Adalimumab was associated with improved symptoms in children with juvenile rheumatoid arthritis, according to the results of a study published in the Aug. 21 issue of the New England Journal of Medicine.
WEDNESDAY, Aug. 20 (HealthDay News) -- Adalimumab was associated with improved symptoms in children with juvenile rheumatoid arthritis, according to the results of a study published in the Aug. 21 issue of the New England Journal of Medicine.
Daniel J. Lovell, M.D., of the Cincinnati Children's Hospital Medical Center in Ohio, and colleagues analyzed data from patients aged 4 to 17 with active juvenile rheumatoid arthritis. Some were receiving methotrexate and some were not. For a 16-week open-label lead-in phase, 171 received adalimumab every other week. Those with a sufficient response continued. In the following 32-week double-blind phase, the methotrexate group and the non-methotrexate group were randomized to receive adalimumab or placebo. An open-label extension phase then followed.
In the non-methotrexate group, 43 percent receiving adalimumab and 71 percent receiving placebo had disease flares, the researchers report. In the methotrexate group, 37 percent receiving adalimumab had flares, as did 65 percent of those receiving placebo. At the end of 48 weeks, more patients in the methotrexate group treated with adalimumab than placebo had American College of Rheumatology Pediatric (ACR Pedi) 30, 50, 70 and 90 percent responses, they note. Fourteen serious adverse events -- half of them serious infections -- were possibly related to the study drug, the report indicates.
"Adalimumab, alone or in combination with methotrexate, appears to be an efficacious option for the treatment of children with polyarticular juvenile rheumatoid arthritis. Responses were sustained through two years of continued treatment," the authors write.
Abbott Laboratories supported the study. Lovell and several co-authors disclosed financial relationships with Abbott and/or other pharmaceutical companies.
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