Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Approximately 10-15% of patients (pts) with juvenile idiopathic arthritis (JIA) experience comorbid uveitis. The objective of this study is to explore events of uveitis and associated safety in pts with moderately/severely active polyarticular or polyarticular-course JIA (pJIA) who were prescribed and treated with adalimumab (ADA) and/or methotrexate (MTX) in routine clinical practice.
Methods: STRIVE is an ongoing, multicenter, non-interventional, observational registry of up to 10 years duration in pts with moderately/severely active pJIA who are treated with either ADA±MTX or MTX alone as part of routine clinical care. Pts could initiate ADA and/or MTX within 24 months prior to registry entry. Pts that completed ADA studies (DE038, M10-444) had option to roll-over into this registry. Ophthalmologists performed slit-lamp examination for uveitis at registry entry and specified visits in 3-6 month intervals through 5 yrs. Beyond 5 yrs, uveitis events were collected solely through adverse event (AE) reporting. Observational ocular AEs (e.g. cataract, glaucoma) were recorded from registry entry through yr 6.
Results: As of 1 June 2015, a total of 21/303 (6.9%) and 68/543 (12.5%) enrolled pts reported at least 1 case of JIA-associated uveitis at any visit in the MTX and ADA±MTX groups, respectively. In the JIA-associated uveitis population, 10 (47.6%) in MTX and 42 (61.8%) in ADA±MTX group presented with documented uveitis at registry entry. In the population without uveitis at registry entry, 11/293 (3.8%) and 26/501 (5.2%) pts in MTX and ADA±MTX arms, respectively had first documentation of uveitis post-enrollment. Most pts in the JIA-associated uveitis sub-population were female (73%), white (96%), with a mean age of 8.1 yrs; mean pJIA disease duration was 1.8 and 4.8 yrs for MTX and ADA±MTX groups at registry entry, respectively. Nine (42.9%) MTX and 48 ADA±MTX (72.7%) pts were positive for antinuclear antibodies at registry enrollment. For vast majority of pts,uveitis was localized to anterior layer. In ADA group, 45 (66.2%) pts with documented uveitis received concomitant MTX during the course of the registry. Through Month 42, majority of JIA-associated uveitis sub-population had either no new manifestation of uveitis or stabilized uveitis. A higher proportion of MTX vs ADA±MTX pts discontinued registry drug (15/21 [71.4%] vs. 21/68 [30.9%]), but continued to be monitored for safety follow-up. Of these, 2 (9.5%) and 1 (1.5%) in MTX and ADA±MTX group, respectively, discontinued the registry drug due to an AE, and 4 of the 15 pts in the MTX group discontinued MTX group and switched to ADA±MTX registry group. Two (0.4%) pts with glaucoma and 1 (0.2%) pt with cataract were reported in ADA±MTX group and none in MTX group; 2 of these patients had documented uveitis at registry enrollment.
Conclusion: Among pJIA pts with uveitis documented at registry entry, a higher percentage of pts were enrolled in ADA±MTX group as per investigator judgment. No new safety signals for adalimumab were observed in JIA-associated uveitis sub-population treated per standard of care. Based on this interim analysis, JIA-associated uveitis appeared well-controlled during the course of this registry for pJIA pts with existing uveitis.
To cite this abstract in AMA style:Foeldvari I, Ruperto N, Lovell DJ, Horneff G, Huppertz HI, Quartier P, Simonini G, Bereswill M, Kalabic J, Martini A, Brunner HI. Uveitis Associated to Polyarticular Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/uveitis-associated-to-polyarticular-juvenile-idiopathic-arthritis/. Accessed December 12, 2019.
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