Patients with moderate-to-severe plaque psoriasis achieve significant improvement with ixekizumab

Eli Lilly and CompanyMar 8 2016

Eli Lilly and Company (NYSE: LLY) announced today that patients with moderate-to-severe plaque psoriasis who did not respond to treatment with etanercept achieved significant improvement in their psoriasis plaques when treated with ixekizumab in a Phase 3 clinical trial. Detailed results of the UNCOVER-2 study were presented during the American Academy of Dermatology (AAD) Annual Meeting taking place March 4-8 in Washington, D.C.

In UNCOVER-2, 64 percent (229/358) of patients treated with bi-weekly etanercept did not respond (static Physician's Global Assessment score [sPGA] ≥2) to treatment at 12 weeks. These nonresponders were treated with placebo at 12 weeks, then received ixekizumab every four weeks from Weeks 16 through 60.

This study's co-primary efficacy endpoints at 12 weeks of ixekizumab therapy were 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 required measure the FDA uses to evaluate effectiveness.

Among those patients who did not respond to etanercept, the following was observed at 24 weeks of the study, 12 weeks following treatment with ixekizumab:

• 83.5 percent of patients achieved PASI 75;
• 57.0 percent of patients achieved PASI 90;
• 22.0 percent of patients achieved complete resolution of psoriasis plaques (PASI 100).

At 48 weeks following treatment with ixekizumab, the following was also observed at week 60 of the study among those who did not respond to etanercept:

• 82.5 percent of patients achieved PASI 75
• 68.5 percent of patients achieved PASI 90;
• 43.5 percent of patients achieved complete resolution of psoriasis plaques (PASI 100).

Additionally, 73 percent of those patients who did not respond to etanercept achieved sPGA 0 or 1 12 weeks after starting treatment with ixekizumab.

The majority of treatment-emergent adverse events were mild or moderate. The safety profile after receiving ixekizumab treatment was comparable among patients who initially received etanercept and patients who initially received placebo in this clinical trial.

"Despite the availability of existing treatment options, there are many patients living with moderate-to-severe plaque psoriasis who have not responded to previous treatments and are still looking for an alternative," said Kim Papp, M.D., lead author and president, Probity Medical Research, Inc., Ontario, Canada. "In this study, ixekizumab demonstrated high levels of clearance for all patients. We saw high levels of improvement in biologic-experienced patients, and we saw high levels of improvement in those who have not been treated with a biologic. These results provide further evidence of a robust clinical data profile that, if approved, supports the use of ixekizumab in patients with moderate-to-severe plaque psoriasis."

In UNCOVER-2, patients who did not respond to etanercept after 12 weeks of treatment demonstrated high levels of improvement in their moderate-to-severe plaque psoriasis after receiving treatment with ixekizumab.

Ixekizumab is the company's investigational medicine for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis.