ADJUVITE: A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF ADALIMUMAB IN JUVENILE IDIOPATHIC ARTHRITIS ASSOCIATED UVEITIS

Background: Juvenile idiopathic arthritis (JIA) patients may develop chronic, anterior uveitis. Topical steroids and methotrexate (MTX) often lack of efficacy. Objectives: To asses safety and efficacty of adalimumab in patients with JIA-associated uveitis. Methods: Elligible patients had chronic, “white eyes” uveitis with inadequate response to topical steroids and MTX, no previous anti-TNF antibody therapy and at least one assessable eye with inflammation quantified by laser flare photometry ≥30 photons/ms. Double-blind randomization at Day 1 (D1) into 2 equal groups, one treated with placebo and one with adalimumab (24 mg/m in patients aged 4 to less than 13 years, 40 mg in patients ≥13), every other week subcutaneous injections. Primary objective: to demonstrate a higher response rate at Month 2 (M2) in the adalimumab arm versus the placebo arm. Response was defined as a 30% reduction of inflammation on laser flare photometry in the eye with the highest flare value at D1 and improvement or a stable appearance on slit lamp examination. From M2 to M12, all patients were allowed to receive adalimumab (open phase) (NCT01385826). Results: 34 patients were screened and 31 received at least one injection of study treatment. Table 1. Patients characteristics at study treatment onset Ada (n=16)Placebo (n=15)All (n=31) Female, n (%)15 (94)13 (87)28 (90) Age, median value, years [ranges]10.8 [5.0–20.3]9.2 [4.9–29.1] Active joints, median n [ranges]0 [0–3]0 [0–4]0 [0–4] Uveitis median duration, years [ranges]4.4 [0.4–18.9]4.8 [0.6–24.2] Laser flare (ph/ms), median [ranges]99 [23–322]70 [36–265] Bilateral uveitis, n (%)10 (63)14 (93)24 (78) Ongoing treatments at D1  Oral steroids, patients n (%)7 (44)3 (20)10 (32)  Methotrexate, patients n (%)15 (94)11 (73)26 (84) At M2, in intention-to-treat (Primary objective), there were 9/16 responders in the adalimumab group and 3/15 in the placebo group (p=0.038, Chi-squared test; RR=2.81, CI95%=[0.94–8.45] with log-binomial model estimation). One patient stopped the trial at D14 (adalimumab group, uveitis worsening) and one at M9 (ocular hypertony). 29 patients reached M12 on adalimumab. There were 5 serious adverse events in 4 patients, all in the placebo group, 4 during the open-label phase, none related to study treatment (investigator assessment). Conclusions: Adalimumab was effective in reducing ocular inflammation within 2 months and well tolerated over 12 months in patients with JIA-associated chronic uveitis and an inadequate response to topical steroids and MTX. Laser flare photometry is a valuable tool to assess early improvement. Disclosure of Interest: P. Quartier Grant/research support from: Abbvie, Novartis, Pfizer, Roche, Consultant for: Abbvie, Novartis, SOBI, Speakers bureau: Abbvie, BMS, Novartis, PfiZer, Roche, SOBI, V. Despert: None declared, S. Poignant: None declared, C. Elie: None declared, I. Kone-Paut Grant/research support from: Roche, SOBI, Consultant for: Abbvie, Chugai, Novartis, Pfizer, Roche, SOBI, A. Belot: None declared, L. Kodjikian Consultant for: Alcom, Alimera, Allergan, Bayer, Bausch&Lomb, Novartis, Thea, Speakers bureau: Alcom, Alimera, Allergan, Bayer, Bausch&Lomb, Novartis, Thea, D. Monnet: None declared, M. Weber: None declared, B. Bodaghi Consultant for: Abbvie, A. Baptiste: None declared DOI: 10.1136/annrheumdis-2016-eular.2362Citation: Annals of the Rheumatic Diseases, volume 75, supplement 2, year 2016, page 273Session: Paediatric rheumatology (Poster Presentations )