Paul Feuerstadt, MD: Safety, Efficacy of Live-jslm in Patients Taking Concomitant Medications

Findings from a recent study are providing clinicians with an overview of the safety and efficacy of live-jslm (Rebyota) in patients with recurrent C difficile infection (CDI) taking select concomitant medications associated with potential dysbiosis.

The research was presented at Digestive Disease Week (DDW) 2024 in Washington, DC, this weekend and highlighted similar treatment success and treatment-emergent adverse event rates compared to the overall PUNCH CD3 open-label study population used to support life-jslm’s FDA approval in 2022 for the prevention of recurrence of CDI in patients ≥ 18 years of age following antibiotic treatment for recurrent CDI.

“What we're looking at now is the next phase. We know this works. We know it's safe, but does it work in multiple smaller circumstances, circumstances that we see in clinical practice?” Paul Feuerstadt, MD, assistant clinical professor of medicine at Yale University School of Medicine and gastroenterologist at PACT Gastroenterology Center, told HCPLive.

In PUNCH CD3, live-jslm demonstrated superiority to placebo as a treatment to reduce recurrence of CDI after standard-of-care antibiotic treatment with primarily mild-to-moderate adverse events and no treatment-related serious adverse events. The ad hoc analysis presented at DDW looked specifically at participants taking select concomitant medications associated with potential dysbiosis (n = 483) and found similar treatment success and treatment-emergent adverse event rates as the overall PUNCH CD3 population.

Results showed that among the modified intent-to-treat population (n = 290), 42.1% of patients were taking PPIs, 48.6% were taking statins, and 55.2% were taking psychotropic medications. Treatment success rates at 8 weeks were 77.0%, 75.9%, and 73.8%, respectively, consistent with the overall study population (74.6%).

Investigators also noted the overall incidences of treatment-emergent adverse events for those in the safety population taking PPIs, statins, and psychotropic medications were 64.4%, 59.8%, and 66.9%, respectively, most of which were mild or moderate gastrointestinal disorders and related to preexisting conditions or CDI. Serious treatment-emergent adverse events were not common and all were assessed as unrelated to live-jslm.

“Between the open label study and this subgroup analysis, I think that it really, really adds to our comfort with using this,” Feuerstadt concluded.

Reference:

1. ^{Tillotson GS, Feuerstadt P, Carlson TJ, et al. EFFICACY AND SAFETY OF FECAL MICROBIOTA, LIVE-JSLM IN PARTICIPANTS WITH RECURRENT CLOSTRIDIOIDES DIFFICILE INFECTION RECEIVING CONCOMITANT MEDICATIONS. Abstract presented at Digestive Disease Week (DDW) 2024 Annual Meeting. Washington, DC. May 17-21, 2024.}
2. ^{Ferring Pharmaceuticals. Ferring receives U.S. FDA approval for REBYOTA™ (fecal microbiota, live-jslm) – A novel first-in-class microbiota-based live biotherapeutic. November 30, 2022. Accessed May 20, 2024. https://www.ferring.com/ferring-receives-u-s-fda-approval-for-rebyota-fecal-microbiota-live-jslm-a-novel-first-in-class-microbiota-based-live-biotherapeutic/}