Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial
Primary result · Treatment failureResult — go to the resultHazard ratio 8.7 95% CI 3.6–21.2Authors' conclusion
Discontinuing adalimumab led to higher rates of recurrence of uveitis, arthritis, or both in patients with previously controlled juvenile idiopathic arthritis-associated uveitis. However, all patients who had treatment failure successfully regained control of inflammation by the end of the 48-week study period after restarting adalimumab.
Study context
- Population
- Patients aged ≥2 years with JIA-associated uveitis, with controlled arthritis and uveitis for ≥1 year on adalimumab; 20 ophthalmology and rheumatology clinics in the USA, UK and Australiaall included in analyses
- Participants
- 87 patients
- Comparison
- Continuing adalimumab vs placebo (discontinuation) every 2 weeks until 48-week visit or treatment failure
- Adalimumabn = 43reference
- Placebon = 44
- Primary endpoint
- Time to treatment failure, defined by recurrence of uveitis or arthritis
- Follow-up
- 48 weeks
Methodological detailsmulticentre, double-masked, placebo-controlled, 1:1 randomisation, prespecified interim stopping criteria met; enrolment stopped, Enrolled March 3, 2020, to Feb 14, 2024, Unmasking at treatment failure; open-label adalimumab offered through 48 weeks, One patient in each group dropped out; data included in analyses
- Multicentre
- Double-masked
- Placebo-controlled
- 1:1 randomisation
- Prespecified interim stopping criteria met; enrolment stopped
- Enrolled March 3, 2020, to Feb 14, 2024
- Unmasking at treatment failure; open-label adalimumab offered through 48 weeks
- One patient in each group dropped out; data included in analyses
Primary result
Treatment failure
Hazard ratio
8.7
95% CI 3.6–21.2
P < 0.0001
Events by treatment group
Placebovs Adalimumab
HR 8.7 (95% CI 3.6–21.2); P < 0.0001
As reported in the abstract
Further findings
- Time to re-establishing sustained control of inflammation after restarting adalimumab (placebo) — Placebo
- median 105 (IQR 63–196) days
- Time to treatment failure (placebo)
- 119 · median · IQR 84–243 · days
Safety
Non-serious adverse events
| Outcome | Adalimumab | Placebo |
|---|---|---|
| Serious adverse events | 4 events | — not stated in the abstract |
— not stated in the abstract
Serious adverse events
- Four serious adverse events reported, all in the adalimumab group
Original publication
Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial. Lancet. Published 25 January 2025. doi:10.
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