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Combined Infliximab, Methotrexate More Effective Than Other Strategies in Early Rheumatoid Arthritis: Presented at EULAR

By Paula Moyer


BERLIN, GERMANY -- June 15, 2004 -- Early treatment with a combination of infliximab (Remicade) and methotrexate is more effective than 3 other step-up and step-down treatment strategies for patients with rheumatoid arthritis, say researchers.

Renée Allaart, MD, a consultant rheumatologist at the University of Leiden, in Leiden, the Netherlands, presented study findings here June 10th at the European Congress of Rheumatology.

Dr. Allaart and colleagues undertook a multicenter, randomized, single-blind trial, and recruited 508 patients with newly diagnosed rheumatoid arthritis. The patients had experienced the signs and symptoms of the disease for less than 2 years, and none had previously taken disease-modifying antirheumatic drugs (DMARDs).

The investigators randomized the patients to 4 groups. Group 1 received sequential monotherapy starting with methotrexate up to 25 mg per week, with the next treatment step sulphasalazin followed by leflunomide. Group 2 received step-up therapy starting with methotrexate, followed consecutively by sulphasalazin and hydroxychloroquine. Group 3 started with combined methotrexate, sulphasalazin, and prednisone, starting at 60 mg daily and tapered down to 7.5 mg daily. Group 4 received methotrexate at 7.5 mg per week for 2 weeks and then 15 mg per week, with injections of infliximab at doses of 3 mg/kg at weeks 0, 2, and 6, then every 8 weeks, with doses increased or reduced to 0 depending on the Disease Activity Score (DAS44).

Adjustment in treatment for each strategy was dictated by 3 monthly calculations of DAS44, with the goal of achieving DAS44 2.4 or less. Blinded assessors obtained clinical outcomes, DAS44, and health assessment questionnaires. Two blinded physicians performed the Sharp/van der Heijde radiological scores (SHS).

After 3 months, the average HAQ reduction was 0.4 and 0.3 in groups 1 and 2 respectively, with reductions of 0.8 and 0.7 in group 3 and 4 respectively. After 1 year of follow-up, the reduction in HAQ was 0.7 in groups 1 and 2, and 0.9 in groups 3 and 4 (P =.04). Median radiologic progressions after 1 year were 2.0 for group 1, 2.5 for group 2, 1.0 for group 3, and 0.5 for group 4 (P <.001). In group 1, 27% of patients did not show any radiological progression, compared to 29% in group 2, 37% in group 3, and 46% for group 4 (P =.007).

The groups had similar rates of discontinuation and adverse events, said Dr. Allaart.

[Presentation title: A Comparison of Clinical and Radiological Outcomes of Four Treatment Strategies for Early Rheumatoid Arthritis: Results of the BEST Trial. Abstract OP001]

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