’m willing to state that I don’t believe that’s been well defined.”

Dr. Katz, who recently coauthored an article about PPIs, suggested that more prospective research is needed to identify which patients need PPIs and which don’t.

“What we really need are more studies that look at who really needs [PPIs] long term,” Dr. Katz said, “as opposed to doing it ad hoc.”

The study was funded by the U.S. Department of Veterans Affairs and the National Institute of Diabetes and Digestive and Kidney Diseases. The investigators reported no conflicts of interest. Dr. Katz is a consultant for Phathom Pharma.

While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.

The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.

“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.

The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.

Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
 

Reassuring data that should prompt referral

Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.

“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.

“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
 

Impact of the HOPE Act

Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.

The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.

However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.

Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
 

Progress in a still-underserved population

The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.

Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.

In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.

Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.

In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.

The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.

“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.

Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.

While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.

The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.

“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.

The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.

Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
 

Reassuring data that should prompt referral

Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.

“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.

“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
 

Impact of the HOPE Act

Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.

The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.

However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.

Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
 

Progress in a still-underserved population

The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.

Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.

In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.

Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.

In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.

The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.

“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.

Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.

While liver transplant outcomes were historically poor in people coinfected with HIV and hepatitis C virus (HCV), they have improved significantly in the era of direct-acting antiviral (DAA) therapy, a recent analysis of U.S. organ transplant data showed.

The availability of highly potent DAA therapy should change how transplant specialists view patients coinfected with HIV/HCV who need a liver transplant, according to researcher Jennifer Wang, MD, chief gastroenterology fellow at the University of Chicago, who presented the results of the analysis at the annual Digestive Disease Week® (DDW). Cumulative graft survival rates since the introduction of DAAs are comparable between transplant recipients with HIV/HCV coinfection and recipients who are both HIV and HCV negative, according to the study.

“Having hepatitis C no longer confers worse patient survival in the DAA era, and this is the main takeaway from our study,” Dr. Wang said.

The study also showed that the number of liver transplants among HIV-infected patients has increased over the past 4-5 years. However, the absolute number remains low at 64 cases in 2019, or less than 1% of all liver transplants that year, and only about one-third of those HIV-positive recipients had HCV coinfection, according to Dr. Wang.

Moreover, relatively few centers are performing liver transplants for patients who are HIV/HCV coinfected, and there is significant geographic variation in where the procedures are done, she said in her presentation.
 

Reassuring data that should prompt referral

Taken together, these results should offer reassurance to transplant centers that patients coinfected with HIV/HCV are no longer at increased risk for poor outcomes after transplantation, said Christine M. Durand, MD, associate professor of medicine at Johns Hopkins University, Baltimore.

“The additional call for action should be beyond the transplantation community to ensure that referrals for liver transplant are where they should be,” Dr. Durand said in an interview.

“With a number of only 64 transplants a year, we’re not doing enough, and there are more patients that could benefit from liver transplants,” added Dr. Durand, who is principal investigator of HOPE in Action, a prospective, multicenter, clinical trial evaluating the safety and survival outcomes of HIV-positive deceased donor liver transplants in HIV-positive recipients.
 

Impact of the HOPE Act

Liver transplantation for HIV-positive patients has increased since the signing of the HIV Organ Policy Equity (HOPE) Act in 2013, according to Dr. Wang.

The HOPE act expanded the donor pool to include HIV-positive deceased donors, which not only increased the donor supply overall, but specifically helped HIV-positive individuals, who experience a higher rate of waiting-list mortality, according to a review on the topic authored by Dr. Durand and coauthors.

However, some transplant centers may be reluctant to do liver transplants in HIV-positive patients coinfected with HCV. That’s because, in previous studies that were conducted before the DAA era, outcomes after liver transplant in HIV/HCV-coinfected patients were inferior to those in patients with HIV but no HCV infection, Dr. Wang said.

Accordingly, Dr. Wang and colleagues analyzed Organ Procurement and Transplantation Network (OPTN) data on adult patients who underwent liver transplants between 2008 and 2019 to see if the introduction of DAAs had leveled the playing field for those with HCV coinfection.
 

Progress in a still-underserved population

The practice of liver transplant in the HIV population has been increasing since the HOPE Act, according to Dr. Wang.

Overall, out of 70,125 liver transplant recipients over the 2008-2019 period, 416 (0.6%) were HIV infected, the data show.

In 2014, 28 liver transplants (0.5%) were performed in HIV-infected individuals, which increased to 64 transplants (0.8%) in 2019, data show. Of those 64 HIV-positive liver transplant recipients in 2019, 23 (35.9%) were coinfected with HCV.

Graft survival has greatly improved, from a 3-year survival of only 58% in patients transplanted before the availability of DAAs to 82% in the DAA era, a difference that was statistically significant, Dr. Wang said.

In the DAA era, there was no significant difference in graft failure outcomes when comparing HIV/HCV-coinfected recipients with uninfected recipients, she added.

The largest proportion of liver transplantations in HIV/HCV-coinfected recipients have been done in OPTN Region 9 (New York), both in the pre- and post-DAA eras, according to Dr. Wang. Several regions have very low numbers or have performed no liver transplants in HIV/HCV-coinfected patients in either era.

“The number of transplant centers participating in liver transplant for coinfected patients is still quite low, so this is a very underserved patient population,” Dr. Wang said.

Dr. Wang provided no financial disclosures related to the research. Dr. Durand receives grants to the institution from Abbvie and GlaxoSmithKline and she receives honoraria from Gilead Sciences for serving on a grant review committee.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Pancreatic cancer clinical trials conducted in the United States over the past few decades have not adequately reported or included racial and ethnic minority populations, results of a recent study suggest.

Adequate inclusion of underrepresented minorities in clinical trials is critical to reducing health care disparities and improving patient outcomes, according to investigator Kelly M. Herremans, MD, a surgical research fellow at the University of Florida in Gainesville. For the trials that did report race and ethnicity, Black, Asian/Pacific Islander, American Indian/Alaskan Native, and Hispanic patients were significantly underrepresented, according to the study, which was reported at the annual Digestive Disease Week® (DDW).

“It is unfortunate that we still have not made much headway regarding diversity in clinical trials in order to truly understand the impact that therapeutics may have on the population as a whole,” Dr. Herremans said in a media briefing. “We need to have an accurate representation of the entire population reflected in these studies.”

Only about half of the U.S. pancreatic cancer studies reported the race of participants, and slightly more than one-third reported ethnicity, Dr. Herremans said. She noted that certain racial and ethnic minorities, and in particular Black Americans, have a higher incidence of pancreatic cancer, are diagnosed at younger ages, and die sooner.

Racial and ethnic differences in pancreatic tumor biology have also been reported. Dr. Herremans said patients of African ancestry have both somatic and germline mutations when compared with other subgroups, meaning they may potentially respond differently to specific treatments. “Having diversity in trial participants is critical to ensuring that these differences can be clinically tested,” she said.
 

Objective data on an uncomfortable truth

This review of pancreatic cancer trials is an “excellent and much needed study,” said Antonio H. Mendoza-Ladd, MD, of the division of gastroenterology at Texas Tech University Health Sciences Center, El Paso. “It contributes objective data that brings to the mainstream an unspoken and uncomfortable truth: Systemic racism, bias, and discrimination exist in the medical system,” Dr. Mendoza-Ladd said in an interview.

Pancreatic cancer is one of deadliest malignancies in the world, and underrepresented minorities bear the brunt of its lethality, according to Dr. Mendoza-Ladd. He said researchers should follow the recommendations of the study authors to ensure that underrepresented minorities are enrolled in clinical trials in sufficient numbers. “Pancreatic cancer does not discriminate by ethnicity or socioeconomic status, even if the medical system does,” he said.
 

Pancreatic cancer trial disparities

In their study, Dr. Herremans and colleagues analyzed 207 clinical trials in the United States for pancreatic ductal adenocarcinoma between 2008 and 2020. They identified the studies using ClinicalTrials.gov, a national registry of clinical trial data, then gathered trial data and demographics on 8,429 participants from reported study results and related publications. Using that data, they were able to evaluate the rates at which race, ethnicity, and gender have been reported over the past few decades, as well as the rates of inclusion of racial and ethnic minorities in the studies.

Fewer than half of the trials (49.3%) reported race, and only about one-third (34.7%) reported ethnicity. By comparison, 99% of the studies reported gender. Results did suggest an increase over time in reporting of race and ethnicity, according to Dr. Herremans, particularly since October 2016, when the Food and Drug Administration clarified its expectations on the collection and reporting of race and ethnicity data in clinical trials. However, the clinical trial data suggest minorities were substantially underrepresented in clinical trials during the study period. “Despite this change, we’re not seeing the actual diversity improve in these clinical trials,” Dr Herremans said in an interview.

Black patients represented 8.2% of clinical trial participants despite constituting 12.4% of U.S. incident pancreatic cancer cases (P < .0001), according to data presented by Dr. Herremans. Likewise, the data show that Hispanic patients account for 8.5% of incident cases but made up 6.0% of clinical trial participants; Asian/Pacific Islanders total 3.3% of U.S. incident pancreatic cancer cases but represented 2.4% of trial participants; and American Indian/Alaskan Native patients constitute 0.4% of incident cases versus being 0.3% of participants (P < .0001 for all). Conversely, Dr. Herremans noted that White patients account for 82.3% of the incident cases but made up 84.7% of total trial participants (P = .002).

Dr. Herremans reported no financial disclosures related to the research. Dr. Mendoza-Ladd reported a relationship with ConMed.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Researchers examining GI endoscopes after colonoscopy and esophagogastroduodenoscopy (EGD) procedures found a “startlingly high” rate of retained biopsy samples in the endoscope accessory channel or cap.

Investigators found 64% of 105 total endoscopies featured retained biopsy samples, including 76% of EGDs and 50% of colonoscopies examined.

“The take-home message would be that retained biopsies are much more common than most endoscopists would think. In our institution, many endoscopists guessed 10%-15%, while the actual number was 64%,” Gregory Toy, MD, said in an interview.

Raising awareness about the high proportion of retained biopsy samples “could help change behavior to make this happen less often,” added Dr. Toy, an internal medicine resident at the University of Utah Health in Salt Lake City.

“Another finding of this study was that there were significantly more retained biopsies found in EGDs compared to colonoscopies,” Dr. Toy said.

Dr. Toy presented the findings at the annual Digestive Disease Week® (DDW).
 

‘Very surprising’ findings

“The study is very important as it points out a significant rate of tissue retention in the biopsy channel at the conclusion of endoscopic procedures,” session moderator Serge Sorser, MD, said in an interview. 

The high rate of tissue retention “is very surprising,” added Dr. Sorser, a gastroenterologist at Ascension Michigan Providence Hospital in Novi, Mich.

“Not only does this mean that not all tissue is submitted for pathologic review, but it also brings to light the need for diligent endoscope processing between procedures,” he said.

Because biopsy specimens during GI endoscopy procedures must pass through the device’s biopsy channel and cap, Dr. Toy and colleagues decided to examine the rate of potentially retained samples.

Endoscopists “have noted anecdotally that retained biopsies can be found in the accessory channel and/or cap,” Dr. Toy said during his presentation at DDW. “However, this has not been formally studied.”

After 55 EGDs and 50 colonoscopies, each a standard outpatient procedure, the researchers removed the cap and the male end where the cap attaches. They brushed these areas for residual tissue. Next, they applied a new suction trap and cleared the channel using water and suction. They then brushed the channel and repeated the water and suction procedure. As a final check, they visually inspected the cleaning brush.

They sent any recovered tissue – designated from either the cap or channel – to pathology for evaluation. “The new pathology reads from these retained biopsies changed or added to the diagnosis in only five of our patients. All of these changes were minor, and patients were already on appropriate treatment,” Dr. Toy said.

Dr. Toy and colleagues found no differences between EGDs and colonoscopies with and without retained biopsy samples according to procedure time, doses of propofol or fentanyl, and age or gender of the patient. Likewise, the number of samples collected did not appear to influence the retention rates.

Of retained samples discovered after 42 EGDs, 71% were in the cap, 35% were in the channel, and 29% were found in both locations. Of the 25 colonoscopies with retained samples, 40% were in the cap, 34% were in the channel, and 24% were found in both places.

“The overall incidence of retained biopsies during standard upper and lower endoscopy is high,” the researchers noted.

Inclusion of multiple endoscopists and a hospital outpatient setting were strengths of the study. Limitations included a single center study with a relatively small sample size.

Dr. Toy and Dr. Sorser have disclosed no relevant financial relationships.
 

A version of this article first appeared on Medscape.com.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Help your patients better understand IBS and symptoms by sharing AGA patient education at www.gastro.org/IBS.

This article was update May 27, 2021.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

For veterans, changes in colonoscopy screening caused by the COVID-19 pandemic may have increased risks of delayed colorectal cancer (CRC) diagnosis and could lead to worse CRC outcomes, based on data from more than 33,000 patients in the Veterans Health Administration.

After COVID-19 screening policies were implemented, a significantly lower rate of veterans with red-flag signs or symptoms for CRC underwent colonoscopy, lead author Joshua Demb, PhD, a cancer epidemiologist at the University of California, San Diego, reported at the annual Digestive Disease Week® (DDW).

“As a result of the COVID-19 pandemic, the Veterans Health Administration enacted risk mitigation and management strategies in March 2020, including postponement of nearly all colonoscopies,” the investigators reported. “Notably, this included veterans with red flag signs or symptoms for CRC, among whom delays in workup could increase risk for later-stage and fatal CRC, if present.”

To measure the effects of this policy change, Dr. Demb and colleagues performed a cohort study involving 33,804 veterans with red-flag signs or symptoms for CRC, including hematochezia, iron deficiency anemia, or abnormal guaiac fecal occult blood test or fecal immunochemical test (FIT). Veterans were divided into two cohorts based on date of first red flag diagnosis: either before the COVID-19 policy was implemented (April to October 2019; n = 19,472) or after (April to October 2020; n = 14,332), with an intervening 6-month washout period.

Primary outcomes were proportion completing colonoscopy and time to colonoscopy completion. Multivariable logistic regression incorporated a number of demographic and medical covariates, including race/ethnicity, sex, age, number of red-flag signs/symptoms, first red-flag sign/symptom, and others.

Before the COVID-19 policy change, 44% of individuals with red-flag signs or symptoms received a colonoscopy, compared with 32% after the policy was introduced (P < .01). Adjusted models showed that veterans in the COVID policy group were 42% less likely to receive a diagnostic colonoscopy than those in the prepolicy group (odds ratio, 0.58; 95% confidence interval, 0.55-0.61). While these findings showed greater likelihood of receiving a screening before the pandemic, postpolicy colonoscopies were conducted sooner, with a median time to procedure of 41 days, compared with 65 days before the pandemic (P < .01). Similar differences in screening rates between pre- and postpandemic groups were observed across all types of red flag signs and symptoms.

“Lower colonoscopy uptake was observed among individuals with red-flag signs/symptoms for CRC post- versus preimplementation of COVID-19 policies, suggesting increased future risk for delayed CRC diagnosis and adverse CRC outcomes,” the investigators concluded.

Prioritization may be needed to overcome backlog of colonoscopies

Jill Tinmouth, MD, PhD, lead scientist for ColonCancerCheck, Ontario’s organized colorectal cancer screening program, and a gastroenterologist and scientist at Sunnybrook Health Sciences Centre, Toronto, shared similar concerns about delayed diagnoses.

“We might expect these cancers to present ... at a more advanced stage, and that, as a result, the outcomes from these cancers could be worse,” Dr. Tinmouth said in an interview.

She also noted the change in colonoscopy timing.

“A particularly interesting finding was that, when a colonoscopy occurred, the time to colonoscopy was shorter during the COVID era than in the pre-COVID era,” Dr. Tinmouth said. “The authors suggested that this might be as a result of Veterans Health Administration policies implemented as a result of the pandemic that led to prioritization of more urgent procedures.”

According to Dr. Tinmouth, similar prioritization may be needed to catch up with the backlog of colonoscopies created by pandemic-related policy changes. In a recent study comparing two backlog management techniques, Dr. Tinmouth and colleagues concluded that redirecting low-yield colonoscopies to FIT without increasing hospital colonoscopy capacity could reduce time to recovery by more than half.

Even so, screening programs may be facing a long road to recovery.

“Recovery of the colonoscopy backlog is going to be a challenge that will take a while – maybe even years – to resolve,” Dr. Tinmouth said. “Jurisdictions/institutions that have a strong centralized intake or triage will likely be most successful in resolving the backlog quickly as they will be able to prioritize the most urgent cases, such as persons with an abnormal FIT or with symptoms, and to redirect persons scheduled for a ‘low-yield’ colonoscopy to have a FIT instead.” Ontario defines low-yield colonoscopies as primary screening for average-risk individuals and follow-up colonoscopies for patients with low-risk adenomas at baseline.

When asked about strategies to address future pandemics, Dr. Tinmouth said, “I think that two key learnings for me from this [pandemic] are: one, not to let our guard down, and to remain vigilant and prepared – in terms of monitoring, supply chain, equipment, etc.] ... and two to create a nimble and agile health system so that we are able to assess the challenges that the next pandemic brings and address them as quickly as possible.”The investigators and Dr. Tinmouth reported no conflicts of interest.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.

Irritable bowel syndrome symptoms improved among patients who endured a prolonged COVID-19 lockdown in Argentina, a finding that was unexpected yet reaffirms the gut-brain connection in this gastrointestinal disorder, according to a coauthor of a study presented at the annual Digestive Disease Week® (DDW).

These patients with irritable bowel syndrome (IBS) reported improvements in disease severity and symptoms during the lockdown that were significant in comparison with the prepandemic period, according to Juan Pablo Stefanolo, MD, a lead author on the study.

The proportion of patients with severe IBS dropped from about 50% to 30%, accompanied by decreases in global and individual symptom scores, according to data presented at the meeting.

Investigators had assumed that IBS symptoms would worsen, fueled by new stresses and pressures related to a nationwide lockdown in Argentina that started in March 19, 2020, and didn’t fully end until November.

Now, the hypothesis has changed, according to Dr. Stefanolo, a physician in the neurogastroenterology and motility section at Hospital de Clínicas José de San Martín, Buenos Aires University.

“We think that probably just staying at home in a more relaxed way, and in a more controlled environment, could have improved those symptoms,” Dr. Stefanolo said in an interview.
 

Impact of lifestyle factors?

This reported decrease in overall severity and symptoms associated with IBS during the pandemic lockdown is an “interesting phenomenon” that deserves further study, said Purna C. Kashyap, MBBS, professor of medicine, physiology, and biomedical engineering at the Mayo Medical School, Rochester, Minn.

Diet, exercise, and other lifestyle factors such as spending more time with family could be contributing to the improvement in symptoms, said Dr. Kashyap, who was not involved in the study.

“A follow-up survey which includes these additional factors could help ascertain why there was an improvement in symptoms and could help with developing effective treatment strategies,” Dr. Kashyap said.

A more detailed follow-up survey is definitely warranted, Dr. Stefanolo said, particularly as Argentina faces new and sweeping pandemic-related restrictions caused by a second-wave COVID-19 surge that now includes more than 30,000 new cases per day.

On May 21, Argentina entered a strict 9-day confinement period as President Alberto Fernández said the country was facing its “worst moment” of the pandemic to date.

Although the circumstances are very unfortunate, worsening pandemic conditions in Argentina are nonetheless a “perfect scenario” to explore in more detail how external stress burden impacts IBS symptoms, said Dr. Stefanolo.
 

Study results

To study the impact of the 2020 mandatory lockdown on gut-brain axis symptomatology in IBS patients, Dr. Stefanolo and coauthors assessed a total of 129 patients with IBS-diarrhea or mixed bowel habits subtype. The mean age of participants was 54 years and 78% were female.

Patients were assessed by online survey or phone interview using the Irritable Bowel Syndrome Severity Scale (IBS-SS), Likert scales for IBS symptoms, and the Bristol Stool Scale, along with other measures of mood and comorbidities.

The proportion of patients with severe IBS dropped from 50% (65 patients) in the prepandemic period to 30% (39 patients) during the lockdown, Dr. Stefanolo and coauthors reported at the virtual DDW meeting. Similarly, mean IBS-SS scores dropped from 278.54 to 212.36 during lockdown, translating into a difference of 65.9 points.

Patients reported improvements in global IBS symptoms, pain, and distention. Stool consistency was also improved, with an average decrease on the Bristol scale of 2 points, according to the report.

Similar improvements from the prepandemic period were observed in anxiety and somatization scores, as well as in symptoms of fibromyalgia and chronic fatigue.

By contrast, headache and pyrosis and/or regurgitation symptoms increased from the prepandemic period, possibly because of weight gain, according to Dr. Stefanolo who said that about 60% of patients reported weight gain during the lockdown.
 

Lifestyle advice

The patients in this study were being seen at a tertiary care center, so they tended to have more severe disease than what would be seen in general clinical practice, according to Dr. Stefanolo. Because of that, he advised caution in extrapolating these results to a broader patient population.

Nevertheless, this study does suggest the potential for lifestyle interventions that could make a difference for the average IBS patient, he said.

“It reinforces that outside stress has something to do with it, and that food maybe has something to do with it,” he said. “I think that giving that advice – try to be more relaxed, and maybe control the quality or the type of food you have – could be great to improve ... those symptoms, maybe.”

The study authors reported no financial disclosures related to the research. Dr. Kashyap reported relationships with Novome Biotechnologies, Otsuka Pharmaceuticals, and Pendulum.