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Drug-induced remission of JIA-U did not persist when adalimumab was withdrawn after 1-2 years of treatment.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

• Authors: Sarah Horton, Ashley P Jones, Catherine M Guly, Ben Hardwick, Michael W Beresford, Richard W Lee, Andrew D Dick, Athimalaipet V Ramanan
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 207 Pg. 170-174 (11 2019) ISSN: 1879-1891 [Electronic] United States
• PMID: 31201796 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2019 Elsevier Inc. All rights reserved.

Chemical References

• Antirheumatic Agents
• Adalimumab
• Methotrexate

Topics

• Adalimumab (administration & dosage)
• Antirheumatic Agents (administration & dosage)
• Arthritis, Juvenile (complications, drug therapy)
• Child
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Male
• Methotrexate (administration & dosage)
• Retrospective Studies
• Time Factors
• Treatment Outcome
• Uveitis (drug therapy, etiology, physiopathology)
• Visual Acuity