Efficacy and safety of ixekizumab in patients with plaque psoriasis across different degrees of disease severity: results from UNCOVER-2 and UNCOVER-3
Lajos Kemény, Lovisa Berggren, M. Dossenbach, Yves Dutronc, C. Paul
Abstract
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Lajos Kemény, Lovisa Berggren, M. Dossenbach, Yves Dutronc, C. Paul
Abstract
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PURPOSE: To evaluate short- and long-term efficacy and safety of ixekizumab in patients according to psoriasis severity. MATERIALS AND METHODS: Data were integrated from clinical trials (UNCOVER-2, UNCOVER-3). Patients received placebo, 80-mg ixekizumab every 2 weeks (IXEQ2W), every 4 weeks (IXEQ4W), or 50 mg etanercept (ETN) biweekly for 12 weeks, then open-label IXEQ4W (UNCOVER-3). Psoriasis severity was categorized by baseline Psoriasis Area and Severity Index (PASI <20 and ≥20). Efficacy was evaluated by percentage reaching PASI 75, 90, 100, and absolute PASI ≤5, ≤2, and ≤1. RESULTS: Significantly more patients with PASI ≥20 (vs. PASI <20) were male and had higher body weight. After 12 weeks, both severity groups had significantly more IXEQ2W- than ETN-treated patients reach PASI 75, 90, 100, and absolute PASI ≤5, ≤2, ≤1. Fewer PASI ≥20 vs. PASI <20 patients across treatments reached PASI ≤5, ≤2, and ≤1 at week 12. Efficacy was maintained during 156 weeks of ixekizumab treatment with no differences between groups. The IXEQ2W safety profile was similar between groups except for injection-site reactions (significantly higher in PASI <20). CONCLUSIONS: Ixekizumab demonstrated a high level of efficacy and had a consistent safety profile in patients with different baseline psoriasis severity levels.
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PURPOSE: To evaluate short- and long-term efficacy and safety of ixekizumab in patients according to psoriasis severity. MATERIALS AND METHODS: Data were integrated from clinical trials (UNCOVER-2, UNCOVER-3). Patients received placebo, 80-mg ixekizumab every 2 weeks (IXEQ2W), every 4 weeks (IXEQ4W), or 50 mg etanercept (ETN) biweekly for 12 weeks, then open-label IXEQ4W (UNCOVER-3). Psoriasis severity was categorized by baseline Psoriasis Area and Severity Index (PASI <20 and ≥20). Efficacy was evaluated by percentage reaching PASI 75, 90, 100, and absolute PASI ≤5, ≤2, and ≤1. RESULTS: Significantly more patients with PASI ≥20 (vs. PASI <20) were male and had higher body weight. After 12 weeks, both severity groups had significantly more IXEQ2W- than ETN-treated patients reach PASI 75, 90, 100, and absolute PASI ≤5, ≤2, ≤1. Fewer PASI ≥20 vs. PASI <20 patients across treatments reached PASI ≤5, ≤2, and ≤1 at week 12. Efficacy was maintained during 156 weeks of ixekizumab treatment with no differences between groups. The IXEQ2W safety profile was similar between groups except for injection-site reactions (significantly higher in PASI <20). CONCLUSIONS: Ixekizumab demonstrated a high level of efficacy and had a consistent safety profile in patients with different baseline psoriasis severity levels.
Key concepts: Ixekizumab, Medicine, Psoriasis Area and Severity Index, Psoriasis, Placebo, Etanercept, Internal medicine, Plaque psoriasis