UCB announced results from the RAPID-axSpA Phase 3 study, which evaluated certolizumab pegol (Cimzia) in patients with active axial spondyloarthritis (axSpA), including patients with ankylosing spondylitis (AS) and axSpA without radiographic evidence of AS (non-radiographic axSpA [nr-axSpA]). Certolizumab pegol is a PEGylated anti-TNF (Tumor Necrosis Factor).
The ongoing 158 week RAPID-axSpA study was double-blind and placebo-controlled up to Week 24, dose-blind up to Week 48 and then open-label to Week 158. Patients (n=325) with active axSpA were randomized 1:1:1 to receive certolizumab pegol 200mg every two weeks, 400mg every four weeks or placebo (n=111, 107 and 107). This dosing schedule followed a loading dose of certolizumab pegol (400mg) at Weeks 0, 2 and 4. Patients enrolled in the study must have failed at least one non-steroidal anti-inflammatory drug (NSAID). Up to 40% of patients could have received one previous anti-TNF, provided they were not primary non-responders, as determined by the investigator. Within the placebo arm, patients who failed to achieve an ASAS20 response at Weeks 14 and 16 were re-randomized at Week 16 to receive certolizumab pegol 200mg every 2 weeks or 400mg every 4 weeks, following the loading dose.
The primary efficacy variable of the RAPID-axSpA study was the ASAS20 response rate at Week 12. The study met its primary endpoint and clinical improvements in the ASAS20 responses were statistically significant in both dosing arms vs. placebo (57.7%, 63.6% vs. 38.3% for 200mg every 2 weeks and 400mg every 4 weeks certolizumab pegol vs. placebo, n=111, 107 and 107, P<0.05). Improvements were observed as early as Week One (40.5%, 34.6% vs. 14.2% for 200mg every two weeks and 400mg every four weeks certolizumab pegol vs. placebo).
The improvement in ASAS20 response at Week 12 was observed at Week 24. Sub-population analyses also indicated improvements at Weeks 12 and 24 in both AS and nr-axSpA sub-populations. At Weeks 12 and 24 both dosing regimens of certolizumab pegol indicated improvements vs. placebo in measurements of disease activity, spinal mobility and physical function in the entire axSpA population with improvements also observed vs. placebo in both the AS and nr-axSpA sub-populations.
Cimzia is indicated for the treatment of adult patients with moderately-to-severely active rheumatoid arthritis (RA), and for reducing the signs and symptoms of Crohn’s disease (CD) and maintaining clinical response in adult patients with moderately-to-severely active disease who have had an inadequate response to conventional therapy.
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