C0106 - Real Word Experience of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-analysis

Monday, October 24, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

Kanika Sehgal, MBBS

Yale New Haven Hospital
Rochester, MN

Kanika Sehgal, MBBS¹, Raseen Tariq, MD², Darrell S. Pardi, MD, MS, FACG², Sahil Khanna, MBBS, MS, FACG²
¹Yale New Haven Hospital, Rochester, MN; ²Mayo Clinic, Rochester, MN

Introduction: Two large, placebo-controlled phase III trials, MODIFY I and MODIFY II, demonstrated that patients with Clostridioides difficile infection (CDI) treated with bezlotoxumab (BEZ) had a lower rate of recurrent infection than placebo. The clinical efficacy of BEZ has been evaluated in real-world studies. We aimed to carry out a systematic review and meta-analysis of the efficacy of BEZ in real-world clinical setting.

Methods: A thorough search of literature was run on February 2022, in Cochrane Central Register of Controlled Trials, Embase, Medline, Scopus and Web of Science Core Collection. We included studies that reported CDI resolution rates with BEZ. The random-effects model described by DerSimonian and Laird was used to calculate weighted pooled resolution rates (WPR) with corresponding 95% confidence intervals (CI). Data were weighted based on the sample size in each trial to calculate WPR. We assessed heterogeneity within groups with the inconsistency index (I²) statistic. The primary outcome of our pooled analysis was CDI clinical resolution rates with BEZ i.e. resolution of CDI with no recurrence in the follow up period.

Results: Thirteen studies (11 retrospective cohorts, 2 unspecified) including 1008 CDI patients were included. Recurrence with BEZ was compared with standard-of-care (SOC) antibiotics (metronidazole, vancomycin or fidaxomicin) in 6 studies and with fecal microbiota transplantation (FMT) in 1 study, the other 6 had no comparator arm. A total of 771 patients received BEZ, 237 received SOC and 14 received FMT. Patients were followed for recurrence for a median of 90 days from initial episode (range 84-168 days). Of the 771 on BEZ, 550 had CDI resolution with WPR of 82% (95% CI 79-85%). No significant heterogeneity was noted, with I²=0% (Figure 1). A resolution rate of 50% (7/14) was seen in the FMT group. Subgroup analysis comparing BEZ with SOC revealed a WPR of 84% (95% CI 79-89%) with BEZ vs 67% (95% CI 61-73%) with SOC (p=0.0001).

Discussion: Use of BEZ in real-world clinical settings seems to have a high resolution rate of CDI in patients with recurrence.

Figure: Forest plot depicting weighted resolution rate observed with bezlotoxumab

Disclosures:

Kanika Sehgal indicated no relevant financial relationships.

Raseen Tariq indicated no relevant financial relationships.

Darrell Pardi: Abbvie – Consultant. Boehringer Ingelheim – Consultant. Ferring – Consultant. Finch – Grant/Research Support. Immunic – Consultant. Merck – Consultant. Otsuka – Consultant. Rebiotix – Grant/Research Support. Seres – Grant/Research Support. Takeda – Grant/Research Support. Vedanta – Consultant.

Sahil Khanna: Ferring Pharmaceuticals – Grant/Research Support. Finch – Grant/Research Support. Niche – Consultant. Pfizer – Grant/Research Support. Probiotech – Consultant. Seres Therapeutics – Grant/Research Support. Takeda/Shire – Consultant. Vedanta – Grant/Research Support.

Kanika Sehgal, MBBS¹, Raseen Tariq, MD², Darrell S. Pardi, MD, MS, FACG², Sahil Khanna, MBBS, MS, FACG². C0106 - Real Word Experience of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: A Systematic Review and Meta-analysis, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.