Efficacy of Bezlotoxumab (bezlo) in Prevention of Clostridium difficile Infection Recurrence (rCDI) in Patients Receiving Concomitant Systemic Antibiotics (CAs)

Mullane, Kathleen M.; Wilcox, Mark H.; Golan, Yoav; Murata, Yoshihiko; Shoemaker, Keri; Kelly, Michelle M.; Pedley, Alison; Dorr, Mary Beth

doi:10.1093/ofid/ofw172.1663

Cited by 4 publications

(4 citation statements)

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“…Pooled clinical data from the MODIFY I and II studies demonstrated frequent use of concomitant antibiotics (37% in the BEZ arm vs 41% in the placebo arm) within the follow-up period (defined as the first day after the end of SOC treatment through onset of rCDI or day 90 following the infusion of study medication) [24, 25]. Respectively, 42% of patients in our study used concomitant antibiotics within follow-up period of 3 months.…”

Section: Discussionmentioning

confidence: 89%

Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Oksi

Aalto

Säilä

et al. 2019

Eur J Clin Microbiol Infect Dis

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Reports on real-world experience on efficacy of bezlotoxumab (BEZ) has been lacking thus far. We retrospectively studied the efficacy and safety of BEZ in preventing the recurrence of Clostridium difficile infection (CDI) in five university hospitals in Finland. Seventy-three percent of our 46 patients remained free of recurrence in the following 3 months and the performance remained as 71% effective also among immunocompromised patients. In severe CDI, BEZ prevented recurrence in 63% of cases. From our study patients, 78% had three or more known risk factors for recurrence of CDI. Eight of our patients were waiting for fecal microbiota transplantation but after stopping the antibiotics that were continued to prevent recurrence of CDI and after receiving BEZ, all remained free of recurrence and did not need the procedure. Success with BEZ as an adjunctive treatment in preventing recurrence of CDI in high-risk patients may be rated as high. Among a subgroup of our patients, those already evaluated to be in need of fecal microbiota transplantation, BEZ seems to be an alternative option.

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Section: Discussionmentioning

confidence: 89%

Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Oksi

Aalto

Säilä

et al. 2019

Eur J Clin Microbiol Infect Dis

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“…In addition to the rCDI risk factors evaluated in the above study, data presented at the 2016 IDWeek conference evaluated the efficacy of bezlotoxumab in prevention of CDI recurrence in patients receiving concomitant antibiotics 23. Prior data have demonstrated that concurrent non-CDI antibiotics given during SOC treatment have been associated with CDI treatment failure and risk of rCDI, likely due to continued interruption of the normal bacterial flora 24,25.…”

Section: Methodsmentioning

confidence: 99%

Bezlotoxumab for the prevention of <em>Clostridium difficile</em> infection: a review of current evidence and safety profile

Alonso¹,

Mahoney²

2018

IDR

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Clostridium difficile infection (CDI) is a leading nosocomial disease estimated to cause nearly half a million cases in the United States annually. Recurrent CDI (rCDI) affects ~25% of patients after completion of standard of care therapy and is associated with substantial health care costs and a negative impact on patient’s overall markers of quality of life. Bezlotoxumab is the first of its kind monoclonal antibody directed against C. difficile toxin B and indicated for prevention of rCDI in at-risk patients. For the present review, we assessed English-language studies evaluating the clinical efficacy, safety, and pharmacokinetics of bezlotoxumab in humans. Relevant studies were obtained through PubMed, Embase, Cochrane database library, Web of Science, and clinicaltrials.gov. Overall, bezlotoxumab demonstrated a 40% relative reduction rate (absolute rate reduction of ~10%) and a number needed to treat of 10 patients with a favorable safety profile. Special populations, including the elderly, immunocompromised, and patients with end-stage renal disease were evaluated in post hoc analyses with a similarly favorable reduction in rCDI. This review presents and interprets the most recent safety data and the clinical application of bezlotoxumab, highlighting specific high-risk patient populations.

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“…99 Concomitant antibiotics: bezlotoxumab may be associated with a reduction in rCDI in patients receiving concomitant antibiotics for other infections during initial CDI treatment or in the 90 days following treatment for initial CDI episode. 100 Haematologic malignancies and solid organ tumours: lower rate of rCDI in haematologic malignancies and solid organ transplant but small patient numbers. It requires further investigation.…”

Section: What Is the Role Of Bezlotoxumab In The Management Of Recurrent Clostridioides Difficile Infection?mentioning

confidence: 99%

South African Society of Clinical Microbiology Clostridioides difficile infection diagnosis, management and infection prevention and control guideline

Nana

Moore²,

Boyles

et al. 2020

Southern African Journal of Infectious Diseases

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Clostridioides difficile infection (CDI) is a problem in both developed and developing countries and is a common hospital-acquired infection. This guideline provides evidence-based practical recommendations for South Africa and other developing countries. The scope of the guideline includes CDI diagnostic approaches; adult, paediatric and special populations treatment options; and surveillance and infection prevention and control recommendations.

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Efficacy of Bezlotoxumab (bezlo) in Prevention of Clostridium difficile Infection Recurrence (rCDI) in Patients Receiving Concomitant Systemic Antibiotics (CAs)

Cited by 4 publications

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Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Bezlotoxumab for the prevention of <em>Clostridium difficile</em> infection: a review of current evidence and safety profile

South African Society of Clinical Microbiology Clostridioides difficile infection diagnosis, management and infection prevention and control guideline

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Efficacy of Bezlotoxumab (bezlo) in Prevention of Clostridium difficile Infection Recurrence (rCDI) in Patients Receiving Concomitant Systemic Antibiotics (CAs)

Cited by 4 publications

References 0 publications

Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Real-world efficacy of bezlotoxumab for prevention of recurrent Clostridium difficile infection: a retrospective study of 46 patients in five university hospitals in Finland

Bezlotoxumab for the prevention of&nbsp;<em>Clostridium difficile</em>&nbsp;infection: a review of current evidence and safety profile

South African Society of Clinical Microbiology Clostridioides difficile infection diagnosis, management and infection prevention and control guideline

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Bezlotoxumab for the prevention of <em>Clostridium difficile</em> infection: a review of current evidence and safety profile