Eli Lilly Presents Results of Ixekizumab Phase III Clinical Trials

March 7, 2016
BioPharm International Editors

Clinical trials of Eli Lilly’s ixekizumab showed the drug displayed clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis.

Results from clinical trials of Eli Lilly’s ixekizumab indicate the monoclonal antibody resulted in clinically meaningful improvements in patients with moderate-to-severe plaque psoriasis, as early as one week, compared with patients treated with etanercept or a placebo.

Eli Lilly and Company presented the results of UNCOVER-2 and UNCOVER-3 during the American Academy of Dermatology (AAD) Annual Meeting from March 4–8, 2016 in Washington, D.C. UNCOVER-2 and UNCOVER-3 are double-blind, multicenter, Phase III studies evaluating more than 2500 patients with moderate-to-severe plaque psoriasis across 19 countries. In these comparator studies, patients were assigned to receive placebo, etanercept (50 mg twice a week), or ixekizumab (80 mg every two or four weeks) for 12 weeks, following a 160-mg starting dose.

This combined analysis evaluated 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 among patients treated with ixekizumab, etanercept or placebo. 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.

Significant differences in mean percentage improvement of psoriasis plaques were observed among patients treated with ixekizumab compared with etanercept and placebo:

  • At one week, the mean percentage improvement was 32.7% in the group randomized to receive ixekizumab every two weeks, 10.3% in etanercept and 5.31% in placebo (p < 0.001 for all comparisons).

  • At two weeks, the mean percentage improvement was 53.6% in the group randomized to receive ixekizumab every two weeks, 23.3% in the etanercept cohort, and 9.25% in the placebo group (p < 0.001 for all comparisons).

Treatment with ixekizumab also resulted in clinically meaningful improvements (PASI 50) as early as one week, which were statistically significantly different compared with etanercept and placebo.

  • At one week, PASI 50 was achieved by 22.8% of patients treated with ixekizumab every two weeks compared with 3.9% among those treated with etanercept and 1.4%in placebo (p < 0.001 for all comparisons).

  • At two weeks, PASI 50 was achieved among 58.8% of patients treated with ixekizumab every two weeks compared to 14.6% of those treated with etanercept and 4.2% in placebo (p < 0.001 for all comparisons).

Median time to PASI 75 was 30 days among patients treated with ixekizumab every two weeks and 85 days among those treated with etanercept. The safety profile of the drug was comparable to etanercept in these two clinical studies.

Source: Eli Lilly and Company