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.
Retrospective interventional case series.
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.
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).
Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years of treatment.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.