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Combination methotrexate, leflunomide effective in certain children with polyarticular course JIA
Among certain children with polyarticular course juvenile idiopathic arthritis who did not respond to monotherapy with methotrexate, combination methotrexate and leflunomide treatment appeared to be efficacious and maintain a durable response; however, two patients died after initiating treatment, according to researchers in Mumbai.
The researchers studied 32 patients with polyarticular course juvenile idiopathic arthritis (JIA) at the Jaslok Hospital and Research Centre who were diagnosed according to International League of Associations for Rheumatology (ILAR) criteria. The patients did not respond optimally to methotrexate for at least 3 months and refused biologic treatments due to prohibitive pricing.
Patients received leflunomide in doses based on body weight. Those who weighed less than 20 kg were given 100 mg on day 1 and 10 mg every other day; those who weighed between 20 kg and 40 kg received 100 mg for 2 days and 10 mg per day, thereafter; and patients who weighed more than 40 kg were given 100 mg for 3 days, followed by 20 mg per day. Methotrexate dosages were concurrently reduced to 10 mg/m2 per week. No other disease-modifying anti-rheumatic drugs were permitted during the study period. Pulse steroids, low-dose bridge prednisolone and NSAIDS were permitted.
Adverse effects were monitored through clinical examinations, complete white blood cell counts and liver enzyme tests. Efficacy was assessed at 3 months, 6 months and 1 year after initiation of leflunomide, with the primary efficacy outcome target being American College of Rheumatology
(ACR) Pediatric 30 (Pedi 30) criteria showing a 30% improvement in three of six variables and no worsening in at least one.
At 3 months, 17 (68%) of 25 children met ACR Pedi 30. Seven children dropped out of the study, five due to irregular follow-up in three, and two due to the development of viral hepatitis A, according to the researchers. Between 3 and 6 months, five additional patients withdrew - two due to lack of efficacy, and the development of macrophage activation syndrome in one patient, who later died from the symptoms. Another patient died from the effects of fulminant hepatic failure, a complication of viral hepatitis. One patient withdrew due to lack of adherence, and another due to development of viral hepatitis A.
ACR Pedi 30 was achieved in 17 of 20 patients who completed treatment at 6 months. At 1 year, 18 patients completed follow-up, one reached ACR Pedi 90, 88.8% reached Pedi 30 and 83.3% reached ACR Pedi 50. ACR Pedi 70 was achieved by 61.1% of patients, and 50% met ACR Pedi 90 criteria.
Of the 18 patients who completed follow-up beyond 1 year, 66.6% met ACR Pedi 30, 50 and 70 criteria, according to the researchers. ACR Pedi 90 was reached by 61.1% of patients, who also met Wallace's criteria for remission and were able to discontinue steroid therapy. - by Shirley Pulawski
Disclosur e: The researchers report no relevant financial disclosures.