Live Biotherapeutic Product Remains Effective Against Recurrent CDI After Antibiotic Use

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A study showed the Clostridioides difficile treatment remained effective after subsequent systemic antibiotic exposure.

What You Should Know

The study demonstrated that Rebyota, an LBP, remained effective in preventing the recurrence of Clostridioides difficile infection (rCDI) in patients with multiple episodes rCDI, even when they were later exposed to systemic antibiotics for other conditions, such as urinary tract infections.

This was a post hoc subgroup analysis from the PUNCH Open-Label phase 2 trial, which specifically focused on patients with multiple episodes of recurrent C diff infection who received two doses of Rebyota.

The results of this study suggest that Rebyota has the potential to be an effective treatment for preventing recurrent C diff infection, offering hope for patients suffering from this challenging condition.

The live biotherapeutic product(LBP) fecal microbiota, Live-jslm (Rebyota), remained effective in preventing recurrence of Clostridioides difficile (CDI) in patients after subsequent systemic antibiotic exposure.

The study was reported at IDWeek.

Specifically, a post hoc subgroup analysis from the PUNCH Open-Label phase 2 trial evaluated whether patients with multiple episodes of recurrent C diff infection who received 2 doses of Rebyota remained recurrence free when they were later exposed to antibiotic therapy for another condition, such as a urinary tract infection.

Among participants who received systemic antibiotics within 8 weeks, six months, 12 months and 24 months of REBYOTA administration, 91.6% (11 of 12), 95.7% (22 of 23), 90.6% (29 of 32) and 83.3% (30 of 36) remained free of C. diff infection recurrence, respectively. Among all participants (n=43), 86% were recurrence-free at their last evaluable timepoint.

“The real-world and clinical data presented at IDWeek reinforce the potential of Rebyota to prevent recurrent C diff infection and help patients suffering from this devastating disease,” Elizabeth Garner, MD, MPH, Chief Scientific Officer, Ferring Pharmaceuticals US said in a statement. “Initial experiences with Rebyota in physicians’ offices are promising and this is a positive step forward in changing the treatment paradigm for recurrent C. diff infection.”

Methodology

Investigators examined 43 participants. In terms of the participants. the mean age 65.9 years, with a majority being female (67.4%), and nearly all of them (97.7%) had 3 or more recurrent CDI episodes prior to LBP treatment.

“Most participants were treated with antibiotic monotherapy (n=34/43, 79.1%), received 1 course of treatment (n=28/43, 65.1%), and did not receive CDI prophylaxis (n=38/43, 88.4%),” the investigators wrote. “The median time to antibiotic exposure after the second dose of RBL [Rebyota] was 155 days (interquartile range [IQR], 55-349), and the median duration of treatment per antibiotic course was 8 days (IQR, 4.5-12.5).”

“RBL remained effective in preventing CDI recurrence in patients with multiple episodes of rCDI after subsequent systemic antibiotic exposure,” the investigators concluded.

Ferring's LBP Rebyota was FDA approved for recurrent Clostridioides difficile Infection last year.

Click here for more coverage of IDWeek 2023.

REFERENCE

Reveles K, Gonzales-Luna A, et al. Efficacy of Fecal Microbiota, Live-jslm After Receipt of Non–Clostridioides difficile Infection Antibiotics: Post Hoc Subgroup Analysis of a Phase 2 Open-Label Trial. Presented at: IDWeek 2023. October 11-14, 2023; Boston, MA. Poster 702

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