Long–Term Safety and Efficacy of Adalimumab in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis in an Ongoing Open-Label Study

Eric B. Suhler¹, Glenn J. Jaffe², Quan Dong Nguyen³, Antoine P. Brezin⁴, Manfred Zierhut⁵, Albert Vitale⁶, Mirjam van Velthoven⁷, Alfredo Adan⁸, Lyndell Lim⁹, Michal Kramer¹⁰, Ariel Schlaen¹¹, Eric Fortin¹², Cristina Muccioli¹³, Hiroshi Goto¹⁴, Toshikatsu Kaburaki¹⁵, Anne Camez¹⁶, Alexandra P. Song¹⁷, Martina Kron¹⁶, Samir Tari¹⁷ and Andrew D. Dick¹⁸, ¹Oregon Health & Science University, Casey Eye Institute, and VA Portland Health Care System, Portland, OR, ²Duke University, Durham, NC, ³Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, ⁴Université Paris Descartes, Hôpital Cochin, Paris, France, ⁵Center of Ophthalmology, University of Tuebingen, Tuebingen, Germany, ⁶University of Utah, Salt Lake City, UT, ⁷Rotterdam Eye Hospital, Rotterdam, Netherlands, ⁸Ophthalmology, Hospital Clinic de Barcelona,, Barcelona, Spain, ⁹Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia, ¹⁰Rabin Medical Center, Petach Tikva, Tel Aviv University, Tel Aviv, Israel, ¹¹Austral University, Buenos Aires, Argentina, ¹²University of Montreal, Montreal, QC, Canada, ¹³Federal University of São Paulo, São Paulo, Brazil, ¹⁴Tokyo Medical University, Tokyo, Japan, ¹⁵Ophthalmology, The University of Tokyo School of Medicine, Bunkyo-ku, Japan, ¹⁶Abbvie Deutschland GmbH & Co KG, Ludwigshafen, Germany, ¹⁷AbbVie Inc., North Chicago, IL, ¹⁸University of Bristol, Bristol Eye Hospital; National Institute for Health Research (NIHR) Biomedical Research Centre at Moorfields Eye Hospital and University College London, Institute of Ophthalmology, London, United Kingdom

Meeting: 2016 ACR/ARHP Annual Meeting

Date of first publication: September 28, 2016

Keywords: Adalimumab and uveitis

Session Information

Date: Monday, November 14, 2016

Title: Miscellaneous Rheumatic and Inflammatory Diseases - Poster II

Session Type: ACR Poster Session B

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

Background/Purpose: To evaluate the long-term safety and efficacy of adalimumab (Humira®) in patients with non-infectious intermediate, posterior, or panuveitis (NIPPU) in an open-label clinical trial extension, VISUAL-III.

Methods: Adults who met treatment failure or study completion criteria in VISUAL-I/VISUAL-II and opted to enroll in VISUAL-III received adalimumab 40-mg every other week. Corticosteroids and/or immunosuppressive therapy were permitted as needed. Patients that discontinued VISUAL-I/VISUAL-II due to treatment failure had active disease at VISUAL-III entry. Efficacy endpoints included new inflammatory lesions, anterior chamber (AC) cell, and vitreous haze (VH) grades from study entry (week-0) through week-54 (inactive uveitis) and week-78 (active uveitis). Corticosteroid daily dose was measured over time. Adverse event rates were reported from first adalimumab dose in VISUAL-I/II/III until the data cutoff of 31-August-2015.

Results: Intent-to-treat analyses included 243 (active) and 128 (inactive) uveitis patients at study entry. At week-54, no new inflammatory lesions relative to baseline, AC cell and VH grades of ≤0.5+ were observed in 98.5%, 98.5% and 92.6% of inactive uveitis patients, respectively. At week-78, no new inflammatory lesions relative to week-8, AC cell and VH grades of ≤0.5+ were observed in 96.3%, 91.0% and 87.8% of active uveitis patients, respectively. Mean systemic corticosteroid daily dose decreased from 12.7 to 3.68 prednisone equivalents by year 1 for patients with active uveitis and remained stable from 1.48 to 1.21 prednisone equivalents for inactive patients. Adverse events rates (577 AE/100PY and 19.6 SAE/100PY) were comparable to the VISUAL-I and VISUAL-II trials.

Conclusion: Long-term adalimumab treatment reduced ocular inflammation and corticosteroid burden in NIPPU patients and demonstrated a safety profile consistent with other indications and previous VISUAL studies.

Disclosure: E. B. Suhler, AbbVie, 9,AbbVie, Mallinckrodt, Santen, and XOMA, 5,AbbVie, Bristol Myers Squibb, Clearside, EyeGate, and Genentech, 2,Research to Prevent Blindness and the Department of Veterans Affairs, 9; G. J. Jaffe, AbbVie, 5; Q. D. Nguyen, AbbVie, Santen, XOMA, Bausch & Lomb, 9; A. P. Brezin, AbbVie, 5,AbbVie, 9; M. Zierhut, AbbVie and Santen, 9; A. Vitale, ACIONT, 5; M. van Velthoven, AbbVie Netherlands, Novartis Netherlands and Bayer Netherlands, 8,Allergan Europe, 9; A. Adan, AbbVie, Santen and Allergan, 9; L. Lim, AbbVie, Bayer and Allergan, 5,AbbVie, Bayer and Allergan, 9; M. Kramer, AbbVie, 5; A. Schlaen, None; E. Fortin, AbbVie, Alcon and Allergan, 5,AbbVie, Alcon and Allergan, 9; C. Muccioli, AbbVie, 5; H. Goto, AbbVie, 9; T. Kaburaki, None; A. Camez, Abbvie, 1,AbbVie, 3; A. P. Song, AbbVie, 1,AbbVie, 3; M. Kron, AbbVie, 1,AbbVie, 3; S. Tari, AbbVie, 1,AbbVie, 3; A. D. Dick, AbbVie, 9.

To cite this abstract in AMA style:

Suhler EB, Jaffe GJ, Nguyen QD, Brezin AP, Zierhut M, Vitale A, van Velthoven M, Adan A, Lim L, Kramer M, Schlaen A, Fortin E, Muccioli C, Goto H, Kaburaki T, Camez A, Song AP, Kron M, Tari S, Dick AD. Long–Term Safety and Efficacy of Adalimumab in Patients with Non-Infectious Intermediate, Posterior, or Panuveitis in an Ongoing Open-Label Study [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-adalimumab-in-patients-with-non-infectious-intermediate-posterior-or-panuveitis-in-an-ongoing-open-label-study/. Accessed .

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