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The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication.
The FDA has approved extending the label for Cimzia® (certolizumab pegol) to include a new indication in adults with moderate to severe plaque psoriasis, announced the drug’s manufacturer, UCB, today in a press release. Cimzia is indicated for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
The approval makes Cimzia the first Fc-free, PEGylated anti-TNF treatment option for this indication. The approval also follows a recent FDA label update for Cimzia in pregnancy and breastfeeding.
“The Phase 3 clinical development program for Cimzia in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16. A clinically meaningful response was maintained up to week 48. This compelling body of evidence is especially significant for a disease like psoriasis, which often has significant emotional and social burdens in addition to the more widely recognized physical symptoms,” said Alice Gottlieb, MD, PhD, Professor of Dermatology at New York Medical College and lead investigator. “Today’s approval provides patients and their healthcare professionals with a robust new biologic option that provides durable disease control. The two dose regimens of Cimzia also allow for patient-tailored treatment. Cimzia also demonstrated similar efficacy in both biologic-naive patients and those previously treated with other biologics.”
This FDA approval is based on data from a phase 3 clinical development program consisting of CIMPASI-1, CIMPASI-2 and CIMPACT. The trials enrolled over 1000 patients, of whom nearly one third had prior biologic exposure, and confirmed the durable efficacy up to 48 weeks and safety of Cimzia in the treatment of adults with moderate to severe plaque psoriasis. Each of the three studies included an assessment of the percentage of patients who achieved at least 75% and 90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90, respectively) compared to placebo; within 16 weeks in CIMPASI-1 and CIMPASI-2, and within 12 weeks in CIMPACT.
CIMPASI-1, CIMPASI-2 and CIMPACT also assessed the percentage of patients who achieved at least a two-point improvement on a five-point Physician’s Global Assessment scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16. In all three trials, Cimzia demonstrated statistically significant improvements for all primary and co-primary endpoints compared to placebo at all tested doses, and the clinical benefit was maintained through to week 48. These findings and the new approval in psoriasis that they support are significant because they build on 4 years of efficacy and safety data in psoriatic arthritis.
According to the updated label, the recommended dose of Cimzia for adults with moderate to severe plaque psoriasis is 400 mg (given as two subcutaneous injections of 200 mg each) every other week. For some patients (with body weight ≤ 90 kg), Cimzia 400 mg (given as two subcutaneous injections of 200 mg each) initially and at weeks 2 and 4, followed by 200 mg every other week can be considered.
UCB announces the approval of CIMZIA® (certolizumab pegol) for moderate-to-severe plaque psoriasis, representing an important new option for patients in the U.S. [press release]. Brussels, Belgium: PRNewswire; May 29, 2018.