UCB reported positive top-line results from a 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).
Cimzia selectively neutralizes the pathophysiological effects of TNF-alpha (Tumor Necrosis Factor). Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases.
“The positive top-line results are very encouraging since there is a need for treatments for patients with non-radiographic AxSpA and for additional effective anti-TNF treatments for AS," said Iris Loew-Friedrich, CMO and executive vice president, UCB. "Full analysis of the efficacy and safety data of this study is on-going and we look forward to discussing the results with the regulatory authorities.”
In the 24-week, multicenter, double-blind, placebo-controlled phase III study, 325 patients with AxSpA were randomized to receive certolizumab pegol, 200mg every two weeks, 400mg every four weeks, or placebo. This dosing schedule followed a loading dose of certolizumab pegol (400mg) 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% 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.
The most common treatment emergent adverse events that occurred in ≥ 5% of patients taking certolizumab pegol (all doses) and more frequently than placebo were upper respiratory tract infection, elevated liver function tests and abnormal CPK levels.
Cimziais already approved in the U.S. for the treatment of adults with Cohn’s disease and moderately to severely active rheumatoid arthritis.