E0349 - Health-Related Quality of Life in Patients With One Prior Episode of Recurrent Clostridioides difficile Infection (rCDI): Results from the RBX2660 Phase 3 Randomized, Placebo-Controlled rCDI Trial (PUNCH CD3)

Tuesday, October 25, 2022

3:00 PM – 5:00 PM ET

Location: Crown Ballroom

Has Audio

Presenting Author(s)

AG

Amy Guo, PhD

Ferring Pharmaceuticals
Parsippany, NJ

Paul Feuerstadt, MD, FACG¹, Erik R. Dubberke, MD, MSPH², Amy Guo, PhD³, Adam Harvey, PhD⁴, Min Yang, MD, PhD, MS⁵, Viviana Garcia-Horton, PhD⁶, Mirko Fillbrunn, PhD⁵, Jonathan Salcedo, PhD⁵, Glenn Tillotson, PhD⁷, Lindy Bancke, PharmD⁴, Kevin W. Garey, PharmD, MS, FASHP, FIDSA, FCCP⁸
¹PACT Gastroenterology Center and Yale University School of Medicine, New Haven, CT; ²Washington University School of Medicine, St. Louis, MO; ³Ferring Pharmaceuticals, Parsippany, NJ; ⁴Rebiotix Inc., a Ferring Company, Roseville, MN; ⁵Analysis Group, Inc., Boston, MA; ⁶Analysis Group, Inc., New York, NY; ⁷GST Micro, North, VA; ⁸University of Houston College of Pharmacy, Houston, TX

Introduction: RBX2660 is an investigational live biotherapeutic product (LBP) for the reduction of recurrent Clostridioides difficile infection (rCDI). PUNCH CD3, a RBX2660 phase 3 randomized placebo (PBO) controlled trial (NCT03244644), included patients with at least one prior rCDI episode and at least one round of standard-of-care oral antibiotic therapy, or with at least two episodes of severe CDI resulting in hospitalization within the prior year. Here we report post-hoc analyses of health-related quality of life (HRQL) within an 8-week blinded period for a subgroup of patients in the trial who had the first recurrence.

Methods: HRQL impact (based on Clostridioides difficile Health-related Quality-of-Life Questionnaire [Cdiff32]) was estimated for RBX2660 and PBO arms. The disease-specific Cdiff32 comprises three domains (physical, mental, social) and a total score; scores range from 0–100 (100 best possible). Per trial protocol, patients experiencing recurrence after blinded treatment received open-label RBX2660 per physician discretion; these participants were excluded. We summarized between-treatment differences in Cdiff32 scores from baseline to week 8, and adjusted regressions were conducted controlling for baseline Cdiff32 score, age, sex, number of prior CDI episodes, and other covariates. As-observed data were used.

Results: Of 262 enrolled patients, 86 patients (53 RBX2660, 33 PBO) had 1 prior rCDI episode (33% of all trial patients). Among these, 66 patients (76.7%) had Cdiff32 data at baseline and week 8 (43 RBX2660, 23 PBO), aged (mean±SD) 57.6±18.2 years, with 65.2% female. Unadjusted analyses showed statistically significant greater HRQL improvements with RBX2660 vs PBO for total score (13.5±5.7, p< 0.05) and mental domain (16.2±6.0, p< 0.01), and nonsignificant for physical (11.9±6.1, p=0.07) and social (7.6±7.4, p=0.45) domains (Table 1). Adjusted analyses showed statistically significant differences (all p< 0.05) for total score (11.03, 95% confidence interval: [1.34; 20.72]), physical (10.74, [1.36; 20.13]) and mental (13.07, [2.02; 24.13]) domains.

Discussion: No prior research has reported HRQL impact of an investigational LBP in rCDI patients with 1 prior rCDI. Our findings demonstrated significantly more improvements in HRQL for RBX2660-treated patients in this subgroup of patients. Future research is needed to further evaluate benefits when treating rCDI patients early.

	Baseline score		Week 8 score
Component (Mean ± SD)	RBX2660	Placebo	RBX2660	Placebo	Difference-in-difference	Unadjusted P-value
Total	40.7 ± 15.7	47.3 ± 20.8	75.9 ± 18.6	69.0 ± 23.4	13.5 ± 5.7	< 0.05 *
Physical	47.3 ± 19.4	51.7 ± 22.2	84.2 ± 16.9	76.6 ± 24.1	11.9 ± 6.1	0.07
Mental	31.7 ± 15.0	40.8 ± 21.8	66.5 ± 22.2	59.4 ± 25.3	16.2 ± 6.0	< 0.01 *
Social	51.6 ± 22.0	54.6 ± 26.3	80.4 ± 21.8	75.8 ± 24.7	7.6 ± 7.4	0.45

Table: Cdiff32 component scores at baseline and week 8 by treatment arm.

Disclosures:

Paul Feuerstadt: Ferring/Rebiotix Pharmaceuticals – Advisory Committee/Board Member, Consultant, Speakers Bureau. Merck and Co – Consultant. Seres Therapeutics – Advisory Committee/Board Member, Consultant. Takeda Pharmaceuticals – Advisory Committee/Board Member.

Erik R. Dubberke: Abbott – Consultant. Ferring Pharmaceuticals – Consultant, Grant/Research Support. Merck – Consultant. Pfizer – Consultant, Grant/Research Support. Rebiotix – Advisory Committee/Board Member. Seres – Consultant. Summit – Consultant. Synthetic Biologics – Grant/Research Support.

Amy Guo: Ferring Pharmaceuticals – Employee.

Adam Harvey: Rebiotix Inc., a Ferring Company – Employee.

Min Yang: Analysis Group, Inc. – Employee, Analysis Group has received consulting fees from Ferring Pharmaceuticals.

Viviana Garcia-Horton: Analysis Group, Inc. – Employee, Analysis Group has received consulting fees from Ferring Pharmaceuticals.

Mirko Fillbrunn: Analysis Group, Inc. – Employee, Analysis Group has received consulting fees from Ferring Pharmaceuticals.

Jonathan Salcedo: Analysis Group, Inc. – Employee, Analysis Group has received consulting fees from Ferring Pharmaceuticals.

Glenn Tillotson: Ferring Pharmaceuticals – Consultant. GST Micro LLC – Employee. Spero Pharmaceuticals – Consultant. Taro Pharmaceuticals – Consultant.

Lindy Bancke: Rebiotix Inc., a Ferring company – Employee.

Kevin W. Garey: Acurx – Grant/Research Support. Ferring Pharmaceuticals – Consultant. Paratek Pharmaceuticals – Grant/Research Support. Seres Health – Grant/Research Support. Summit – Grant/Research Support.