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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

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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 DESIGNS
All 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.

RESULTS
In 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<0.001).
89.1 percent of patients treated with Taltz achieved PASI 75 compared to 3.9 percent of patients treated with placebo (p<0.001).
70.9 percent of patients treated with Taltz achieved PASI 90 compared to 0.5 percent treated with placebo (p<0.001).
35.3 percent of patients treated with Taltz achieved complete resolution of psoriasis plaques (PASI 100) compared to zero patients treated with placebo (p<0.001).
In UNCOVER-1 and UNCOVER-2, high levels of clearance also were achieved through 60 weeks among patients treated with Taltz every two weeks who achieved clinically meaningful response (sPGA 0 or 1) at 12 weeks, the majority of whom achieved virtually clear or completely clear skin through 60 weeks when treated with Taltz every four weeks.

In UNCOVER-1 and UNCOVER-2 through 60 weeks:

78.3 percent of patients maintained sPGA 0 or 1.
83.3 percent of patients achieved PASI 75.
76.5 percent of patients achieved PASI 90.
More than half of patients (57.5 percent) achieved complete resolution of skin plaques (PASI 100).
In UNCOVER-3, high levels of clearance were also achieved with Taltz given every four weeks through 60 weeks among patients initially treated with Taltz every two weeks:

74.5 percent of patients achieved sPGA 0 or 1.
83.4 percent of patients achieved PASI 75.
73.2 percent of patients achieved PASI 90.
More than half of patients (55.3 percent) achieved complete resolution of skin plaques (PASI 100).
"Over the last several years, advances in our understanding of psoriasis have led to the development of new treatment targets that may provide higher levels of skin clearance," said Aarti Shah, Lilly's global brand development leader for Taltz. "The results of these analyses are significant, demonstrating that the majority of patients treated with Taltz through 60 weeks achieved or maintained virtually or completely clear skin."

Information regarding the safety of Taltz is drawn from a database of 4,204 patients with moderate-to-severe plaque psoriasis who volunteered in both controlled and uncontrolled clinical trials.

Taltz may increase the risk of infection. Patients treated with Taltz had a higher rate of infections than patients treated with placebo (27 percent vs. 23 percent). Upper respiratory tract infections, oral candidiasis, conjunctivitis and tinea infections occurred more frequently in patients treated with Taltz compared to placebo. Serious infections have occurred. Instruct patients to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. If a serious infection develops, discontinue Taltz until the infection resolves.

Other warnings and precautions for Taltz include pre-treatment evaluation for tuberculosis, hypersensitivity reactions, inflammatory bowel disease and immunizations. See Important Safety Information below.

Results from 12-week data in UNCOVER-2 and UNCOVER-3 were published in The Lancet in June 2015. Results from the UNCOVER-3 long-term extension study were also recently presented at the American Academy of Dermatology (AAD) Annual Meeting, March 4-8, 2016.

Indications and Usage
Taltz® is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

Posted-In: News FDA Press Releases

 

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