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FRI0618 Adalimumab in non-infectious uveitis – efficacy across different etiologies in the visual i and visual ii trials
  1. PT Merrill1,
  2. A Vitale2,
  3. M Zierhut3,
  4. E Forton4,
  5. H Goto5,
  6. M Kron6,
  7. S Tari7,
  8. S Pathai8
  1. 1Rush University Medical Center, Chicago
  2. 2University of Utah, Salt Lake City, United States
  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 & Co KG, Ludwigshafen, Germany
  7. 7AbbVie Inc., North Chicago, United States
  8. 8AbbVie Ltd, Maidenhead, United Kingdom

Abstract

Background There is increasing interest in understanding the efficacy of adalimumab across different etiologies of uveitis. No prospective analysis has been conducted to date to determine the efficacy of adalimumab among non-infectious uveitis patients with different etiologies.

Objectives To assess adalimumab (ADA) efficacy in active and inactive, non-infectious uveitis across different etiologies in patients who were recruited as part of the VISUAL program.

Methods Exploratory data analyses from two global phase 3, double-masked trials: VISUAL I (patients with active uveitis despite ≥2 weeks of prednisone 10–60 mg/day) and VISUAL II (patients with inactive disease dependent on 10–35 mg/day of prednisone to maintain inactivity) were performed. Patients received placebo (PBO) or ADA subcutaneously (80 mg week 0, followed by 40 mg every other week from week 1 up to 80 weeks). In VISUAL I, all patients received a prednisone burst followed by taper to 0 mg by week 15. In VISUAL II, prednisone taper to 0 mg was mandatory by week 19. The primary endpoint was time to treatment failure (TF) at or after week 6 for VISUAL I; and at or after week 2 for VISUAL II1,2. For this analysis, patients were categorized into different uveitis etiologies which they presented at study entry. Hazard ratios (HR) for time to TF were obtained for each uveitis etiology.

Results The efficacy of ADA was significantly greater than PBO in the largest subgroup of patients with Idiopathic/other uveitis (VISUAL I: 103 and VISUAL II: 90) etiology in both VISUAL I1 and VISUAL II trials. All other subgroups showed a trend in favor of ADA, except for Sarcoidosis subgroup in the VISUAL II trial (Figure). Overall safety for both trials has been previously reported 1,2.

Conclusions These exploratory analyses from the VISUAL I and VISUAL II trials show significantly higher efficacy in ADA-treated patients over PBO in “idiopathic/other” diagnoses of patients with both active and inactive non-infectious uveitis. Furthermore, across different uveitis etiologies, these analyses suggest that ADA-treated patients had a prolonged time to treatment failure compared to PBO.

References

  1. Jaffe GJ, Dick AD, Brezin AP, et al. N Engl J Med (2016); 375:932–43.

  2. Nguyen QD, Merrill PT, Jaffe GJ, et al. The Lancet (2016); 388(10050): 1183–92.

References

Acknowledgements AbbVie funded the VISUAL I and VISUAL II studies and provided 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 Gaurav Patki, PhD of AbbVie Inc.

Disclosure of Interest P. T. Merrill Consultant for: Santen, AbbVie, A. Vitale Consultant for: ACIONT, M. Zierhut Consultant for: AbbVie and Santen, E. Forton Consultant for: AbbVie, Alcon and Allergan, H. Goto Consultant for: AbbVie, M. Kron Shareholder of: AbbVie, Employee of: AbbVie, S. Tari Shareholder of: AbbVie, Employee of: AbbVie, S. Pathai Shareholder of: AbbVie, Employee of: AbbVie

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