Since 2017, the Italian National Agency for Drugs has approved of the off-label use of infliximab and adalimumab for juvenile idiopathic arthritis-associated uveitis, and has created a patient registry to collect anonymized data from patients in 24 pediatric rheumatology and ophthalmology centers across Italy.
Uveitis, one of the most serious extra-articular manifestations of juvenile idiopathic arthritis (JIA), can cause sight-threatening complications. While corticosteroids and methotrexate can be used to treat chronic uveitis, in patients who are refractory to these therapies, anti—tumor necrosis factor (anti-TNF) agents are sometimes used as off-label treatments.
Since 2017, the Italian National Agency for Drugs has approved of the off-label use of infliximab and adalimumab for JIA-associated uveitis, and has created a patient registry to collect anonymized data from patients in 24 pediatric rheumatology and ophthalmology centers across Italy.
A study published in The Journal of Rheumatology used the database to identify 154 patients with JIA-associated uveitis who were treated with either infliximab (n = 59) or adalimumab (n = 95) and who had 24 months or more of follow-up.
During the 2-year follow-up period, 27 patients switched from infliximab to adalimumab because of loss of efficacy, infusion reaction, or intolerance. One patient switched from adalimumab to infliximab, and 3 switched from adalimumab to other biologics.
At 2 years, 57 (60.0%) patients receiving adalimumab achieved remission of JIA-associated uveitis, as did 12 (20.3%) patients receiving infliximab, and no serious adverse events (AEs) were reported. Twenty patients (16.4%) experienced 35 minor AEs, including infections, infusion reactions, and systemic symptoms (such as headache, irritability, and gastrointestinal symptoms). Interestingly, the incidence rate (IR) of AEs was significantly lower in the adalimumab group (IR, 10.6 per 100 patient years [PY]) than in the infliximab group (IR, 25.0 per 100 PY), and more patients taking infliximab developed multiple AEs (P =.014).
There were 63 new ocular complications (38 in 24 patients in the adalimumab group and 25 in 13 patients in the infliximab group), with cataract being the most commonly reported complication, followed by keratopathy, synechiae, cystoid macular edema (CME), ocular hypertension, and vitreitis. There was no significant difference between adalimumab and infliximab in terms of the types of complications observed, except for CME and cataract, which were more common in the infliximab group.
The authors of the study concluded that both of the anti-TNF agents were safe and effective in reducing the number of uveitis flares, and that adalimumab was more effective than infliximab. The lower incidence of minor AEs and the greater efficacy of adalimumab—as well as the easier subcutaneous route of administration for adalimumab versus the infused administration of infliximab—may help to explain a high retention rate for those taking adalimumab (94.7%) at 2 years, compared with 54.2% 2-year retention rate for those taking infliximab.
Cecchin V, Zannin MA, Ferrari D, et al. Longterm safety and efficacy of adalimumab and infliximab for uveitis associated with juvenile idiopathic arthritis [Published online April 15, 2018]. J Rheumatol. doi: 10.3899/jrheum.171006.