P0686 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-naïve Patients With Late Crohn’s Disease: Results from the EVOLVE Expansion Study

Britt Christensen, MD¹, Michael Scharl, MD², Brian Bressler, MD, MS, FRCPC³, Yuliya Halchenko, MA⁴, Lauren Gianchetti, MPH⁵, Pravin Kamble, PhD⁶, Shashi Adsul, MD, MBA⁶, Zeinab Farhat, PhD⁶, Marc Ferrante, MD^7
1University of Melbourne and Royal Melbourne Hospital, Melbourne, Victoria, Australia; ²University of Zurich, Zurich, Zurich, Switzerland; ³St. Paul’s Hospital, Vancouver, BC, Canada; ⁴PPD, Part of Thermo Fisher Scientific, Montreal, PQ, Canada; ⁵PPD, Part of Thermo Fisher Scientific, Philadelphia, PA; ⁶Takeda Pharmaceuticals, Cambridge, MA; ⁷University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

Introduction: Real-world data comparing the clinical effectiveness and safety of vedolizumab (VDZ) and ustekinumab (UST) in patients (pts) with late Crohn’s Disease (CD, with a disease duration ≥2 years) is limited.

Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective medical chart review study in Australia, Belgium, and Switzerland from 2016 to 2021 in which biologic-naïve pts with CD (≥18 years old) initiated first-line biologic treatment with VDZ or UST were included. In this analysis, we assessed treatment outcomes in CD patients with late treatment commencement with biologics (disease duration >2 years). Data collected were from treatment initiation to chart abstraction, death, treatment discontinuation or loss to follow-up, whichever came first. The Kaplan Meier method was used to estimate cumulative rates of clinical response, remission, mucosal healing, and treatment persistence over 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations and CD-related hospitalizations and surgeries were also evaluated. Baseline demographic and clinical characteristics across treatment groups were balanced using inverse probability weighting (IPW).

Results: A total of 203 patients initiating late treatment with VDZ and 168 with UST were included. After IPW, both groups had similar baseline characteristics (Table 1). Over 36 months, cumulative rates were similar between VDZ- and UST-treated pts for clinical response (VDZ 82.1%, UST 86.7%; p=0.49), clinical remission (VDZ 89.9%, UST 91.6%; p=0.98) and mucosal healing (VDZ 90.5%, UST 88.2%, p=0.36). Treatment persistence was significantly higher with UST (VDZ 70.2%, UST 76.8%; p=0.03). There were no significant differences in the risk of safety outcomes: SAEs (hazard ratio [HR]=1.07; CI 0.56-2.04; p=0.83), SIs (HR=6.93; CI 0.71-67.28; p=0.10), CD exacerbations (HR=1.07; CI 0.70-1.61; p=0.76), CD-related surgeries (HR=0.87; CI 0.49-1.56; p=0.64) or CD-related hospitalizations (HR=1.48; CI 0.63-3.50; p=0. 37).

Discussion: In CD pts with late initiation of treatment with a biologic, there were no significant differences between the VDZ and UST cohorts for clinical response, clinical remission, or mucosal healing. The probability of treatment persistence was greater in pts treated with UST. The risks of CD-related surgeries, hospitalizations, and SIs were similar between cohorts.



Disclosures:


Britt Christensen, MD¹, Michael Scharl, MD², Brian Bressler, MD, MS, FRCPC³, Yuliya Halchenko, MA⁴, Lauren Gianchetti, MPH⁵, Pravin Kamble, PhD⁶, Shashi Adsul, MD, MBA⁶, Zeinab Farhat, PhD⁶, Marc Ferrante, MD⁷. P0686 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-naïve Patients With Late Crohn’s Disease: Results from the EVOLVE Expansion Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.