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FDA Approves Cimzia (Certolizumab Pegol) for Ankylosing Spondylitis
Treatment gets fourth U.S. indication (October 18)
The FDA has approved Cimzia (certolizumab pegol, UCB) for the treatment of adults with active ankylosing spondylitis (AS).
The approval was based on results from a phase III, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of certolizumab pegol in patients with active axial spondyloarthritis (axSpA), in which most of the patients had AS.
In the study, patients with active axSpA, including AS, were randomly assigned to receive certolizumab pegol 200 mg every 2 weeks, certolizumab pegol 400 mg every 4 weeks, or placebo. Of the 325 patients in the study, 178 (55%) had AS. All of the patients received a loading dose of certolizumab pegol or placebo at weeks 0, 2, and 4. The trial’s primary efficacy endpoint — the proportion of patients achieving an improvement of ≥ 20% on the Assessment of Ankylosing Spondylitis (ASAS 20) scale at week 12 — was met with clinical and statistical significance in both dosing arms compared with placebo.
A greater proportion of AS patients treated with certolizumab pegol 200 mg every 2 weeks or 400 mg every 4 weeks achieved an ASAS 20 response at week 12 compared with AS patients given placebo. The responses were similar in the two active-treatment groups.
The FDA recently approved Cimzia (certolizumab pegol) for the treatment of adults with active psoriatic arthritis. Cimzia is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. In addition, the drug is approved for reducing the signs and symptoms of Crohn’s disease (CD) and for maintaining a clinical response in adult patients with moderately to severely active CD who have had an inadequate response to conventional therapy.
Source: UCB; October 18, 2013.