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| |  Rituximab Retreatment Preflare Advised in Patients Responding to Rituximab After TNF Failure: Presented at EULAR By Jill Stein PARIS -- June 15, 2008 -- Patients with rheumatoid arthritis (RA) who respond to rituximab after an inadequate response to at least 1 tumour necrosis factor (TNF) inhibitor are more likely to have a good outcome after a second course of rituximab, but the response is related to the amount the disease activity worsened before retreatment, new results suggest. The less it worsened, the better the result. The data were announced on June 12 at EULAR 2008, the Annual Congress of the European League Against Rheumatism. Philip J. Mease, MD, Seattle Rheumatology Associates, Seattle, Washington, and colleagues conducted a study to examine whether the Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) can predict disease activity after a second course of rituximab treatment for RA. Composite measures of RA disease activity assessed on a regular basis are essential to adjust therapies to prevent disease progression and improve quality of life, the authors noted in their poster presentation. When the 28-joint Disease Activity Score (DAS28) was previously examined as a predictor for when to treat patients with RA with a second course of rituximab, it was found that every 1.0 point the DAS28 worsened before retreatment led to a 0.32 (+-0.04)-point higher DAS28 after retreatment. The SDAI and CDAI are measures that are closely correlated with the DAS28 and have been found to be more practical to use in the clinic, and an optimal treatment paradigm could involve a relatively easy but exact measure of disease upon which to base further treatment, Dr. Mease's team pointed out in their poster presentation. In a 24-week, phase 3 trial, patients with RA who had discontinued at least 1 TNF inhibitor due to toxicity or lack of efficacy were randomised to rituximab or placebo plus methotrexate (MTX). During the open-label extension phase, patients who achieved >=20% improvement in swollen and tender joint counts could receive additional courses of rituximab for active RA at the physician's discretion. SDAI and CDAI were calculated about every 4 weeks. Patients were considered evaluable if they had made at least 1 visit to the clinic after the second course of rituximab. Overall, 168 patients who entered the extension phase and received a second course of rituximab were evaluable. After both rituximab courses, the lowest mean SDAI and CDAI scores occurred at week 20. SDAI and CDAI after the second course of rituximab were independently increased by 4 factors. These included age at enrollment, scores immediately before the second course of treatment, and 2 measures after the initial course (SDAI/CDAI at week 20 and Health Assessment Questionnaire-Disability Index at week 16). Every 1.0 point that SDAI worsened before retreatment with rituximab was associated with a 0.21 (+-0.03)-point higher SDAI score after retreatment. Every additional 1.0 point increase in CDAI before retreatment resulted in a 0.24 (+-0.03)-point higher CDAI score after retreatment. The analysis suggests that retreatment with rituximab before patients are allowed to flare results in improved disease activity following retreatment and that more simple measures, such as the SDAI and CDAI, may be more practical for the clinical practice setting, Dr. Mease and his group said. Funding for the study was provided by Genentech. [Presentation title: SDAI and CDAI for Predicting Outcome of a Second Course of Rituximab for Patients With Rheumatoid Arthritis (RA). Abstract THU0188.]
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