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SAT0590 Long-term efficacy and safety of adalimumab by aetiologyin patients with non-infectious uveitis in the visual iii trial
  1. P.T. Merrill1,
  2. A. Vitale2,
  3. M. Zierhut3,
  4. E. Fortin4,
  5. H. Goto5,
  6. M. Kron6,
  7. A. Song7,
  8. K. Douglas7,
  9. S. Pathai8
  1. 1Rush University Medical Center, Chicago
  2. 2University of Utah, Salt Lake City, USA
  3. 3University of Tuebingen, Center of Ophthalmology, Tuebingen, Germany
  4. 4University of Montreal, Montreal, Canada
  5. 5Tokyo Medical University, Tokyo, Japan
  6. 6AbbVie Deutschland GmbH and Co KG, Ludwigshafen, Germany
  7. 7AbbVie Inc., North Chicago, USA
  8. 8AbbVie Ltd, Maidenhead, UK


Objectives To evaluate the long-term safety and efficacy of adalimumab in patients with non-infectious intermediate, posterior, or panuveitis, across different disease etiologies.

Methods Adult patients in the Phase III VISUAL I/II trials, who met treatment failure (TF) criteria or who completed the study without TF, were eligible to enter the Phase III open-label extension study, VISUAL III, wherein patients received adalimumab 40 mg every other week. In this exploratory analysis, endpoints were analysed by six uveitis etiologies: i) idiopathic/other (IO), ii) birdshot chorioretinopathy (BCR), iii) multifocal choroiditis and panuveitis (MCP), iv) Vogt-Koyanagi-Harada syndrome (VKH), v) sarcoidosis, vi) Behçet’s disease (BD). Endpoints assessed through Week 78 of treatment were proportion of patients with: no active inflammatory lesions in both eyes; anterior chamber (AC) cell grade ≤0.5 +in both eyes; vitreous haze (VH) grade ≤0.5 +in both eyes; and quiescence (defined as no active inflammatory lesions AND AC cell grade ≤0.5 + AND VH grade ≤0.5+). Mean best corrected visual acuity (BCVA) was also assessed. Missing data were reported using non-responder imputation for categorical endpoints and last observation carried forward for continuous variables. Adverse events (AEs) were collected from first adalimumab dose in VISUAL III through the interim cut-off date of Oct 31, 2016.

Results Of 371 patients included in the intent-to-treat analysis, disease etiology subgroups were (n[%]): IO (155 [41.8]); BCR (51 [13.7]); MCP (14 [3.8]); VKH (72 [19.4]); Sarcoidosis (52 [14.0]); BD (27 [7.3]). The proportion of patients achieving quiescence improved over time in all uveitis etiologic subgroups: IO 28.4%/63.9% (Week 0/Week 78), BCR 43.1%/64.7%, MCP 35.7%/50.0%, VKH 37.5%/63.9%, sarcoidosis 32.7%/69.2%, and BD 44.4%/74.1%. The proportions of patients with no active inflammatory lesions, AC cell grade ≤0.5+, or VH grade ≤0.5+, showed moderate increases or decreases between Weeks 0 and 78 within specific etiology subgroups; percentage ranges across all subgroups at Weeks 0/78, were 60.8–87.5/57.1–78.8% (no active inflammatory lesions), 47.2–92.2/50.0–77.8% (AC cell grade ≤0.5+), and 42.9–72.2/57.1–77.8% (VH grade ≤0.5+), respectively. Improvement or maintenance of mean BCVA was observed over time across the etiologic subgroups. AE rates were consistent with the VISUAL I and II trials.

Conclusions Adalimumab increased the percentage of patients achieving quiescence and improved or maintained visual acuity at Week 78 of the VISUAL III study, with consistent results across uveitis etiologic subgroups. No new safety signals were detected with long-term adalimumab treatment.

Acknowledgements AbbVie funded the study and provided medical writing support. All authors contributed to the development of the content. The authors and AbbVie reviewed and approved the abstract. The authors maintained control over the final content. Medical writing assistance was provided by Kevin Hudson PhD, of 2theNth, which was funded by AbbVie Inc.

Disclosure of Interest P. T. Merrill Consultant for: Steering Committee for the VISUAL studies and has served as a consultant and on advisory boards for Santen, Allergan, Alimera and pSivida, A. Vitale Consultant for: AbbVie and Aciont, M. Zierhut Consultant for: Scientific advisory board for AbbVie, Gilead, and Santen, E. Fortin Consultant for: advisory boards and as a consultant for AbbVie, Alcon and Allergan, H. Goto Consultant for: advisory boards for AbbVie, M. Kron Shareholder of: AbbVie, Employee of: AbbVie, A. Song Shareholder of: AbbVie, Employee of: AbbVie, K. Douglas Shareholder of: AbbVie, Employee of: AbbVie, S. Pathai Shareholder of: AbbVie, Employee of: AbbVie

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