Treatment with the PEGylated anti-tumor necrosis factor biologic certolizumab pegol (CZP) in patients with chronic plaque psoriasis improves patients’ symptoms, with superior efficacy reported at the higher dose compared with etanercept (ETN) or placebo, according to the results of a phase 3, multicenter, randomized, double-blinded study (CIMPACT) conducted at outpatient clinic sites in North America and Europe and published in the Journal of the American Academy of Dermatology.

The investigators sought to evaluate the safety and effectiveness of CZP in adults with moderate to severe chronic plaque psoriasis. A total of 559 participants were randomly assigned in a 3:3:1:3 ratio to CZP 400 mg (n=167), CZP 200 mg (n=165), or placebo (n=57) every 2 weeks for 16 weeks, or ETN 50 mg (n=170) twice weekly for 12 weeks.

CZP-treated patients who achieved ≥75% reduction in Psoriasis Area and Severity Index (PASI 75) at week 16 were rerandomized to CZP or placebo for 32 weeks.


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The primary study endpoint was responder rate (PASI 75) vs placebo (primary analysis) and ETN (secondary analysis) at week 12. Statistically significant improvements in PASI 75 were reported with CZP 400 mg and CZP 200 mg vs placebo at 12 weeks (P <.0001 for both). Secondary endpoints included responder rates on a variety of measures compared with placebo at weeks 12, 16, and 48. Safety was evaluated on the basis of the occurrence of treatment-emergent adverse events.

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All endpoints were significantly greater with CZB vs placebo, with the greatest response reported with CZP 400 mg. Moreover, CZP 400 mg was superior to ETN and CZP 200 mg was noninferior to ETN. Adverse events observed were consistent with those associated with the anti-tumor necrosis factor class of biologic agents.

The investigators concluded that both CZP treatment regimens improved the symptoms of psoriasis among the participants, with the greatest response observed at the higher dose. No new safety events were reported at either CZP dose during the 48 weeks of treatment. The study results suggest that CZP is a unique tumor necrosis factor biologic agent that offers a novel treatment option for patients with chronic plaque psoriasis.

Reference

Lebwohl M, Blauvelt A, Paul C, et al. Certolizumab pegol for the treatment of chronic plaque psoriasis: results through 48 weeks of a phase 3, multicenter, randomized, double-blinded, etanercept- and placebo-controlled study (CIMPACT) [published online April 13, 2018]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2018.04.013