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.
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.