Adalimumab Combined with Methotrexate as the Initial Treatment for Active Noninfectious Uveitis in Chinese Children: A Pilot Study

Abstract

Objectives: To investigated the effectiveness, safety and corticosteroids-sparing effects of adalimumab (ADA) plus methotrexate (MTX) as initial treatment in active pediatric noninfectious intermediate uveitis, posterior uveitis or panuveitis (NIPPU).

Methods: This was a prospective open-label pilot trial in 30 patients (54 eyes) between three to seventeen years old diagnosed with new-onset active NIPPU. All of the patients were treated with ADA plus MTX. Main outcome measures were remission rate and the time to reach remission. Corticosteroids-sparing effects and other ocular parameters were recorded. Approval Number: 2020KYPJ104. ClinicalTrials.gov identifier: NCT04588818.

Results: The remission rate within 6 months was 76.67% (23/30) and reached to 90.0% (27/30) at 12 months. The average time to reach remission was 5.3±1.5 months with a follow-up time of 12.1±2.6 months. The initial dosage of oral corticosteroids was 0.43±0.34 mg/kg/day with a corticosteroid stopping time of 14.2 (IQR 3.50, 29.29) weeks. The cumulative corticosteroids dose was 456.25 (IQR 142.50, 1396.25) mg/per patient. All ocular parameters improved significantly during follow up.

Conclusions: ADA plus MTX as initial treatment shows great effectiveness and safety in active pediatric NIPPU patients, providing a satisfying corticosteroid-sparing effect. More aggressive ADA therapy as initial treatment might lead to better prognosis in these children.