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Speedy Improvement in PsA Seen with Certolizumab Pegol

Speedy Improvement in PsA Seen with Certolizumab Pegol

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.

 

 
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