# Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial

> **NIH NIH UG1** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $1,203,374

## Abstract

PROJECT SUMMARY/ABSTRACT
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-TNF-α 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 significant financial burden for the patient and healthcare system. However, stopping
adalimumab may come with risks of its own; it has been shown that stopping and restarting anti-
TNF-α therapy in patients with other autoimmune diseases is associated with reduced
responsiveness to the drug. Collectively, these reasons contribute to a growing interest in
developing evidence-based guidelines for stopping adalimumab treatment once control of
inflammation has been achieved.
We propose a multicenter, double-masked, randomized controlled trial to address clinically
relevant questions about stopping adalimumab in patients with controlled JIA-associated uveitis.
In patients with controlled JIA-associated uveitis, we will compare rate of recurrence and time to
recurrence of ocular inflammation in patients randomized to discontinue adalimumab compared
to those who continue treatment (Aim 1). We will also evaluate key predictors of JIA-associated
uveitis recurrence by assessing clinical characteristics and potential biomarkers associated with
recurrence of uveitis (Aim 2). Finally, we will determine if stopping adalimumab leads to overall
less control of inflammation at the 6 and 12-month visits, even if patients restart adalimumab after
a uveitis recurrence (Aim 3). By following patients from randomization to potential relapse and re-
treatment, we can better understand the consequences of stopping and restarting adalimumab.
With the increasing use of TNF-α inhibitors, understanding the risks and benefits of stopping
adalimumab in patients with controlled JIA-associated uveitis is important to inform clinical
practice for management of these patients. This study could also identify predictors of relapse
and drug response that would be useful in making evidence-based treatment decisions.
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## Key facts

- **NIH application ID:** 10155488
- **Project number:** 5UG1EY029658-03
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** NISHA ACHARYA
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,203,374
- **Award type:** 5
- **Project period:** 2019-05-01 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10155488

## Citation

> US National Institutes of Health, RePORTER application 10155488, Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (5UG1EY029658-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10155488. Licensed CC0.

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