PMID- 33166553 OWN - NLM STAT- MEDLINE DCOM- 20211012 LR - 20211012 IS - 1549-4713 (Electronic) IS - 0161-6420 (Linking) VI - 128 IP - 6 DP - 2021 Jun TI - Ophthalmic Immune-Related Adverse Events after Anti-CTLA-4 or PD-1 Therapy Recorded in the American Academy of Ophthalmology Intelligent Research in Sight Registry. PG - 910-919 LID - S0161-6420(20)31042-3 [pii] LID - 10.1016/j.ophtha.2020.11.001 [doi] AB - PURPOSE: Detailed study of ophthalmic immune-related adverse events (AEs), including determination of incidence and recurrence rates, is of integral importance in cancer immunotherapy to inform management and treatment guidelines. DESIGN: Retrospective registry study. PARTICIPANTS: Patients newly diagnosed with ophthalmic immune-related AEs between January 1, 2013, and December 31, 2017, in the American Academy of Ophthalmology's Intelligent Research in Sight (IRIS(R)) Registry. METHODS: Data were collected from electronic health records of IRIS(R) Registry participating ophthalmology practices. Patients with select ophthalmic immune-related AEs were identified by International Classification of Diseases diagnosis codes. The primary exposure of interest was prior initiation of immune checkpoint inhibitors (ICIs). MAIN OUTCOME MEASURES: Incidence of ophthalmic immune-related AEs within 1 year after initiation of ICI therapy was determined. Incidence rate ratios (IRRs) were derived by comparing incidence of ophthalmic immune-related AEs after ICIs versus rates of the same ocular complications in patients not taking ICIs in the entire registry population. Rates of ophthalmic immune-related AEs in patients with a past history of ocular inflammation or other specific ophthalmic condition before initiation of ICIs were examined further. RESULTS: A total of 3123 patients who received anti-CTLA-4 or anti-programmed cell death 1 (PD-1) therapy were identified, 112 of whom demonstrated an ophthalmic immune-related AE. Incidence rates for anterior uveitis, the most common ophthalmic immune-related AE, were 8209 per 100 000 for ipilimumab (anti-CTLA-4), 2542 per 100 000 for nivolumab (anti-PD-1), 2451 per 100 000 for pembrolizumab (anti-PD-1), 5556 per 100 000 for ipilimumab plus nivolumab, and 3740 per 100 000 among all ICIs. Rates of ophthalmic immune-related AEs among patients receiving ICI therapy were higher compared with baseline rates in the general registry population (anterior uveitis IRR, 13.9; other uveitis IRR, 43.0; papilledema IRR, 38.3). Patients with a history of uveitis or other ocular inflammatory condition demonstrated high recurrence rates of ophthalmic immune-related AEs after initiating ICIs (up to 51.1%). CONCLUSIONS: For patients initiating ICI therapy, early coordination with ophthalmic subspecialist care is important because rates of ophthalmic immune-related AEs are elevated compared with ocular complication rates in the entire registry population and patients with a history of prior autoimmune ocular disease are at high risk of recurrence of ocular complications. CI - Copyright (c) 2020 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved. FAU - Sun, Michel M AU - Sun MM AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California. FAU - Kelly, Scott P AU - Kelly SP AD - American Academy of Ophthalmology, San Francisco, California. FAU - Mylavarapu Bs, Apoorva L AU - Mylavarapu Bs AL AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California. FAU - Holland, Gary N AU - Holland GN AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California. FAU - Coleman, Anne L AU - Coleman AL AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California; Department of Epidemiology, Fielding School of Public Health, University of California at Los Angeles, Los Angeles, California. FAU - Yu, Fei AU - Yu F AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California. FAU - Hsu Ms, Stephen AU - Hsu Ms S AD - American Academy of Ophthalmology, San Francisco, California. FAU - Lum, Flora AU - Lum F AD - American Academy of Ophthalmology, San Francisco, California. FAU - Gordon, Lynn K AU - Gordon LK AD - Department of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine at the University of California at Los Angeles, Los Angeles, California. Electronic address: LGordon@mednet.ucla.edu. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20201106 PL - United States TA - Ophthalmology JT - Ophthalmology JID - 7802443 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents, Immunological) RN - 0 (CTLA-4 Antigen) RN - 0 (CTLA4 protein, human) RN - 0 (Immune Checkpoint Inhibitors) RN - 0 (Ipilimumab) RN - 0 (Programmed Cell Death 1 Receptor) RN - DPT0O3T46P (pembrolizumab) SB - IM MH - Academies and Institutes MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/*adverse effects MH - Antineoplastic Agents, Immunological/adverse effects MH - CTLA-4 Antigen/antagonists & inhibitors/*immunology MH - Electronic Health Records MH - Female MH - Humans MH - Immune Checkpoint Inhibitors/adverse effects MH - Immunotherapy/*adverse effects MH - Incidence MH - Ipilimumab/*adverse effects MH - Male MH - Middle Aged MH - Ophthalmology MH - Programmed Cell Death 1 Receptor MH - *Registries MH - Retrospective Studies MH - United States/epidemiology MH - Uveitis, Anterior/*chemically induced/epidemiology MH - Young Adult OTO - NOTNLM OT - Adverse events OT - Anti-CTLA-4 OT - Anti-PD-1 OT - IRIS(R) Registry OT - Immune checkpoint inhibitor OT - Immune-related adverse events OT - Uveitis EDAT- 2020/11/10 06:00 MHDA- 2021/10/13 06:00 CRDT- 2020/11/09 20:12 PHST- 2020/07/14 00:00 [received] PHST- 2020/10/21 00:00 [revised] PHST- 2020/11/02 00:00 [accepted] PHST- 2020/11/10 06:00 [pubmed] PHST- 2021/10/13 06:00 [medline] PHST- 2020/11/09 20:12 [entrez] AID - S0161-6420(20)31042-3 [pii] AID - 10.1016/j.ophtha.2020.11.001 [doi] PST - ppublish SO - Ophthalmology. 2021 Jun;128(6):910-919. doi: 10.1016/j.ophtha.2020.11.001. Epub 2020 Nov 6.