Guidance on Noncorticosteroid Systemic Immunomodulatory Therapy in Noninfectious Uveitis Fundamentals Of Care for UveitiS (FOCUS) Initiative

Topic: An international, expert-led consensus initiative to develop systematic, evidence-based recommendations for the treatment of noninfectious uveitis in the era of biologics. Clinical Relevance: The availability of biologic agents for the treatment of human eye disease has altered practice patterns for the management of noninfectious uveitis. Current guidelines are insufficient to assure optimal use of noncorticosteroid systemic immunomodulatory agents. Methods: An international expert steering committee comprising 9 uveitis specialists (including both ophthalmologists and rheumatologists) identified clinical questions and, together with 6 bibliographic fellows trained in uveitis, conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analyses protocol systematic review of the literature (English language studies from January 1996 through June 2016Medline [OVID], the Central Cochrane library, EMBASE, CINAHL, SCOPUS, BIOSIS, and Web of Science). Publications included randomized controlled trials, prospective and retrospective studies with sufficient follow-up, case series with 15 cases or more, peer-reviewed articles, and hand-searched conference abstracts from key conferences. The proposed statements were circulated among 130 international uveitis experts for review. A total of 44 globally representative group members met in late 2016 to refine these guidelines using a modified Delphi technique and assigned Oxford levels of evidence. Results: In total, 10 questions were addressed resulting in 21 evidence-based guidance statements covering the following topics: when to start noncorticosteroid immunomodulatory therapy, including both biologic and nonbiologic agentswhat data to collect before treatmentwhen to modify or withdraw treatmenthow to select agents based on individual efficacy and safety profilesand evidence in specific uveitic conditions. Shared decision-making, communication among providers and safety monitoring also were addressed as part of the recommendations. Pharmacoeconomic considerations were not addressed. Conclusions: Consensus guidelines were developed based on published literature, expert opinion, and practical experience to bridge the gap between clinical needs and medical evidence to support the treatment of patients with noninfectious uveitis with noncorticosteroid immunomodulatory agents. (C) 2018 by the American Academy of Ophthalmology.AbbVie, Inc.Fundamentals of Care for Uveitis Initiative National FacultyAbbVieUniv Bristol, Sch Clin Sci, Ophthalmol, Bristol, Avon, EnglandUCL, Inst Ophthalmol, London, EnglandUCL, Moorfields Eye Hosp, Biomed Res Ctr, NIHR, London, EnglandUCL, Inst Ophthalmol, London, EnglandLegacy Devers Eye Inst, Portland, OR USAOregon Hlth & Sci Univ, Dept Ophthalmol, Portland, OR 97201 USAOregon Hlth & Sci Univ, Dept Med, Portland, OR 97201 USAOregon Hlth & Sci Univ, Dept Cell Biol, Portland, OR 97201 USAKing Khalid Eye Specialist Hosp, Div Vitreoretinal Surg & Uveitis, Riyadh, Saudi ArabiaUniv Fed Sao Paulo, Paulista Sch Med, Dept Ophthalmol & Visual Sci, Sao Paulo, BrazilVis Inst, Sao Paulo, BrazilUniv Paris 05, Hop Cochin, Serv Ophtalmol, Paris, FranceSingapore Natl Eye Ctr, Ocular Inflammat & Immunol Serv, Singapore, SingaporeSingapore Eye Res Inst, Singapore, SingaporeNatl Univ Singapore, Yong Loo Lin Sch Med, Dept Ophthalmol, Singapore, SingaporeDuke Natl Univ, Singapore Med Sch, Ophthalmol & Visual Sci Acad Clin Program, Singapore, SingaporeUniv Miami, Miller Sch Med, Bascom Palmer Eye Inst, Miami, FL 33136 USAUniv Hosp Bristol NHS Fdn Trust, Pediat Rheumatol, Bristol, Avon, EnglandKyushu Univ, Grad Sch Med Sci, Dept Ophthalmol, Fukuoka, JapanUniv Hosp Bristol NHS Fdn Trust, Bristol Eye Hosp, Ophthalmol, Bristol, Avon, EnglandUniv Fed Sao Paulo, Uveitis Serv, Sao Paulo, BrazilJohns Hopkins Univ, Sch Med, Wilmer Eye Inst, Baltimore, MD 21205 USACent Manchester Univ Hosp, Manchester Royal Eye Hosp, Manchester, Lancs, EnglandUniv Manchester, Manchester Acad Hlth Sci Ctr, Manchester, Lancs, EnglandUniv Fed Sao Paulo, Paulista Sch Med, Dept Ophthalmol & Visual Sci, Sao Paulo, BrazilUniv Fed Sao Paulo, Uveitis Serv, Sao Paulo, BrazilWeb of Scienc