Certolizumab Pegol Shows Efficacy in Psoriatic Arthritis

Kate Johnson

June 08, 2012

June 8, 2012 (Berlin, Germany) — Certolizumab pegol (Cimzia, UCB Pharma), a tumor necrosis factor (TNF) inhibitor approved by the US Food and Drug Administration for the treatment of rheumatoid arthritis (RA) and Crohn's disease, has been shown to be effective in both skin and joint symptoms of psoriatic arthritis, compared with placebo. This finding comes from the interim results of the RAPID-PsA phase 3 trial presented here at the European League Against Rheumatism Congress 2012.

"What we've learned from this trial is that certolizumab certainly works in psoriatic arthritis. This will be the basis for seeking regulatory approval for this drug in the treatment of psoriatic arthritis," said Philip Mease, MD, lead author of the study, during a press conference.

The study, which was sponsored by UCB Pharma, the drug's manufacturer, is the first to report the clinical efficacy and safety of certolizumab in patients with psoriatic arthritis, said Dr. Mease, who is director of the Rheumatology Research Swedish Medical Center and clinical professor at the University of Washington School of Medicine in Seattle.

"This is very important because we don't have quite the armamentarium of drugs for treating psoriatic arthritis that we have for RA," he noted.

The study, which is still ongoing, involves 409 patients randomized to placebo or 1 of 2 dosing regimens of certolizumab. After a loading dose of 400 mg every 2 weeks for the first 4 weeks, patients received either 200 mg once every 2 weeks or 400 mg once a month.

By week 12, patients in the 200 mg and 400 mg groups were twice as likely to have met the American College of Rheumatology 20% response criteria (ACR20) as those in the placebo group (58.0% and 51.9%, respectively, vs 24.3%).

Similarly, ACR50 response rates were better in the 200 mg and 400 mg groups than in the placebo group (36.2% and 32.6% vs 11%), as were ACR70 responses rates (24.6% and 12.6% vs 2.9%).

Perhaps more important, a difference can be seen between certolizumab and placebo in as little as 1 week. "There's a very fast onset of action," said Dr. Mease.

Functional improvement was also significant, compared with placebo, and the skin response was "quite robust, with roughly 47% achieving a 75% improvement in the Psoriasis Area and Severity Index score at week 12, and up to 62% at week 24."

One of the unique features of the trial is that not all patients were anti-TNF-naïve, said Dr. Mease.

"Approximately 20% of the population had previous exposure to an anti-TNF agent; that makes it presumably tougher to achieve the kinds of responses we have seen in trials in which patients were naïve to anti-TNF medicines," he noted.

Given this, the results are encouraging, he said.

"We've seen this in RA when you switch to another anti-TNF after a first one has lost response; you can get quite a robust response. We don't fully understand why patients, over time, lose response to these agents, but this is something that's seen with the oral DMARDs, with the anti-TNFs, and with other biologics."

"For whatever reason, a new molecule with a slightly different configuration allows that person's immune system to respond," Dr. Mease said.

There was no new safety signal for certolizumab in this psoriatic arthritis population, compared with the RA population, he reported. Adverse events occurred in 62% of the 2 certolizumab groups and in 68% of the placebo group. Serious adverse events were noted in 7% of the certolizumab groups and in 4% of the placebo group. Two deaths occurred in the certolizumab group — one was a sudden death of unknown cause and the other was from a myocardial infarction; none occurred in the placebo group.

Dr. Mease reports receiving a grant and research support from and being a consultant and on the speakers' bureau for UCB Pharma. All of his coauthors have ties to or are employees and shareholders in the company.

European League Against Rheumatism (EULAR) Congress 2012: Abstract LB0001. Presented June 7, 2012.

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