EFFICIENCY OF TRIPLE (METHOTREXATE + SULFASALAZINE + HYDROXYCHLOROQUINE) COMBINATION DISEASE-MODIFYING THERAPY VERSUS METOTREXATE MONOTHERAPY IN PATIENTS WITH RHEUMATOID ARTHRITIS

Objective: to compare the efficiency and tolerability of combination disease-modifying therapy with methotrexate (MT), sulfasalazine (SS), and hydroxychloroquine (HC) with that of MT monotherapy in patients with rheumatoid arthritis (RA).
Subjects and methods. Sixty patients with RA, who had received no disease-modifying anti-inflammatory drugs, were enrolled in a 24-month open-label study. The patients were randomized into two groups at a 1:1 ratio. Group 1 received combination therapy with MT (its starting dose was 7.5 mg weekly), SS (2.0 g/day), and HC (200 mg/day); Group 2 had MT therapy. If there was no remission, the dose of MT was gradually increased from 7.5 to 17.5 mg weekly. The basic efficiency rate was a 50% improvement according to the American College of Rheumatologists criteria (ACR 50), which persisted at 9 months of therapy to the end of the study in the absence of adverse reactions (AR) requiring the therapy in question to be discontinued.
Results. At 24 months of therapy, the effect corresponding to ACR 50 was observed in 16 (59.3%) of the 27 patients in Group 1 and in 11 (40.7%) of the 27 patients in Group 2 (p = 0.174). This effect persisted at 9 to 24 months in 9 (33.3%) patients in Group 1 and in 2 (7.4%) in Group 2 (p = 0.039). These patients had no AR that required treatment correction. By the end of the study, remission (DAS < 1.6) was seen in 6 (22.2%) patients in Group 1 and in 2 (7.4%) in Group 2 (p = 0.259). The groups showed no significant differences in the progression of X-ray signs of joint destruction. The assessment using the Sharp method indicated that the median erosion scores increased by a point in Groups 1 and 2; the median joint-space narrowing score rose by 8 and 7 points and the median total score increased by 10 and 6.5 points, respectively. There was a functional improvement in both groups. The median HAQ dropped from 1.5 to 0.5 scores in Group 1 and from 2.0 to 0.75 scores in Group 2. The tolerability of combination therapy and MT therapy did not differ greatly. Only 4 (13.3%) patients in Group 1 and 7 (23.3%) were withdrawn from the study because of AR.
Conclusions. Combination disease-modifying therapy with MT, SS, and HC is more effective than MT monotherapy. Tolerability was comparable for both treatments.

rheumatoid arthritis, combination disease-modifying therapy, methotrexate

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