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Cimzia® (certolizumab pegol) Data Showed Rapid Improvement in Signs and Symptoms Predicted Better Long-Term Outcomes in Rheumatoid Arthritis Patients
Date:5/10/2011

.2% versus 6.1%). Patients who responded at week 12 also experienced less radiographic progression than those who did not. The majority of patients (approximately 75%) who responded at week 12 had a clinical response at week 6. These patients reported further improved outcomes such as pain, physical function and fatigue, a significantly greater response in terms of ACR20, 50 and 70 measures as well as higher rates of DAS28 LDA and remission, relative to those who showed response at week 12.

The data published were from the RAPID 1 study - a Phase III double-blind placebo-controlled trial.  The trial was designed to establish the efficacy and tolerability of certolizumab pegol together with MTX, in the treatment of moderate to severely active RA in patients who did not adequately respond to conventional treatment. The co-primary end points were ACR20 score at week 24 and change in mTSS (modified Total Sharp Score) at week 52. The post hoc analysis focused on patients who received MTX and either 200mg subcutaneously or placebo every 2 weeks for 52 weeks accounting for 393 patients in the ITT population (30 patients were excluded due to nonimputable data).  

Patients participating in the trial all met the ACR classification for RA, and had active disease at screening and an inadequate response to MTX treatment (greater than or equal to 6 months with a stable dose of greater than or equal to 10 mg weekly for greater than or equal to 2 months prior to baseline).    

For the purpose of this post hoc analysis, patients were classified as responders or non-responders based on DAS 28 > 1.2 and ACR20 response at week 6 and 12 respectively. Low disease activity was defined as DAS28 less than or equal to 3.2. Remission was defined as DAS28 less than or equal to 2.6. Improvement in disease activity, as measured by DAS28, was classified according to the EULAR response criteria.

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1. Cimzia® (certolizumab pegol) Data Showed Broad and Rapid Relief From Burden of Symptoms In Rheumatoid Arthritis Patients
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