S869 Real World Clinical Effectiveness and Safety of Vedolizumab and Adalimumab in Biologic-Naïve Patients With Crohn’s Disease: Results From the EVOLVE Study

Abstract

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. 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. Conclusion: 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. Table 1. - Baseline Characteristics of Biologic Naïve Patients with Crohn’s Disease Treated with Vedolizumab or Adalimumab Baseline Characteristics VedolizumabN=218 AdalimumabN=144 p-value Age, Mean (SD) 51.7 (16.8) 40.0 (14.9) < 0.001 Male, n (%) 114 (52.3) 75 (52.1 0.969 Disease duration, n with available data 176 111 0.016 < 2 years, n (%) 50 (28.4) 50 (45.0) 2- < 5 years, n (%) 32 (18.2) 16 (14.4) ≥ 5 years, n (%) 94 (53.4) 45 (40.5) Median (min-max) observation period, (months)* 15.7 (4.2-45.9) 19.3 (6.1-49.3) < 0.001 Crohn’s disease location at index, n with available data 196 121 0.047 Colonic with/without upper GI disease, n (%) 42 (21.4) 35 (28.9) Ileal with/without upper GI disease, n (%) 85 (43.4) 36 (29.8) Ileocolonic with/without upper GI disease, n (%) 69 (35.2) 50 (41.3) Disease severity at index, n with available data 180 116 0.161 Moderate, n (%) 84 (46.7) 58 (50.0) Severe, n (%) 17 (9.4) 17 (14.7) Abbreviations: GI = gastrointestinal; SD = standard deviation.*While all patients were required to have 6 months follow-up from time of treatment initiation to data abstraction, some patients were lost to follow-up and therefore minimum duration during the observation period was <6 months.