RESUMO
Clostridium difficile infections (CDI) are a leading cause of antibiotic-associated diarrhea, and recurrent infections are common despite effective antibiotic treatments. Recurrent CDI causes a significant burden to the patient and healthcare system, which has led to efforts to find an effective treatment to prevent recurrent CDI. Recent studies have shown the efficacy and safety of orally and rectally administered microbiota treatment to prevent recurrent Clostridium difficile. This study systematically reviewed the data on the efficacy and safety of RBX2660 (REBYOTA®), the first rectally administered microbiota product to prevent recurrent Clostridium difficile infections approved by the United States Food and Drug Administration (FDA). Our analysis showed that RBX2660 (REBYOTA) effectively prevented recurrent CDI. Patients who received RBX2660 (REBYOTA) were significantly less likely to have recurrent Clostridium difficile than controls eight weeks after treatment. This effect is seen in both those who got one or two doses of RBX2660 (REBYOTA), although the FDA currently approves one dose.
RESUMO
Background: Recurrence of Clostridioides difficile infection (rCDI) is common, prolonging disease morbidity and leading to poor quality of life. We evaluated disease-specific health-related quality of life (HRQL) in patients with rCDI treated with fecal microbiota, live-jslm (REBYOTA [RBL]; Rebiotix) versus placebo. Methods: This was a secondary analysis of a randomized, double-blind, placebo-controlled phase 3 study (PUNCH CD3). The disease-specific Clostridioides difficile Quality of Life Survey (Cdiff32) was administered at baseline and at weeks 1, 4, and 8. Changes in Cdiff32 total and domain (physical, mental, social) scores from baseline to week 8 were compared between RBL and placebo and for responders and nonresponders. Results: Findings were analyzed in a total of 185 patients (RBL, n = 128 [69.2%]; placebo, n = 57 [30.8%]) with available Cdiff32 data. Patients from both arms showed significant improvements in Cdiff32 scores relative to baseline across all outcomes and at all time points (all P < .001); RBL-treated patients showed significantly greater improvements in mental domain than those receiving placebo. In adjusted analyses, RBL-treated patients showed greater improvements than placebo in total score and physical and mental domains (all P < .05). Similar improvement in mental domain was observed among responders, while nonresponders showed numerical improvements with RBL but not placebo. Conclusions: In a phase 3 double-blinded clinical trial, RBL-treated patients reported more substantial and sustained disease-specific HRQL improvements than placebo-treated patients. Clinical Trials Registration: ClinicalTrials.gov NCT03244644 (https://clinicaltrials.gov/ct2/show/NCT03244644).