Objective: To study the safety profile of MTX+LEF combination in patients with active RA at 03 and 06 months.
Study Design: Quasi-experimental study.
Place and Duration of Study: Rheumatology department, Fauji Foundation Hospital Rawalpindi, from Jun 2015 to Dec 2015.
Material and Methods: This quasi-experimental study was conducted at Rheumatology department, Fauji Foundation Hospital, Rawalpindi. Seventy two patients who had an active RA despite optimal dose (20- 25mg/week) of MTX were enrolled and leflunomide 20mg/day was added. Patients underwent clinical and laboratory review at 0, 1, 3 and 6 months to note any adverse effects.
Results: Seventy two patients were enrolled with a mean age (years) ± SD of 51.5 ± 9.1 and a mean duration of disease (years) of 8.25 ± 6.1. Patients had active disease at baseline with a mean disease activity score (DAS28) of 6.2 ± 0.7. At 6 months the most frequent side effects (mostly mild); were abdominal pain and nausea. Fifty Seven patients (79.1%) continued with the combination therapy. Only 3 patients stopped the treatment temporarily (due to raised ALT and vomiting). Twelve patients discontinued treatment due to diarrhea, severe oral ulcers, markedly raised ALT; (Each affecting 2 patients) and severe vomiting, abscess, MTX Induced pneumonitis, severe chest infection (each affecting 1 patient).
Conclusion: MTX + LEF combination is safe to use in RA patients if vigilant clinical and laboratory monitoring is ensured.
Keywords : Methotrexate, Rheumatoid arthritis, Safety, Leflunomide.