Real World Safety of Vedolizumab and Anti-TNF Therapies in Biologic-Naϊve Ulcerative Colitis and Crohnʼs Disease Patients: Results From the EVOLVE Study: 795

INTRODUCTION: The GEMINI phase III clinical trials showed a favorable safety profile for vedolizumab (VDZ) in treating patients (pts) with moderate-to-severely active ulcerative colitis (UC) and Crohn's disease (CD). Real-world studies are needed comparing the safety of VDZ to anti-tumor necrosis factors (anti-TNF) agents in biologic (bio)-naïve pts. METHODS: This was a multi-country (Canada, Greece and the United States) and multi-center, retrospective study including bio-naïve pts (≥18 years old) with ≥6 months follow-up, initiating treatment (Tx) with VDZ or an anti-TNF (adalimumab, infliximab, golimumab, certolizumab pegol) as standard of care between May 2014-March 2018. Data were collected from Tx initiation to earliest of death, chart abstraction date or 6 months post-Tx discontinuation (Canada only). Serious adverse events (SAEs) and serious infections (SIs) (defined as either life threatening, requiring hospital admission, resulting in significant disability/incapacity, or recorded in the chart as an important medical event) occurring from Tx initiation up to five half-lives post-Tx discontinuation were assessed. Incidence rates (per 100 person-years [PYs]) of SAEs and SIs were estimated. A Cox proportional hazards model adjusted for baseline characteristics was used to compare incidence rates between Tx cohorts. Adjusted hazard ratios (HR) with 95% confidence intervals (CI) are reported. RESULTS: This study included 1,095 pts (VDZ: 598 [UC: 380; CD: 218]; anti-TNF: 497 [UC: 224; CD: 273]) from 42 sites. Compared to anti-TNF pts, the VDZ cohort were older (mean [SD] age [years]: VDZ, 47.9 [17.4]; anti-TNF, 39.6 [15.2] [ P < 0.01]), were proportionately more male (VDZ, 56.9%; anti-TNF, 49.9% [ P = 0.02]) and had a longer disease duration (median [range: min-max] disease duration [years]: VDZ, 5.0 [0.04– 54.0]; anti-TNF, 2.0 [<0.1–49.0] [ P < 0.01]). Median (range: min-max) follow-up (months) was: VDZ, 15.3 (3.0-47.0); anti-TNF, 16.3 (3.5-51.0). Incidence rates of first occurrence of SAEs and SIs (Table 1) were significantly lower in VDZ versus anti-TNF pts (adjusted HR: SAE, 0.42 [0.27-0.66]; SI, 0.33 [0.18-0.58]). Similar trends were shown when data were stratified by UC and CD, separately (Table 1). CONCLUSION: Bio-naïve pts treated with VDZ were significantly less likely to experience SAEs and SIs than those treated with anti-TNF therapies. These data support a favourable safety profile of VDZ versus anti-TNF in bio-naïve inflammatory bowel disease pts in real-world clinical practice.