Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase

Abstract Dupilumab is a dual inhibitor of interleukin-4 and interleukin-13 and is mainly used to treat moderate-to-severe atopic dermatitis. Post-marketing safety data related to dupilumab have been accumulated, and it has been found that ocular surface diseases are closely associated with dupilumab...

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Autores principales:	Sunny Park, Jung Hyun Lee, Ji Hyun Park, So Hyang Park, Song Yi Park, Yong Woo Jung, Soo An Choi
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/91b553811e6f4579b0f1c7d94711a33c
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spelling	oai:doaj.org-article:91b553811e6f4579b0f1c7d94711a33c2021-12-02T16:14:10ZOcular surface disorders associated with the use of dupilumab based on WHO VigiBase10.1038/s41598-021-93750-32045-2322https://doaj.org/article/91b553811e6f4579b0f1c7d94711a33c2021-07-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-93750-3https://doaj.org/toc/2045-2322Abstract Dupilumab is a dual inhibitor of interleukin-4 and interleukin-13 and is mainly used to treat moderate-to-severe atopic dermatitis. Post-marketing safety data related to dupilumab have been accumulated, and it has been found that ocular surface diseases are closely associated with dupilumab treatment. The aim of this study was to detect dupilumab-related signals and to determine the safety characteristics of dupilumab with respect to eye disorders using real-world big data. Data on dupilumab use until December 29, 2019 were collected. The data were mined by calculating three indices: proportional reporting ratios, reporting odds ratios, and information components. The detected signals were classified using the primary system organ class in MedDRA terminology. Among 21,161,249 reports for all drugs, 20,548 reports were recorded for dupilumab. A total of 246 signals in the preferred terms were detected for dupilumab. Among the 246 positive signals obtained, 61 signals were related to eye disorders, which accounted for the largest percentage (24.8%), and 38 signals were anatomically related to the ocular surface. Dupilumab may cause extensive eye disorders; however, the underlying mechanisms and risk factors remain unclear. Our findings may facilitate broad safety screening of dupilumab-related eye disorders using real-world big data.Sunny ParkJung Hyun LeeJi Hyun ParkSo Hyang ParkSong Yi ParkYong Woo JungSoo An ChoiNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-8 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Sunny Park Jung Hyun Lee Ji Hyun Park So Hyang Park Song Yi Park Yong Woo Jung Soo An Choi Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
description	Abstract Dupilumab is a dual inhibitor of interleukin-4 and interleukin-13 and is mainly used to treat moderate-to-severe atopic dermatitis. Post-marketing safety data related to dupilumab have been accumulated, and it has been found that ocular surface diseases are closely associated with dupilumab treatment. The aim of this study was to detect dupilumab-related signals and to determine the safety characteristics of dupilumab with respect to eye disorders using real-world big data. Data on dupilumab use until December 29, 2019 were collected. The data were mined by calculating three indices: proportional reporting ratios, reporting odds ratios, and information components. The detected signals were classified using the primary system organ class in MedDRA terminology. Among 21,161,249 reports for all drugs, 20,548 reports were recorded for dupilumab. A total of 246 signals in the preferred terms were detected for dupilumab. Among the 246 positive signals obtained, 61 signals were related to eye disorders, which accounted for the largest percentage (24.8%), and 38 signals were anatomically related to the ocular surface. Dupilumab may cause extensive eye disorders; however, the underlying mechanisms and risk factors remain unclear. Our findings may facilitate broad safety screening of dupilumab-related eye disorders using real-world big data.
format	article
author	Sunny Park Jung Hyun Lee Ji Hyun Park So Hyang Park Song Yi Park Yong Woo Jung Soo An Choi
author_facet	Sunny Park Jung Hyun Lee Ji Hyun Park So Hyang Park Song Yi Park Yong Woo Jung Soo An Choi
author_sort	Sunny Park
title	Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
title_short	Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
title_full	Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
title_fullStr	Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
title_full_unstemmed	Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase
title_sort	ocular surface disorders associated with the use of dupilumab based on who vigibase
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/91b553811e6f4579b0f1c7d94711a33c
work_keys_str_mv	AT sunnypark ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT junghyunlee ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT jihyunpark ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT sohyangpark ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT songyipark ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT yongwoojung ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase AT sooanchoi ocularsurfacedisordersassociatedwiththeuseofdupilumabbasedonwhovigibase
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Ocular surface disorders associated with the use of dupilumab based on WHO VigiBase

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