THURSDAY, Feb. 3 (HealthDay News) -- Treatment of systemic onset juvenile idiopathic arthritis (SOJIA) with Givinostat, an orally active histone deacetylase inhibitor, for 12 weeks appears to be safe, well-tolerated, and effective, according to a study published online Jan. 18 in Arthritis & Rheumatism.
Jelena Vojinovic, M.D., Ph.D., of the University Clinic Center in Serbia, and colleagues administered 1.5 mg/kg Givinostat daily for at least one month and up to 12 weeks in 17 SOJIA patients with active disease. Disease activity was evaluated clinically using the ACR Pedi 30, 50, or 70, and a systemic feature score. Safety was considered the primary objective, with the primary end point the number of patients to complete 12 weeks of treatment.
The researchers found the drug to be safe and well tolerated. Adverse events were mild or moderate, of short duration, and self-limiting. No patient was withdrawn from the study due to adverse effects of the drug. Among the per protocol population (nine of 17 patients), the ACR Pedi 30, 50, or 70 improvement was 77.8, 55.6, and 22.2 percent, respectively, at week four, and further improved to 77.8, 77.8, and 66.7 percent, respectively, at week 12. The most consistent finding was a decrease in the number of active joints and/or joints with limited range of motion.
"Givinostat induced significant benefits, particularly in reducing the arthritic component of the disease. The study also established an excellent safety profile," the authors write.
One of the study authors disclosed financial ties with Italfarmaco S.p.A., which also provided partial funding for the study.
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