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

doi:10.1016/j.ophtha.2017.11.017

Ophthalmology

Volume 125, Issue 5, May 2018, Pages 757-773

Presented at: American Academy of Ophthalmology Annual Meeting, New Orleans, Louisiana, November 2017.

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Fundamentals of Care for Uveitis International Consensus Group

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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 2016; Medline [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 agents; what data to collect before treatment; when to modify or withdraw treatment; how to select agents based on individual efficacy and safety profiles; and 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.

Abbreviations and Acronyms

adverse event

ankylosing spondylitis

BCVA

best-corrected visual acuity

evidence level

ISC

International Steering Committee

NCSIT

noncorticosteroid systemic immunomodulatory therapy

NIU

noninfectious uveitis

PsA

psoriatic arthritis

RCT

randomized controlled trial

visual acuity

VKH

Vogt-Koyanagi-Harada

Cited by (0)

: Financial Disclosure(s): The author(s) have made the following disclosure(s): A.D.D.: Consultant – AbbVie, Roche, Novartis

: J.T.R.: Consultant – AbbVie, Gilead, Regeneron, UCB, Santen, Cavtherx, Eyevensys, Portage; Lecturer – Mallinckrodt; Equity owner – UptoDate

: H.A.-D.: Financial support – AbbVie

: R.B.: Financial support – AbbVie, Alcon Novartis, Allergan, Roche, Turing, Zeiss

: A.P.B.: Consultant – AbbVie, Alcon, Eyevensys; Financial support – AbbVie

: S.P.C.: Consultant and Financial support – AbbVie, Santen Pharmaceutical Asia Pte Ltd., Allergan Singapore Pte Ltd., Alcon Laboratories, Inc., Abbott Medical Optics, Inc., Hoya Surgical Optics Pte Ltd., Bausch & Lomb Technolas, Carl Zeiss Pte Ltd.

: J.L.D.: Consultant and Financial support – AbbVie

: A.V.R.: Consultant – AbbVie, UCB, Eli Lilly; Financial support – AbbVie

: K.-H.S.: Financial support – AbbVie

: E.C.: Consultant – Santen; Financial support – AbbVie

: H.N.: Financial support – AbbVie

: S.Salah: Financial support – AbbVie

: S.Salek: Financial support – AbbVie

: J.S.: Financial support – AbbVie

: L.S.: Financial and non-financial support – AbbVie

: Supported by AbbVie, Inc., and the Fundamentals of Care for Uveitis Initiative National Faculty. This manuscript was developed subsequent to an AbbVie-sponsored literature review of noninfectious, nonanterior uveitis. The meeting was conducted to understand the available literature regarding the management of patients with noninfectious, nonanterior uveitis. The program involved a total of 139 experts from 28 countries, who were selected for participation by AbbVie. However, AbbVie was not involved in the development of the manuscript. The authors maintained complete control over the content and this manuscript reflects the opinions of the authors. AbbVie selected the discussion participants and reviewed the final manuscript draft for scientific accuracy, but the authors determined the final content. All authors made substantial contributions to the article or critically revised it for important intellectual content and approved the final manuscript. AbbVie provided funding to invited participants, including honoraria for their attendance at the meetings. Travel to and from the meetings was reimbursed. No payments were made to the authors for the development of this manuscript. Dhinakaran Sambandan, PhD, and Shula Sarner, PhD, of Lucid Partners, Burleighfield House, Buckinghamshire, United Kingdom, provided medical writing and editorial support to the authors in the development of this manuscript; financial support for these services was provided by AbbVie. AbbVie reviewed the manuscript, but was not involved in the methodology, data collection and analysis, or completion of this manuscript.

: HUMAN SUBJECTS: No human subjects were included in this study.

: Author Contributions:

: Conception and design: Dick, Rosenbaum, Al-Dhibi, Belfort, Brézin, Chee, Davis, Ramanan, Sonoda

: Analysis and interpretation: Dick, Rosenbaum, Al-Dhibi, Belfort, Brézin, Chee, Davis, Ramanan, Sonoda, Carreño, Nascimento, Salah, Salek, Siak, Steeples

: Data collection: Dick, Rosenbaum, Al-Dhibi, Belfort, Brézin, Chee, Davis, Ramanan, Sonoda, Carreño, Nascimento, Salah, Salek, Siak, Steeples

: Obtained funding: none

: Overall responsibility: Dick, Rosenbaum, Al-Dhibi, Belfort, Brézin, Chee, Davis, Ramanan, Sonoda, Carreño, Nascimento, Salah, Salek, Siak, Steeples

: Supplemental material available at www.aaojournal.org.

^∗: A complete listing of the members of the Fundamentals of Care for Uveitis Initiative International Consensus Group appears in Appendix 9, available at www.aaojournal.org.

^†: Both authors contributed equally as first authors.

© 2018 by the American Academy of OphthalmologyThis is an open access article under the CC BY-NC-ND license ?(<inter-ref xlink: href=http://creativecommons.org/licenses/by-nc-nd/4.0/>http://?creativecommons.org/licenses/by-nc-nd/4.0/</inter-ref>).