Adalimumab in combination with methotrexate is an effective treatment for children with JIA associated uveitis, a study in this week’s NEJM reports.
The randomised placebo controlled SYCAMORE trial involving 90 children and adolescents with JIA and active uveitis was stopped early because of a strong beneficial effect in the treatment arm.
Overall, at two-year follow up 27 percent of the adalimumab (Humira) and methotrexate treated patients met the primary outcome of treatment failure (defined by the Standardization of Uveitis Nomenclature score) compared to 60% of patients randomised to placebo and methotrexate (HR 0.25; 95% CI 0.12 to 0.49).
However, adverse and serious adverse events occurred in a greater proportion of patients in the adalimumab arm compared to patients taking methotrexate alone (10.1 adverse events and 0.3 serious adverse events per patient year vs 6.5 and 0.2 events per patient year).
The most common adverse events in the adalimumab group were minor infections, respiratory infections and gastrointestinal disorders.
According to an accompanying editorial the trial was ‘notable’ given there are very few controlled trials investigating treatments for childhood uveitis.
The trial was also a welcome addition to the literature as it provided “valuable efficacy and safety data for the use of adalimumab in children with JIA associated uveitis”.
All patients in the study received weekly oral or subcutaneous methotrexate (10 to 20mg per sqm up to 25mg). Patients randomised to adalimumab received 20mg every two weeks if they weighed less than 30kg or 40mg if they weighed above 30kg).
The study was funded by the NIHR health technology assessment programme and Arthritis Research UK.