FDA Expands Psoriasis Drug Indication

05/29/2018
fda alertThe FDA has approved expanding the indication for certolizumab pegol (Cimzia) 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, certolizumab pegol was granted approval following a Phase 3 clinical program comprised of 3 trials: CIMPASI-1, CIMPASI, 2, and CIMPACT. More than 1000 patients were enrolled in the trials.


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

On the updated label for certolizumab pegol, 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 certolizumab pegol, 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.

The drug is already approved for use in psoriatic arthritis (PsA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), and Crohn disease (CD).