Efficacy and safety of methotrexate in the treatment of rheumatoid arthritis: a retrospective study

Background: The clinical efficacy and safety of leflunomide (LFN) at a dose of 10 mg/day in the treatment of patients with rheumatoid arthritis (RA) is still unclear. We conducted this retrospective study to identify its efficacy and safety in comparison with methotrexate (MTX) at a dose of 10 mg/week. Methods: We enrolled RA patients who were treated in our hospital from January 2013 to December 2020, and the American College of Rheumatology ( ACR) 1987 criteria were adopted. The following data was collected: age, duration of disease, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor (RF), cyclic citrullinated peptide (CCP) antibody, white blood cell (WBC), and hemoglobin (Hb) level. The primary outcomes included the changes of the above variables and the incidence of adverse events after treatment in both groups. Results: From January 2013 to December 2020, a total of 612 patients with RA treated in our hospital were screened. After excluding cases that did not meet the inclusion criteria, 33 cases remained in LFN group, and there were 59 cases in the MTX group. The baseline characteristics were similar between the LFN and MTX groups. After 24 weeks of treatment, there were still no significant differences between the two groups in all of the above variables. The infection rate was slightly higher in patients treated with MTX than those treated with LFN, while diarrhea episodes were more common in the LFN group. Conclusions: Our data indicated that compared with MTX at a dose of 10 mg/week, a low dose of LFN at 10 mg/day might be a preferable treatment choice for RA patients.