UCB and Dermira have announced topline results from their Phase 3 trial (CIMPASI-1) evaluating the safety and efficacy of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.
CIMPASI-1 was a multi-center, placebo-controlled trial which enrolled 234 patients. The co-primary endpoints were the percentage of patients who achieved a ≥75% disease improvement from baseline as measured by the Psoriasis Area and Severity Index (PASI 75) and the percentage of patients achieving at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.
The patients were randomized into three dosing groups: 400mg every two weeks (n=88), 400mg at weeks 0, 2, and 4 followed by 200mg every two weeks (n=95), or placebo every two weeks (n-51). Results showed a significant response rate for those in the Cimzia dosing groups, with 75.8% of those receiving the 400mg dose every two weeks and 66.5% of those receiving the 200mg dose every two weeks achieving PASI 75 compared to 6.5% of those receiving placebo.
The response rate for patients achieving at least a two-point improvement to a final score of clear or almost clear skin on the PGA scale was 57.9% for the 400mg dose group and 47% for the 200mg dose group, compared to 4.2% for the patients receiving placebo.
Cimzia, a tumor necrosis factor (TNF) blocker, is currently approved to treat adults with moderately to severely active rheumatoid arthritis, adults with active psoriatic arthritis (PsA), and adults with active ankylosing spondylitis (AS). In addition, it is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
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