In 96-week extension data from a Phase 3 trial the tumor necrosis factor (TNF) inhibitor shows sustained improvements in symptoms of spondyloarthropathies, with no signs of new adverse events.
Sieper J. LandewÃ© R, Rudwaleit M, et al., Effect of Certolizumab Pegol over 96 Weeks in Patients with Axial Spondyloarthritis: Results from a Phase 3 Randomized Trial.Arthritis & Rheumatism. 2014. Accepted article. doi: 10.1002/art.38973.
Certolizumab pegol (CZP) produces sustained improvements in back pain, spinal mobility, function, and quality of life at almost two years in axial spondyloarthritis (axSpA), according to long-term data from a major clinical trial.
The 96-week interim data come from the dose-blind and the open-label extension periods of the phase 3 RAPID-axSpA trial, involving 315 patients treated with one of two dosing regimens of the anti-tumor-necrosis (TNF) drug- 200 mg of CZP every 2 weeks or 400 mg every 4 weeks.
The trial found a rapid improvement in ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA) among 325 patients originally randomized to receive CZP for 24 weeks.
Placebo patients judged to be non-responders according to the 20% Assessment in Ankylosing Spondylitis Response Criteria (ASAS20) at both weeks 14 and 16 were re-randomized one of the two CZP dose regimens in the dose-blind phase, as were placebo patients who completed 24 weeks. The open-label extension began at 48 weeks.
At 96 weeks, both CZP dose regimens were found to be equally effective at reducing disease activity in the Bath ankylosing spondylitis disease activity index (BASDI) and the Ankylosing Spondylitis Disability Assessment Score (ASDAS).
Spinal mobility, back pain, and physical function improved similarly at 96 weeks.
The ASAS20 results are comparable to those for adalimumab in nr-axSPA patients and for etanercept, adalimumab, infliximab, and golimumab in AS patients, the study authors say.
The safety profile was in line with previous data, with no new safety signals after longer exposure to CZP. Adverse events (AEs), assessed at every study week, affected 279 of patients (88.6%), mostly mild to moderate, predominantly infections. No deaths or malignancies were reported, but 41 (13% ) experienced serious adverse events, nearly all of them serious infections.