Tanner M Johnson1,2, Kyle C Molina1,2, Amanda H Howard1,2, Kerry Schwarz1,2, Lorna Allen3, Misha Huang3,4, Valida Bajrovic3,4, Matthew A Miller1,2. 1. Department of Pharmacy, University of Colorado Hospital, Aurora, Colorado, USA. 2. Department of Clinical Pharmacy, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Colorado, USA. 3. Department of Medicine-Infectious Diseases, University of Colorado Hospital, Aurora, Colorado, USA. 4. Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, Colorado, USA.
Abstract
BACKGROUND: Bezlotoxumab (BEZ) is a monoclonal antibody used to prevent recurrent Clostridioides difficile infection (rCDI). This study investigates BEZ effectiveness in relation to rCDI and patient-specific risk factors in a real-world setting. METHODS: A matched, retrospective cohort study was conducted from 2015 to 2019 to compare BEZ to historical standard of care (SoC) therapy with vancomycin or fidaxomicin. The primary outcome was incidence of 90-day rCDI. Secondary outcomes were incidence of all-cause hospital readmission and all-cause mortality at 90 days, infusion-related reactions, and incidence of heart failure exacerbation. Baseline confounding was addressed using inverse probability of treatment weighting (IPTW). RESULTS: Overall, 107 participants were included (54 BEZ and 53 SoC). Mean number of prior CDI episodes was 2, median number of risk factors for rCDI was 4, and 28% of participants had severe CDI. Incidence of 90-day rCDI was 11% BEZ vs 43% SoC (P = < .001) and 90-day all-cause readmission was 40% BEZ vs 64% SoC (P = .011). In IPTW-adjusted analyses, BEZ was associated with significantly reduced odds of rCDI (odds ratio [OR], 0.14 [95% confidence interval {CI}: .05-.41]) and all-cause readmission (OR, 0.36 [95% CI: .16-.81]). No safety signals were detected with BEZ use. CONCLUSIONS: BEZ is effective for the prevention of rCDI and reduction in all-cause hospital readmission for patients at high risk for recurrence, supporting current guideline recommendations.
BACKGROUND: Bezlotoxumab (BEZ) is a monoclonal antibody used to prevent recurrent Clostridioides difficile infection (rCDI). This study investigates BEZ effectiveness in relation to rCDI and patient-specific risk factors in a real-world setting. METHODS: A matched, retrospective cohort study was conducted from 2015 to 2019 to compare BEZ to historical standard of care (SoC) therapy with vancomycin or fidaxomicin. The primary outcome was incidence of 90-day rCDI. Secondary outcomes were incidence of all-cause hospital readmission and all-cause mortality at 90 days, infusion-related reactions, and incidence of heart failure exacerbation. Baseline confounding was addressed using inverse probability of treatment weighting (IPTW). RESULTS: Overall, 107 participants were included (54 BEZ and 53 SoC). Mean number of prior CDI episodes was 2, median number of risk factors for rCDI was 4, and 28% of participants had severe CDI. Incidence of 90-day rCDI was 11% BEZ vs 43% SoC (P = < .001) and 90-day all-cause readmission was 40% BEZ vs 64% SoC (P = .011). In IPTW-adjusted analyses, BEZ was associated with significantly reduced odds of rCDI (odds ratio [OR], 0.14 [95% confidence interval {CI}: .05-.41]) and all-cause readmission (OR, 0.36 [95% CI: .16-.81]). No safety signals were detected with BEZ use. CONCLUSIONS: BEZ is effective for the prevention of rCDI and reduction in all-cause hospital readmission for patients at high risk for recurrence, supporting current guideline recommendations.
Authors: Christina M Surawicz; Lawrence J Brandt; David G Binion; Ashwin N Ananthakrishnan; Scott R Curry; Peter H Gilligan; Lynne V McFarland; Mark Mellow; Brian S Zuckerbraun Journal: Am J Gastroenterol Date: 2013-02-26 Impact factor: 10.864
Authors: L Clifford McDonald; Dale N Gerding; Stuart Johnson; Johan S Bakken; Karen C Carroll; Susan E Coffin; Erik R Dubberke; Kevin W Garey; Carolyn V Gould; Ciaran Kelly; Vivian Loo; Julia Shaklee Sammons; Thomas J Sandora; Mark H Wilcox Journal: Clin Infect Dis Date: 2018-03-19 Impact factor: 9.079
Authors: Ellie J C Goldstein; Diane M Citron; Dale N Gerding; Mark H Wilcox; Lori Gabryelski; Alison Pedley; Zhen Zeng; Mary Beth Dorr Journal: Clin Infect Dis Date: 2020-08-14 Impact factor: 9.079
Authors: Shelley S Magill; Jonathan R Edwards; Wendy Bamberg; Zintars G Beldavs; Ghinwa Dumyati; Marion A Kainer; Ruth Lynfield; Meghan Maloney; Laura McAllister-Hollod; Joelle Nadle; Susan M Ray; Deborah L Thompson; Lucy E Wilson; Scott K Fridkin Journal: N Engl J Med Date: 2014-03-27 Impact factor: 91.245
Authors: Derrick W Crook; A Sarah Walker; Yin Kean; Karl Weiss; Oliver A Cornely; Mark A Miller; Roberto Esposito; Thomas J Louie; Nicole E Stoesser; Bernadette C Young; Brian J Angus; Sherwood L Gorbach; Timothy E A Peto Journal: Clin Infect Dis Date: 2012-08 Impact factor: 9.079
Authors: Jarmo Oksi; A Aalto; P Säilä; T Partanen; V-J Anttila; E Mattila Journal: Eur J Clin Microbiol Infect Dis Date: 2019-07-29 Impact factor: 3.267
Authors: Stuart Johnson; Diane M Citron; Dale N Gerding; Mark H Wilcox; Ellie J C Goldstein; Susan P Sambol; Emma L Best; Karen Eves; Erin Jensen; Mary Beth Dorr Journal: Clin Infect Dis Date: 2021-11-02 Impact factor: 9.079