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Analyses of Dupilumab-Related Ocular Adverse Drug Reactions Using the WHO’s VigiBase

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Abstract

Introduction

Dupilumab is a drug that inhibits the action of interleukin (IL)-4 and IL-13 and is a potent therapeutic drug for allergic diseases such as atopic dermatitis. Although its use has been associated with significant ocular adverse drug reactions (ADRs), the IL-4 and IL-13 inhibition may also have favorable therapeutic effects. The aim of this study was to determine the disease spectrum in which the use of dupilumab may have been associated with an increase or decrease of ocular ADRs.

Methods

We searched the World Health Organization’s VigiBase for ADRs associated with the use of dupilumab for data up to 12 June 2022. The number of all ADRs that were retrieved was compared with the number of ocular ADRs associated with the use of dupilumab. Disproportionate reporting was assessed by calculating the information component (IC) values and odds ratios.

Results

Since the introduction of dupilumab, 100,267 ADRs have been reported. Of all the ADRs associated with dupilumab, 28,522 ADRs were ocular complications, and it ranked fourth in the ocular complications by organ level. By assessments of the IC for age ≤ 44 years, the most significantly associated ADRs were dry eye followed by blepharitis including eyelid crusting and dryness and conjunctivitis. Crusting and dryness of the eyelids were the most significant ADRs for all age groups. Other ocular ADRs reported include meibomian gland dysfunction, keratitis, glaucoma, and retinal disorders. In contrast, periorbital edema, neuro-ophthalmic disorders, optic neuritis, and macular edema were significantly reduced by the use of dupilumab.

Conclusions

Dupilumab-related ADRs included an increase or decrease of various ocular disorders. The results indicate that dupilumab also has potential therapeutic effects.

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Acknowledgements

Funding

No funding or sponsorship was received for this study or publication of this article. The Rapid Service Fee was funded by the authors.

Author Contributions

Eri Hirai and Dai Miyazaki wrote the first draft of the manuscript. Dai Miyazaki and Eri Hirai organized data analysis and edited the manuscript. Eri Hirai, Tomoko Haruki and Takashi Baba discussed the results and provided constructive comments to the final version of manuscript. All authors have read and agreed to the published version of the manuscript.

Disclosures

Dai Miyazaki has received a speaker honorarium from Sanofi. Eri Hirai, Tomoko Haruki and Takashi Baba declare that they have no competing interests.

Compliance with Ethics Guidelines

All the procedures used conformed to the tenets of the Declaration of Helsinki. This article is based on previously collected anonymous adverse drug reaction reports by WHO public database, and does not contain any new studies with human participants. Need for study protocol approval was waived by the institutional review board.

Data Availability

The datasets analyzed during the current study are available in VigiBase, which is a publicly available database via https://who-umc.org/vigibase/.

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Authors and Affiliations

  1. Division of Ophthalmology and Visual Science, Faculty of Medicine, Tottori University, 36-1 Nishicho, Yonago, 683-8504, Japan

    Eri Hirai, Tomoko Haruki, Takashi Baba & Dai Miyazaki

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  1. Eri Hirai
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Correspondence to Dai Miyazaki.

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Hirai, E., Haruki, T., Baba, T. et al. Analyses of Dupilumab-Related Ocular Adverse Drug Reactions Using the WHO’s VigiBase. Adv Ther 40, 3830–3856 (2023). https://doi.org/10.1007/s12325-023-02573-3

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