FDA Approves Certolizumab Pegol for Moderate-to-Severe Plaque Psoriasis

CIMZIA is the first Fc-free biologic of its kind for this patient population.

The US Food and Drug Administration (FDA) approved UCB’s certolizumab pegol (CIMZIA) label to include a new indication in adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The approval makes CIMZIA the first FC-free, PEGylated anti-TNF treatment option for plaque psoriasis patients, and follows a recent FDA label update for CIMZIA in pregnancy and breastfeeding that provides essential information to health care professionals and women.

A phase 3 clinical development program that included CIMPASI-1, CIMPASI-2 and CIMPACT backed the FDA’s decision. The trials enrolled more than 1000 patients, of whom nearly one third had prior biologic exposure.

“The phase 3 clinical development program for CIMZIA in plaque psoriasis demonstrated statistically significant improvements in efficacy endpoints at week 16,” lead investigator, Alice Gottlieb, MD, PhD, professor of dermatology, New York Medical College, said in a statement. “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.”

Each of the studies included an assessment of the percentage of patients that achieved at least 75% and 90% or greater disease improvement from baseline, 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.

Additionally, the trials assessed the percentage of patients who achieved at least a 2-point improvement on a 5-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin, each compared with placebo, at week 16.

CIMZIA demonstrated statistically significant improvements for all primary and co-primary endpoints versus placebo at all tested doses, with the clinical benefit maintained through to week 48.

The recommended dose for adults with moderate-to-severe plaque psoriasis is 400 mg (given as 2 subcutaneous injections of 200 mg each) every other week.

For patients with a body weight ≤90 kg, CIMZIA 400 mg should be given as 2 subcutaneous injections of 200 mg each initially and at weeks 2 and 4, followed by 200 mg every other week can be considered.

The adverse effects across all 3 trials appears consistent with the safety profile for CIMZIA in other approved indications. In the placebo-controlled portions, elevated liver enzymes were reported more frequently in the CIMZIA-treated patients than in placebo-treated patients, 4.3% in the 200 mg group, 2.3% in the 400 mg group, and 2.5% in placebo.

Cases of other psoriasis subtypes were reported including erythrodermic, pustular and guttate in <1% of CIMZIA-treated patients.

“Today’s approval provides patients and their health care professionals with a robust new biologic option that provides durable disease control,” Gottlieb added. “The 2 dose regimens of CIMZIA also allow for patient-tailored treatment. CIMZIA also demonstrated similar efficacy in both biologic-naïve patients and those previously treated with other biologics.”

CIMZIA has been previously approved for use in psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis and Crohn’s disease.