To investigate whether the association of methotrexate (MTX) and corticosteroids introduced concomitantly is more effective than MTX alone in patients with rheumatoid arthritis (RA).
Twenty-eight RA patients (group 1) were treated with MTX (mean dose: 10 +/- 1.4 mg/week) and corticosteroids (mean dose: 14.9 +/- 5.6 mg/day, range: 5-25) introduced concomitantly, and were compared to 251 RA patients (group 2) treated with MTX alone (mean dose: 9.8 +/-1.5 mg/week). Variations in the clinical (number of swollen and painful joints, morning stiffness, Ritchie's articular index), biological (ESR, CRP), and radiological parameters were studied. Remission was defined according to Pinals' criteria. At baseline, there were no significant differences between the two groups, except for a greater number of swollen and painful joints in group 1 (p = 0.03 and p = 0.01, respectively). The total MTX dose and the duration of treatment (26 +/- 21.8 months in group 1 versus 33.5 +/- 27.2) months in group 2) did not differ between the two groups.
We noted a more marked reduction in the number of swollen and the number of painful joints in group 1 (p = 0.03). No differences were noted for the other clinical and biological parameters. The proportion of patients fulfilling Pinals' remission criteria was higher in group 1 (25% versus 10.1% in group 2, p = 0.04). The steroid dosage could be significantly reduced in group 1 (-3.4 +/- 6.1 mg/day, p = 0.05) and corticosteroids were stopped in 11 patients. The frequency and type of side effects, as well as the frequency and reasons leading to MTX withdrawal, did not significantly differ between the two groups.
The association of MTX and corticosteroids seems to bring about a greater improvement in the different clinical activity parameters of RA than MTX alone, without any significant increase in the frequency of side effects. These results need to be confirmed in larger scale prospective studies.