A retrospective analysis of patients in real-world settings who received Rebyota for recurrent Clostridioides difficile infection (rCDI) found the treatment was safe and highly effective, researchers reported last week in Open Forum Infectious Diseases.
Rebyota is a fecal microbiota-based live (FMBL) therapeutic that was approved by the US Food and Drug Administration (FDA) for treatment of rCDI in December 2022, based on data from five prospective clinical trials. For the study, researchers retrospectively identified patients at five sites who had been deemed ineligible for trials because of comorbidities but were offered the drug through an FDA program that expands access to investigative drugs in settings that mimic real-world practice. The primary objective was to evaluate the safety and tolerability of FMBL through 6 months after treatment, and secondary objectives included evaluating efficacy after 8 weeks and sustained response after 6 months.
A total of 94 patients (mean age 59.8 years, 44.7% aged 65 years and older, 72.3% female) received treatment with FMBL from November 2015 through September 2019, with 64 in the primary safety set (PSS). Of the patients in the PSS, 70.3% had gastrointestinal and non-specific inflammation and dysfunctional conditions, and 65.6% had immune-mediated/autoimmune disorders. The vast majority (92%) of treatment-emergent adverse events (TEAEs) were mild to moderate in severity and comparable between comorbidity subgroups and the overall population.
In the PSS, 82.8% of Rebyota-treated patients responded at 8 weeks, of whom 88.7% had sustained response at 6 months. The rates of sustained clinical response were similar in patients who received one (90%) or two (87.9%) doses.
"Overall, this retrospective analysis is representative of real-world diagnostics and a patient population typically encountered in everyday practice," the study authors wrote. "The findings reinforce the potential efficacy and safety of FMBL in real-world populations with common rCDI comorbidities representative of clinical practice."