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- Title
Efficacy of Bezlotoxumab in Trial Participants Infected With Clostridioides difficile Strain BI Associated With Poor Outcomes.
- Authors
Johnson, Stuart; Citron, Diane M; Gerding, Dale N; Wilcox, Mark H; Goldstein, Ellie J C; Sambol, Susan P; Best, Emma L; Eves, Karen; Jensen, Erin; Dorr, Mary Beth
- Abstract
Background Bezlotoxumab reduced rates of recurrent Clostridioides difficile infection (rCDI) vs placebo in Monoclonal Antibodies for C. difficile Therapy (MODIFY) I/II trial participants receiving antibacterial drug treatment for CDI. A secondary objective of MODIFY I/II was to assess bezlotoxumab's efficacy against C. difficile strains associated with increased rates of morbidity and mortality. Methods In this post-hoc analysis of pooled MODIFY I/II data, efficacy endpoints were assessed in participants infected with restriction endonuclease analysis BI and non-BI strains of C. difficile at study entry. Treatment outcomes were compared between participants receiving bezlotoxumab (alone or with actoxumab [B, B+A]) and those receiving no bezlotoxumab (placebo or actoxumab [P, A]). Results From 2559 randomized participants, C. difficile was isolated from 1588 (67.2%) baseline stool samples. Participants with BI strains (n = 328) were older and had more risk factors for rCDI than non-BI strain participants (n = 1260). There were no differences in initial clinical cure rate between BI and non-BI strains in either group. The rCDI rate for BI strains treated with bezlotoxumab was lower than for the no bezlotoxumab group (B, B+A vs P, A: 23.6% vs 43.9%) and was also lower for the non-BI strains (B, B+A vs P, A: 21.4% vs 36.1%). Rates of 30-day CDI-associated rehospitalization were greater with BI vs non-BI strains in both groups. Conclusions Infection with BI strains of C. difficile predicted poor outcomes in the MODIFY I/II trials. Bezlotoxumab (alone or with actoxumab) treatment was effective both in BI and non-BI subpopulations.
- Subjects
THERAPEUTIC use of monoclonal antibodies; DRUG efficacy; STATISTICS; CLOSTRIDIOIDES difficile; PATIENT readmissions; CLOSTRIDIUM diseases; COMPARATIVE studies; DISEASE relapse; DESCRIPTIVE statistics; DATA analysis; COLLECTION &; preservation of biological specimens
- Publication
Clinical Infectious Diseases, 2021, Vol 73, Issue 9, pe2616
- ISSN
1058-4838
- Publication type
Article
- DOI
10.1093/cid/ciaa1035