SAN DIEGO, CA—Patients with psoriatic arthritis both with and without previous exposure to tumor necrosis factor inhibitor (TNFi) therapy reported clinical efficacy to Week 48 with certolizumab pegol, a PEGylated Fc-free anti-TNF agent, according to results of the RAPID-PsA randomized trial presented at the 2013 ACR/ARHP Annual Meeting.
In addition, low radiographic progression and improvements in Psoriasis Area Severity Index (PASI) were maintained, and the safety profile was in line with that observed for certolizumab pegol in patients with rheumatoid arthritis, noted Philip J. Mease, MD, Swedish Medical Center and University of Washington, Seattle, WA, and colleagues.
Previously, the RAPID-PsA trial demonstrated the efficacy and safety of certolizumab pegol over 24 Weeks in patients with active psoriatic arthritis, including those with prior TNFi therapy, who had failed at least one disease-modifying anti-rheumatic drug (DMARD). The study is double-blind and placebo-controlled to Week 24 and dose-blind to Week 48.
In the dose-blind phase, patients who were originally randomized to certolizumab pegol (200mg every 2 weeks or 400mg every 4 weeks, following 400mg loading dose at Weeks 0, 2, 4) continued on their assigned dose. Those in the placebo arm entering the dose-blind phase were re-randomized to certolizumab pegol loading dose followed by certolizumab pegol (200mg every 2 weeks or 400mg every 4 weeks).
The investigators reported the Week 48 efficacy results for patients originally randomized to certolizumab pegol. Primary end points were ACR20 response at Week 12 and change from baseline in modified Total Sharp Score (mTSS) at Week 24. Other preplanned endpoints included PASI75/90 and ACR20/50/70 response, change from baseline HAQ-DI, PsAQoL, pain (VAS) and fatigue (NRS) at Week 24 and 48, and mTSS at Week 48.
Post-hoc analyses evaluated minimal disease activity at Weeks 24 and 48, and compared ACR response rates to Week 48 in patients with and without prior TNFi exposure. All patients treated with certolizumab pegol at any stage of the 48-week trial comprised the safety population.
Of the 409 patients randomized, 273 received certolizumab pegol from Week 0; 54 (19.8%) of whom had prior TNFi exposure. These patients had similar baseline characteristics to those who had not received TNFi therapy.
A total of 91% of patients randomized to certolizumab pegol completed to Week 24 and 87% to Week 48. ACR20/50/70 and MDA response rates were maintained from Week 24 to Week 48, and similar ACR response rates to Week 48 were observed in patients with and without prior TNFi exposure. Change from baseline in HAQ-DI, PsAQoL, pain (VAS) and fatigue (NRS) were maintained to Week 48. In the 60.8% of patients with ≥3% skin involvement at baseline, PASI75 and PASI90 responses were maintained from Week 24 to Week 48. Radiographic progression in patients treated with certolizumab pegol remained low (LS mean mTSS change from baseline was Week 24, 0.00; Week 48, 0.13).
In the safety population (n=393), adverse events (AEs) occurred in 304 patients (77.4%; event rate [ER] per 100 patient-years=394.6), and serious AEs in 39 (9.9%; ER=15.3). Serious AEs included eight infections (2.0%; ER=3.0), 1 case of tuberculosis (0.3%; ER=0.3), and 3 deaths in the overall 48-week period (0.8%); one death (0.3%; breast cancer) occurred between Week 24 and 48.
“Maintenance of efficacy was observed in patients regardless of prior TNFi exposure,” concluded Dr. Mease.