SAFETY PROFILE OF METHOTREXATE ALONE VS COMBINATION METHOTREXATE PLUS LEFLUNOMIDE IN PATIENTS WITH RHEUMATOID ARTHRITIS
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Keywords
Rheumatoid arthritis, Methotrexate, Leflunomide, Safety profile, Adverse events, Liver function, Renal function, DMARDs
Abstract
Background: Rheumatoid arthritis (RA) is a chronic inflammatory disorder causing significant morbidity and impaired quality of life. Methotrexate (MTX) is a cornerstone treatment for RA, but combination therapy with other disease-modifying antirheumatic drugs (DMARDs) like leflunomide (LEF) is often used for better disease control. Despite its widespread use, the safety profile of this combination needs thorough assessment.
Objective: This study aims to evaluate the safety profiles of MTX alone versus MTX plus LEF in patients with RA, focusing on liver and renal function tests, hematological disturbances, gastrointestinal side effects, and infections.
Methods: This prospective cohort study was conducted at the Department of Rheumatology, Lady Reading Hospital, Peshawar, from April, 2024 to Sep, 2024. A total of 303 participants were enrolled and divided into two groups one receiving MTX alone (n=151) and the other receiving MTX plus LEF (n=152). Baseline characteristics, adverse events, and laboratory results were collected and analyzed using SPSS version 25, with a p-value of <0.05 considered significant.
Results: The combination therapy group (MTX+LEF) exhibited a higher incidence of elevated
liver function tests (26.3% vs. 18.5%,p=0.034).Elevated renal function tests were more common
in the MTX+LEF group (14.5% vs. 11.3%,p= 0.219), as was anemia (29.6% vs. 22.5%, p=0.099). Gastrointestinal side effects were reported more frequently in the combination group (22.4% vs. 15.2%, p=0.075), along with infections (14.5% vs. 9.9%, p= 0.188). While these differences were not statistically significant for renal function, anemia, gastrointestinal side effects, and infections, they are clinically relevant.
Conclusion: The combination of MTX and LEF in RA patients is associated with a higher incidence of elevated liver function tests and other adverse events compared to MTX alone. These findings underscore the importance of vigilant monitoring and patient education in managing RA with DMARD therapy.
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Farah Rabbani
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Medrar Ullah Khan
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Qasim Shah
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Muhammad Waqas
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Muhammad Sajid
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Tarmim Lal
Trainee Medical Officer, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan
Zia Ud Din
Assistant Professor, Department of Rheumatology, Lady Reading Hospital, Peshawar, Pakistan