Effectiveness of leflunomide in patients with juvenile idiopathic arthritis in clinical practice.

OBJECTIVE

To evaluate the effectiveness of leflunomide in children with juvenile idiopathic arthritis (JIA) as used in actual clinical practice.

METHODS

We conducted a retrospective review of medical records of patients with JIA who initiated leflunomide treatment between April 2001 and October 2006. Data derived from these charts included patient baseline characteristics, reason for starting leflunomide, adverse events, joint outcomes, Childhood Health Assessment Questionnaire (CHAQ) scores, visual analog scale pain and well-being scores, and current treatment status.

RESULTS

Fifty-eight patients (33 female, 25 male) were included in this study. Forty-eight patients were switched from methotrexate (MTX) to leflunomide, primarily because of MTX-related adverse events, and leflunomide was added to ongoing MTX in 10 patients. The mean duration of leflunomide therapy was 1.45 years. The mean swollen joint count decreased from 1.40 at treatment initiation to 0.60 at last followup, while the mean tender joint count decreased from 1.83 to 0.29. Improvements were also observed in CHAQ, pain, and well-being scores. At last followup, 44.8% of patients were continuing leflunomide therapy, 29.3% had discontinued because of remission, and the rest had discontinued treatment because of side effects (22.4%) or other reasons (3.4%).

CONCLUSION

Leflunomide treatment, as employed in actual clinical practice, was well tolerated and resulted in substantial improvements in joint and functional status outcomes in children with JIA. Approximately 30% of the patients attained remission during leflunomide therapy. Leflunomide is thus a safe and effective alternative for patients with JIA who cannot tolerate or do not respond to MTX monotherapy.