Combination Pulse Therapy with Methotrexate and Dexamethasone in Patients with Early Rheumatoid Arthritis and Poor Prognostic Factors: an Open-Label Randomized Trial

Objective: To study the efficiency and tolerance of two pulse therapy regimens: combination pulse therapy with highdose methotrexate (MT) and high-dose dexamethasone and pulse therapy with dexamethasone. Subjects and methods. The trial enrolled 100 patients with early rheumatoid arthritis (RA) treated with two pulse therapy regimens and then followed up for 1 year during standard MT therapy. The efficiency of the treatment was evaluated using the ACR 20/50/70 criteria. The number of swollen and tender joints (SJ and TJ), erythrocyte sedimentation rate, C-reactive protein levels, systemic disease activity and a need for nonsteroidal anti-inflammatory drugs and glucocorticoids were determined. Results and discussion. After 1 month of therapy, the patients of both groups showed significant positive changes in all assessed parameters of RA activity. By this time, after combination pulse therapy with MT and dexamethasone, there was a more significant reduction in the number of SJ, total activity scores given by a patient and a physician, and pain intensity according to the visual analogue scale. By the end of 1and 3-month follow-ups, a 70% improvement was significantly more frequently noted in the combination pulse therapy group than in the monotherapy group. During a subsequent follow-up, the number of TJ and SJ tended to further decrease; however, the group differences were leveled. Evaluation of X-ray progression trends at 12 months of follow-up revealed no significant differences between the patients of the study groups. There were neither differences in the rate of adverse reactions nor severe complications. Conclusion. Combination pulse therapy with MT and dexamethasone was an effective and well tolerated option, the use of which could lower RA activity considerably, accelerate the therapeutic effect of MT, and reduce symptomatic therapy volume in the shortest possible time.