A 16-week multicenter observational study of the efficiency and safety of rheumatoid arthritis therapy with methotrexate

Objective: to evaluate the efficiency of combination therapy with methotrexate (MTX) and hydroxychloroquine (HC) in rheumatoid arthritis (RA) in real clinical practice.

Patients and methods. The investigation enrolled 430 patients with documented RA who had been followed up for 16 weeks by rheumatologists in different regions of the country. Individual schedules were filled out for the patients, by adding demographic, clinical, and laboratory parameters that made it possible to assess the activity of the disease and to estimate the level of glucose, cholesterol, and low-density lipoproteins (LDL). The results of the investigation were evaluated at the inclusion of patients in it and then at 8 and 16 weeks. Taking into account the insufficient previous effect of MTX, the treatment was enhanced by HC.

Results and discussion. By the end of the investigation, the combination therapy with MTX + HC led to significant decreases in the number of swollen and tender joints, the duration of morning stiffness, the severity of pain, and the integrated DAS28 index. The therapy showed a positive effect on the levels of fasting glucose, cholesterol, and LDL. The quality of life improved in patients by Visit 3. The results obtained are in good agreement with the data by foreign and Russian investigators on the greater efficiency of combination therapy with MTX + HC than that of MTX monotherapy and on the pleiotropic (hypolipidemic and hypolipidemic) effect of HC.

Conclusion. It is concluded that in Russian practice when monotherapy with MTX shows an insufficient effect or its high doses cannot be administered to enhance the efficacy of RA therapy, it is possible to use a combination of MTX + HC, especially in older patients with comorbidity (hyperglycemia and hypercholesterolemia).

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