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Certolizumab Pegol Shows Rapid Therapeutic Effect in Rheumatoid Arthritis: Presented at ACR-ARHP

By Bruce Sylvester

SAN FRANCISCO, Calif -- October 31, 2008 -- Certolizumab pegol provides rapid relief of the signs and symptoms of rheumatoid arthritis when given as monotherapy or as add-on to methotrexate, researchers reported here at the American College of Rheumatology (ACR) - Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting American College of Rheumatology (ACR) - Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting.

Lead investigator Roy Fleischmann, MD, University of Texas Southwestern Medical Center, Dallas, Texas, presented the results on October 27.

Data from 2 studies were included in this analysis: the Efficacy and Safety of Certolizumab pegol - 4 Weekly Dosage in Rheumatoid Arthritis (FAST 4WARD, study 011) and the Rheumatoid Arthritis Prevention of structural Damage (RAPID 1).

As background, the authors noted that the purpose of this analysis was to investigate the speed of response to certolizumab pegol as monotherapy and in combination with methotrexate.

Study 011 and RAPID 1 were phase 3, multicentre, double-blind, placebo-controlled trials investigating the safety and efficacy of certolizumab pegol as monotherapy (study 011) or in combination with methotrexate (RAPID 1) in subjects with active rheumatoid arthritis.

In study 011, investigators enrolled subjects who had already failed at least 1 disease-modifying antirheumatic drug (DMARD) and randomised them to receive SC certolizumab pegol 400 mg (n=111) or placebo (n=109) every 4 weeks.

In RAPID 1, investigators enrolled patients who had inadequate response after 6 months or more of methotrexate and randomised them to SC certolizumab pegol plus methotrexate or placebo plus methotrexate. Certolizumab pegol was administered at 400 mg on weeks 0, 2, and 4 and then reduced to 200 mg every 2 weeks in 393 patients, while 390 continued at 400 mg every 2 weeks.

The primary endpoint in both studies was a 20% improvement in the signs and symptoms of disease (ACR20) at week 24. The researchers also evaluated the response rates of patients who achieved 50% (ACR50) and 70% (ACR70) improvement in signs and symptoms.

Subjects who withdrew from either trial for any reason or took rescue medication in RAPID 1 were considered to be nonresponders. Baseline demographics and disease status were similar across all treatment arms in the 2 studies.

The investigators reported that onset of ACR20 response in both studies was rapid, and significant differences from placebo appeared by week 1. At weeks 1, 2, and 4, 36.7%, 43.0%, and 44.5% of patients receiving certolizumab pegol 400 mg monotherapy achieved ACR20 responses, respectively (P ≤ .05 vs placebo).

Also, they reported that 22.9%, 33.5%, and 43.6% of patients in the certolizumab pegol 200 mg plus methotrexate group achieved ACR20 response at weeks 1, 2, and 4, respectively versus placebo plus methotrexate (P ≤ .05). They reported similar results for certolizumab pegol 400 mg plus methotrexate.

ACR50 responses with certolizumab pegol monotherapy were significantly higher than placebo by week 1 (P ≤ .05) and by week 2 with certolizumab plus methotrexate (P ≤ .05). ACR70 responses were significantly higher than control by week 8 (P ≤ .05) and weeks 4 to 6 (P ≤ .05), respectively.

The investigators also reported significant improvements in all core components of ACR scoring by week 1 in both trials -- swollen joint count, tender joint count, patient assessment of global status, and acute phase reactant (erythrocyte sedimentation rate or C-reactive protein).

"Improvements were sustained throughout the duration of both studies," the authors noted.

Funding for this research was provided by UCB Pharma.

[Presentation title: Patients With Rheumatoid Arthritis Achieve a Rapid Response When Treated With Certolizumab Pegol Irrespective of Background Treatment. Abstract 979]

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