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| |  Efficacy of Rituximab Is Sustained in Patients With Rheumatoid Arthritis: Reported at ACR-ARHP By Bruce Sylvester SAN FRANCISCO, Calif -- November 1, 2008 -- Patients with rheumatoid arthritis who had an inadequate response to prior therapy with an anti-tumour necrosis factor (anti-TNF) agent can achieve sustained responses when they receive repeated treatments with the monoclonal antibody rituximab. Researchers reported these findings on October 26 at the American College of Rheumatology (ACR) - Association of Rheumatology Health Professionals (ARHP) Annual Scientific Meeting. "In patients with active rheumatoid arthritis and an inadequate response to TNF inhibitors, repeated courses of rituximab showed a comparable degree of sustained efficacy relative to original baseline," said lead investigator Edward Keystone, MD, University of Toronto, Toronto, Ontario, Canada. As background to this open-label extension study, Dr. Keystone and colleagues noted that eligible subjects had responded previously to an initial course of rituximab during the original randomised, double-blind, phase 3 Randomized Evaluation of Long-Term Efficacy of Rituximab in RA (REFLEX) study and received repeated open-label treatment courses of the same rituximab regimen. Placebo subjects in the original study were also eligible to enter the open-label extension study; they then received their first course of rituximab. The investigators determined efficacy according to changes from original baseline clinical measures. At the time of this analysis, 235 subjects from the REFLEX study population had received at least 3 courses of rituximab. Efficacy data were available for 179 subjects who had completed at least 24 weeks of follow-up in each treatment course. Comparison of efficacy in these subjects at 24 weeks after each of 3 courses showed that, for all measures, repeated treatment with rituximab remained effective. A 20% improvement in signs and symptoms of disease as determined by ACR criteria (ACR20) was achieved by 70.9% after course 1, 72.6% after course 2, and 73.2% after course 3. A 50% improvement (ACR50) was achieved by 38.5% after course 1, 43.0% after course 2, and 47.5% after course 3. A 70% improvement (ACR70) was achieved by 14.0% after course 1, 20.7% after course 2, and 25.7% after course 3. Remission rates, determined using the Disease Activity Score (DAS), increased from 8.8% to 17.6% from course 1 to course 3. The repeated courses of rituximab were generally well tolerated, according to the researchers. The main adverse events were infusion-related reactions and infections. Infusion-related reactions were generally mild and required no treatment. The overall rate of serious infection was 6.75 events per 100 patient-years (95% confidence interval 5.47-8.33) and was consistent with data reported previously. There were no cases of opportunistic infections or tuberculosis. The authors concluded, "These results indicate that repeated courses of [rituximab] produced sustained efficacy relative to original baseline and were well tolerated." Funding for this study was provided by Roche. [Presentation title: Efficacy and Safety of Repeat Treatment Courses of Rituximab (RTX) in RA Patients (pts) With Inadequate Response (IR) to Tumor Necrosis Factor (TNF) Inhibitors: Long-Term Experience From the REFLEX Study. Abstract 367]
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