Will Pass

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at http://ow.ly/szHz30rdKyx.

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at http://ow.ly/szHz30rdKyx.

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

Help your patients better understand their IBD treatment options by sharing AGA’s patient education, “Living with IBD,” in the AGA GI Patient Center at http://ow.ly/szHz30rdKyx.

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

The gut-selective alpha₄beta₇ integrin antibody vedolizumab is safe and effective for long-term use in patients with inflammatory bowel disease (IBD), according to data from more than 2,200 patients in the GEMINI LTS trial.

With a median cumulative exposure of approximately 3 years and some patients taking vedolizumab for more than 9 years, the study revealed no new safety concerns and showed that responses were stable over time, reported lead author Edward V. Loftus Jr., MD, of the Mayo Clinic in Rochester, Minn., and colleagues.

“Interim analyses (based on 4 years of follow-up) demonstrated that long-term vedolizumab therapy was well-tolerated and also provided clinical and health-related quality of life (HRQOL) benefits,” the investigators wrote in Alimentary Pharmacology & Therapeutics. “In this final analysis ... we report the final safety outcomes, along with exploratory clinical and HRQOL outcomes.”

The phase 3 trial involved 1,822 patients with IBD from previous phase 2 and 3 trials, plus 421 vedolizumab-naive patients. Out of 2,243 participants in the final analysis, 894 had ulcerative colitis, and 1,349 had Crohn’s disease.

All patients received vedolizumab 300 mg IV every 4 weeks, which the investigators noted is more frequent than the dosing interval of 8 weeks that was approved after the trial was designed.

Median cumulative exposure times among patients with ulcerative colitis and Crohn’s disease were 42.4 months and 31.5 months, respectively. Adverse events of any grade occurred in 93% of patients with ulcerative colitis and 96% of patients with Crohn’s disease, approximately one-third of which were exacerbations of IBD. Serious adverse events occurred in 31% and 41% of patients with ulcerative colitis and Crohn’s disease, respectively. Adverse events led to discontinuation in 15% of ulcerative colitis patients and 17% of those with Crohn’s disease. Of the 10 deaths that occurred during the study period, the investigators categorized 2 of them as drug related (hepatocellular carcinoma and West Nile virus infection–related encephalitis). No increase in the rate of overall malignancies was observed.

Dr. Loftus and colleagues noted that rates of serious infection with vedolizumab treatment were superior to historical long-term data for adalimumab, at 18.0 (ulcerative colitis) and 33.6 (Crohn’s disease) per 1,000 person-years for vedolizumab, compared with 35 (ulcerative colitis) and 67 (Crohn’s disease) per 1,000 person-years for adalimumab, as reported by Colombel and colleagues.

“While these data suggest a decreased risk of systemic infections with vedolizumab, an increased risk of gastrointestinal infections is plausible given the gut-selective mechanism of action and evidence for reduced immune response in the gastrointestinal tract,” the investigators wrote, reporting rates of 34.9 and 39.6 per 1,000 person-years for ulcerative colitis and Crohn’s disease, respectively. Comparative, historical rates for adalimumab were not provided.

In the present trial, clinical response rates, clinical remission rates, and HRQOL estimates remained stable over time. At 400 treatment weeks, clinical remission was maintained in 33% and 28% of patients with ulcerative colitis and Crohn’s disease, respectively.

“[T]he final analysis of GEMINI LTS comprehensively demonstrates that vedolizumab therapy has a safety and tolerability profile suitable for long-term treatment of patients with moderately to severely active ulcerative colitis or Crohn’s disease,” the investigators concluded.

According to Randy Longman, MD, director of the Jill Roberts Center for Inflammatory Bowel Disease at Weill Cornell Medicine and New York-Presbyterian, “The results from the GEMINI LTS trial help to solidify the favorable safety profile of vedolizumab for the treatment of IBD. With large patient numbers and cumulative duration of vedolizumab exposure, these pivotal data convincingly reveal low rates of serious infections, identified no cases of progressive multifocal leukoencephalopathy, and showed no increased risk of malignancy. Arthralgias, or joint pain, was the most common treatment-emergent adverse event, but occurred largely in patients with a history of IBD-associated arthralgia and suggest that these symptoms should be monitored during treatment. Overall, these results provide meaningful reassurance to patients and providers using vedolizumab for the treatment of IBD.”

GEMINI LTS was funded by Takeda. The investigators reported additional relationships with AbbVie, Janssen, Amgen, and others. Dr. Longman reported no conflicts of interest.

SOURCE: Loftus Jr EV et al. AP&T. 2020 Sep 2. doi: 10.1111/apt.16060.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.

International normalized ratio (INR) does not predict periprocedural bleeding in patients with cirrhosis, according to a meta-analysis of 29 studies.

This finding should deter the common practice of delivering blood products to cirrhotic patients with an elevated INR, reported lead author Alexander J. Kovalic, MD, of Novant Forsyth Medical Center in Winston Salem, N.C., and colleagues.

“INR measurement among cirrhotic patients is important in MELD [Model for End-Stage Liver Disease] prognostication and assessment of underlying hepatic synthetic function, however the INR alone does not capture the complicated interplay of anticoagulant and procoagulant deficiencies present in cirrhotic coagulopathy,” Dr. Kovalic and colleagues wrote in Alimentary Pharmacology & Therapeutics. “Yet, the ‘correction’ of these aberrancies among peripheral coagulation tests remains common ... even in modern practice, and not uncommonly occurs in the periprocedural setting.”

According to investigators, addressing INR with blood transfusion can have a litany of negative effects. Beyond the risks faced by all patient populations, increasing blood volume in those with cirrhosis can increase portal venous pressure, thereby raising risks of portal gastropathy or variceal hemorrhage. In addition, giving plasma products to patients with cirrhotic coagulopathy may further disrupt the balance between anticoagulants and procoagulants, potentially triggering disseminated intravascular coagulation.

Dr. Kovalic and colleagues noted that the lack of correlation between peripheral coagulation tests and bleeding risk has been a longstanding subject of investigation, citing studies from as early as 1981.

To add further weight to this body of evidence, the investigators conducted a systematic review and meta-analysis involving 13,276 patients with cirrhosis who underwent various procedures between 1999 and 2019. Primary outcomes included periprocedural bleeding events and the association between preprocedural INR and periprocedural bleeding events. Secondary outcomes included mortality, quantity of blood and/or plasma products used, and relationship between preprocedural platelet count and periprocedural bleeding events.

The analysis showed that preprocedural INR was not significantly associated with periprocedural bleeding events (pooled odds ratio, 1.52; 95% confidence interval, 0.99-2.33; P = .06), a finding that held across INR threshold subgroups. Similarly, no significant difference was found between mean INR of patients who had bleeding events versus that of those who did not (pooled mean difference, 0.05; 95% CI, 0.03-0.13; P = .23).

Preprocedural platelet count was also a poor predictor of periprocedural bleeding, with a pooled odds ratio of 1.24 (95% CI, 0.55-2.77; P = .60), although the investigators noted that platelet count thresholds varied widely across studies, from 30 to 150 × 10⁹/L. When studies were stratified by procedural bleeding risk or procedure type, subgroup effects were no longer significant. Other secondary endpoints were incalculable because of insufficient data.

“Hopefully, these findings will spark initiation of more large-scale, higher-quality studies ... to reinforce minimizing administration of fresh frozen plasma for inappropriate correction of INR, which carries a multitude of adverse effects among cirrhotic [patients],” the investigators concluded.

According to Stephen H. Caldwell, MD, of the University of Virginia in Charlottesville, “The present paper augments accumulating literature over the past 15 years that INR should be discarded as a measure of procedure-related bleeding risk.”

Dr. Caldwell pointed out that “bleeding in cirrhosis is usually related to portal hypertension not with impaired hemostasis, with the occasional exception of hyperfibrinolysis, which is very different from a prolonged INR.”

He went on to suggest that the present findings should dissuade clinicians from a practice that, for some, is reflexive rather than evidence based.

“It’s remarkable how many medical practices become entrenched based on hand-me-down teaching during our early training years, and remain so for many years beyond as we disperse into various medical and surgical fields,” Dr. Caldwell said. “These learned approaches to common problems can clearly persist for generations despite overwhelming evidence to the contrary that usually evolve slowly and well-insulated within subspecialties or sub-subspecialties, and hence take several generations of training to diffuse into the wider practice of medical care for common problems. These may become matters of expedience in decision-making, much like the old antibiotic conundrum of ‘no-think-a-cillin,’ as critics referred to over-use of broad spectrum antibiotics. And so it has been with the INR.”The investigators disclosed relationships with AbbVie, Eisai, Gilead, and others. Dr. Caldwell disclosed research support from Daiichi concerning the potential role of anticoagulation therapy in preventing cirrhosis progression.

SOURCE: Kovalic AJ et al. Aliment Pharmacol Ther. 2020 Sep 10. doi: 10.1111/apt.16078.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association (AGA) has issued guidance for pre-endoscopy coronavirus testing based on a review of existing literature and a survey of endoscopist risk tolerance.

While serologic antibody testing is not recommended for any patients, use of nucleic acid amplification testing (NAAT) for viral RNA should be informed by local prevalence of asymptomatic individuals, reported lead guideline panelist Shahnaz Sultan, MD, of the University of Minnesota in Minneapolis and colleagues.

“The two main concerns with a pretesting strategy are the false positives and false negatives,” the panelists wrote in Gastroenterology. When performing endoscopy in a false-negative patient, health care providers who wear a surgical mask instead of an N95/N99 respirator may have an increased risk of infection, and the patient undergoing the procedure may be falsely reassured that they are not contagious, the panelists wrote.

Among false-positive individuals, “implications for the patient include cancellation of the procedure, self-quarantine for 14 days, apprehension, and loss of work.”

Because of these concerns, the panelists concluded that pretesting strategies should be tailored to the local prevalence of asymptomatic infection because this rate is associated with likelihood of encountering false-positive and false-negative patients.

To determine appropriate prevalence thresholds, Dr. Sultan and colleagues first conducted a meta-analysis of 12 studies comparing the accuracy of various NAAT tests. This revealed a pooled sensitivity of 0.941 and a pooled specificity of 0.971. These figures remained consistent when only studies with low risk bias were considered; pooled sensitivity and specificity were 0.929 and 0.968, respectively.

“An important caveat of these studies is that tests were validated in samples from symptomatic individuals and it is likely that in asymptomatic individuals the tests may not perform as well and have lower sensitivity and specificity,” the panelists noted.

Next, Dr. Sultan and colleagues conducted an online survey of U.S. endoscopists to determine their tolerance for risk of coronavirus transmission, with proposed risk thresholds ranging from 1/40,000 to 1/1,000. Out of 74 respondents, 28 (37.8%) said that they would be willing to accept a risk level of 1/40,000, whereas 27 (36.5%) would accept risks between 1/10,000 and 1/2,500, and 19 (25.7%) would accept a risk level of 1/1,000. Among clinicians expressing the highest risk tolerance (1/1,000), almost two-thirds (63.2%) were private practitioners.

Drawing on these findings, the panelists issued three tiered recommendations for pretesting based on local prevalence of asymptomatic infection.

• Low prevalence (less than 0.5%): Pretesting is not recommended.
• Intermediate prevalence (0.5-2%): Pretesting is recommended.
• High prevalence (greater than 2%): Pretesting is not recommended.

The panelists recommended against pretesting in low and high prevalence settings because of the likelihood of false positives and false negatives, respectively. For “hotspot” areas, in which hospital capacity is acutely burdened, the panelists noted that “resumption of outpatient endoscopy may depend on availability of PPE.”

In areas of intermediate prevalence, the pretesting recommendation stands only if “testing is feasible and there is less perceived burden on patients, and when the benefits outweigh the downsides (e.g., false positives do not significantly outnumber the true positives).” According to the guidance, when performing upper and lower endoscopies on negative patients in areas of intermediate prevalence, surgical masks are appropriate for endoscopists and staff, with the caveat that those unwilling to accept any increased risk may still wear an N95/N99 respirator or a powered air-purifying respirator (PAPR).

Finally, the panelists made a recommendation against pretesting for antibodies in all areas, regardless of asymptomatic infection prevalence.

“Evidence supporting the role of seroconversion for return to work or hospital staffing policies is also lacking,” they added.

All recommendations were based on low or very low certainty evidence.

To help endoscopy centers determine an appropriate pretesting strategy, the AGA has created an online interactive tool that allows for input of diagnostic test accuracy and local prevalence rate.The investigators reported no conflicts of interest. 

Instructions for using the tool, along with additional COVID-19 guidance, can be found on the AGA website: www.gastro.org/COVID. 

The investigators reported no conflicts of interest.

This story was updated on 10/13/2020 and on 11/6/2020.

SOURCE: Sultan S et al. Gastroenterology. 2020 Jul 28. doi: 10.1053/j.gastro.2020.07.043.

The American Gastroenterological Association has published a clinical practice update that characterizes postendoscopy esophageal adenocarcinoma (EAC) and offers recommendations to improve endoscopic detection of dysplastic and neoplastic lesions in patients with Barrett’s esophagus.

While emerging technologies may improve detection rates in the future, short-term progress will depend on human expertise, reported lead author Sachin Wani, MD, of the University of Colorado at Denver, Aurora, and colleagues.

Writing in Gastroenterology, Dr. Wani and colleagues noted that EAC incidence has increased sevenfold over the past 4 decades, and 40% of patients with EAC have advanced disease at diagnosis, with a “dismal” 5-year survival rate.

Attempts to catch EAC earlier through Barrett’s esophagus surveillance endoscopy have been generally fallen short, the investigators added. They discussed a variety of obstacles to success, including divergence from recommended screening timelines, nonadherence to the Seattle biopsy protocol, sampling errors, and variability of dysplastic tissue interpretation between pathologists.

“Even in the face of suboptimal impact of current strategies on population-based EAC mortality, medical societies consistently recommend [Barrett’s esophagus] screening and surveillance,” the investigators wrote. “In this context, similar to postcolonoscopy colorectal cancer, the concept of missed EAC is gaining importance in endoscopic Barrett’s esophagus screening and surveillance.”

In the present update, the investigators first aimed to standardize definitions of postendoscopy and interval EAC.

“We propose that postendoscopy EAC be defined as EAC and/or [Barrett’s esophagus]–related high-grade dysplasia identified within a finite time period (typically 1 year) following a nondiagnostic endoscopy,” the investigators wrote. “Interval EAC may be defined as EAC or [Barrett’s esophagus]–related high-grade dysplasia diagnosed after a negative screening or surveillance endoscopy before the date of the next recommended test.”

The latter definition, the investigators noted, was written with acknowledgment of emerging, noninvasive, nonendoscopic screening tools.

Next, Dr. Wani and colleagues dove deeper into the incidence of postendoscopy EAC in the Barrett’s esophagus population. Across multiple cohort studies and meta-analyses, incidence within 1 year of screening endoscopy ranged widely, from 3% to 25%. Data from Barrett’s esophagus patients undergoing endoscopic eradication therapy suggest that incidence of postendoscopy EAC may be greatest within 1-2 years of complete eradication of intestinal metaplasia; one meta-analysis involving 22 studies reported that the risk of EAC was 92% higher within the first year of eradication, compared with subsequent years.

“These data support that high-grade dysplasia/EAC identified within 1 year after complete eradication of intestinal metaplasia likely represents missed and/or incompletely treated prevalent disease rather than recurrent or incident neoplasia,” the investigators wrote.

In support of this conclusion, Dr. Wani and colleagues drew upon data from colorectal cancer screening programs, which suggest that 89% of postcolonoscopy colorectal cancers “may be avoidable, attributable to technical endoscopic factors, compromised decision-making, and administrative factors.”

Regulatory agencies measure quality of colorectal cancer screening programs with adenoma detection rate, which has been shown to correlate inversely with colorectal cancer and mortality; but no analogous measure has been established for Barrett’s esophagus screening. Candidate quality markers include neoplasia detection rate and dysplasia detection rate, though more work is needed to confirm their reliability.

“While easier to measure, compared to postendoscopy EAC rates, neoplasia detection rate remains a surrogate endoscopy quality marker in Barrett’s esophagus surveillance, while postendoscopy EAC rates serve as a true outcome measure that matters clinically,” the investigators wrote.

Dr. Wani and colleagues proposed four clinical strategies that may immediately improve quality of Barrett’s esophagus screening.

• First, they recommended “assiduous identification and photo-documentation of esophageal landmarks” coupled with lesion descriptions that adhere to Prague and Paris classification schemes, along with resection or referral upon identification.
• Second, they called for consistent use of high-definition white-light endoscopy and virtual chromoendoscopy.
• Third, they suggested that endoscopists “spend adequate time for inspection,” with biopsies taken in accordance with the Seattle protocol.
• Fourth, Dr. Wani and colleagues suggested that all practices conducting Barrett’s esophagus screening and surveillance establish continuously active quality control programs.

The investigators concluded the clinical practice update with a discussion of future directions.

“Prospective trials are needed to evaluate the impact of better dissemination of guidelines and quality indicators, improved endoscopic dysplasia detection using interactive web-based educational tools, advanced imaging techniques with artificial intelligence, and improved sampling modalities that reduce sampling errors,” they wrote. “Finally, increased emphasis is needed on improving training in both the cognitive and procedural aspects of [Barrett’s esophagus] endoscopy through structured educational programs among trainees and practicing endoscopists.”

The study was supported by the University of Colorado department of medicine’s Outstanding Early Scholars Program. The investigators disclosed relationships with Medtronic, Boston Scientific, Ironwood, and others.

SOURCE: Wani S et al. Gastroenterology. 2020 Jul 13. doi: 10.1053/j.gastro.2020.06.089.

The American Gastroenterological Association has published a clinical practice update that characterizes postendoscopy esophageal adenocarcinoma (EAC) and offers recommendations to improve endoscopic detection of dysplastic and neoplastic lesions in patients with Barrett’s esophagus.

While emerging technologies may improve detection rates in the future, short-term progress will depend on human expertise, reported lead author Sachin Wani, MD, of the University of Colorado at Denver, Aurora, and colleagues.

Writing in Gastroenterology, Dr. Wani and colleagues noted that EAC incidence has increased sevenfold over the past 4 decades, and 40% of patients with EAC have advanced disease at diagnosis, with a “dismal” 5-year survival rate.

Attempts to catch EAC earlier through Barrett’s esophagus surveillance endoscopy have been generally fallen short, the investigators added. They discussed a variety of obstacles to success, including divergence from recommended screening timelines, nonadherence to the Seattle biopsy protocol, sampling errors, and variability of dysplastic tissue interpretation between pathologists.

“Even in the face of suboptimal impact of current strategies on population-based EAC mortality, medical societies consistently recommend [Barrett’s esophagus] screening and surveillance,” the investigators wrote. “In this context, similar to postcolonoscopy colorectal cancer, the concept of missed EAC is gaining importance in endoscopic Barrett’s esophagus screening and surveillance.”

In the present update, the investigators first aimed to standardize definitions of postendoscopy and interval EAC.

“We propose that postendoscopy EAC be defined as EAC and/or [Barrett’s esophagus]–related high-grade dysplasia identified within a finite time period (typically 1 year) following a nondiagnostic endoscopy,” the investigators wrote. “Interval EAC may be defined as EAC or [Barrett’s esophagus]–related high-grade dysplasia diagnosed after a negative screening or surveillance endoscopy before the date of the next recommended test.”

The latter definition, the investigators noted, was written with acknowledgment of emerging, noninvasive, nonendoscopic screening tools.

Next, Dr. Wani and colleagues dove deeper into the incidence of postendoscopy EAC in the Barrett’s esophagus population. Across multiple cohort studies and meta-analyses, incidence within 1 year of screening endoscopy ranged widely, from 3% to 25%. Data from Barrett’s esophagus patients undergoing endoscopic eradication therapy suggest that incidence of postendoscopy EAC may be greatest within 1-2 years of complete eradication of intestinal metaplasia; one meta-analysis involving 22 studies reported that the risk of EAC was 92% higher within the first year of eradication, compared with subsequent years.

“These data support that high-grade dysplasia/EAC identified within 1 year after complete eradication of intestinal metaplasia likely represents missed and/or incompletely treated prevalent disease rather than recurrent or incident neoplasia,” the investigators wrote.

In support of this conclusion, Dr. Wani and colleagues drew upon data from colorectal cancer screening programs, which suggest that 89% of postcolonoscopy colorectal cancers “may be avoidable, attributable to technical endoscopic factors, compromised decision-making, and administrative factors.”

Regulatory agencies measure quality of colorectal cancer screening programs with adenoma detection rate, which has been shown to correlate inversely with colorectal cancer and mortality; but no analogous measure has been established for Barrett’s esophagus screening. Candidate quality markers include neoplasia detection rate and dysplasia detection rate, though more work is needed to confirm their reliability.

“While easier to measure, compared to postendoscopy EAC rates, neoplasia detection rate remains a surrogate endoscopy quality marker in Barrett’s esophagus surveillance, while postendoscopy EAC rates serve as a true outcome measure that matters clinically,” the investigators wrote.

Dr. Wani and colleagues proposed four clinical strategies that may immediately improve quality of Barrett’s esophagus screening.

• First, they recommended “assiduous identification and photo-documentation of esophageal landmarks” coupled with lesion descriptions that adhere to Prague and Paris classification schemes, along with resection or referral upon identification.
• Second, they called for consistent use of high-definition white-light endoscopy and virtual chromoendoscopy.
• Third, they suggested that endoscopists “spend adequate time for inspection,” with biopsies taken in accordance with the Seattle protocol.
• Fourth, Dr. Wani and colleagues suggested that all practices conducting Barrett’s esophagus screening and surveillance establish continuously active quality control programs.

The investigators concluded the clinical practice update with a discussion of future directions.

“Prospective trials are needed to evaluate the impact of better dissemination of guidelines and quality indicators, improved endoscopic dysplasia detection using interactive web-based educational tools, advanced imaging techniques with artificial intelligence, and improved sampling modalities that reduce sampling errors,” they wrote. “Finally, increased emphasis is needed on improving training in both the cognitive and procedural aspects of [Barrett’s esophagus] endoscopy through structured educational programs among trainees and practicing endoscopists.”

The study was supported by the University of Colorado department of medicine’s Outstanding Early Scholars Program. The investigators disclosed relationships with Medtronic, Boston Scientific, Ironwood, and others.

SOURCE: Wani S et al. Gastroenterology. 2020 Jul 13. doi: 10.1053/j.gastro.2020.06.089.

The American Gastroenterological Association has published a clinical practice update that characterizes postendoscopy esophageal adenocarcinoma (EAC) and offers recommendations to improve endoscopic detection of dysplastic and neoplastic lesions in patients with Barrett’s esophagus.

While emerging technologies may improve detection rates in the future, short-term progress will depend on human expertise, reported lead author Sachin Wani, MD, of the University of Colorado at Denver, Aurora, and colleagues.

Writing in Gastroenterology, Dr. Wani and colleagues noted that EAC incidence has increased sevenfold over the past 4 decades, and 40% of patients with EAC have advanced disease at diagnosis, with a “dismal” 5-year survival rate.

Attempts to catch EAC earlier through Barrett’s esophagus surveillance endoscopy have been generally fallen short, the investigators added. They discussed a variety of obstacles to success, including divergence from recommended screening timelines, nonadherence to the Seattle biopsy protocol, sampling errors, and variability of dysplastic tissue interpretation between pathologists.

“Even in the face of suboptimal impact of current strategies on population-based EAC mortality, medical societies consistently recommend [Barrett’s esophagus] screening and surveillance,” the investigators wrote. “In this context, similar to postcolonoscopy colorectal cancer, the concept of missed EAC is gaining importance in endoscopic Barrett’s esophagus screening and surveillance.”

In the present update, the investigators first aimed to standardize definitions of postendoscopy and interval EAC.

“We propose that postendoscopy EAC be defined as EAC and/or [Barrett’s esophagus]–related high-grade dysplasia identified within a finite time period (typically 1 year) following a nondiagnostic endoscopy,” the investigators wrote. “Interval EAC may be defined as EAC or [Barrett’s esophagus]–related high-grade dysplasia diagnosed after a negative screening or surveillance endoscopy before the date of the next recommended test.”

The latter definition, the investigators noted, was written with acknowledgment of emerging, noninvasive, nonendoscopic screening tools.

Next, Dr. Wani and colleagues dove deeper into the incidence of postendoscopy EAC in the Barrett’s esophagus population. Across multiple cohort studies and meta-analyses, incidence within 1 year of screening endoscopy ranged widely, from 3% to 25%. Data from Barrett’s esophagus patients undergoing endoscopic eradication therapy suggest that incidence of postendoscopy EAC may be greatest within 1-2 years of complete eradication of intestinal metaplasia; one meta-analysis involving 22 studies reported that the risk of EAC was 92% higher within the first year of eradication, compared with subsequent years.

“These data support that high-grade dysplasia/EAC identified within 1 year after complete eradication of intestinal metaplasia likely represents missed and/or incompletely treated prevalent disease rather than recurrent or incident neoplasia,” the investigators wrote.

In support of this conclusion, Dr. Wani and colleagues drew upon data from colorectal cancer screening programs, which suggest that 89% of postcolonoscopy colorectal cancers “may be avoidable, attributable to technical endoscopic factors, compromised decision-making, and administrative factors.”

Regulatory agencies measure quality of colorectal cancer screening programs with adenoma detection rate, which has been shown to correlate inversely with colorectal cancer and mortality; but no analogous measure has been established for Barrett’s esophagus screening. Candidate quality markers include neoplasia detection rate and dysplasia detection rate, though more work is needed to confirm their reliability.

“While easier to measure, compared to postendoscopy EAC rates, neoplasia detection rate remains a surrogate endoscopy quality marker in Barrett’s esophagus surveillance, while postendoscopy EAC rates serve as a true outcome measure that matters clinically,” the investigators wrote.

Dr. Wani and colleagues proposed four clinical strategies that may immediately improve quality of Barrett’s esophagus screening.

• First, they recommended “assiduous identification and photo-documentation of esophageal landmarks” coupled with lesion descriptions that adhere to Prague and Paris classification schemes, along with resection or referral upon identification.
• Second, they called for consistent use of high-definition white-light endoscopy and virtual chromoendoscopy.
• Third, they suggested that endoscopists “spend adequate time for inspection,” with biopsies taken in accordance with the Seattle protocol.
• Fourth, Dr. Wani and colleagues suggested that all practices conducting Barrett’s esophagus screening and surveillance establish continuously active quality control programs.

The investigators concluded the clinical practice update with a discussion of future directions.

“Prospective trials are needed to evaluate the impact of better dissemination of guidelines and quality indicators, improved endoscopic dysplasia detection using interactive web-based educational tools, advanced imaging techniques with artificial intelligence, and improved sampling modalities that reduce sampling errors,” they wrote. “Finally, increased emphasis is needed on improving training in both the cognitive and procedural aspects of [Barrett’s esophagus] endoscopy through structured educational programs among trainees and practicing endoscopists.”

The study was supported by the University of Colorado department of medicine’s Outstanding Early Scholars Program. The investigators disclosed relationships with Medtronic, Boston Scientific, Ironwood, and others.

SOURCE: Wani S et al. Gastroenterology. 2020 Jul 13. doi: 10.1053/j.gastro.2020.06.089.

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Share AGA GI Patient Center content to help your patients understand the symptoms and complications of pancreatitis at http://ow.ly/j1AN30r8ZDa.

This story was updated on 9/14/2020.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Gyanprakash Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Gyanprakash Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

Mounting data support acute pancreatitis as one possible GI manifestation of COVID-19, according to investigators.

While previous case reports suggested that infection with SARS-CoV2 may lead to pancreatitis, this retrospective analysis, which is the largest to date, is the first to offer substantial evidence for this claim, reported lead author Sumant Inamdar, MBBS, of the University of Arkansas, Little Rock, and colleagues.

“It has become increasingly clear that COVID-19 has systemic effects that also includes the gastrointestinal and pancreaticobiliary systems,” the investigators wrote in Gastroenterology. “As islet cells of the pancreas contain ACE2 receptor proteins, SARS-CoV2 can bind to these receptors and cause pancreatic injury.”

For the present analysis, Dr. Inamdar and colleagues reviewed charts from 48,012 patients who were hospitalized in New York between March and June of this year. While pancreatitis is usually diagnosed based on two out of three criteria, disease classification in the study required all three: characteristic upper abdominal pain upon admission, lipase greater than three times the upper limit of normal, and evidence of pancreatitis on cross-sectional imaging.

“[B]y including all three criteria for pancreatitis in our definition, we may be underestimating the rate of pancreatitis,” the investigators wrote. “However, we felt including diagnostic lipase levels and imaging was important for the accuracy of the diagnosis.”

Primary outcomes included mechanical ventilation, length of stay, development of pancreatic necrosis, and mortality. Outcomes were compared between patients with and without COVID-19.

Out of 48,012 hospitalized patients, 11,883 (24.75%) tested positive for SARS-CoV2. Across the entire population, 189 patients had pancreatitis (0.39%), and of these, 32 (17%) also had COVID-19. This translates to a point prevalence for pancreatitis of 0.27% for patients hospitalized with COVID-19.

Among patients with pancreatitis who did not have COVID-19, the most common etiologies for pancreatitis were gallstones (34%) and alcohol (37%), compared with just 16% and 6% of SARS-CoV2-positive cases of pancreatitis, respectively. Idiopathic pancreatitis was significantly more common among patients with COVID-19 than those without (69% vs 21%; P less than .0001).

Black or Hispanic patients with pancreatitis were 4-5 times more likely to have COVID-19 than patients with pancreatitis who were white. Across all races/ethnicities, patients with pancreatitis and COVID-19 more often required mechanical ventilation (odds ratio [OR], 5.65) and longer hospital stays (OR, 3.22), compared with those who had pancreatitis alone. While rates of mortality and pancreatic necrosis showed similar trends, associations with COVID-19 were not statistically significant.

“These findings support the notion that pancreatitis should be included in the list of GI manifestations of COVID-19,” the investigators wrote.

When caring for patients with COVID-19, Dr. Inamdar and colleagues recommended that clinicians pay close attention to any history of abdominal pain, and consider testing serum lipase levels.

“Further large studies are needed to confirm our findings,” they concluded.

Gyanprakash Avinash Ketwaroo, MD, of Baylor College of Medicine in Houston, agreed that more work is needed; in the meantime, he suggested that evidence is now strong enough for clinicians to take notice.

SOURCE: Inamdar S et al. Gastroenterology. 2020 Aug 26. doi: 10.1053/j.gastro.2020.08.044.

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

A recent study that reported no association between race and in-hospital mortality among patients with COVID-19 failed to capture broader health care inequities, according to a leading expert.

During an AGA FORWARD Program webinar, Darrell Gray II, MD, deputy director of the Center for Cancer Health Equity at Ohio State University in Columbus, noted that the study by Baligh R. Yehia, MD, and colleagues had several important limitations: specifically, a lack of data from before or after hospitalization, flawed neighborhood deprivation indices, and poorly characterized comorbidities.

While Dr. Yehia and colleagues described these limitations in their publication, Dr. Gray suggested that future studies evaluating race and health outcomes need to be “deliberate and intentional with collecting data.”

According to Dr. Gray, statistics from the Centers for Disease Control and Prevention and the APM Research Lab paint a more accurate picture of health care inequities. The CDC, for instance, reports that people who are Black are nearly five times as likely to be hospitalized for COVID-19, and approximately twice as likely to die from the disease, compared with those who are White. The APM Research Lab reports an even more striking relative mortality rate for Black Americans – almost four times higher than that of White Americans.

“People of color have been disproportionately impacted by COVID-19, whether it be by cases, hospitalizations, or deaths,” Dr. Gray said. “We have to think about why that is, and what has led to this.”

Dr. Gray emphasized that poorer outcomes among people of color are “not necessarily biological.”

“It’s the environment and social constructs that contribute to why there’s a disproportionate burden of chronic disease and why there’s a disproportionate burden of COVID-19,” he said.

According to Dr. Gray, disparate health care outcomes can be traced back to social determinants of health, which he and his colleagues highlighted in a June comment published in Nature Reviews Gastroenterology & Hepatology.

“Although much attention has focused on the high burden of chronic disease among [people of color], which predisposes them to poor outcomes if they acquire COVID-19, there is less recognition of the nonmedical health-related social needs and social determinants of health that represent the root causes of such health disparities,” they wrote.

Social determinants of health include an array of population factors, including economic stability, social and community context, neighborhood and environment, education, and access to health care.

For each, Dr. Gray encouraged comprehensive and nuanced assessment.

“Is there access to health care?” Dr. Gray asked. “Not just access in the sense of having insurance – certainly that’s a benefit – but if someone has insurance, can they get to where the health center is? Or is that something they might have to catch three buses and a cab to get to?”

Dr. Gray said that such obstacles are not outside the scope of the medical community.

“This is not beyond our responsibility ... to address social determinants of health,” Dr. Gray said.

When asked by a webinar attendee how the medical community can tackle racism, Dr. Gray offered several practical steps to move forward.

First, he suggested that clinicians and researchers listen to affected patient populations.

“Many of us, including clinicians, have been privileged to have their blinders on, if you will, to issues of racism that have been affecting our patients for a long time,” he said.

Second, Dr. Gray encouraged those who have learned to teach others.

“You need to start teaching your peers, your colleagues, your family, and friends about how racism affects patient outcomes.”

Third, he recommended that clinicians incorporate these lessons into routine practice, whether in a private or an academic setting.

“Are there ways in which you can refer patients to address social determinants of health? Are you capturing that information in your check-in materials?” Dr. Gray asked. “If you’re an investigator, when you’re doing research – whether it’s health disparities research or other – are you looking at your research through a health equity lens? Are you asking questions about social determinants of health?”

Finally, Dr. Gray called for stronger community engagement during design and conduction of clinical trials.

“People don’t care how much you know until they know how much you care,” he said. “And they won’t know how much you care unless you’re visible, and unless you’re there, and these are sustainable relationships.”

The FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.

Suspension of disease screening and nonurgent procedures because of the COVID-19 pandemic will negatively impact long-term outcomes of GI and liver disease, and people of color will be disproportionately affected, according to a leading expert.

Novel, multipronged approaches are needed to overcome widening disparities in gastroenterology and hepatology, said Rachel Issaka, MD, of Fred Hutchinson Cancer Research Center in Seattle.

“The COVID-19 pandemic has led to unprecedented drops in breast, colorectal, and cervical cancer screenings,” Dr. Issaka said during an AGA FORWARD Program webinar. Screening rates for these diseases are down 83%-90%, she said.

“Certainly this creates a backlog of cancer screenings that need to occur, which poses very significant challenges for health systems as they’re adapting to this new state of health care that we have to provide,” Dr. Issaka said.

During her presentation, Dr. Issaka first addressed pandemic-related issues in colorectal cancer (CRC).

The sudden decrease in colonoscopies has already affected diagnoses, she said, as 32% fewer cases of CRC were diagnosed in April 2020 compared with April 2019, a finding that is “obviously very concerning.” All downstream effects remain to be seen; however, one estimate suggests that over the next decade, delayed screening may lead to an additional 4,500 deaths from CRC.

“These effects are particularly noticeable in medically underserved communities where CRC morbidity and mortality are highest,” Dr. Issaka wrote, as coauthor of a study published in Gastrointestinal Endoscopy.

Dr. Issaka and colleagues predict that the pandemic will likely worsen “persistent CRC disparities” in African-American and Hispanic communities, including relatively decreased screening participation, delayed follow-up of abnormal stool results, limited community-based research and partnerships, and limited community engagement and advocacy.

“COVID-19 related pauses in medical care, as well as shifts in resource allocation and workforce deployment, threaten decades worth of work to improve CRC disparities in medically underserved populations,” wrote Dr. Issaka and colleagues.

Dr. Issaka described similar issues in hepatology. She referred to a recent opinion article by Tapper and colleagues, which predicted that the COVID-19 pandemic will impact patients with liver disease in three waves: first, by delaying liver transplants, elective procedures, imaging, and routine patient follow-up; second, by increasing emergent decompensations, transplant wait-list dropouts, and care deferrals; and third, by losing patients to follow-up, resulting in missed diagnoses, incomplete cancer screening, and progressive disease.

“This could disproportionately impact Black, Hispanic, and Native-American populations, who may have already had difficulty accessing [liver care],” Dr. Issaka said.

To mitigate growing disparities, Dr. Issaka proposed a variety of strategies for CRC and liver disease.

For CRC screening, Dr. Issaka suggested noninvasive modalities, including mailed fecal immunochemical tests (FIT), with focused follow-up on patients with highest FIT values. For those conducting CRC research, Dr. Issaka recommended using accessible technology, engaging with community partners, providing incentives where appropriate, and other methods. For cirrhosis care, Dr. Issaka suggested that practitioners turn to telehealth and remote care, including weight monitoring, cognitive function testing, home medication delivery, and online education.

More broadly, Dr. Issaka called for universal health insurance not associated with employment, research funding for health disparities, sustainable employment wages, climate justice, desegregation of housing, and universal broadband Internet.

“The solutions to these problems are multipronged,” Dr. Issaka said. “Some will happen locally; for instance, well-executed planning around telehealth. Some will happen at the state level through opportunities like advocacy or even just reaching out to your own [congressional representative]. And then some will also happen programmatically – How can we as a health system begin to leverage something like mailed FIT?”

Finally, Dr. Issaka suggested that tools from another branch of science can help improve screening rates.

“We don’t, in medicine, tap into the benefits of behavioral psychology enough,” she said. “That’s a great discipline with really great tools that we can all use.”

Dr. Issaka described the power of community, in that people are more likely to undergo screening if they know how many others in their community are also being screened.

“I think as much as we can gather those kinds of data and share those with individuals to provide reassurance about the safety and importance of screening, I think [that] will help,” she said.

The AGA FORWARD program is funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health (DK118761). Dr. Issaka has no conflicts of interest.

SOURCES: Issaka. AGA FORWARD Program Webinar. 2020 Aug 27; Balzora et al. Gastrointestinal Endoscopy. 2020 June 20. doi: 10.1016/j.gie.2020.06.042; Tapper et al. Journal of Hepatology. 2020 Apr 13. doi: 10.1016/j.jhep.2020.04.005.