medwireNews: Trial results published in The New England Journal of Medicine suggest that adding adalimumab to methotrexate treatment enhances the control of inflammation and reduces the rate of treatment failure among children and adolescents with juvenile idiopathic arthritis (JIA)-associated uveitis.
“Uveitis in children is an important cause of loss of vision,” said study lead Athimalaipet Ramanan (Bristol Royal Hospital for Children, UK) in a press release.
“This is the first randomised trial of its kind worldwide and the results will have a major impact in children with uveitis all around the world,” he continued.
In the phase II/III SYCAMORE trial, children and adolescents with active JIA-associated uveitis who were taking a stable dose of methotrexate were randomly assigned to receive either the humanized anti–tumor necrosis factor-α monoclonal antibody at a dose of 20 or 40 mg or placebo for 18 months.
Treatment failure – defined with the use of a multicomponent inflammation score based on the Standardization of Uveitis Nomenclature grading scale for anterior uveitis – occurred in 27% of 60 patients in the adalimumab group compared with 60% of 30 patients in the placebo group, a significant difference.
And the addition of adalimumab significantly delayed the time to treatment failure, with the median not reached in those receiving adalimumab versus 24.1 weeks for patients taking placebo.
These findings suggest that adalimumab combined with methotrexate is “an effective therapy in children and adolescents with JIA-associated uveitis,” say the study authors.
However, adverse events (AEs) and serious AEs occurred more frequently among children receiving adalimumab compared with placebo, with respective rates of 10.07 and 0.29 per patient–year versus 6.51 and 0.19 per patient–year.
The most commonly reported AEs in the adalimumab group were cough, vomiting, and oropharyngeal pain, experienced by 37%, 30%, and 27% of participants, respectively, compared with 10%, 17%, and 23% of the placebo group. Infections and infestations were the most common serious AEs, reported by 13% of patients receiving adalimumab and none of the placebo group.
The author of an accompanying editorial, Jennifer Thorne (Johns Hopkins University School of Medicine, Baltimore, Maryland, USA), believes that the SYCAMORE trial “provides valuable efficacy and safety data” for the use of adalimumab in this patient population.
However, she cautions that as the study was limited to participants who had active disease despite methotrexate treatment, “the patients in the trial probably had more severe disease than is typically the case,” meaning that the findings “are most likely not generalizable to all patients being treated for JIA-associated uveitis.”
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