RBX-DT-QA-001 Plain Language Summary with DOI 6 Sep.pdf (278.23 kB)

RBX2660 (REBYOTA®) in preventing recurrence of Clostridioides difficile infection: a profile of its use in the USA

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posted on 2023-09-06, 00:51 authored by Hannah A. Blair

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest Hannah A. Blair is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the article and are responsible for its content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

RBX2660 (fecal microbiota, live-jslm; REBYOTA®) is an emerging option for the prevention of recurrent Clostridioides difficile infection (CDI) following standard of care (SOC) antibiotics. RBX2660 is a first-in-class, live biotherapeutic product available as a single-dose microbiota suspension for rectal administration. RBX2660 was effective in reducing recurrent CDI following SOC antibiotic therapy in the pivotal, phase 3 PUNCH CD3 trial. In a Bayesian analysis model, RBX2660 was superior to placebo in terms of treatment success, defined as the absence of CDI diarrhea within 8 weeks of study treatment. Most patients with treatment success at 8 weeks remained free of CDI recurrence at 6 months. The effectiveness of RBX2660 has also been demonstrated in the real-world setting. RBX2660 was well tolerated in the PUNCH CD3 trial, with a manageable adverse event (AE) profile. The most common AEs with RBX2660 were gastrointestinal in nature. Most AEs occurred during the first 2 weeks after treatment and were of mild or moderate severity.