VIDEO: No change in concomitant medications after Rebyota for recurrent C. difficile, IBD
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CHICAGO — Treatment with Rebyota did not affect concurrent medication use in patients with inflammatory bowel disease and recurrent Clostridioides difficile infection, Jessica R. Allegretti, MD, MPH, explains in this Healio video.
Allegretti presented data at Digestive Disease Week on safety outcomes and concomitant medication changes after treatment with Rebyota (fecal microbiota, live-jslm/RBX2660, Ferring Pharmaceuticals) — the first microbiota-based, live biotherapeutic product approved by the FDA to prevent recurrent C. difficile infection in adults after antibiotic treatment.
“The impetus for this study is that we know that patients with IBD are at greater risk for C. difficile infection as well as C. diff recurrence, and we know that this can be a disease defining event for many of these patients, leading to worsening IBD outcomes,” Allegretti, medical director of the Crohn’s and Colitis Center at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, said. “We know overall that our patients with IBD and C. diff are at greater risk for adverse events.
“Diagnosis and management of these patients can be tricky,” she added, “because of the overlap of symptoms and complications with treatment, given that we need immunosuppressive therapies to treat the IBD, and then understanding which antibiotics and how long to treat their underlying C. diff infection.”
Allegretti and colleagues performed an ad-hoc analysis of pooled data from the ongoing PUNCH-CD3 open-label study, as well as retrospective data collected from patients with IBD who received RBX2660 under enforcement discretion for recurrent C. difficile infection.
Researchers included 18 patients with Crohn’s disease and 38 with ulcerative colitis, and assessed the number of IBD-related medication changes after treatment with RBX2660, as well as occurrence of adverse events.
Compared with non-IBD patients, there was no significant increase in adverse events among patients with IBD, particularly gastrointestinal-related adverse events such as diarrhea, constipation, abdominal pain or worsening of IBD, Allegretti said.
She also noted that many patients in both cohorts were on concomitant IBD medication going into the study, the most common of which were steroids, mesalamine and anti-tumor necrosis factor agents.
Over the initial 8-week period, Allegretti said most patients had “absolutely no change in their concomitant medications” and remained stable, with several patients discontinuing steroid use.
“This is exciting data in this space with a complicated patient population — those with IBD and C. diff,” Allegretti said. “I think this is promising for the management of recurrent C. diff in the future with this population.”
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Allegretti JR, et al. Abstract 699: Safety outcomes and concomitant medication changes in patients with inflammatory bowel disease being treated with RBX2660 for recurrent Clostridioides difficile infection. Presented at: Digestive Disease Week; May 5-9, 2023; Chicago (hybrid meeting).
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