Background Early treatment of severe rheumatoid arthritis (RA) with cyclosporine (CsA) and methotrexate (MTX) in combination is now considered one of the best strategies to control the arthritic symptoms and prevent structural joint deterioration.
Objectives This trial was aimed at evaluating the clinical and radiographic outcome of a cohort of patients with early rheumatoid arthritis (RA) first treated with an association of CsA and MTX, and then randomly stepped down to one of two agents.
Methods Fifty-seven patients (54 F and 3 M) (mean age 49.5 yr., range 20–64) with early, active RA (mean disease duration 0.8 yr., range 0.5–2), were treated with CsA (3 mg/kg/day) and MTX (10–15 mg/week) in combination for 6 months and then 49 of them were randomised to receive single therapy with either CsA (22 patients) or MTX (27 patients) for another 18 months. The radiographic evaluation was carried out on an intention-to-treat basis on all of the patients who completed the combination period using hand and foot radiographs taken at baseline, and after 12 and 24 months. The reading was blindly performed by two radiologists using the 32-joint damage score (DS) of the Larsen-Dale method and the count of the eroded joints (EJC).
Results Seven patients discontinued the study therapy because of adverse events during the first period of the trial, and 18 patients prematurely withdrew, mainly because of lack of efficacy, during the second study phase. Using the last-observation-carried-forward method, the good or moderate responders according the EULAR criteria were 42 (73.7%) at the end of the 6-month combination period, and 36 (73.5%) at the end of the single agent phase. Overall, safety and tolerability was good. At baseline, the mean DS (± SEM) in the CsA and MTX groups was respectively 5.1 ± 1.5 and 5.0 ± 1.7, and the mean EJC (± SEM) was 1.1 ± 0.3 and 0.7 ± 0.3. The differences in the radiographic scores after 12 and 24 months were as follows. In the CsA group: DS12 month-0 = +7.3 ± 3.2, EJC12 month-0 = +2.1 ± 1.1, DS24 month-0 = +10.5 ± 2.6 (p < 0.01), EJC24 month-0 = +3.2 ± 0.8 (p < 0.01). In the MTX group: DS12 month-0 = +5.2 ± 2.0, EJC12 month-0 = +1.5 ± 0.7 (p = 0.01), DS24 month-0 = +10.4 ± 1.7 (p < 0.01), EJC24 month-0 = +2.3 ± 0.5 (p < 0.01). The comparison between the two therapy groups did not show any significant difference.
Conclusion Radiographic deterioration occurred in both treatment groups but was mild and slow. Combination therapy with CsA and MTX followed by single agent maintenance treatment seems to induce a persistent retardation of radiographic damage. Longer period of combination therapy could yield better control of the joint structural damage.
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