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P573 Real-world effectiveness and safety of vedolizumab and anti-TNF in biologic-naive ulcerative colitis patients: Results from the EVOLVE study

A. Yarur*1, G. Mantzaris2, M. Silverberg3, M. Walshe3, P. Zezos3, D. Stein4, M. Bassel5, T. Lissoos6, C. Lopez6, A. Natsios7, G. Radulescu8, H. Patel9, D. Demuth10, B. Bressler11

1Medical College of Wisconsin, Milwaukee, USA, 2Evangelismos Hospital, Athens, Greece, 3IBD Center, Mount Sinai Hospital, Toronto, Canada, 4Evidera, London, UK, 5Evidera, Montreal, Canada, 6Takeda USA Inc., Chicago, USA, 7Takeda SA Inc., Athens, Greece, 8Takeda Canada Inc., Toronto, Canada, 9Takeda Pharmaceuticals International, Deerfield, USA, 10Takeda International - UK Branch, London, UK, 11St. Paul's Hospital, Vancouver, Canada

Background

This study aimed to compare the real-world clinical effectiveness and safety of vedolizumab (VDZ), a gut-selective anti-α4β7-integrin, and anti-tumour necrosis factor (TNF) agents in biologic (bio)-naïve ulcerative colitis (UC) patients.

Methods

A retrospective chart review study was conducted in adult (≥18 years), bio-naïve UC pts treated with VDZ or anti-TNF (June 2014 to February 2018) in Canada, Greece and the USA. Data were collected from treatment (Tx) initiation to earliest of death, chart abstraction date or 6 months post-Tx discontinuation. Cumulative rates of clinical response, clinical remission, mucosal healing, Tx persistence and dose escalations were estimated over 24 months (Kaplan–Meier method). Incidence rates (per 100 person-years [PYs]) of UC exacerbations, colectomy, serious adverse events (SAEs) and serious infections (SIs) were assessed. A Cox proportional hazards model was used to compare outcomes with adjustments for baseline confounders: age, sex, albumin, C-reactive protein, disease location and duration, UC-related hospitalisations (prior 12 mo) and disease severity; adjusted hazard ratios (HR) with 95% confidence interval are reported.

Results

Overall, 527 UC patients (VDZ: 325; anti-TNF: 202 [adalimumab: 58, infliximab: 120, golimumab: 24]) from 37 sites were included (median [min–max] follow-up [mo]: VDZ, 16.1 (3.0–47.0); anti-TNF, 20.0 [3.5–50.6]). Baseline characteristics are shown in Table 1.

Table 1. Baseline characteristics of real-world biologic-naive ulcerative colitis patients treated with vedolizumab and anti-TNF agents

At 24 months, cumulative rates of clinical response (91% vs. 86%), clinical remission (79% vs. 66%) and mucosal healing (92% vs. 84%) were high in VDZ and anti-TNF patients, respectively, and did not differ significantly between groups. Higher Tx persistence (75% vs. 54%; p < 0.0001) and similar rates of dose escalations (25% vs. 31%; p < 0.05) occurred in VDZ vs. anti-TNF patients. The incidence rate (per 100 PYs) of UC exacerbations (28.3 vs. 43.9) and SAEs (4.9 vs. 10.4) were significantly (p < 0.05) lower in VDZ vs. anti-TNF patients but similar for colectomy (1.8 vs. 2.2) and SIs (1.9 vs. 2.2). Adjusted HR for outcomes are shown in Table 2.

Table 2. Clinical effectiveness and safety of vedolizumab and anti-TNF agents in real-world biologic-naïve ulcerative colitis patients.

Conclusion

VDZ and anti-TNF have similar rates of clinical effectiveness in bio-naïve UC patients in real-world clinical practice. Bio-naïve UC patients receiving VDZ are significantly more likely to persist with Tx and experience fewer exacerbations and SAEs than anti-TNF patients.