Longterm prospective study of methotrexate in rheumatoid arthritis: conclusion after 132 months of therapy.

Objective: To conclude observations of efficacy of longterm methotrexate (MTX) treatment of rheumatoid arthritis (RA).
Methods: Twenty-six patients with RA entered a prospective study of MTX in 1983. The study was completed after 132 months of therapy.
Results: Significant improvement (p < 0.001) was noted in the number of painful joints, swollen joints, and physician and patient global assessments. There was 50% improvement in the joint pain index and joint swelling index in > 65% of the patients. A significant reduction in prednisone dose was achieved. Sixteen patients withdrew from the study. Toxicity led to 3 drug related withdrawals of study patients (alopecia 1; pneumonitis 2). At 132 months, 10 patients (38%) had completed the study; 3 patients (11%) discontinued due to MTX toxicity.
Conclusion: MTX was an effective treatment for RA in this 132 month prospective study.