According to UCB, certolizumab pegol achieved top-level results in a phase 3 study, which assessed the drug’s efficacy and safety in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases, including ankylosing spondylitis (AS).

Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President at UCB explained:

“The population in this study included both patients with AS and with an early stage of the disease, called non-radiographic axial spondyloarthritis. Both populations are part of a recently defined group of rheumatic diseases, axial spondyloarthritis.

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. 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.”

325 patients with AxSpA were randomized to either receive 200 mg of certolizumab pegol every two weeks, or 400 mg every four weeks, or placebo after being administered with a loading dose of 400 mg certolizumab pegol at weeks 0, 2 and 4 in a 24-week, multi-center, double blind, placebo-controlled phase 3 study.

Week 12 results demonstrated that compared with patients in the placebo group, a statistically important number of patients who received certolizumab pegol achieved the primary endpoint of at least 20% change in the Assessment of SpondyloArthritis international Society improvement criteria (ASAS20).

The primary endpoint was determined as the ASAS20 improvement criteria, which is defined as a minimum improvement of 20% and overall improvement of at least 1 unit on a scale of 0-10 in a minimum of three categories, including patient global assessment, pain assessment, patient function, and inflammation and absence of deterioration in the remaining domain.

Compared with placebo, the most common and more frequently observed adverse events reported in ≥ 5% of both certolizumab pegol groups consisted of upper respiratory tract infection, elevated liver function tests and abnormal CPK levels. Serious adverse events in both certolizumab pegol groups were similar to those in the placebo group; however, the certolizumab pegol group had a higher incidence of serious infections/infestations.

Cimzia is approved in the U.S. to treat adults with moderately to severely active rheumatoid arthritis and to reduce the signs and symptoms of Crohn’s disease as well as to maintain clinical response in adult patients with moderate to severely active disease, who failed to respond adequately to traditional treatment. In the E.U., Cimzia combined with methotrexate (MTX) is approved to treat moderate to severe active RA in adult patients who failed to respond insufficiently to disease-modifying antirheumatic drugs (DMARDs), such as MTX.

Written By Petra Rattue