Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis. Ixekizumab is a monoclonal antibody with high affinity and specificity that binds to and neutralizes the pro-inflammatory cytokine interleukin-17A (IL-17A).
Patients enrolled in the UNCOVER studies had a confirmed diagnosis of chronic plaque psoriasis for at least six months prior to randomization. Additionally, at screening and at randomization they demonstrated at least 10% BSA of psoriasis, an Static Physician Global Assessment (sPGA) score of at least 3 and the Psoriasis Area and Severity Index (PASI) score of at least 12. UNCOVER-1 compared the safety and efficacy of different dosing regimens of ixekizumab to placebo after 12 weeks and 60 weeks of treatment. UNCOVER-2 and 3 evaluated different dosing regimens of ixekizumab compared to either placebo or etanercept for 12 weeks.
Patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint. For patients treated with ixekizumab either every four weeks or every two weeks, between 78– 90% of patients achieved at least a 75% reduction in PASI score (PASI 75) at 12 weeks. Additionally, 31–41% of these patients achieved PASI 100, or clear skin, at week 12. For comparison, between 5–7% of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100.
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