Secukinumab demonstrates sustained high efficacy and a tolerable safety profile in moderate-to-severe psoriasis patients through 4 years of treatment
Introduction: Secukinumab, targets IL-17A for the treatment of moderate to severe psoriasis. Here we report an interim analysis of a phase 3 extension study evaluating efficacy and safety up to 4 years (208 weeks) of treatment.
Materials and Methods: During the core SCULPTURE study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of secukinumab 300mg or 150mg, either at a 4-week fixed-interval (FI) or in a retreatment-as-needed (RAN) regimen. Subjects who completed 52 weeks of treatment continued into the extension and received the same blinded maintenance to the end of Year-3. In the fourth year the study became open label with patients attending site visits every 12-16 weeks. Here we report the PASI90/100, DLQI-0/1 and safety profile over 4 years of treatment with the secukinumab 300mg arm. Efficacy data are reported as observed.
Results: Secukinumab 300mg demonstrated sustained efficacy over 4 years of treatment in patients with moderate to severe psoriasis. PASI90/100 responses at year 4 were 66.4%/43.5% respectively. The median percentage change in PASI from Baseline to Year 1 (98.4%) was maintained to Year 4 (97.8%). DLQI-0/1 response (representing no impact of skin problems on patient’s lives) was sustained over 4 years (72.7% at year 1 and 70.8% at year 4). The safety profile of secukinumab remained tolerable, and similar to previous studies, over the 4 years. No cumulative or unexpected safety concerns were identified.
Conclusion: Secukinumab 300mg treatment results in sustained efficacy over 4 years with no new or unexpected safety signals.
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Mr Eric Mate
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