TY  - JOUR
AV  - public
Y1  - 2025/01/25/
EP  - 313
TI  - Stopping of adalimumab in juvenile idiopathic arthritis-associated uveitis (ADJUST): a multicentre, double-masked, randomised controlled trial
PB  - Elsevier BV
N2  - Background:
Adalimumab is an effective treatment for juvenile idiopathic arthritis-associated uveitis. Data are scarce on the effects of discontinuing adalimumab after control of the disease had been reached. We aimed to assess efficacy and safety of discontinuing treatment in patients with juvenile idiopathic arthritis-associated uveitis.
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Methods:
We conducted a multicentre, double-masked, randomised, placebo-controlled trial at 20 ophthalmology and rheumatology clinics across the USA, the UK, and Australia. Patients aged at least 2 years who had controlled arthritis and uveitis for at least 1 year on adalimumab were randomly assigned in a 1:1 ratio using a web-based system to receive adalimumab or placebo, administered subcutaneously every 2 weeks until the 48-week visit or treatment failure. The primary outcome was the time to treatment failure, defined by recurrence of uveitis or arthritis; all participants were included in the primary and safety analysis. Unmasking occurred at treatment failure, and patients were offered open-label adalimumab through 48 weeks of follow-up. This trial was registered with ClinicalTrials.gov (NCT03816397).
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Findings:
87 patients were enrolled from March 3, 2020, to Feb 14, 2024, whereafter the prespecified interim stopping criteria were met and enrolment was stopped. One patient in each group dropped out but data were included in analyses. Six (14%) of 43 patients in the adalimumab group and 30 (68%) of 44 patients in the placebo group had treatment failure (hazard ratio 8·7, 95% CI 3·6?21·2; p<0·0001). The median time to treatment failure in the placebo group was 119 days (IQR 84?243). The median time to re-establishing sustained control of inflammation in the placebo group after restarting adalimumab was 105 days (63?196). 226 non-serious adverse events occurred in the adalimumab group (7·5 events per person-year, 95% CI 6·5?8·5), and 115 non-serious adverse events occurred in the placebo group (6·8 events per person-year, 5·6?8·1). Four serious adverse events were reported, all in the adalimumab group.
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Interpretation:
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.
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Funding:
US National Institutes of Health (National Eye Institute).
ID  - discovery10204324
IS  - 10475
N1  - Copyright © 2025 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0
license, https://creativecommons.org/licenses/by/4.0/.
VL  - 405
SP  - 303
A1  - Acharya, Nisha R
A1  - Ramanan, Athimalaipet V
A1  - Coyne, Alison B
A1  - Dudum, Kathryn L
A1  - Rubio, Elia M
A1  - Woods, Sydney M
A1  - Guly, Catherine M
A1  - Moraitis, Elena
A1  - Petrushkin, Harry JD
A1  - Armon, Kate
A1  - Puvanachandra, Narman
A1  - Choi, Jessy T
A1  - Hawley, Daniel P
A1  - Arnold, Benjamin F
A1  - Lietman, Thomas
A1  - Porco, Travis
A1  - Von Scheven, Emily
A1  - Keenan, Jeremy
A1  - Lopez, Sarah
A1  - Gonzales, John
A1  - Ebert, Caleb
A1  - Lionetti, Geraldina
A1  - Malli, Shreya
A1  - Shantha, Jessica
A1  - Richards, Jason
A1  - Nixon, Danaye
A1  - Jackson, Kaitlyn
A1  - Doan, Thuy
A1  - Ouimette, Kevin
A1  - Zhong, Lina
A1  - Chen, Cindi
A1  - Cleary, Gavin
A1  - Gonzales-Martin, Jose
A1  - Angeles-Han, Sheila T
A1  - Utz, Virginia Miraldi
A1  - Lerman, Melissa A
A1  - Davidson, Stefanie
A1  - Stahl, Erin
A1  - Cooper, Ashley M
A1  - Dacey, Mark
A1  - Moore, Katharine F
A1  - Cooper, Jennifer C
A1  - Muthusamy, Brinda
A1  - Emami-Naeini, Parisa
A1  - Herrera Guerra, Angel Alberto
A1  - Jandial, Sharmila
A1  - Connor, Alan
A1  - Solebo, Ameenat Lola
A1  - Wedderburn, Lucy R
A1  - Ralph, Elizabeth
A1  - Sridhar, Arani
A1  - Kapoor, Bharat
A1  - Davis, Janet L
A1  - Pala, Ozlem
A1  - Renton, William D
A1  - Troutbeck, Robyn
A1  - Ashworth, Jane
A1  - Chieng, Alice
A1  - Crowell, Eric
A1  - Orrock, Janet
A1  - Vitale, Albert
A1  - Hersh, Aimee
A1  - Gangaputra, Sapna
A1  - Graham, Thomas Brent
JF  - The Lancet
UR  - https://doi.org/10.1016/s0140-6736(24)02468-1
SN  - 0140-6736
ER  -