Trial results for the study "Adalimumab in JIA-associated Uveitis Stopping Trial" (NCT03816397) were posted on ClinicalTrials.gov on 2025-03-26. The study investigated discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA). Results showed that stopping adalimumab led to a median time to treatment failure of 119 days, with a hazard ratio of 8.7 for treatment failure compared to continuing treatment.
Background
The study aimed to determine the feasibility of discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU).
Trial design
The "Adalimumab in JIA-associated Uveitis Stopping Trial" (NCT03816397) was a Phase 4, stratified, block-randomized, double-masked, controlled trial that enrolled 87 participants. The study investigated adalimumab in patients with uveitis associated with juvenile idiopathic arthritis (JIA) or chronic anterior uveitis (CAU). The trial compared continuing adalimumab treatment versus discontinuing it.
Key results
The trial evaluated "Time to Treatment Failure" as a key outcome:
- For the group that continued adalimumab, the median time to treatment failure was NA.
- For the group that stopped adalimumab, the median time to treatment failure was 119 days.
A Log Rank analysis was conducted to compare time to treatment failure between the adalimumab and placebo groups up to 48 weeks. The analysis showed a Hazard Ratio (HR) of 8.7 (95.0% CI: 3.6 to 21.2) with a p-value of 0.0001. This indicates a significantly increased risk of treatment failure for patients who discontinued adalimumab compared to those who continued treatment.
What this means
These results indicate that discontinuing adalimumab treatment in patients with quiescent uveitis associated with juvenile idiopathic arthritis significantly increases the risk of treatment failure. The median time to treatment failure of 119 days for those who stopped treatment, coupled with a high hazard ratio, suggests that continued adalimumab therapy is important for maintaining disease control in this patient population. Clinicians should consider these findings when evaluating treatment strategies for patients with JIA-associated uveitis who are in remission.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03816397, titled "Adalimumab in JIA-associated Uveitis Stopping Trial," were posted on 2025-03-26 on clinicaltrials.gov.