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Leflunomide Dose Should Not Be Reduced in Active Rheumatoid Arthritis: Presented at EULAR
By Adrian Burton
LISBON, PORTUGAL -- June 20, 2003 -- The standard dose of 20 mg/day of leflunomide cannot be reduced if full efficacy is to be maintained in patients with active rheumatoid arthritis– and reducing the dose does not reduce the risk of side effects, researchers reported here June 19th at the Annual European Congress of Rheumatology.
"The usual dose is 20 mg/day," explained Gyula Poor, a professor of rheumatology at the National Institute of Rheumatology and Physiotherapy, in Budapest, Hungary. "But we were interested in whether we could reduce the dose to 10 mg/day to see if this was not inferior, and to see if we could reduce side effects."
In a phase IIIb, 12-country trial, Dr. Poor and colleagues randomised 202 subjects to receive leflunomide 10 mg/day and 200 to receive 20 mg/day of leflunomide following a 100 mg loading dose. Baseline demographic and disease characteristics of the two groups were not significantly different.
The efficacy of the two doses was evaluated by tender and swollen joint counts, and the Health Assessment Questionnaire Disability Index (HAQDI).
At the 16-week end point, the mean reduction in the number of tender joints for the 10 mg and 20 mg groups was 7.57 and 8.89, respectively (P=0.0617). With respect to mean HAQDI score, the 10 mg group saw a reduction of 0.37 and the 20 mg group a reduction of 0.49 (P=0.0946).
Although there was no significant difference in the reduction of the mean number of swollen joints between the two groups (-6.38 for the 10 mg group and –6.96 in the 20 mg group), overall, the results clearly show the 10 mg regimen to be inferior, Dr. Poor said.
The inferior efficacy of the 10 mg regimen was not compensated for by lower incidence of side effects, the research shows. No significant differences were seen in the number of patients in both groups show developed diarrhoea, alopecia, nausea, hypertension, headache and gastrointestinal pain.
"The message to take home is please stick to the 20 mg regimen," concluded Dr. Poor.
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