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| |  Rituximab Maintains Inhibition of Structural Damage at 2 Years in Patients With Rheumatoid Arthritis: Presented at EULAR By Jill Stein PARIS -- June 12, 2008 -- Rituximab provides continued inhibition of structural damage after 2 years of use in patients with rheumatoid arthritis who had an inadequate response to tumour necrosis factor (TNF) inhibition, according to data presented here at the European Union League Against Rheumatism (EULAR) Congress 2008. Structural joint damage is detectable early in the course of disease and causes disability over time in a significant percentage of patients. Rituximab is the only biological therapy for rheumatoid arthritis that has been proven to retard or inhibit joint damage in a patient population with an inadequate response to a TNF inhibitor, according to Stan Cohen, MD, Metroplex Clinical Research Center, Dallas, Texas, and colleagues. In the same study population, rituximab combined with methotrexate was previously shown to inhibit the progression of structural joint damage at week 56. Patients in the intent-to-treat (ITT) analysis included those randomised at baseline to placebo and subsequently switched to the rituximab arm, and patients initially randomised to rituximab who later received standard of care. The researchers obtained X-rays of the hands and feet for all patients at the start of the trial, at week 24, week 56, and week 104. For the 2-year analysis, all X-rays were re-scored by trained radiologists who were blinded to treatment assignment and order of the radiographs using the Sharp-Genant method. The ITT population consisted of 187 baseline placebo- and 281 rituximab-treated patients who had a baseline and postbaseline film. Results, presented on June 12, showed that rituximab led to significant inhibition of structural damage progression over 2 years as determined by the Total Sharp Score (TSS) (rituximab, 1.14 vs baseline-placebo, 2.81; P < .0001). The benefits of treatment were apparent within 1 year. Similar effects on erosion scores and joint space narrowing were observed. Over the first year, 60% of rituximab patients had no progression in TSS compared with 46% of baseline-placebo patients. During the second year, 68% of rituximab and 54% of baseline-placebo patients did not progress. Rituximab consistently inhibited progression since 87% of those rituximab-treated patients who did not progress during the first year had no progression during the second year. Overall, the results demonstrate that rituximab treatment consistently continues to inhibit joint damage with longer treatment (104 weeks) in patients with an inadequate response to TNF inhibitors, Dr. Cohen said. Also, reduced rates of progression were observed in the placebo group reflective of their switch to rituximab. Funding for the study was provided by Roche Laboratories Inc.
[Presentation title: Continued Inhibition of Structural Damage in Rheumatoid Arthritis Patients Treated With Rituximab at 2 Years: REFLEX Study. Abstract THU0167]
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