Adalimumab Plus Methotrexate for JIA-Associated Uveitis
New England Journal of Medicine
Ramanan et al. evaluated the efficacy of adalimumab for uveitis associated with juvenile idiopathic arthritis (JIA) and found that the combination of adalimumab and methotrexate controls inflammation and results in fewer treatment failures than does methotrexate alone. However, they also found that adverse events are more common in patients treated with adalimumab.
In this placebo-controlled study, the efficacy and safety of adalimumab were assessed among 90 children and adolescents (≥ 2 years of age) who had active JIA-associated uveitis. All patients were on a stable dose of methotrexate at study entry and were assigned randomly (2:1) to receive either adalimumab (20 mg or 40 mg, according to body weight) or placebo every 2 weeks by subcutaneous injection. The trial regimen was continued until treatment failure or until 18 months had elapsed. The primary endpoint was time to treatment failure.
During follow-up of ≤ 2 years, treatment failure occurred in 16 (27%) of the 60 children who received adalimumab and in 18 (60%) of the 30 who received placebo (hazard ratio, 0.25; 95% confidence interval, 0.12-0.49; p < .0001). With regard to adverse events, 10.07 events occurred per patient-year in the adalimumab arm, versus 6.51 events per patient-year in the placebo group. The frequency of serious adverse events also was greater in the adalimumab group: 0.29 events per patient-year versus 0.19 events per patient-year in the placebo group. The most common adverse effects associated with adalimumab were minor infections, respiratory disorders, and gastrointestinal conditions. The follow-up time was insufficient to detect events such as cancer or demyelinating diseases.
The original article can be found here.