Skip to main content

FDA Expands Indication of Psoriasis Drug

May 29, 2018

The US Food and Drug Administration has approved expanding the indication for Cimzia (certolizumab pegol) to include adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The first Fc-free, PEGylated anti-tumor necrosis factor treatment option for this indication, Cimzia was granted approval following a Phase 3 clinical program comprised of 3 trials: CIMPASI-1, CIMPASI, 2, and CIMPACT. Overall, more than 1000 patients were enrolled.

In all 3 trials, Cimzia demonstrated statistically significant improvements in all primary and co-primary endpoints compared with placebo, and a clinically meaningful response was maintained with Cimzia use for up to 48 weeks of use.

On the updated label for Cimzia, the recommended dose for adults with moderate-to-severe plaque psoriasis is 400 mg, administered as 2 subcutaneous injections of 200 mg each, every other week.

A dose of 400 mg Cimzia, administered as 2 subcutaneous injections of 200 mg per dose initially and at weeks 2 and 4, followed by 200 mg every other week, can be considered for some patients with a body weight of approximately 198 lbs (90 kg) or less.

—Christina Vogt

For more Pharmacy Learning Network articles, visit the homepage

To learn about Pharmacy Learning Network Live meetings, click here

Back to Top