Speedy Improvement in PsA Seen with Certolizumab Pegol

August 26, 2013

The anti-TNF agent certolizumab pegol (CZP) produced significant improvements in symptoms of psoriatic arthritis (PsA) in as little as a week, and sustained for 24 weeks, in an international trial.

Mease PJ, Fleischmann R, Deodhar AA, et al., Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA).Ann Rheum Dis. (2013) Aug 13. doi: 10.1136/annrheumdis-2013-203696. [Epub ahead of print]

An ongoing international clinical trial shows that the anti-TNF agent certolizumab pegol (CZP) produces significant improvements in symptoms of psoriatic arthritis (PsA) -- including tender and swollen joints, skin lesions, enthesitis, dactylitis, and nail disease – in as little as a week, and sustained for 24 weeks.

In the placebo-controlled segment of the 158-week RAPID-PsA trial, a randomized, double-blind, phase III study, 60% of CZP-treated patients had improvement in their symptoms as judged by American College of Rheumatology 20% (ACR20) responses at 12 weeks, compared with fewer than one-quarter of placebo patients.

In this segment, 409 patients with active PsA (half of them female, with a mean age of 47) were randomly assigned 1:1:1 to subcutaneous injections of either placebo(saline) or a loading dose of CZP 400 mg for 2 weeks followed by 200 mg CZP every 2 weeks or 400 mg CZP every 4 weeks.

A total of 368 patients (70% of them already taking DMARDs, either methotrexate, sulfasalazine, or leflunomide) completed 24 weeks. Concomitant DMARDs did not affect response to CZP.

Placebo patients not achieving a 10% improvement from baseline in both swollen and tender joints (n=59) at 14 or 16 weeks were re-randomized to CZP treatment.

At 12 weeks, 58% in the CZP 400 mg group and 51.9% in the CZP 200 mg group achieved the primary clinical endpoint of an ACR20 response, compared with 24.3% of placebo recipients.

The clinically significant ACR20 response, seen as early as week 1 among the CZP groups, continued to 24 weeks, as did a statistically significant improvement in physical function (using the Health Assessment Questionnaire Disability Index, HAQ-DI) and radiographic changes from baseline in modified Total Sharp/van der Heijde Scores.
 
The RAPID-PsA trial, being conducted at 92 centers in North and Latin America, Western, Central, and Eastern Europe, is dose-blinded to week 48 and then open label through week 158.