UCB announced that the Food and Drug Administration (FDA) has approved a new indication for Cimzia (certolizumab pegol) to treat moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. This marks Cimzia as the first Fc-free, PEGylated, anti-tumor necrosis factor (TNF) treatment option for this indication. 

The expanded approval was supported by findings from a Phase 3 clinical program (CIMPASI-1, CIMPASI-2, and CIMPACT), which enrolled ~1000 patients who were biologic-naive or biologic-experienced. The data confirmed durable efficacy, as well as safety, for up to 48 weeks in patients with moderate-to-severe plaque psoriasis. Each study evaluated the percentage of patients who achieved ≥75% (Psoriasis Area and Severity Index [PASI] 75) and ≥90% (PASI 90) improvement from baseline vs placebo within 12 or 16 weeks. In CIMPASI-1, the rate of PASI 90 response was 44% (Cimzia 400mg) and 36% (Cimzia 200mg) vs 0% (placebo). In CIMPASI-2, the rate of PASI 90 response was 52% (Cimzia 400mg) and 50% (Cimzia 200mg) vs 5% (placebo). In CIMPACT, the rate of PASI 90 response was 49% (Cimzia 400mg) and 40% (Cimzia 200mg) vs 0% (placebo). 

The studies also evaluated the percentage of patients who achieved ≥2-point improvement on the Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin vs placebo at week 16. Treatment with Cimzia led to statistically significant improvements for all primary and co-primary endpoints vs placebo for the studied dose; the clinical benefit lasted through week 48. The safety profile appeared consistent across all 3 trials with that seen with Cimzia for other approved indications. 

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Alice Gottlieb, MD, PhD, lead author and Professor of Dermatology at New York Medical College stated, “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 is already indicated for rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease. It is supplied as 200mg lyophilized powder in a single-dose vial or 200mg/mL solution in a single-dose prefilled syringe.

For more information call (800) 234-5535 or visit Cimzia.com.