The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660

Orenstein, Robert

doi:10.1007/s40121-022-00714-9

Cited by 12 publications

(6 citation statements)

References 34 publications

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“…However, at 7 and 30 days after treatment, the gut microbiome of the non-responders showed little similarity with the RBX2660 composition. In addition, prior studies showed that patients with recurrent Clostridium difficile successfully treated with RBX2660 at eight weeks had a long-term sustained clinical response with greater than 90% of treatment responders remaining CDI-free at 6, 12, and 24 months [20].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis

Doosetty,

Umeh,

Eastwood

et al. 2024

Cureus

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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.

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Section: Discussionmentioning

confidence: 99%

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis

Doosetty,

Umeh,

Eastwood

et al. 2024

Cureus

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“…Results from a phase 3 trial of RBX2660, analyzed with a Bayesian hierarchical model formally incorporating data from a phase 2b trial, showed a treatment success rate of 70.6% ( 68 ). Long-term data (up to 24 months) after treatment with RBX2660 in a phase 2 trial showed durable treatment success, with more than 90% of treatment responders remaining CDI-free at 6, 12, and 24 months ( 69 , 70 ). Microbiota analyses from this phase 2 trial also showed a highly dysbiotic composition before treatment, which converged toward the RBX2660 composition within 7 days after treatment ( 69 , 71 ).…”

Section: Approaches To Restoring the Gut Microbiotamentioning

confidence: 99%

Gut microbiota and microbiota-based therapies for Clostridioides difficile infection

Chopra

Hecht²,

Tillotson³

2023

Front. Med.

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Clostridioides difficile infection poses significant clinical challenges due to its recurrent nature. Current antibiotic management does not address the underlying issue, that of a disturbed gastrointestinal microbiome, called dysbiosis. This provides a supportive environment for the germination of C. difficile spores which lead to infection and toxin production as well as an array of other health conditions. The use of microbiome restoration therapies such as live biotherapeutics can reverse dysbiosis and lead to good clinical outcomes. Several such therapies are under clinical investigation.

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“… 124 Durability of this protective response at 6, 12, and 2 years was demonstrated in a subsequent publication. 125 A phase 2B, placebo-controlled, dose-ranging study followed, showing favorable recurrence rates after a single dose of REBYOTA; in the per-protocol population, 19% (3/24) of participants had recurrence after one dose of drug and one dose of placebo, compared to 52% (13/31) of those who received two doses placebo (p = 0.017). 126 These results culminated in PUNCH CD3, the randomized, double-blind phase 3 trial comparing REBYOTA to placebo that gained FDA approval.…”

Section: Clinical Trials Of the Fda Approved Lbps (Rebyota And Vowst)mentioning

confidence: 99%

Microbiota-Based Live Biotherapeutic Products for Clostridioides Difficile Infection- The Devil is in the Details

Monday,

Tillotson,

Chopra

2024

IDR

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Clostridioides difficile infection (CDI) remains a significant contributor to healthcare costs and morbidity due to high rates of recurrence. Currently, available antibiotic treatment strategies further disrupt the fecal microbiome and do not address the alterations in commensal flora (dysbiosis) that set the stage for CDI. Advances in microbiome-based research have resulted in the development of new agents, classified as live biotherapeutic products (LBPs), for preventing recurrent CDI (rCDI) by restoring eubiosis. Prior to the LBPs, fecal microbiota transplantation (FMT) was available for this purpose; however, lack of large-scale availability and safety concerns have remained barriers to its widespread use. The LBPs are an exciting development, but questions remain. Some are derived directly from human stool while other developmental products contain a defined microbial consortium manufactured ex vivo, and they may be composed of either living bacteria or their spores, making it difficult to compare members of this heterogenous drug class to one another. None have been studied head-to head or against FMT in preventing rCDI. As a class, they have considerable variability in their biologic composition, biopharmaceutic science, route of administration, stages of development, and clinical trial data. This review will start by explaining the role of dysbiosis in CDI, then give the details of the biopharmaceutical components for the LBPs which are approved or in development including how they differ from FMT and from one another. We then discuss the clinical trials of the LBPs currently approved for rCDI and end with the future clinical directions of LBPs beyond C. difficile .

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The Role of Microbiome-Based Therapeutics in Clostridioides difficile Infection: Durable, Long-Term Results of RBX2660

Cited by 12 publications

References 34 publications

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis

Efficacy of Fecal Microbiota (REBYOTA) in Recurrent Clostridium difficile Infections: A Systematic Review and Meta-Analysis

Gut microbiota and microbiota-based therapies for Clostridioides difficile infection

Microbiota-Based Live Biotherapeutic Products for Clostridioides Difficile Infection- The Devil is in the Details

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