Our study aims to compare between the effect of methotrexate monotherapy and the effect of combination therapy of methotrexate and leflunomide on blood picture, liver enzymes and disease activity scores in early active rheumatoid arthritis patients.

In summary, our results showed that MTX + LEF combination therapy is an attractive option to consider especially in early active RA patients more than the monotherapy. This is not only because it’s more substantial clinical benefit in improving disease outcomes but also to aim remission as soon as possible where rapid effective treatment intervention becomes a priority to prevent future possible disease complications.

With respect to safety, the combination of MTX + LFN was reasonably well tolerated where it caused less hematological toxicity than MTX monotherapy. Despite that MTX+ LEF combination therapy showed more hepatotoxicity than MTX monotherapy, however, both agents should be preferably avoided in patients with underlying liver disease or those on other hepatotoxic medication. Close monitoring for liver enzymes is advised for both drugs especially when they are combined. Noteworthy that despite these limitations, so far, there is no evidence that leflunomide treatment is associated with the development of clinically significant liver disease