Certolizumab pegol improved symptoms in PsA patients with anti-TNF exposure

WASHINGTON — Patients with psoriatic arthritis and previous anti-tumor necrosis factor exposure showed improved symptoms after treatment with certolizumab pegol compared with placebo, according to study results presented at the American College of Rheumatology Annual Meeting.

Researchers studied 409 patients with active psoriatic arthritis (PsA) who had failed at least one disease-modifying antirheumatic drug (DMARD) and could have experienced secondary failure to at least one previous anti-tumor necrosis factor (anti-TNF) therapy. The ongoing RAPID-PsA 158-week trial was double masked and placebo controlled through week 24, dose-masked to week 48 and open label through study conclusion. The patients were equally and randomly assigned to placebo, 200 mg certolizumab pegol (Cimzia, UCB) biweekly or 400 mg certolizumab pegol every 4 weeks. Loading dose was 400 mg certolizumab pegol at initiation, weeks 2 and 4. At baseline, nearly 20% of patients had received previous anti-TNF therapy.

Patients treated with certolizumab pegol showed improvements in ACR20 response compared with placebo patients with prior anti-TNF exposure (59.3% vs. 11.5%) and without prior anti-TNF exposure (60.3% vs. 26.4%).

Both groups receiving certolizumab pegol had greater response at week 12, a primary endpoint, compared with placebo patients (58% for 200 mg, 51.9% for 400 mg vs. 24.3%). Sixty-two percent of patients receiving certolizumab pegol experienced adverse events compared with 68% of placebo patients (7% vs. 4% for serious adverse events). Nasopharyngitis and upper respiratory tract infection were the most common adverse events (>5% incidence in all patients). Infections and infestations (1.2% in certolizumab pegol combined patients vs. 0.7% in control patients) were the most common serious events. By week 24, two deaths occurred, one from unknown cause (400 mg certolizumab pegol) and one myocardial infarction (200 mg certolizumab pegol).

Certolizumab pegol is not approved as PsA therapy; UCB intends to file global regulatory submissions for the drug by the end of 2012, according to a company press release. In the European Union, Cimzia, in combination with methotrexate, is indicated for treating moderate to severe rheumatoid arthritis and for reducing symptoms of Crohn’s disease.

“The RAPID-PsA study is the first randomized, controlled clinical study of an anti-TNF in psoriatic arthritis to include patients with and without prior anti-TNF exposure,” Phillip J. Mease, MD, director of rheumatology research at Swedish Medical Center and clinical professor at University of Washington School of Medicine in Seattle, said in the release. “Studies such as RAPID-PsA … are informative since in day-to-day clinical practice we see that a greater number of patients have prior exposure to an anti-TNF therapy.”

Disclosure: The researchers report numerous financial disclosures.

For more information:

Mease PJ. P2613: Effect of Certolizumab Pegol on Signs and Symptoms in Patients with Psoriatic Arthritis with and without Prior Anti-TNF Exposure: 24 Week Results of Phase 3 Double-Blind Randomized Placebo-Controlled Study. Presented at: American College of Rheumatology 2012 Annual Meeting; Nov. 10-14, Washington.