Two Years After its FDA Approval, Rebyota Continues to Show Efficacy and Safety
Paul Feuerstadt, MD, FACG, AGAF, discusses what the data says as well as offers insights about what patients can expect and medical peer-to-peer information about the procedure.
It has been 2 years this month since fecal microbiota, live – jslm (Rebyota) was FDA approved for the indication of recurrent Clostridioides difficile (C diff) treatment in individuals 18 years of age and older, following antibiotic treatment for recurrent C diff infection.
New data was released at this year’s ID Week showing its continued efficacy and safety 2 years after the approval. Ferring Pharmaceuticals announced results of its outpatient real-world study using Rebyota.
In one of the analysis, investigators reviewed the medical records of 64 adult patients from 32 physician offices nationally who received Rebyota from February 2023 to March 2024. In total, 59 patients completed the 8-week follow-up period, of which 75% (n=44) had no CDI recurrence. There were no adverse events reported with treatment aside from minor leakage during administration in 4 patients (6.2%).1
Participants in the analysis had a median age of 75 years and were predominantly female (65.6%). Patients had multiple comorbidities (Charlson score 4.5) and 59.4% had 2 or more rCDI risk factors, the most common being age, 65 years or older (75%), and concurrent use of gastric acid suppressants (59.4%). The median number of prior CDI episodes was 3. Fidaxomicin (57.8%) was the most utilized standard-of-care antibiotic for treatment of CDI prior to Rebyota administration.1
Additionally there has been other data being released from the PUNCH CD3 trial.
“The open label study data that was published earlier in 2024, which was the largest study that looked at live biotherapeutic products, looked at 697 total patients, so a massive group expanding upon the PUNCH CD3 trial—the randomized control trial that had a placebo arm within this open label study,” said Paul Feuerstadt, MD, FACG, AGAF an associate clinical professor of medicine at the Yale School of Medicine. “Patients with IBS are going to show up in a provider's office with their current C difficile. Patients with ulcerative colitis and Crohn's disease are also going to show up in providers offices' with C difficile so how does this work in a real world type scenario? And across those 697 patients, they found an efficacy of 73.8% further validating the randomized control trial from phase 3. And of those 73.8%, 91% remained responsive at 6 months. So in a real world, formalized study setting, we see very, very encouraging data.”
Feuerstadt also says in his conversations with patients he explains the differences from taking antibiotics and getting this treatment.
“If we explain it appropriately, the patients will understand that the antibiotic controls the phase that causes symptoms, but that spore phase, the phase that remains in their system after the antibiotics that requires a healthy, diverse microbiota, and that regrowth of the microbiota without supplementation causes a recurrence. Therefore, if you're putting the microorganisms into the place where the infection is, you're preventing that recurrence. So patients can wrap their head around that concept and understand how you're treating the entire infection and how you're shutting down that cycle of recurrence. And that clicks in their head, where they have that aha moment,” Feuerstadt said.
For those not familiar with Rebyota, it is a live biotherapeutic product (LBP) that is a pre-packaged, single-dose 150 mL microbiota suspension for rectal administration consisting of a liquid mix of up to trillions of live microbes, including Bacteroides. Rebyota is delivered directly to the gut microbiome and is administered by a healthcare professional in 1 visit.
