Comparative Effects of Combination Therapies; Methotrexate with Leflunomide & Sulfasalazine in the Treatment of Rheumatoid Arthritis

Abstract

Objective: To study the role of combination therapies in the treatment of rheumatoid arthritis. Methodology: This open-label, randomized 180-day clinical trial was conducted in the Department of Pharmacology and Therapeutics, BMSI and Medical unit ward 6, after approval of JPMC ethical committee, in which enrolled patients were 89. Patients were divided into two groups, A and B. 44 patients of group A received methotrexate (MTX) 7.5-20 mg/ week orally and Leflunomide (LEF) 10-20 mg/ day orally as maximally tolerated. 45 patients of group B were given MTX 7.5-20 mg/ week orally and Sulfasalazine (SSZ) 500 mg to 1 gm daily orally as maximally tolerated. Result: Comparing the combination of group A with group B, group B showed highly significant improvement in mean swollen joint count (1.9±0.9) and morning stiffness (46.0=19.06) as compared to group A (2.9=1.71, 54.4=10.14). The drugs of group A showed significant improvement in mean pain (2.9= 1.71), physician’s global assessment (2.80±0.97) and patient’s global assessment (1.4=0.66) as compared to group B (1.9= 1.45, 3.8±1.22, 2.0=0.99). Therefore, our study revealed that patients receiving combination of MTX and LEF responded slightly better than MTX and SSZ. Both the combination treatments were well tolerated. Conclusion: Both combinations of MTX & SSZ and MTX & LEF were well tolerated but the efficacy of MTX and LEF was marginally superior to combination of MTX and SSZ.