Adalimumab Dose Adjustment for Pediatric uveitis Treatment (ADAPT) Trial

NIH RePORTER · EY · UG1 · $1,655,047 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY Juvenile idiopathic arthritis (JIA) is the most common rheumatologic condition in children, and 12-38% of patients with JIA develop chronic asymptomatic anterior uveitis, typically within 4 to 7 years of arthritis onset. JIA- associated uveitis can cause significant morbidity, with as many as 1/3 of all patients developing substantial visual impairment and up to 15% becoming legally blind. The anti-tumor necrosis factor (TNF) human monoclonal antibody adalimumab has shown efficacy in treating JIA-associated uveitis but is associated with a risk of serious adverse events, including opportunistic infections and malignancy. Furthermore, long-term treatment with adalimumab is expensive and causes a significant financial burden for the patient and healthcare system. The Adalimumab in Juvenile Idiopathic Arthritis (JIA)-associated Uveitis Stopping Trial (ADJUST), an NEI-funded, double-masked, randomized controlled trial recently conducted by our team, revealed 64% cumulative failure among patients with previously stable JIA-associated uveitis at 24 weeks after stopping adalimumab. The rate of recurrence of inflammation when stopping adalimumab was high, even when over 70% of the patients had over two years of controlled uveitis. Encouragingly, all patients who relapsed regained control upon restarting treatment. Collectively, these reasons contribute to a growing interest in developing evidence-based guidelines for reduction in adalimumab dose frequency once control of inflammation has been achieved. We propose to conduct a multicenter, parallel-treatment, observer-masked, randomized trial to generate an adalimumab regimen-response curve with rates of treatment failure in patients with controlled JIA-associated uveitis across a range of adalimumab injection frequencies. (Aim 1). 160 patients across eighteen clinical centers will be randomized to one of four regimens: 1) injections administered every 2 weeks (standard of care) 2) injections administered eve

Key facts

NIH application ID
11265117
Project number
1UG1EY038172-01
Recipient
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
Principal Investigator
NISHA ACHARYA
Activity code
UG1
Funding institute
EY
Fiscal year
2026
Award amount
$1,655,047
Award type
1
Project period
2026-01-01T00:00:00 → 2030-12-31T00:00:00