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

Abstract

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.

Challenges for Clinical Development of Vaccines for Prevention of Hospital-Acquired Bacterial Infections

“…These data indicated that patients with transient deficiency in IgA might be more susceptible for infection. Well in line with this observation Bezlotoxumab, a monoclonal antibodies directed against TcdB, prevented recurrence of CDI, highlighting the value of antibody-mediated toxin neutralization ( 119 , 120 ).…”

Bezlotoxumab for Preventing Recurrent Clostridioides difficile Infection: A Narrative Review from Pathophysiology to Clinical Studies

“…A higher risk of rCDI was observed in patients with ≥ 2 previous recurrences before receiving bezlotoxumab (hazard ratio 2.77, 95% CI 1.14–6.76, p = 0.025) [ 68 ]. Another multicentre, retrospective case series was conducted in five university hospitals in Finland [ 69 ]. The study included 46 CDI patients who received a standard dose of bezlotoxumab.…”

“…This could have resulted in a greater proportion of diarrhoea recurrences classified as rCDI The study observed successful prevention of rCDI with bezlotoxumab comparable to clinical trial results. Multiple prior rCDI were associated with a higher risk of subsequent rCDI Oksi J et al 2019 [ 69 ] Retrospective study April 2017–December 2017 Finland 46 CDI patients treated with bezlotoxumab. Mean age: 66 years (range 15–97) Mean number of CDI previous episodes: 2.74 (range 1–7) 28/46 (61%) were immunocompromised and 36/46 (78%) had three or more risk factors for rCDI Vancomycin in 37/46 patients, metronidazole in 9/46, fidaxomicin in 7/46, and tigecycline in 2/46 rCDI in the 3 months after bezlotoxumab infusion Overall, 73% of the patients remained free of rCDI in the following 3 months after bezlotoxumab infusion, 71% of the immunocompromised patients remained free of rCDI during the follow-up, 63% of the severe CDI cases remained free of rCDI during the follow-up Two possible infusion-related adverse reactions: one patient experienced startling sensations after the infusion; one patient presented with fever in the following day after the infusion Detection of CD toxin gene by polymerase chain reaction was the only method used to detect CDI Bezlotoxumab infusion as an adjunctive treatment to anti-CD antimicrobial treatment prevented rCDI in a major proportion of enrolled patients, including immunocompromised individuals CD Clostridioides difficile , CDI Clostridioides difficile infection, rCDI recurrent Clostridioides difficile infection, RCTs randomized controlled trials …”

“…In the previously described multicentre, observational case series conducted in Finland, possible bezlotoxumab infusion-related adverse reactions were observed in two patients [ 69 ]. One experienced startling sensations after the infusion, and the other one presented with fever the day after the infusion [ 69 ]. No infusion-related reactions were observed in the US case series by Hengel and colleagues [ 68 ].…”

“…A similar result was observed in immunocompromised patients (71%). In severe CDI cases, the proportion of patients with no rCDI at 3 months was 63% [69]. Of note, eight were waiting for faecal microbiota transplantation but all remained free of recurrence and did not need the procedure.…”