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Home Research & Development News Ixekizumab demonstrates rapid, improvements as among patients with moderate-to-severe plaque psoriasis
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6 Mar 2016

Ixekizumab demonstrates rapid, improvements as among patients with moderate-to-severe plaque psoriasis

In a combined analysis of UNCOVER-2 and UNCOVER-3, significant improvement of psoriasis plaques was observed in patients treated with ixekizumab at 1, 2 and 4 weeks.

Eli Lilly and Company has announced that treatment for moderate-to-severe plaque psoriasis with ixekizumab resulted in clinically meaningful improvements as early as one week, compared to patients treated with etanercept or placebo. Detailed results of this combined analysis of UNCOVER-2 and UNCOVER-3 were presented during the American Academy of Dermatology (AAD) Annual Meeting taking place 4-8 March in Washington, DC.

UNCOVER-2 and UNCOVER-3 are double-blind, multicenter, Phase III studies evaluating more than 2,500 patients with moderate-to-severe plaque psoriasis across 19 countries. In these comparator studies, patients were assigned to receive either placebo, etanercept (50 mg twice a week) or ixekizumab (80 mg every 2 or 4 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.

"Studies have shown that clinical improvement observed early during psoriasis treatment can help predict clinical response at later times," said Craig Leonardi, lead study author and clinical professor of dermatology at St Louis University School of Medicine. "In this analysis of ixekizumab, early results were seen in patients with moderate-to-severe plaque psoriasis, an extensive and difficult-to-treat disease. According to patients and their dermatologists, rapid clearing of psoriasis plaques is one of the most important attributes for treatment success."

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

  • At 1 week, the mean percentage improvement was 32.7% in the group randomized to receive ixekizumab every 2 weeks, 10.3% in etanercept and 5.31% in placebo (p < 0.001 for all comparisons).
  • At 2 weeks, the mean percentage improvement was 53.6% in the group randomized to receive ixekizumab every 2 weeks, 23.3% in etanercept and 9.25% etanercept in placebo (p < 0.001 for all comparisons).

    • Treatment with ixekizumab also resulted in clinically meaningful improvements (PASI 50) as early as 1 week, which were statistically significantly different compared with etanercept and placebo.

  • At 1 week, PASI 50 was achieved by 22.8% of patients treated with ixekizumab every 2 weeks compared to 3.9% among those treated with etanercept and 1.4% in placebo (p < 0.001 for all comparisons).
  • At 2 weeks, PASI 50 was achieved among 58.8% of patients treated with ixekizumab every 2 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 2 weeks and 85 days among those treated with etanercept.

    The majority of treatment-emergent adverse events were mild or moderate. The most frequently reported adverse drug reactions were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis) and generally did not lead to treatment discontinuations. Overall, the safety profile was comparable to etanercept in these two clinical studies.

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

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