Journal article
Safety and Efficacy of Adalimumab in Patients with Noninfectious Uveitis in an Ongoing Open-Label Study: VISUAL III
EB Suhler, A Adán, AP Brézin, E Fortin, H Goto, GJ Jaffe, T Kaburaki, M Kramer, LL Lim, C Muccioli, QD Nguyen, J Van Calster, L Cimino, M Kron, AP Song, J Liu, S Pathai, A Camez, A Schlaen, MEJ van Velthoven Show all
Ophthalmology | ELSEVIER SCIENCE INC | Published : 2018
Open access
Abstract
Purpose: To evaluate safety and efficacy of adalimumab in patients with noninfectious intermediate, posterior, or panuveitis. Design: Phase 3, open-label, multicenter clinical trial extension (VISUAL III). Participants: Adults meeting treatment failure (TF) criteria or who completed VISUAL I or II (phase 3, randomized, double-masked, placebo-controlled) without TF. Methods: Patients received adalimumab 40 mg every other week. Interim follow-up data were described from VISUAL III weeks 0 through 78. Main Outcome Measures: Disease quiescence, steroid-free quiescence, active inflammatory chorioretinal/retinal vascular lesions, anterior chamber cell grade, vitreous haze grade, best-corrected vis..
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Awarded by Japan Society for the Promotion of Science
Funding Acknowledgements
The authors have made the following disclosures: E.B.S.: Steering committee - AbbVie; Consultant - AbbVie, Gilead, Inotek, Mallinckrodt, XOMA, Santen; Research support - AbbVie, Aldeyra, Bristol-Myers Squibb, EyeGate, Clearside, Genentech, pSivida. J.V.C.: Research support - Novartis; Personal fees - Novartis, Bayer, AbbVie, MSD, DORC, Allergan, Santen, Zeiss; Nonfinancial support - Novartis, Bayer, AbbVie, DORC, Allergan. Sponsored by AbbVie Inc (North Chicago, IL). The sponsor participated in study design and conduct; data management, analysis, and interpretation; and manuscript preparation, review, and approval. Medical writing support was provided by Heather D. Starkey, PhD, and Natalia Zhukovskaya, PhD, of Complete Publication Solutions, LLC (North Wales, PA), and was funded by AbbVie Inc.