Health Canada Approves Certolizumab Pegol & NICE Issues Guidance for Certolizumab Pegol

Certolizumab pegol (Cimzia) is the first Fc-free, PEGylated anti-tumor necrosis factor therapy for adults with moderate to severe plaque psoriasis. The treatment has recently been approved for this patient population in Canada. Additionally, the U.K. has issued its final guidance for the clinical use of certolizumab pegol.

Health Canada Approves Certolizumab Pegol
In late March, Health Canada approved certolizumab pegol for treating adults with moderate to severe plaque psoriasis.¹ Additionally, Health Canada has approved updated product labeling for pregnant and breastfeeding patients based on two pivotal pharmacokinetic studies. This update signifies major progress for Canadian women of all ages living with plaque psoriasis and other autoimmune diseases.

This approval was based on data from three clinical trials: CIMPASI-1, CIMPASI-2 and CIMPACT, which included 1,020 adult patients. Nearly one third of enrolled patients had prior biologic exposure. Each study assessed the percentage of patients who achieved at least 75–90% or greater disease improvement from baseline, as measured by the Psoriasis Area and Severity Index (PASI75 and PASI90) compared with placebo. The PASI75 response was a primary endpoint.

The CIMPASI-1 and CIMPASI-2 trials were 16 weeks, and the CIMPACT trial was 12 weeks. At Week 16, all three trials assessed the percentage of patients who achieved at least a two-point improvement on a five-point Physician’s Global Assessment (PGA) scale to a final score representing clear or almost clear skin compared with placebo.

At Week 12, certolizumab pegol demonstrated statistically significant improvements in the percentage of patients achieving 75% or greater disease improvement from baseline (PASI75) compared with placebo-treated patients. In all three trials, certolizumab pegol-treated patients demonstrated statistically significant improvements for all primary and co-primary endpoints compared with placebo-treated patients at all tested doses. The clinical benefit of treatment was maintained through Week 48.

According to the updated label, the recommended dose of certolizumab pegol for adults with moderate to severe plaque psoriasis, including women who are pregnant and breastfeeding, is 400 mg every other week, given as two subcutaneous injections of 200 mg each. A dose of 400 mg initially (Week 0) and at Weeks 2 and 4, followed by 200 mg every two weeks, may be also considered.

NICE Guidance on Certolizumab Pegol
In April, the National Institute for Health and Care Excellence (NICE) in the U.K. published its final guidance for use of certolizumab pegol for treating adults with severe plaque psoriasis for whom other systemic therapies have not worked. The guidance notes that women can use this treatment before and during pregnancy if needed, as well as while breastfeeding.²