Treatment efficacy of fecal microbiota-based live biotherapeutics (RBX2660) for the prevention of recurring Clostridioides difficile infection

Javed, Qurat Ul Ain; Afzal, Muhammad; Ilyas, Khola; Sarfraz, Azza; Sarfraz, Zouina

doi:10.1016/j.ejim.2022.12.020

Cited by 3 publications

(3 citation statements)

References 7 publications

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“…Despite the promising results of FMT, there has been a lack of regulatory oversight and standardization in the field, limiting its adoption as a standard care approach in healthcare. This is expected to change with the recent approval of a first-in-class microbiota-based live biotherapeutic, originally termed RBX2660, by the U.S. Food and Drug Administration (FDA) on November 30, 2022 [11]. RBX2660 is specifically indicated for the prevention of recurrent CDI in adults aged 18 or above and is expected to significantly impact the healthcare delivery system.…”

Section: Systematic Review Articlementioning

confidence: 99%

Fecal Microbiota Transplantation for the Management of Recurrent Clostridium Difficile Infections: A Systematic Review

Nwankwo

Yousaf

Oboli

et al. 2023

JAMMR

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Background: Fecal microbiota transplantation (FMT) is a promising therapeutic option for managing Clostridium difficile infections (CDI). CDI is a significant health concern, particularly in antibiotic-resistant cases impairing the quality of life among the patient population. This systematic review aims to pool current clinical trial evidence of FMT (RBX2660) success rates when used for recurrent CDI in the clinical trial setting. Methods: In accordance with PRISMA Statement 2020 guidelines, the following databases were systematically searched: Embase, PubMed, and Scopus. There were no time or language restrictions. The following keywords were used in all the databases: fecal, microbiota, transplantation, recurrent, Clostridium difficile, infection, and antibiotic-resistant. Only clinical trials, controlled or single-arm, were included in this systematic review. Results: A total of five clinical trials, of which four were phase II, and one was phase III, were included. Seven hundred ninety-five participants were pooled across all trials. Patients were included in the trials with 1-2 recurrent CDI. In most cases, they had undergone standard antibiotic therapy before enrolling. The treatment success rate in the RBX2660 intervention group was 69.5% (335/482) compared to 49.6% (123/248) in the placebo group. The intervention was safe and effective, with no grade III or higher adverse events reported in treating recurrent CDI. Conclusion: RBX2660, recently approved as a therapy for recurrent CDI in the United States, is a significant milestone in expanding treatment options. This study reports the potential benefits of FMT and other microbiota-based therapies. While many challenges require addressing, including sample control and patient compliance, FMT is heading toward ongoing acceptance in the broad medical community.

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Section: Systematic Review Articlementioning

confidence: 99%

Fecal Microbiota Transplantation for the Management of Recurrent Clostridium Difficile Infections: A Systematic Review

Nwankwo

Yousaf

Oboli

et al. 2023

JAMMR

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“…This study aims to systematically review the data on the efficacy and safety of RBX2660 (REBYOTA ® ), the first rectally administered microbiota product for the prevention of recurrent Clostridium difficile approved by the United States Food and Drug Administration (FDA) in November 2022 [11]. A previous meta-analysis was published using interim results of the PUNCH CD2 study [12]. In addition, the meta-analysis included multiple publications of the PUNCH CD2 study that reported slightly different data as separate studies [12].…”

Section: Introductionmentioning

confidence: 99%

“…A previous meta-analysis was published using interim results of the PUNCH CD2 study [12]. In addition, the meta-analysis included multiple publications of the PUNCH CD2 study that reported slightly different data as separate studies [12]. With the publication of the final result of the PUNCH CD2 result, which included some corrections to the population definitions and analysis used in the preliminary reports, we updated the meta-analysis to reflect the updated results of the studies.…”

Section: Introductionmentioning

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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Beyond faecal microbiota transplantation, the non-negligible role of faecal virome or bacteriophage transplantation

Zhang

et al. 2023

Journal of Microbiology, Immunology and Infection

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Treatment efficacy of fecal microbiota-based live biotherapeutics (RBX2660) for the prevention of recurring Clostridioides difficile infection

Cited by 3 publications

References 7 publications

Fecal Microbiota Transplantation for the Management of Recurrent Clostridium Difficile Infections: A Systematic Review

Fecal Microbiota Transplantation for the Management of Recurrent Clostridium Difficile Infections: A Systematic Review

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

Beyond faecal microbiota transplantation, the non-negligible role of faecal virome or bacteriophage transplantation

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