The Food and Drug Administration ( FDA ) has approved Cimzia ( Certolizumab pegol ) for the treatment of adults with active ankylosing spondylitis ( AS ).
The FDA also issued a Complete Response Letter relating to the supplemental Biologics License Application ( sBLA ) of Cimzia for the treatment of adults with active axial spondyloarthritis ( axSpA ).
The approval of Cimzia for adults with active ankylosing spondylitis was based on a Phase 3, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of Cimzia in patients with active axSpA, in which the majority had ankylosing spondylitis.
In the efficacy and safety study of Cimzia, patients with active axSpA, including ankylosing spondylitis, were randomized ( 1:1:1 ) to receive Certolizumab pegol 200 mg every two weeks, 400 mg every four weeks or placebo. There were a total of 325 patients in the study, of which 178 had ankylosing spondylitis.
All patients received a loading dose with Cimzia or placebo at weeks 0, 2 and 4.
The primary efficacy variable, the proportion of patients achieving an ASAS20 response rate at week 12, was met with clinical and statistical significance in both dosing arms versus placebo.
A greater proportion of ankylosing spondylitis patients treated with Cimzia 200 mg every two weeks or 400 mg every four weeks achieved ASAS20 response at week 12, compared with ankylosing spondylitis patients treated with placebo.
Responses were similar in patients receiving Cimzia 200 mg every two weeks and 400 mg every four weeks.
In this study, adverse events occurred in 70.4% of patients in the Cimzia group ( combined dose ) compared to 62.6% of patients in the placebo group.
Serious adverse events occurred in 4.7% of patients in both the Cimzia group ( combined dose ) and in the placebo group.
The safety profile for patients with ankylosing spondylitis treated with Cimzia was similar to the safety profile seen in patients with rheumatoid arthritis and in patients with previous experience with Cimzia.
The FDA recently approved a filing for Cimzia in the treatment of adults with active psoriatic arthritis ( PsA ). In the U.S., Cimzia is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. In addition, it is approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. ( Xagena )
Source: UCB, 2013