CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for... (find treatments that lead to a better ov...)

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CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

Date:10/27/2008

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In RAPID 1, patients treated with CIMZIA together with MTX reported gains in additional work and household work days per month and productive work and household work days per month as early as week 4. Over 6 months, improvements continued compared to the control group. These improvements were maintained for up to one year.

Additionally, data presented shows Health Reported Quality of Life Measurements (HRQoL) approached population norms in the "vitality" and "mental health" domains. As assessed by the Fatigue Assessment Scale of 1 to 10, patients in the trial also reported a mean reduction in fatigue to 3.1 points at week 100 with CIMZIA together with MTX treatment.

Notes to Editors:

RAPID Clinical Trials Program

The international, multi-center, double-blind placebo-controlled RAPID (RA PreventIon of structural Damage) clinical trials were designed to establish the efficacy and tolerability of CIMZIA(R) (certolizumab pegol) together with methotrexate (MTX) in the treatment of active rheumatoid arthritis who did not adequately respond to conventional treatment. The program is comprised of two large, international, multi-center placebo-controlled studies - RAPID 1 (027) and RAPID 2 (050).

In the year-long RAPID 1 trial, patients randomly received one of three treatment regimens: 393 patients received CIMZIA 400 mg at weeks 0, 2 and 4, then CIMZIA 200 mg together with MTX every two weeks; 390 patients received CIMZIA 400 mg together with MTX every 2 weeks; 199 patients received placebo together with MTX every 2 weeks. RAPID 1 met co-primary endpoints: ACR20 response rate(a) at week 24 and the change from baseline in mTSS(b) at week 52. An open-label extension study continued to evaluate the effects of CIMZIA over two years.

In the six-month RAPID 2 trial, 619 patients randomly received one of three treatment regimens: 246 patients received CIMZIA 400 mg at w
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