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THU0235 Adjuvite: A Double-Blind, Randomized, Placebo-Controlled Trial of Adalimumab in Juvenile Idiopathic Arthritis Associated Uveitis
  1. P. Quartier1,
  2. V. Despert2,
  3. S. Poignant3,
  4. C. Elie4,
  5. I. Kone-Paut5,
  6. A. Belot6,
  7. L. Kodjikian7,
  8. D. Monnet8,
  9. M. Weber9,
  10. B. Bodaghi10,
  11. A. Baptiste4
  1. 1Pediatric Immunology-Hematology and Rheumatology Unit, Necker Hospital,: Paris
  2. 2Pediatrics, CHU, Rennes
  3. 3Pediatrics, CHU, Nantes
  4. 4Clinical Research Unit, Necker Hospital, Paris
  5. 5Pediatrics, CHU, Kremlin-Bicetre
  6. 6Pediatrics
  7. 7Ophtalmology, CHU, Lyon
  8. 8Ophtalmology, Cochin Hospital, Paris
  9. 9Ophtalmology, CHU, Nantes
  10. 10Ophtalmology, Pitie-Salpetriere Hospital, Paris, France

Abstract

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/m2 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

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

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