Adalimumab in Juvenile Idiopathic Arthritis-Associated Uveitis: 5-Year Follow-up of the Bristol Participants of the SYCAMORE Trial

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 vs 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 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 days). Two participants stopped adalimumab for uncontrolled JIA-U. One participant had a reduction in vision to 0.3 owing 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Conclusions: Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years of treatment. Adalimumab was well tolerated and visual acuity outcomes were excellent.