Real World Study Looking at Safety, Efficacy of C diff Therapeutic

A retrospective analysis studied the safety and efficacy of fecal microbiota, live-jslm (FMBL; Rebyota) across 5 study sites between November 1, 2015 and September 30, 2019. Investigators reviewed data of adult patients with recurrent Clostridioides difficile (rCDI) treated with FMBL. The primary safety set (PSS) included patients who were naïve to previous FMBL treatment and had continuously comprehensive medical records for 6 months following treatment.

The primary objective was to evaluate the safety and tolerability of Rebyota through six months after treatment. The secondary objectives were to evaluate efficacy in preventing rCDI within 8 weeks of treatment and sustained response for six months after treatment. The PSS served as the analysis set for the safety and efficacy endpoints, and included 64 patients.

“In the PSS, 82.8% of FMBL-treated patients responded at 8 weeks, of whom 88.7% had sustained response through 6 months,” the investigators wrote.

The study was published in Open Forum Infectious Diseases.

According to the investigators, the most treatment-emergent adverse events (TEAEs) were mild to moderate in severity and comparable between patients with comorbid conditions and the overall patient population. The most common TEAEs occurring in five percent or more of patients in the PSS were GI disorders at 45.3%, including abdominal pain (14.1%), diarrhea (14.1%), bloating (6.3%), gas (6.3%) and nausea (6.3%), and infections at 25%, including urinary tract infection (10.9%) and C diff infection (7.8%).

Serious TEAEs were experienced by 12.5% of patients. There were no serious adverse events related to Rebyota or the administration procedure. Four patients in the PSS received Rebyota via colonoscopy.

“This is the first analysis evaluating safety and efficacy of Rebyota in patients who are often seen in clinical practice struggling with other gastrointestinal illnesses in addition to C diff infection, who may be able to prevent recurrence of C diff infection with a microbiome-based treatment following antibiotics,” said lead author Paul Feuerstadt, MD, FACG, AGAF, Yale University School of Medicine.

In conclusion, the authors found favorable findings utilizing the treatment. “Together with prospective clinical trial outcomes, these findings support the efficacy and safety of FMBL to prevent rCDI, with diagnostics and comorbidities representative of real-world clinical practice,” they wrote.