B0386 - Real World Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-Naïve Patients With Crohn’s Disease: Results From the EVOLVE Study

Andres Yarur, MD¹, Brian Bressler, MD, MS², Neil Brett, PhD³, Marielle Bassel, PhD³, Shashi Adsul, MD⁴, Pravin Kamble, PhD⁵, Gerassimos J. Mantzaris, MD, PhD^6
1Cedars-Sinai Medical Center, Los Angeles, CA; ²University of British Columbia, Vancouver, BC, Canada; ³PPD, part of Thermo Fisher Scientific, Montreal, PQ, Canada; ⁴Takeda Pharmaceuticals International AG, Zurich, Zurich, Switzerland; ⁵Takeda Pharmaceuticals International, Cambridge, MA; ⁶Evangelismos-Polykliniki’ General Hospital, Athens, Attiki, Greece

Introduction: Vedolizumab (VDZ, a gut selective anti-α4β7-integrin) and adalimumab (ADA, anti-tumor necrosis factor) are approved biologic treatments for moderate to severe Crohn’s disease (CD). We aimed to evaluate the real-world clinical effectiveness and safety of VDZ versus ADA in biologic-naïve patients with CD.

Methods: This was a retrospective cohort study in adult patients with CD who received first-line biologic treatment with VDZ or ADA at 37 sites in the US, Canada, and Greece. The index date was defined as the date of first-line biologic initiation between May 2014 and March 2018. Cumulative rates of treatment persistence and clinical outcomes over 12 months were estimated using the Kaplan-Meier method. Patients were censored at loss of follow up, death, end of chart abstraction, treatment discontinuation, or dose escalation, whichever came first. Clinical outcomes were assessed using pre-defined hierarchical algorithms of standard measures.¹ Survival analyses were conducted for safety outcomes, CD-related exacerbations and CD surgeries. Adjusted analyses were performed using stabilized inverse probability weighting using baseline covariates.

Results: 362 patients were included (VDZ: 218; ADA: 144). Baseline characteristics are shown in Table 1. Cumulative rates of clinical response (68.5% vs 61.1%; p=0.59) and mucosal healing (67.7% vs 56.0%; p=0.56) over 12 months were similar between treatment cohorts, whilst clinical remission rates (66.3% vs 46.4%; p< 0.01) were greater in VDZ- versus ADA-treated patients. Over 12 months, VDZ-treated patients were more likely to persist on treatment versus ADA-treated patients (89.3% vs 77.5%; p=0.02). VDZ-treated patients were significantly less likely to experience (incidence rates per 1000 person-years; HR [95%CI]) serious adverse events within 1 year (78.9 vs 166.2; 0.45 [0.22-0.93]), but there were no statistical differences in CD exacerbations (207.7 vs 261.8; 0.91 [0.56-1.47]), CD-related surgeries (10.3 vs 16.0; 1.55 [0.21-11.15]) or serious infections (20.5 vs 71.2; 0.27 [0.06-1.20]) versus ADA-treated patients.



Discussion: In a real-world setting in biologic-naïve patients with CD, VDZ-treated patients had equivalent rates of response and mucosal healing but a greater likelihood of persisting on treatment and achieving clinical remission versus ADA-treated patients. Studies assessing outcomes after dose optimization are needed.



¹Bressler, B. et al. J Crohns Colitis. 2021 Oct 7;15(10):1694-1706.





Disclosures:


Andres Yarur, MD¹, Brian Bressler, MD, MS², Neil Brett, PhD³, Marielle Bassel, PhD³, Shashi Adsul, MD⁴, Pravin Kamble, PhD⁵, Gerassimos J. Mantzaris, MD, PhD⁶. B0386 - Real World Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-Naïve Patients With Crohn’s Disease: Results From the EVOLVE Study, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.