Studies Demonstrate Lilly's Taltz® (ixekizumab) Maintained or Achieved High Levels of Skin Clearance for Patients with Moderate-to-Severe Plaque Psoriasis through 60 Weeks

Eli Lilly and Company (NYSE: LLY) announced today that the New England Journal of Medicine has published detailed results from three pivotal Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—that demonstrated the efficacy and safety of Taltz® (ixekizumab) through 60 weeks in patients with moderate-to-severe plaque psoriasis. This publication also detailed 12-week efficacy data for patients treated with Taltz in UNCOVER-1.In all three studies, responders to Taltz through 12 weeks demonstrated high levels of skin clearance through 60 weeks. "This group of studies show that patients on Taltz are able to achieve high levels of efficacy, and that the majority of patients are able to maintain or continue to improve their response with continued treatment through 60 weeks," said Kenneth Gordon, M.D., a professor of dermatology at Northwestern University Feinberg School of Medicine and first author of the paper.STUDY DESIGNSAll three studies evaluated the safety and efficacy of Taltz (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks. All three studies also evaluated response rates with Taltz every four weeks through 60 weeks. In UNCOVER-1 and UNCOVER-2, patients treated with Taltz who achieved clinical response (static Physician's Global Assessment score [sPGA] 0 or 1) at 12 weeks were re-randomized to receive Taltz (80 mg every four weeks) or placebo through 60 weeks. In UNCOVER-3, all patients completing 12 weeks continued the study receiving Taltz (80 mg every four weeks) through 60 weeks. In all three studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index score (PASI) 75 and sPGA 0 or 1. PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a recommended measure the FDA uses to evaluate effectiveness.1 In all three studies, sPGA and PASI were also assessed through 60 weeks.RESULTSIn UNCOVER-1, Taltz given every two weeks was statistically superior to placebo, with high levels of clearance achieved at 12 weeks among patients treated with Taltz, the majority of whom achieved virtually clear (PASI 90) or completely clear skin (PASI 100, sPGA 0). 81.8 percent of patients treated with Taltz achieved sPGA 0 or 1 compared to 3.2 percent of those treated with placebo (p