C0105 - Real World Experience of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: A Mayo Clinic Experience

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 demonstrated that bezlotoxumab when combined with antibiotics had lower recurrent Clostridioides difficile infection (CDI) rates compared to placebo. Patients with one or more of these: age ≥65 years, an immunocompromised state, severe CDI or a prior history of CDI in the last 6 months benefit the most. Those with 3 or more risk factors have the greatest recurrence reduction. We report differences in recurrence rates in patients with recurrent CDI receiving bezlotoxumab stratified by these prespecified risk factors.

Methods: We conducted a retrospective study of all patients treated with bezlotoxumab from 2017-2021 at Mayo Clinic. Patient demographics, CDI diagnostics, number of CDI episodes, antibiotics received and the number of prespecified risk factors were analyzed. Recurrence was defined as a subsequent CDI episode within 56 days of the previous episode. A Kaplan Meier survival curve and Cox model was constructed to generate hazard ratio (HR) and confidence intervals (CI).

Results: A total of 47 patients treated with bezlotoxumab, of which 59.6% (28/47) were female, with median age 62 years (range 23-94) were included. Patients had a median of 3 prior CDI episodes (range 1-10) (Table 1). Of these, 34 patients (72.3%) had CDI resolution and the other 13 patients recurred (27.6%). Recurrence rates with different number of risk factors is displayed in Table 1. Kaplan Meier survival curve analysis showed that after treatment with bezlotoxumab, there was a significantly higher probability of recurrence in groups of patients with 1, 2 or 3 risk factors (log-rank test, p=0.018) (Figure 1). With an increase in the total number of risk factors, there is also an increase in the risk of recurrence (HR 3.97, 95% CI 1.37-11.50) (p=0.010).

Discussion: The benefit of bezlotoxumab treatment is lower in CDI patients with a greater number of risk factors. More studies are needed to evaluate the clinical efficacy of bezlotoxumab in patients with a higher number of prespecified risk factors.

Figure: Kaplan-Meier curve depicting probability of recurrence of Clostridioides difficile infection with 1, 2 or 3 risk factors after treatment with bezlotoxumab

No. of Risk Factors	Median Prior Episodes (range)	Recurrence Rate (%)
1	3.5 (1-8)	0/8 (0%)
2	3 (1-10)	4/22 (18.2%)
3	4 (1-7)	9/17 (53%)

Table: Median prior episodes of Clostridioides difficile and recurrence rates associated with 1, 2 or 3 risk factors in patients treated 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. C0105 - Real World Experience of Bezlotoxumab for the Prevention of Recurrent Clostridioides difficile Infection: A Mayo Clinic Experience, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.