Patients who received the targeted agent certolizumab for chronic moderate-to-severe plaque psoriasis achieved better outcomes than patients assigned to placebo -- even to the point of having nearly clear skin after 16 weeks of treatment, according to results from 2 similar phase 3 trials, reported at the 2017 Annual Meeting of the American Academy of Dermatology (AAD).
The primary endpoint of CIMPASI 1 was the percentage of patients who responded enough to therapy to achieve a Psoriasis Area and Severity Index 75% improvement (PASI-75) score, explained lead author Alice Gottlieb, MD, PhD, New York Medical College, Valhalla, New York, speaking here at an oral late-breaker session on March 4. This result was 6.5% among placebo subjects and 66.5% for patients on certolizumab 200 mg taken every 2 weeks and 75.8% of patients on certolizumab 400 mg administered every 2 weeks (P < .0001 vs placebo for both active arms).
In the CIMPASI 2 trial, 11.6% of people on placebo achieved a PASI-75 compared with 81.4% of patients on certolizumab 200 mg and 82.6% of patients on certolizumab 400 mg (P < .0001).
The results were similar when the researchers considered Physicians Global Assessment scores of 0/1. In CIMPASI 1, that goal was reached by 4.2% of subjects on placebo but 47.0% of patients on certolizumab 200 mg and 57.9% of patients on certolizumab 400 mg (P < .0001). In CIMPASI 2, two percent of placebo subjects reached the standard compared with 66.8% of patients on certolizumab 200 mg and 71.6% of patients on certolizumab 400 mg (P < .0001).
On the Dermatology Life Quality Index, after 16 weeks of therapy in CIMPASI 1, placebo subjects experienced a mean decline of 3.3 points compared with a 9.3-point reduction among patients on certolizumab 200 mg and a 10.2-point decline among patients on certolizumab 400 mg (P < .0001). In CIMPASI 2, placebo subjects achieved a 3.8-point decline compared with a 10.4-point decline among patients on certolizumab 200 mg and a 10.0-point decline among patients on certolizumab 400 mg (P < .0001).
In reviewing the adverse events in the study, Dr. Gottlieb said there were no new certolizumab-related concerns.
Funding for this study was provided by Dermira, Inc., Menlo Park, California.
[Presentation title: Certollzumab Pegol Treatment for Chronic Plaque Psoriasis: 16-Week Primary Results From two Phase 3, Multicenter, Randomized, Placebo-Controlled Studies. Abstract 5077]
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