Certolizumab Offers 2-Year Durable Response in Treating Plaque Psoriasis
By Marielle Fares, PharmD
Washington, DC -- March 8, 2019 -- Certolizumab offers a durable long-term response to plaque psoriasis over 96 weeks, according to an open-label extension of the phase 3 CIMPASI-1 and CIMPASI-2 trials presented here at the 2019 Annual Meeting of the American Academy of Dermatology (AAD).
Kenneth Gordon, MD, Medical College of Wisconsin, Milwaukee, Wisconsin, presented the study on March 2.
In CIMPASI-1 and CIMPASI-2, 175 patients received certolizumab 400 mg every 2 weeks, and 186 patients received 200 mg every 2 weeks for the treatment of plaque psoriasis. Patients demonstrated 48-week durability of response through several efficacy measures.
Dr. Gordon and colleagues sought patients who had achieved PASI75 (a 75% reduction in the Psoriasis Area and Severity Index score) at weeks 16 and 48 in the 2 trials, with 117 patients from the 400-mg arm and 101 patients from the 200-mg arm joining an open-label extension trial.
The researchers randomised all recruits to begin receiving certolizumab 200 mg every 2 weeks, meaning that some patients received a dose reduced from 400 mg every 2 weeks.
At week 96, 74.3% and 87.3% of the reduced-dose and continued-dose groups, respectively, achieved PASI75.
Three-quarters of the participants in the extension trial had achieved PASI90 on starting the extension phase, and a high proportion still reported PASI90 after 2 years (52.8% and 70.4% of the reduced- dose and continued-dose groups, respectively).
At week 96, 45.5% and 63.5% of the respective groups achieved the Dermatology Life Quality Index (DLQI) 0/1 score.
Notably, , PASI90 and DLQI 0/1 response rates declined in patients who were switched from certolizumab 400 mg every 2 weeks to 200 mg every 2 weeks, whereas those in patients who continued on certolizumab 200 mg every 2 weeks were maintained.
The researchers reported no new safety signals for certolizumab in this study.
Baseline characteristics were comparable among the patient groups.
Certolizumab pegol is the only anti-tumour necrosis factor therapy approved for plaque psoriasis. Plaque psoriasis is the most common form of psoriasis.
Funding for this study was provided by Dermira Inc., Menlo Park, California, and UCB (Union Chimique Belge), Brussels, Belgium.
[Presentation title: Durability of Response in Plaque Psoriasis Treated With Certolizumab Pegol: Two Year Data From the CIMPASI-1 and CIMPASI-2 Phase 3 Trials. Abstract 10365]