Cimzia Improves Signs and Symptoms of Psoriatic Arthritis
UCB announced results from the Phase 3 RAPID-PsA study which showed that compared to placebo, certolizumab pegol (Cimzia) provided improvements in the signs and symptoms of psoriatic arthritis (PsA) in adult patients with and without prior anti-TNF (tumor necrosis factor) exposure. Certolizumab pegol is a PEGylated anti-TNF.
The RAPID-PsA study was an ongoing 158 week study that was double-blind and placebo controlled to Week 24, dose-blind to Week 48 and open label to Week 158. The study randomized 409 patients (1:1:1) with active psoriatic arthritis to receive either certolizumab pegol 200mg every 2 weeks or 400mg every 4 weeks or placebo. In the certolizumab pegol arms, patients received a loading dose of 400mg certolizumab pegol at Weeks 0, 2 and 4. Patients enrolled in this study failed at least one prior disease-modifying anti-rheumatic drug (DMARD). Patients in the study 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 did not respond to treatment (response defined as ≥10% decrease in tender joint count and swollen joint count) 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 ACR20 response at Week 12 was significantly higher in both the certolizumab pegol arms of the study compared with placebo (58%, 51.9% vs. 24.3% in 200mg every 2 weeks, 400mg every 4 weeks vs. placebo respectively, P<0.001) and the response was observed as early as Week One (21%, 23% vs. 7.4% in 200mg every 2 weeks, 400mg every 4 weeks vs. placebo, respectively).
At baseline, 20% of patients had received previous anti-TNF therapy. At Week 24, improvements in signs and symptoms of psoriatic arthritis with certolizumab pegol combined doses vs. placebo were observed in patients with prior anti-TNF exposure (59.3% vs.11.5%) and without prior anti-TNF exposure (60.3% vs. 26.4%).
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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