Adalimumab Alone Is Superior to Adalimumab Plus Methotrexate in Juvenile Idiopathic Arthritis Associated Uveitis: Data from the ORCHIDEA Registry

Gabriele Simonini¹, Fabio Vittadello ², Francesca Tirelli ³, Maria Elisabetta Zannin ², Emanuela Del Giudice ⁴, Claudia Bracaglia ⁵, Serena Pastore ⁶, Mariolina Alessio ⁷, Angelo Ravelli ⁸, Francesco La Torre ⁹, Romina Gallizzi ¹⁰, Ilaria Maccora ¹¹ and Francesco Zulian ², ¹Rheumatology Unit Anna Meyer Children's Hospital NEUROFARBA Dpt University of Florence, Firenze, Italy, ²Department of Woman and Child Health, University of Padua, Italy, Padova, Italy, ³Post Graduate School of Pediatrics, University of Florence, Florence, Italy, Firenze, Italy, ⁴Department of Pediatrics, Sapienza University, Rome, Italy, Roma, Italy, ⁵Division of Rheumatology, IRCCS Ospedale Pediatrico Bambino Gesù, Rome, Italy, ⁶Institute for Maternal and Child Health IRCCS "Burlo Garofolo," Trieste, Italy, Trieste, Italy, ⁷University Hospital Federico II, Naples, Napoli, Italy, ⁸IRCCS Istituto Giannina Gaslini, Università degli Studi di Genova, Genova, Italy, ⁹Rheumatology Unit, Giovanni XXIII Children’s Hospital, Bari, Italy, Bari, Italy, ¹⁰Azienda Ospedaliera Universitaria Gaetano Martino, Messina, Messina, Italy, ¹¹Post Graduate School of Pediatrics, University of Florence, Florence, Italy, Florence, Toscana, Italy

Meeting: 2019 ACR/ARP Annual Meeting

Keywords: juvenile idiopathic arthritis (JIA) and anti-TNF therapy, Uveitis

Session Information

Date: Tuesday, November 12, 2019

Title: Pediatric Rheumatology – ePoster III: Systemic JIA, Fever, & Vasculitis

Session Type: Poster Session (Tuesday)

Session Time: 9:00AM-11:00AM

Background/Purpose: To compare the efficacy and safety of Adalimumab alone (ADA) versus ADA in combination with Methotrexate (ADA-MTX) in an open-label, retrospective, comparative, multicentre cohort study of Juvenile Idiopathic Arthritis Uveitis (JIA-U).

Methods: Patients with JIA-U treated with ADA were managed by astandardized protocol and data were entered in the ORCHIDEA registry. At baseline, all patients wererefractory to standard immunosuppressive MTX treatment. Data recordedevery 3 months were uveitis course, number/type of ocular flares and complications, drug-relatedadverse events (AE), and treatment switch or withdrawal. The primary outcome was to assess the time to the first uveitis relapse on ADA treatment, once persistent inactive disease has been achieved. Inactive uveitis was defined as rare or < 1 cell per field at standard slit-lamp examination for at least 3 months. The choice of keeping MTX at 15mg/mq2 with ADA was an opinion-based decision shared between treating ophthalmologist and rheumatologist, at the time of the anti-TNFa start. Data of patients treated for ≥1 year were analyzed.

Results: Up to December 2018, 201 patients (40 Males, median age 4 yrs, range 1-17) with ≥12 months follow-up were enrolled 170 were in the ADA-MTX group, 31 in ADA group. Median age at uveitis onset resulted lower in ADA-MTX group (4 yrs, range 1-17) than ADA (5 yrs, 1-17, Mann-Whitney U test, p< 0.05). No statistical differences between the two groups with regard to age at arthritis onset, number of relapses previous anti TNF treatment, uveitis duration at anti TNF starting and presence of eye complications at base-line have been detected. The overall median time of follow-up without uveitis flares in remission was 24 months (range 1–154). ADA-MTX group showed a shorter relapse-free interval as compared with the ADA group (22 months, range 1-154 vs34 months, range 10-102, Mann-Whitney U test, p= 0.004). Stratifying the two groups by the presence of eye complications at base-line, no significant difference has been noted in 144 JIA-U children without complications. In 57 complicated JIA-U (48 ADA-MTX; 9 ADA), time on remission on treatment resulted shorter in ADA-MTX as compared to ADA (29.2 +24.9 months vs 53.2 +24.5 months, Mann-Whitney U test, p=0.006). Cox regression analysis, at mean of the above-reported covariates, showed a higher probability of maintaining remission on ADA treatment compared to ADA +MTX administration (Mantel-Cox chi-square =19.6, p < 0.001; Figure). The number of pts who experienced drug-related adverse events was not different between the groups: ADA-MTX 44/170 (25.9%) vs ADA 5/31 (16.1%), p: n.s.

Conclusion: JIA-U treating physicians commonly use ADA in combination with MTX. However, according these retrospective data from the ORCHIDEA registry, this approach, even if safe, seems not to provide significant benefits in controlling JIA-U activity over time.

ACR Figure

Disclosure: G. Simonini, None; F. Vittadello, None; F. Tirelli, None; M. Zannin, None; E. Del Giudice, None; C. Bracaglia, None; S. Pastore, None; M. Alessio, None; A. Ravelli, Angelini, AbbVie, Bristol-Myers Squibb, Johnson & Johnson, Novartis, Pfizer, Reckitt Benkiser, and Roche, 2, 5, 8; F. La Torre, None; R. Gallizzi, None; I. Maccora, None; F. Zulian, None.

To cite this abstract in AMA style:

Simonini G, Vittadello F, Tirelli F, Zannin M, Del Giudice E, Bracaglia C, Pastore S, Alessio M, Ravelli A, La Torre F, Gallizzi R, Maccora I, Zulian F. Adalimumab Alone Is Superior to Adalimumab Plus Methotrexate in Juvenile Idiopathic Arthritis Associated Uveitis: Data from the ORCHIDEA Registry [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10). https://acrabstracts.org/abstract/adalimumab-alone-is-superior-to-adalimumab-plus-methotrexate-in-juvenile-idiopathic-arthritis-associated-uveitis-data-from-the-orchidea-registry/. Accessed .

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