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.
