P0685 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Early Crohn’s Disease: Results from the EVOLVE Expansion Study

Award: Presidential Poster Award

Britt Christensen, MD¹, Michael Scharl, MD², Brian Bressler, MD, MS, FRCPC³, Zaeem Khan, MPH⁴, Yuliya Halchenko, MA⁵, 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, Montreal, PQ, Canada; ⁶Takeda Pharmaceuticals, Cambridge, MA; ⁷University Hospitals Leuven, Leuven, Vlaams-Brabant, Belgium

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

Methods: EVOLVE Expansion (NCT05056441) was a multicenter, observational, retrospective medical chart review study in biologic-naïve pts with CD (≥18 years old) who initiated VDZ or UST treatment in Australia, Belgium, or Switzerland from 2016 to 2021. This analysis looked at treatment outcomes in patients with early treatment (disease duration ≤2 years) who initiated VDZ or UST as first-line biologic. Data were collected from treatment initiation to chart abstraction, treatment discontinuation, death, or loss to follow-up. Cumulative rates of clinical response, remission, mucosal healing, and treatment persistence were estimated using the Kaplan Meier method over 12, 24 and 36 months. Serious adverse events (SAEs), serious infections (SIs), CD exacerbations, and CD-related hospitalization and surgeries were also evaluated. Baseline demographic and clinical characteristics across treatment groups were balanced using inverse probability weighting (IPW).

Results: There were 141 VDZ and 108 UST pts with early treatment. 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 80.8%, UST 79.0%; p=0.52) and clinical remission (VDZ 85.3%, UST 82.8%; p=0.52). Mucosal healing rates were significantly higher in VDZ- versus UST-treated pts (VDZ 92.5%, UST 87.0%, p=0.02). Treatment persistence (VDZ 64.6%, UST 76.7%; p=0.57) was not significantly different over 36 months. There were no significant differences in the risk of safety outcomes: SAEs (hazard ratio [HR]=1.23; CI 0.56-2.72; p=0.60), SIs (HR=6.57; CI 0.44-98.04; p=0.17), CD exacerbations (HR=1.07; CI 0.65-1.75; p=0.79), CD-related surgeries (HR=0.82; CI 0.38-1.76; p=0.61) or CD-related hospitalizations (HR=0.83; CI 0.35-1.95; p=0.67).

Discussion: In CD pts with early initiation of biologic treatment, rates of mucosal healing were significantly greater with VDZ vs UST. There were no significant differences between the VDZ and UST cohorts in clinical remission, clinical response, or treatment persistence. The probability of mucosal healing was significantly greater in pts treated with VDZ. The risk of CD-related hospitalization, surgeries, SAEs and SIs was similar between cohorts.



Disclosures:


Britt Christensen, MD¹, Michael Scharl, MD², Brian Bressler, MD, MS, FRCPC³, Zaeem Khan, MPH⁴, Yuliya Halchenko, MA⁵, Pravin Kamble, PhD⁶, Shashi Adsul, MD, MBA⁶, Zeinab Farhat, PhD⁶, Marc Ferrante, MD⁷. P0685 - Real-World Clinical Effectiveness and Safety of Vedolizumab and Ustekinumab in Bio-Naïve Patients With Early Crohn’s Disease: Results from the EVOLVE Expansion Study, ACG 2023 Annual Scientific Meeting Abstracts. Vancouver, BC, Canada: American College of Gastroenterology.