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The Fc-free and PEGylated antitumor necrosis factor biologic certolizumab pegol was associated with clinically meaningful and statistically significant improvements in the signs and symptoms of moderate to severe chronic plaque psoriasis for patients who both have and have not received prior biologic therapy, according to a study published in the Journal of the European Academy of Dermatology and Venereology.
Researchers pooled data from the first 16 weeks of 3 ongoing, double-blind, randomized, phase 3, placebo-controlled clinical trials in adult patients with moderate to severe chronic plaque psoriasis. Patients were randomly assigned to receive placebo, certolizumab 200 mg, or certolizumab 400 mg every 2 weeks for 16 weeks, with the primary endpoints of a physician global assessment (PGA) of clear or almost clear (0/1) with a 2-category improvement, and a ≥75% reduction in both the total psoriasis area and the severity index (PASI 75). The safety profile was evaluated by treatment-emergent adverse events.
Of the 850 total participants, 342 were treated with 400 mg certolizumab, 351 with 200 mg certolizumab, and 157 with placebo. At week 16, 63.7% of the 400 mg group showed PGA 0/1 and 80.1% showed PASI 75, 54.6% of the 200 mg group showed PGA 0/1 and 74.5% showed PASI 75, and 2.8% in the placebo group showed PGA 0/1 and 7.5% showed PASI 75 (P<.0001 for both doses vs placebo).
Participants who had and had not previously received biologic therapy showed substantially higher responder rates on the 200 mg and 400 mg doses of certolizumab compared with placebo. The 400 mg certolizumab group had a similar incidence of adverse events to the placebo group, and the 200 mg group had a somewhat lower incidence than the placebo group. The overall safety profile of certolizumab was consistent with the general safety profile of antitumor necrosis factor biologics.
Study investigators conclude that “[c]linically meaningful efficacy was observed with both [certolizumab] doses compared with placebo in patients with and without prior exposure to systemic therapy, including anti-TNF and anti-IL-17 biologics. This finding is of potential clinical importance, given current recommendations for switching therapies when patients fail to achieve desired treatment goals or are otherwise dissatisfied with current treatment.”
Disclosures: Funding for the clinical trials was provided by Dermira, Inc. in collaboration with UCB, Inc.
Reference
Blauvelt A, Reich K, Lebwohl M, et al. Certolizumab pegol for the treatment of patients with moderate-to-severe chronic plaque psoriasis: pooled analysis of week 16 data from three randomized controlled trials. J Eur Acad Dermatol Venereol. 2018 Sep 22. doi: 10.1111/jdv.15258.
