33025 Stability of PASI

Abstract

Background: Tildrakizumab, a high-affinity anti–interleukin 23p19 monoclonal antibody approved for the treatment of moderate to severe plaque psoriasis, has demonstrated efficacy and safety for up to 5 years. Absolute Psoriasis Area and Severity Index (PASI) <3 is considered a clinically relevant treatment target for moderate to severe plaque psoriasis. We determined the percentages of patients in the Phase 3 reSURFACE 1/2 (NCT01722331/NCT01729754) trials with PASI <3 at ≥80% and all follow-up visits up to week (W) 244. Methods: Methodology of these randomized controlled trials was previously published. At W64/W52, patients with at least a PASI 50 response entered an optional 4-year extension up to W256 (reSURFACE 1)/W244 (reSURFACE 2). Tildrakizumab 100 and 200 mg were administered at W0, W4, and every 12W thereafter. Study population included patients with PASI <3 at W28 (PASI <3 responders) who were randomized to continue treatment. Missing data were handled using multiple imputation. Results: At W28, 263 and 180 PASI <3 responders receiving tildrakizumab 100 and 200 mg, respectively, continued treatment. The mean (SD) numbers of visits with an absolute PASI <3 were 16.0 (3.5) and 16.6 (3.3) for tildrakizumab 100 and 200 mg, respectively; the median for both was 18.0. Among responders receiving tildrakizumab 100 and 200 mg, 80.2% and 87.2%, respectively, maintained PASI <3 response at ≥80% of follow-up visits and 58.9% and 70.0%, respectively, at all scheduled follow-up visits through W244. Conclusions: Tildrakizumab provided steady disease control over 5 years in most patients who were PASI <3 responders at W28.