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Am J Ophthalmol. 2019 Jun 12. pii: S0002-9394(19)30274-0. doi: 10.1016/j.ajo.2019.06.007. [Epub ahead of print]

Adalimumab in juvenile-idiopathic arthritis-associated uveitis (JIA-U): 5-year follow-up of the Bristol participants of the SYCAMORE trial.

Author information

1
Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
2
Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool, Liverpool, UK.
3
Department of Women's and Children's Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK; Department of Paediatric Rheumatology, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
4
Bristol Eye Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK; University of Bristol, Bristol, UK; National Institute of Health Research and Biomedical Research Centre at Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.
5
University of Bristol, Bristol, UK; Department of Paediatric Rheumatology, University Hospital Bristol NHS Foundation Trust, Bristol, UK. Electronic address: avramanan@hotmail.com.

Abstract

PURPOSE:

To determine longer-term outcomes of participants enrolled from a single center in the SYCAMORE trial, a randomized placebo-controlled trial of adalimumab versus placebo in children with juvenile idiopathic arthritis-associated uveitis (JIA-U) uncontrolled on methotrexate.

DESIGN:

Retrospective interventional case series.

METHODS:

Medical records of all 28 SYCAMORE participants recruited at the Bristol Eye Hospital were reviewed at approximately 3-monthly intervals up to 5 years from the trial randomization date. Uveitis activity, treatment course, visual outcomes, ocular complications and adverse events were recorded. Data are presented using summary statistics.

RESULTS:

Following withdrawal of the investigational medicinal product (IMP), 25 of the 28 participants were started on adalimumab for active juvenile idiopathic arthritis-associated uveitis (JIA-U). Of the 12 participants in the active treatment arm of the SYCAMORE study, 11 (92%) were restarted on adalimumab after withdrawal of the IMP for active JIA-U (median time to flare 188 days (range 42-413)). Two participants stopped adalimumab for uncontrolled JIA-U. One participant had a reduction in vision to 0.3 due to cataract. Mean visual acuity for the remaining 27 participants was -0.04 (right eye) and -0.05 (left eye).

CONCLUSIONS:

Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years treatment. Adalimumab was well tolerated and visual acuity outcomes were excellent.

PMID:
31201796
DOI:
10.1016/j.ajo.2019.06.007

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