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Safety and efficacy of Methotrexate Monotherapy Vs Methotrexate Plus Leflunomide Combination Therapy in Early Active Rheumatoid Arthritis Patients

Mariane S. Boshra, Amira S Ahmed, Heba F. Salem, Mohamed N. Abd El Hamid.

MTX has long been considered as the anchor drug in RA treatment, however given, its high failure rate and the multifactorial nature of the disease, there has been a great interest in developing more powerful and tolerable MTX combination therapies. Leflunomide has long been appreciated to be a suitable alternative therapy used on its own or with MTX due to its equivalent efficacy and structural similarity. The aim of the study was to compare the efficacy and safety of a combination therapy of MTX plus LEF to MTX alone when used with early active rheumatoid arthritis patients. Fifty female patients with early active RA were randomly allotted in two groups each of 25. Patients were randomized to receive MTX or MTX+LEF. Analysis of DAS28 score, complete blood picture, and liver enzymes at the start and post 24 weeks of treatment with study regimens was performed, compared and evaluated. MTX+LEF combination therapy was more significantly beneficial in decreasing DAS28 score compared to MTX alone. The combination therapy showed less effect on blood components, but was more hepatotoxic compared to MTX monotherapy. The combination therapy is a more attractive option to consider especially in early active RA patients than MTX monotherapy. It is more clinically beneficial in improving disease outcomes, well tolerated, with less hematological toxicity and only showed mild hepatotoxicity. Taken into consideration proper monitoring of liver toxicity, this combination is safe and more effectively intervene early in the disease process thus preventing future possible complications and aiming better remission.

Key words: Rheumatoid, methotrexate, leflunomide, liver enzymes, DAS28

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