Positive results have been reported from a pivotal phase 3 study of certolizumab pegol (Cimzia, UCB/Dermira, Inc.) in adults with moderate-to-severe chronic plaque psoriasis. Based on the findings from this study, UCB plans to submit a marketing application to the FDA in the third quarter of 2017. Certolizumab pegol is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.
The CIMPACT trial was a randomized, blinded, parallel-group, placebo- and active-controlled, multicenter study designed to evaluate the efficacy and safety of certolizumab pegol in patients with moderate-to-severe chronic plaque psoriasis. The study’s primary endpoint assessed the percentage of patients treated with certolizumab pegol who achieved a 75% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75), compared with placebo at week 12. Several secondary endpoints were also assessed, including comparisons of the efficacy of certolizumab pegol and etanercept (Enbrel, Amgen), based on PASI 75 response rates at week 12, and comparisons of the response rates of patients treated with certolizumab pegol or placebo at week 16 using PASI 75 scores and at least a two-point improvement on the five-point Physician’s Global Assessment (PGA) scale to determine a final score representing “clear” or “almost clear” skin.
In the study, 559 patients with moderate-to-severe chronic plaque psoriasis were randomly assigned to one of four dosing arms: certolizumab pegol 400 mg every two weeks (n = 167); certolizumab pegol 400 mg at weeks 0, 2, and 4 followed by 200 mg every two weeks (n = 165); etanercept 50 mg twice weekly (n = 170); or placebo every two weeks (n = 57).
Certolizumab pegol demonstrated statistically significant improvements in the primary endpoint. At week 12, the response rates for patients who achieved PASI 75 were 66.7% for those receiving certolizumab pegol 400 mg every two weeks and 61.3% for those receiving certolizumab pegol 200 mg every two weeks compared with 5.0% for patients receiving placebo.
Secondary findings included the following:
Certolizumab pegol is the only Fc-free, PEGylated anti-tumor necrosis factor (TNF). The compound has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiologic effects of TNF-alpha.
In the United States, certolizumab pegol is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis; adults with active psoriatic arthritis; and adults with active ankylosing spondylitis. In addition, it is indicated for reducing the signs and symptoms of Crohn’s disease and for maintaining the clinical response in adults with moderately to severely active disease who have shown an inadequate response to conventional therapy.
Source: UCB; January 18, 2017.