Abstract
BackgroundThe approved dose of rituximab (RTX) in rheumatoid arthritis is 1000 mg × 2, but some data have suggested similar clinical efficacy with 500 mg × 2. The purpose of this study was to compare the effectiveness of the regular and low doses given as first treatment course.MethodsTwelve European registries participating in the CERERRA collaboration (The European Collaborative Registries for the Evaluation of Rituximab in Rheumatoid Arthritis) submitted anonymized datasets with demographic, efficacy and treatment data for patients who had started RTX. Treatment effectiveness was assessed by DAS28 reductions and EULAR responses after 6 months.ResultsData on RTX dose were available for 2,873 patients, of whom 2,625 (91.4 %) and 248 (8.6 %) received 1000 mg × 2 and 500 mg × 2, respectively. Patients treated with 500 mg × 2 were significantly older, had longer disease duration, higher number of prior DMARDs, but lower number of prior biologics and lower baseline DAS28 than those treated with 1000 mg × 2. Fewer patients in the low-dose group received concomitant DMARDs but more frequently received concomitant corticosteroids.Both doses led to significant clinical improvements at 6 months. DAS28 reductions at 6 months were comparable in the 2 dose regimens [mean DeltaDAS28 ± SD -2.0 ± 1.3 (high dose) vs. -1.7 ± 1.4 (low dose), p = 0.23 adjusted for baseline differences]. Similar percentages of patients achieved EULAR good response in the two dose groups, 18.4 % vs. 17.3 %, respectively (p = 0.36).ConclusionsIn this large observational cohort initial treatment with RTX at 500 mg × 2 and 1000 mg × 2 led to comparable clinical outcomes at 6 months.
Highlights
The approved dose of rituximab (RTX) in rheumatoid arthritis is 1000 mg × 2, but some data have suggested similar clinical efficacy with 500 mg × 2
Rituximab (MabThera, Rituxan) is a chimeric, monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in combination with methotrexate in patients with active RA who have not responded to at least one tumor necrosis factor (TNF) inhibitor
Information about RA treatment, such as doses of RTX and use of concomitant diseasemodifying anti-rheumatic drugs (DMARDs) and glucocorticoids was included in the dataset
Summary
The approved dose of rituximab (RTX) in rheumatoid arthritis is 1000 mg × 2, but some data have suggested similar clinical efficacy with 500 mg × 2. The purpose of this study was to compare the effectiveness of the regular and low doses given as first treatment course. Rituximab (MabThera, Rituxan) is a chimeric, monoclonal anti-CD20 antibody approved for the treatment of rheumatoid arthritis (RA) in combination with methotrexate in patients with active RA who have not responded to at least one tumor necrosis factor (TNF) inhibitor. In the SERENE trial both 500 mg × 2 and 1000 mg × 2 of RTX significantly improved clinical outcomes (based on criteria of the American College of Rheumatology (ACR) responses, the European League Against Rheumatism (EULAR) responses, and improvement in the Disease Activity Score in 28 joints (DAS28) and in the Health Assessment Questionnaire (HAQ)) compared to placebo in a biologic-agent-naïve population of patients with RA [5]. In all the above trials no significant difference was detected between the different doses in almost all clinical outcomes
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