Five?year efficacy and safety of tildrakizumab in patients with moderate?to?severe psoriasis who respond at week 28: pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2)*

Background The phase III reSURFACE 1 and 2 (NCT01722331/NCT01729754) trials of the anti-interleukin-23p19 monoclonal antibody tildrakizumab (TIL) for psoriasis treatment are complete. Objectives We present 5-year pooled data from 2. Methods were double-blind, randomized, controlled studies with optional long-term extensions. Adults moderate-to-severe chronic plaque randomized : to TIL 100 mg (TIL 100) or 200 200) placebo at weeks 0 4, every 12 thereafter [reSURFACE included an etanercept (ETN) arm]. Efficacy outcomes proportions patients achieving absolute relative improvement baseline Psoriasis Area Severity Index (PASI) score through week 244 in responders (? 75% PASI; PASI 75 response) continuously receiving same dose ETN partial nonresponders (PASI < switched 28. Safety was assessed adverse events (AEs) all as treated. Results analyses 329 227 28 200, respectively, 121 responders/nonresponders Of entering extensions, 235/302, 176/213 85/107, evaluated 244, 88·7%, 92·5% 81·3%, achieved response. Exposure-adjusted rates serious AEs 6·3 6·0 per patient-years respectively. Conclusions provided sustained disease control over 5 years responders/nonresponders, a reassuring safety profile.