Comparative Effectiveness of Methotrexate Monotherapy versus Combination Therapy in Rheumatoid Arthritis Patients in Pakistan

Abstract

Background: RA remains one of the chief causes of morbidity in Pakistan. In the existing environment of Pakistan, there are delays in the diagnosis of RA and limited access to biologic therapy. MTX has been the frontline treatment of RA. Pakistan has not explored combining MTX and conventional DMARDs. Objectives: To evaluate the clinical efficacy and safety of MTX monotherapy compared to MTX plus LEF combination therapy in the treatment of active RA. Methods: A parallel group clinical trial was performed at the Iqra Medical Complex in Lahore. A total of 48 adult patients with active RA were randomly allotted to treatment groups at a 1:1 ratio, receiving MTX alone and combined MTX and LEF therapy. End points used in the study were the change in the intensity of the DAS-28 measure of the level of pain, the HAQ scale of activity, joint counts, ESR, CRP levels, and the number of adverse events. The study used intention-to-treat analysis. Results: In both groups there was a significant improvement within groups (p < 0.001). The combination group showed a greater reduction in DAS28 (-1.72 vs. -1.18), VAS pain (-3.0 vs. -2.1), HAQ (-0.61 vs. -0.42), ESR levels, and CRP levels compared to the other group. In addition, there were no severe side effects. The frequency of mild hepatic enzyme Conclusion: MTX plus LEF has clear short-term benefits over MTX therapy in controlling the disease and can be considered a feasible treatment approach in resource-limited clinical settings.