Safety Profile Of Methotrexate And Leflunomide In Rheumatoid Arthritis
Keywords:
Rheumatoid arthritis, Methotrexate, Leflunomide, Laboratory parameters, Adverse effectsAbstract
Objective: To compare the safety profile of Methotrexate and Leflunomide in patients of rheumatoid arthritis. Material and Methods: A 24-week, single-blind, interventional, study was carried out on 274 patients of either sex, aged 29-69 years, diagnosed to have rheumatoid arthritis. One group was given tablet Methotrexate, 10 mg (four 2.5 mg tablets), once weekly and the other was put on tablet Leflunomide, 20 mg, once daily, orally. At each follow up laboratory parameters (Hb%, TLC, ESR, PC, SGPT,S Creatinine) and adverse effects were evaluated. Results: Of the 274 patients, 126 were on Methotrexate (70.63 % females, 61.11% RF positive, mean age 45.57 + 10.32 years) and 148 on Leflunomide (79.72 % females, 73.64 % RF positive, mean age 46.35 + 9.68 years). Laboratory parameters (TLC, SGPT, creatinine) between the two groups showed statistically significant results at the end of the study. Nausea was seen in 30.2% & 10.8% patients at 6 weeks and 5.6% and 0% at 24 weeks in the Methotrexate and Leflunomide groups respectively while alopecia was seen in 0% & 19.6% patients at 6 weeks and 1.6% & 24.3% at 24 weeks in the Methotrexate and Leflunomide groups respectively. All values were significant statistically. Conclusion: Leflunomide was found to have a better safety profile than Methotrexate as it produced greater improvement in laboratory parameters with lesser adverse effects in comparison to the traditionally used, first-choice, drug Methotrexate.
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