Triple DMARD Therapy Effective for Aggressive Treatment of Early Rheumatoid Arthritis: Presented at ACR/ARHP
By Liz Meszaros
PHILADELPHIA -- October 21, 2009 -- Initial use of methotrexate monotherapy with the addition of sulfasalazine/hydroxychloroquine or etanercept if necessary after 6 months, is a reasonable therapeutic strategy for early rheumatoid arthritis (RA), according to a study presented here at the 2009 Annual Scientific Meeting of the American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP).
Larry W. Moreland, MD, University of Pittsburgh, Pittsburgh, Pennsylvania, presented data from the multicentre, randomised Treatment of Early Aggressive RA (TEAR) study on October 20.
The study included 755 patients and compared immediate versus step-up strategy with methotrexate, etanercept, and triple disease-modifying antirheumatic drugs (DMARDs) therapy in 4 arms: immediate methotrexate plus etanercept (IE) or triple therapy (IT); step-up from methotrexate to methotrexate plus etanercept (SE) or to triple DMARD (ST). In the SE and ST arms, if Disease Activity Score using 28 joint counts (DAS28) was >=3.2 at 6 months of methotrexate, patients were blindly stepped-up to IE/IT.
All patients were started on methotrexate 10 mg/week, and this was escalated to 20 mg over week 12. Sulfasalazine was begun at a dosage of 500 mg twice daily, and escalated to 1,000 mg twice daily. Patients were also permitted to receive stable doses of nonsteroidal anti-inflammatory drugs, or low dose corticosteroids, with prednisone <=10 mg per day.
No differences in mean levels of DAS28 were seen among patients randomised to etanercept or triple DMARD therapy, regardless of whether they received immediate combination treatment or methotrexate monotherapy with a step-up during weeks 48 to 102 of the study. At week 102, DAS28 was 3.0 in the IE group, 2.9 in the IT group, 3.1 in the SE group, and 2.8 in the ST group.
At 6 months, immediate combination treatment with either strategy was more effective than monotherapy with methotrexate. In the IE group, ACR70 was 13.1 at 6 months, compared with 11.4 in the IT group, 3.2 in the SE group, and 4.7 in the ST group.
Patients who initially received IE or IT were significantly more likely to achieve an ACR 20/50/70 response at 6 months than those randomised to step-up arms (all P < .0001), regardless of treatment (etanercept vs DMARD).
No significant differences in the incidence of adverse events occurred during the trial.
“Based on the results of the primary analysis of TEAR, the average DAS28 of the 276 patients who completed year 2 of the trial was 3.0, all treatment groups resulted in improvement in DAS28 from baseline,” said Dr. Moreland. “Sex, race, starting DAS, disease duration, and BMI [Body Mass Index] all contributed to a higher DAS score at year 2.”
“There was no difference in DAS28 between weeks 48 and 102 either by treatment received or treatment regimen,” he said. “Subjects receiving immediate treatment improved more quickly than those who received step-up at month 6. However, by year 1 of treatment, all groups had comparable DAS28 scores,” he concluded.
Funding for this study was provided by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Immunex Corp., Barr Pharmaceuticals, and Pharmacia.
[Presentation title: TEAR: Treatment of Early Aggressive RA: A Randomized, Double-Blind, 2-Year Trial Comparing Immediate Triple DMARD Versus MTX Plus Etanercept to Step-up From Initial MTX Monotherapy. Abstract 1895]
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