Weekly doses of adalimumab are a safe treatment for juvenile arthritis patients or children with chronic eye inflammation, a study reports.
Adalimumab, sold as Humira and under other brand names, is a biological agent that the U.S. Food and Drug Administration approved as a treatment for moderate-to-severe polyarticular juvenile arthritis.
Doctors also prescribe it off-label to treat other inflammatory conditions, including enthesitis-related juvenile arthritis, oligoarticular juvenile arthritis, juvenile psoriatic arthritis, and the eye inflammation chronic uveitis. Physicians sometimes prescribe approved drugs for conditions not listed on the treatments’ label — a practice that’s legal.
The FDA recommends that adalimumab be administrated every other week — a regimen that clinical trials showed to be safe and effective. But many doctors prescribe weekly doses of the therapy to help children manage their rheumatic diseases better.
Scientists know the weekly doses are safe in children and adults with several autoimmune diseases, but they didn’t know whether they were safe for children with rheumatic diseases.
University of Minnesota researchers decided to see if they were safe for children with juvenile arthritis or uveitis.
Their research, “Safety of weekly adalimumab in the treatment of juvenile idiopathic arthritis and pediatric chronic uveitis,” appeared in the journal Clinical Rheumatology.
The study included 60 children and adolescents treated at the University of Minnesota and Gillette Children’s Hospital between January 2003 and November 2015. Of the patients who received adalimumab during that time, 26 percent were on weekly doses at some point.
Twenty-eight percent of the patients who received adalimumab weekly took it for uveitis, 25 percent for rheumatoid factor-negative polyarticular juvenile arthritis, and 17 percent for oligoarticular juvenile arthritis. The mean age at which patients started the weekly doses was about 14. Ninety percent stayed on the regimen more than three months.
While they were receiving weekly doses of adalimumab, most of the patients were also on other therapies. Eighty-three percent were receiving methotrexate, 67 percent non-steroidal anti-inflammatory drugs, and 47 percent oral prednisone.
Twenty-four patients on the weekly adalimumab doses, or 40 percent, developed infections that did not need to be treated. Twenty-four other patients developed infections requiring antibiotics. And three developed infections that were bad enough to require hospitalization.
Serious reactions to the weekly doses were rare. Only two patients developed a new autoimmune disease — one multiple sclerosis and one autoimmune hepatitis.
Taken together, the results showed that off-label weekly administration of adalimumab is a safe option for treating children with juvenile arthritis or chronic uveitis.
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