To determine the efficacy and safety of the combination of leflunomide (LEF) and methotrexate (MTX) for the treatment of patients with active RA in an open, non-comparative, multicentre trial.
Combination Treatment with Leflunomide and Methotrexate for Patients with Active RA
22 Sep, 10
Combination Treatment with Leflunomide and Methotrexate for Patients with Active Rheumatoid Arthritis
Objective
Methods
- 74 patients with active RA were enrolled to receive concomitantly LEF (no loading dose, 10 mg/day) and MTX (starting at 7.5 mg/week and titrating up to 15 mg/week) for 20 weeks.
- Primary end-point - 20% improvement in the ACR criteria at 20 weeks
- Safety measures - evaluation of adverse events at each visit and laboratory data, including haematology and liver function tests. Intention-to-treat analyses were conducted.
Results
65 patients completed 20 weeks of treatment, and 71.6% were responders based on the ACR20 criteria. Mean changes after 20 weeks -
- Adverse events occurred in 40.5% of the patients, and were considered serious in 4 patients who discontinued therapy.
- Abnormal liver function was noted for 16 patients (21.6%). 2 of these patients were withdrawn from the study; after discontinuing the medication, their liver function recovered fully.
Conclusions
The combination of LEF and MTX was effective and well tolerated in the treatment of active RA patients. This combination may be a useful option as an initial treatment for active RA before starting biological agents.
Scand J Rheumatol. 2009; 38(1): 11-4.
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