Anila Nisar, Abid Zaheer Farooqi, Wajahat Aziz, Uzma Rasheed.
Efficacy of Methotrexate Versus Leflunomide Versus Combination of Both in Active Rheumatoid Arthritis.
Ann Pak Inst Med Sci Jan ;12(1):21-6.

Objective: To compare the efficacy and safety of methotrexate (MTX) versus leflunomide (LEF) versus combination of both in patients with active rheumatoid arthritis (RA) Place and duration: This prospective, interventional, open-label, randomized trial was carried out in Department of Rheumatology, Pakistan Institute of Medical Sciences (PIMS), Islamabad over 24 weeks. Materials and Methods: It included 100 adult patients with active RA. Patients were randomized to receive methotrexate, leflunomide or combination of both in a 1:1:1 ratio. Dose adjustment was done according to clinical response. Disease Activity Score (DAS) 28, American College of Rheumatology (ACR) response & and adverse effects were noted at each visit. Results: Seventy-three patients completed 24 weeks of the trial including 26, 24 and 23 patients in methotrexate, leflunomide and combination group respectively. DAS 28 remission was achieved in 30.8%, 37.5% and 26.1% patients at 24 weeks in methotrexate, leflunomide and combination group respectively. ACR 20 response was seen in 84.6%, 83.3%, 78.3%; ACR 50 response was seen in 53.8%, 45.8%, 43.5% and ACR 70 response was seen in 23.1%, 16.7% & 21.7% in methotrexate, leflunomide and combination groups respectively. However this difference in response between three groups was not statistically significant. Adverse effect profile was also comparable between 3 groups with anorexia, nausea, raised alanine transaminase (ALT) and infections being the commonest. Conclusion: Both methotrexate and leflunomide are equally effective in patients with active RA. There is no added benefit of combination treatment in DMARD naïve patients. Combination of methotrexate and leflunomide is safe and well tolerated and can be used if regularly monitored for adverse effects.

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