Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Trial (ADJUST) - Diversity Supplement

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PROJECT SUMMARY Up to one-third of all patients with juvenile idiopathic arthritis (JIA) develop chronic, asymptomatic, anterior uveitis within 4 to 7 years of their arthritis onset. Patients with JIA-associated uveitis often have poor long-term visual outcomes, including nearly 10 to 15% of patients becoming legally blind. Adalimumab, a TNF-alpha inhibitor, has been demonstrated to be an effective treatment for juvenile idiopathic arthritis-associate (JIA) uveitis, but there is no evidence-based guidelines for the optimal duration of treatment. There are safety concerns with long-term adalimumab treatment as TNF-alpha inhibitors are associated with an increased risk of opportunistic infections and development of immune-mediated resistance to drug. Adalimumab is also expensive for patients and the healthcare systems. The National Health Service in the UK has implemented a policy to withdraw adalimumab from children who respond well to the treatment because of economic reasons, yet there is no scientific evidence to back up this policy of mandatory withdrawal. The ADalimumab in Juvenile Idiopathic Arthritis (JIA)-associated Uveitis Stopping Trial (ADJUST) is a randomized controlled trial to examine uveitis recurrence rates between patients who discontinue adalimumab treatment compared to patients who continue treatment with the following aims: (1) In patients with controlled JIA-associated uveitis, to compare rate of recurrence and time to recurrence of ocular inflammation in patients randomized to discontinue adalimumab compared to those who continue treatment, (2) To determine predictors of JIA-associated uveitis disease recurrence, and (3) To determine if stopping adalimumab leads to overall less control of inflammation at the 12-month visit, even if patients restart adalimumab after a uveitis recurrence. This study will provide an evidence base for guidelines on the risks and benefits of withdrawing adalimumab in patients with JIA-associated uveitis. This proposed diversity supplement will support our candidate in learning how to manage international clinical trials in ophthalmology and gain first-hand experience in data management and analysis by working on ADJUST and other established datasets.