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Cimzia demonstrates efficacy at 16 weeks as psoriasis treatment
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ORLANDO, Fla. — Patients treated with Cimzia reported statistically significant improvement in moderate-to-severe plaque psoriasis at 16 weeks, according to research presented at a late-breaking research forum of the American Academy of Dermatology meeting.
Cimzia (certolizumab pegol, UCB and Dermira) is FDA-approved for treating psoriatic arthritis but not for psoriasis.
“The 16-week primary results from CIMPASI-1 and CIMPASI-2 showed that treatment with Cimzia provided significant benefit to patients living with chronic plaque psoriasis, which is important given that the disease is historically difficult to treat and therefore requires multiple treatment options,” Alice Gottlieb, MD, PhD, professor of dermatology, Department of Dermatology, New York Medical College, at Metropolitan Hospital, who presented the data, stated in a press release from UCB and Dermira.
Adults with moderate-to-severe plaque psoriasis were enrolled in CIMPASI-1 or CIMPASI-2 phase 3, multicenter, double-blind trials and were randomized in a 2:2:1 fashion to receive certolizumab pegol every 2 weeks in 400 mg or 200 mg, following 400 mg loading doses at weeks 0, 2 and 4, or placebo every 2 weeks.
In the CIMPASI-1 trial, 88, 95 and 51 patients were randomized to receive certolizumab pergol 400 mg, 200 mg and placebo, respectively; while in the CIMPASI-2 trial, 87, 91, and 49 patients were randomized to receive the treatments.
There were comparable baseline psoriasis area severity index (PASI) and body surface area (BSA) scores across the treatment cohorts in both studies.
At week 16, PASI 75 response rates were 75.8%, 66.5% and 6.5 % in the CIMPASI-1 trial, and 82.6%, 81.4% and 11.6% in the CIMPASI-2 trial, while Physician Global Assessment (PGA) 0/1 response rates were 57.9%, 47% and 4.2% in the CIMPASI-1 trial and 71.6%, 66.8% and 2% in the CIMPASI-2 study.
Patients achieving PASI-90 response were 43.6%, 35.6% and 0.4% in the CIMPASI-1 group and 55.4%, 52.6% and 4.5% in the CIMPASI-2 cohort (P < .0001, all comparisons against placebo).
Upper respiratory tract infections were the most frequent adverse events (AEs) in both studies, while serious AEs were infrequent, according to Gottlieb’s research.
“[The] 16-week [certolizumab pegol] therapy was associated with statistically significant, clinically-meaningful improvements in moderate-to-severe chronic plaque psoriasis,” according to the research abstract. “AEs were consistent with the known safety profile of anti-TNF therapy.”
Reference:
Gottlieb AL. F056 – Late-breaking Research Forum Clinical Trials. Presented at: American Academy of Dermatology Annual Meeting; March 3-7, Orlando.
Disclosure: Healio.com/Dermatology was unable to determine any relevant financial disclosures at time of publication.