WASHINGTON, DC—Juvenile idiopathic arthritis (JIA)-associated uveitis was well-controlled with adalimumab and/or methotrexate, according to results of an interim analysis of an observational registry presented at the 2016 ACR/ARHP Annual Meeting.
The study explored uveitis events and associated safety in patients with moderately/severely active polyarticular or polyarticular-course JIA (pJIA) who were treated with methotrexate or adalimumab ± methotrexate in routine clinical practice.
Approximately 10% to 15% of patients with JIA experience comorbid uveitis, noted Hermine I. Brunner, MD, MSc, MBA, director of the division of rheumatology; professor, UC Department of Pediatrics; and scientific director of the Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati, OH.
The ongoing, multicenter, non-interventional, observational registry of up to 10 years’ duration is known as STRIVE. Within 24 months prior to registry entry, patients could have initiated adalimumab and/or methotrexate; in addition, those who completed adalimumab studies had the option of rolling over into STRIVE.
“Ophthalmologists performed slit-lamp examination for uveitis at registry entry and specified visits in 3 to 6 month intervals through 5 years,” Dr. Brunner noted. Beyond 5 years, uveitis events were collected through adverse event (AE) reporting, with observational ocular AEs such as cataract or glaucoma recorded from registry entry through year 6.
As of June 1, 2015, 21 of 303 patients (6.9%) enrolled in the registry reported at least 1 case of JIA-associated uveitis at any visit in the methotrexate group, as did 68 of 543 (12.5%) in the adalimumab ± methotrexate group. Of these, 10 (47.6%) in methotrexate group and 42 (61.8%) in adalimumab ± methotrexate group presented with documented uveitis at registry entry. For most patients, uveitis was localized to the anterior layer.
Among those without uveitis at registry entry, 11 of 293 (3.8%) in the methotrexate group and 26 of 501 (5.2%) in the adalimumab ± methotrexate group had first documentation of uveitis after they enrolled in the registry.
In the JIA-associated uveitis subpopulation, the majority were female (73%) and white (96%), with a mean age of 8.1 years. At registry entry, mean pJIA disease duration was 1.8 years in the methotrexate group and 4.8 years in the adalimumab ± methotrexate group; 9 (42.9%) and 48 (72.7%) patients, respectively, were positive for antinuclear antibodies.
Through Month 42, the majority of patients in the JIA-associated uveitis sub-population “had either no new manifestation of uveitis or stabilized uveitis,” she noted.
A total of 15 of 21 patients (71.4%) in the methotrexate arm discontinued the drug, compared with 21 of 68 (30.9%) in the adalimumab group; all continued to be monitored for safety follow-up.
Of these, 2 patients (9.5%) in the methotrexate group and 1 (1.5%) in the adalimumab ± methotrexate group discontinued due to an AE, and 4 of the 15 patients who discontinued methotrexate switched to the adalimumab ± methotrexate group.
Two patients (0.4%) with glaucoma and 1 (0.2%) with cataract were reported in adalimumab ± methotrexate group compared with none in methotrexate group; 2 of whom had documented uveitis at enrollment.
In the adalimumab group, 45 patients (66.2%) with documented uveitis received concomitant methotrexate.