Cimzia success in Phase III trial for Axial Spondyloarthritis

UCB has announced positive top-line results from the phase III study designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases which includes ankylosing spondylitis (AS).In this 24-week, multicenter, double-blind, placebo-controlled phase III study, 325 patients with AxSpA were randomized to receive certolizumab pegol, 200 mg every two weeks, or 400 mg every four weeks, or placebo. This dosing schedule followed a loading dose of certolizumab pegol (400 mg) at weeks 0, 2 and 4. At week 12, a statistically significant higher proportion of patients receiving certolizumab pegol compared to those receiving placebo achieved the primary endpoint of at least 20 per cent change in the Assessment of SpondyloArthritis international Society improvement criteria (ASAS20). Sub-population analyses indicated that certolizumab pegol also improved the signs and symptoms of AS and non-radiographic AxSpA, pre-specified sub-groups of the overall population.