Lilly announced positive results from two Phase 3 studies, UNCOVER-2 and UNCOVER-3, of ixekizumab for the treatment of moderate-to-severe plaque psoriasis compared to etanercept or placebo. Study findings were recently presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C.
UNCOVER-2 and UNCOVER-3 are double-blind, multicenter Phase 3 studies evaluating the efficacy and safety of ixekizumab in more than 2,500 patients with moderate-to-severe plaque psoriasis. Patients received either ixekizumab 160mg loading dose, followed by 80mg every 2 or 4 weeks, etanercept 50mg twice a week, or placebo. The combined analysis assessed the speed of onset of clinical improvement as measured by mean percentage improvement in Psoriasis Area Severity Index (PASI) score from baseline, as well as, time to PASI 50 and PASI 75. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions, weighted by the body surface area of involved skin.
Study results showed that patients treated with ixekizumab demonstrated clinically significant differences in mean percentage improvement of psoriasis plaques as early as 1 week of treatment compared to etanercept or placebo. At 1 week, the mean percentage improvement was 32.7% in the ixekizumab every 2 weeks group, 10.3% in the etanercept group, and 5.31% in the placebo group (P<0.001 for all comparisons). At 2 weeks, the mean percentage improvement was 53.6%, 23.3%, and 9.25%, respectively (P<0.001 for all comparisons).
Treatment with ixekizumab also resulted in statistically significant improvements (PASI 50) vs. etanercept and placebo. At 1 week, PASI 50 was achieved by 22.8% of patients treated with ixekizumab every two weeks, 3.9% with etanercept, and 1.4% with placebo (P<0.001 for all comparisons). At 2 weeks, PASI 50 was achieved by 58.8%, 14.6%, and 4.2% of patients, respectively (P<0.001 for all comparisons). Patients treated with ixekizumab every 2 weeks had a median time to PASI 75 of 30 days vs. 85 days in etanercept-treated patients.
Ixekizumab is an IgG4 monoclonal antibody that selectively inhibits interleukin-17A (IL-17A).
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