Leflunomide or methotrexate? Comparison of clinical efficacy and safety in low socio-economic rheumatoid arthritis patients

Modern Rheumatology, 01/18/2011

Ishaq M et al. – The results of this study indicate that both leflunomide and methotrexate are effective drugs for the long-term treatment of RA. It was concluded that methotrexate, which is a much cheaper drug than leflunomide, is the drug of choice, especially for patients who belong to low socioeconomic groups.


  • Double-blind randomized clinical trial was carried out at the Department of Medicine, Jinnah Medical College Hospital, Korangi, Karachi
  • 368 enrolled in this study
  • 128 subjects withdrawn during screening phase
  • Of 240 subjects who were randomized and treated, 129 received leflunomide and 111 received methotrexate
  • Duration was 1 year
  • RA activity was clinically assessed by noting changes in the four primary (tender joint count, swollen joint count, physician and patient global assessment score) and three secondary (morning stiffness, pain intensity, HAQ) clinical efficacy end-point
  • Data expressed as mean ± SD
  • P value of <0.05, calculated by paired t test, was considered significant


  • Difference between baseline and 12 month end-point measurements of all primary clinical efficacy end-points was significantly greater in methotrexate-treated than in leflunomide-treated subjects
  • Both leflunomide and methotrexate resulted in significant improvements in all secondary clinical efficacy end-points after 1 year of treatment
  • In both treatment groups, most common reason for withdrawal during treatment was adverse events

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