Mease PJ, Fleischmann R, Deodhar AA et al.
University of Washington, Seattle, WA, USA.
Ann Rheum Dis 2014;73:48–55.
Ben Parker’s review: Certolizumab pegol has been shown to be clinically effective in the management of active rheumatoid arthritis but has yet to be evaluated in other inflammatory arthritides (Rheumatology [Oxford] 2012;51:2204–14). The current Phase III, randomized, placebo-controlled trial was performed to assess the efficacy of certolizumab pegol in patients with active psoriatic arthritis (PsA). The initial 6-month results are presented in this article. In total, 409 patients with active PsA (defined by three or more tender joints and three or more swollen joints) were recruited and randomized to either placebo or certolizumab pegol (200 mg every 2 weeks or 400 mg every 4 weeks). Concomitant methotrexate or leflunomide was permitted but not essential. The primary outcome measure was a 20% improvement in American College of Rheumatology criteria (ACR20) at week 12, and key secondary outcomes included ACR20 at week 24, change in Health Assessment Questionnaire Disability Index score, 75% reduction in Psoriasis Area and Severity Index score (PASI75), and improvement in enthesitis, dactylitis, and nail disease scores.