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Abstract Number: 416

Uveitis Associated to Polyarticular Juvenile Idiopathic Arthritis

Ivan Foeldvari1, Nicolino Ruperto1, Daniel J Lovell2, Gerd Horneff1, Hans-Iko Huppertz3, Pierre Quartier4, Gabriele Simonini1, Mareike Bereswill5, Jasmina Kalabic5, Alberto Martini1 and Hermine I. Brunner2, 1PRINTO-IRCCS, Genova, Italy, 2PRCSG, Cincinnati, OH, 3PRINTO-IRCCS, Genoa, Italy, 4Hôpital Necker-Enfants Malades, Paris, France, 5AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab, juvenile idiopathic arthritis (JIA), methotrexate (MTX) and uveitis

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Session Information

Date: Sunday, November 13, 2016

Session Title: Pediatric Rheumatology – Clinical and Therapeutic Aspects - Poster I: Juvenile Idiopathic Arthritis, Uveitis

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.


Disclosure: I. Foeldvari, None; N. Ruperto, Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono,Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Avent, 2,Abbott, AbbVie, Amgen, Biogen Idec, Astellas, Alter, AstraZeneca, Boehringer, Bristol-Myers Squibb, CD-Pharma, Celgene, Crescendo Bioscience, EMD Serono, Hoffman-La Roche, Italfarmaco, Janssen, MedImmune, Medac, Novartis, Novo Nordisk, Pfizer, Sanofi Aven, 8; D. J. Lovell, AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UBC, Xoma, and Genentech, 5,Wyeth Pharmaceuticals, 8,Amgen and Forest Research, 9; G. Horneff, AbbVie, Pfizer, and Roche, 2,AbbVie, Novartis, Pfizer, and Roche, 8; H. I. Huppertz, Wyeth Pharmaceuticals, Essex Pharmaceuticals, and Abbott Laboratories, 5,Wyeth Pharmaceuticals and Essex Pharmaceuticals, 9,Wyeth Pharmaceuticals and Essex Pharmaceuticals, 9; P. Quartier, AbbVie, Novartis, Pfizer, BMS, Chugai-Roche, Medimmune, Servier, and Swedish Orphan Biovitrum, 2,Sanofi Trial, 9; G. Simonini, None; M. Bereswill, AbbVie, 1,AbbVie, 3; J. Kalabic, AbbVie, 1; A. Martini, GASLINI Hospital, 3,AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., "Francesco Angelini", GlaxoSmithKline, Italfarmaco, Novartis, Pfizer, Roche, Sanofi Aventis, Schwarz Biosciences GmbH, Xoma, and Wyeth Pharmaceuticals, 2,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, and MedImmune, 8; H. I. Brunner, AbbVie Inc., AstraZeneca, Centocor, Bristol-Myers Squibb, Boehringer-Ingelheim, Pfizer, Regeneron, Hoffman La-Roche, Novartis, UCB, and Genentech, 5,Genentech Pharmaceuticals, 8.

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 January 21, 2021.
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