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New Data From REALISTIC Study Showed Cimzia® (certolizumab pegol) Provided Rapid and Sustained Efficacy, Over 28 Weeks, in a Broad Population of Patients With Moderate to Severe Rheumatoid Arthritis (RA) Including Those Who Discontinued Prior Anti-T
Date:11/7/2011

itor use, concomitant use of methotrexate (MTX), and disease duration (<2 y vs greater than or equal to 2 y). Treatment effect differences between subgroups were assessed by interactions (treatment by covariate) at 10% significance level.

Active RA patients with inadequate response to greater than or equal to 1 DMARD were randomized 4:1 to CZP 400mg (n=851) at Weeks 0, 2 and 4 followed by 200mg every 2 weeks or placebo injection (control, n=212) every 2 weeks added to current therapy. PROs included fatigue (Fatigue Assessment Scale [FAS; 0–10 numeric rating scale]), pain (0–100mm visual analogue scale [VAS]), and patient's global assessment of disease activity (PtGA, 0–100mm VAS). The minimal clinically important difference (MCID) is a clinically relevant change in a patient's status. The percentage of patients reporting MCIDs was determined: greater than or equal to 1 for FAS, greater than or equal to 6 for MOS-SPI, and greater than or equal to 10mm for pain-VAS and PtGA. Correlations between PROs and DAS28 were also assessed (Pearson correlations [rho], CZP group only).

About CIMZIA®

Cimzia® is the only PEGylated anti-TNF (Tumor Necrosis Factor). Cimzia® has a high affinity for human TNF-alpha, selectively neutralizing the pathophysiological effects of TNF-alpha. Over the past decade, TNF-alpha has emerged as a major target of basic research and clinical investigation. This cytokine plays a key role in mediating pathological inflammation, and excess TNF-alpha production has been directly implicated in a wide variety of diseases. The U.S. Food and Drug Administration (FDA) has approved Cimzia® for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy and for the treatment of adults with moderat
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