• Ann. Intern. Med. · Apr 1996

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    The effectiveness of early treatment with "second-line" antirheumatic drugs. A randomized, controlled trial.

    • A van der Heide, J W Jacobs, J W Bijlsma, A H Heurkens, C van Booma-Frankfort, M J van der Veen, H C Haanen, D M Hofman, G A van Albada-Kuipers, E J ter Borg, H L Brus, H J Dinant, A A Kruize, and Y Schenk.
    • Department of Public Health, Faculty of Medicine, Erasmus University, Rotterdam, The Netherlands.
    • Ann. Intern. Med. 1996 Apr 15; 124 (8): 699-707.

    ObjectiveTo compare two therapeutic strategies for patients with recent-onset rheumatoid arthritis.DesignOpen, randomized clinical trial.SettingOutpatient clinics of six clinical centers.Patients238 consecutive patients with recently diagnosed rheumatoid arthritis.InterventionsDelayed or immediate introduction of treatment with slow-acting antirheumatic drugs (SAARDs).MeasurementsPrimary end points were functional disability, pain, joint score, and erythrocyte sedimentation rate at 6 and 12 months and progression of radiologic abnormalities at 12 months.ResultsStatistically significant advantages at 12 months for patients receiving the SAARD strategy (immediate treatment with SAARDs) with regard to all primary end points that may be clinically important are indicated by the differences in improvements from baseline and their 95% CIs. These differences were 0.3 (95% CI, 0.2 to 0.6) for disability (range, 0 to 3), 10 mm (CI, 1 to 19 mm) for pain (range, 0 to 100 mm), 39 (CI, 4 to 74) for joint score (range, 0 to 534), and 11 mm/h (CI, 3 to 19 mm/h) for erythrocyte sedimentation rate (range, 1 to 140 mm/h), all in favor of SAARD treatment. The SAARD strategy also appears to be advantageous at 6 months. Radiologic abnormalities progressed at an equal rate in the SAARD and the non-SAARD groups; the difference in progression (range, 0 to 448) was 1 (CI, -3 to 5). Analyses were based on the intention-to-treat principle and thus included 29% of patients in the non-SAARD group who discontinued the non-SAARD treatment strategy; treatment was usually discontinued because of insufficient effectiveness. The SAARD strategy including two alternative SAARDs could not be continued by 8% of patients, usually because of adverse reactions.ConclusionsEarly introduction of SAARDs may be more beneficial than delayed introduction for patients with recently diagnosed rheumatoid arthritis.

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