Research Article

Ocular toxicities in chimeric antigen receptor T-cell therapy: a real-world study leveraging FAERS database

https://orcid.org/0000-0001-7100-797X

Ophthalmology Department, Naval Hospital of Eastern Theater of PLA, Zhejiang Province, Zhoushan, China

‡Authors contributed equally

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Fangyuan Hu‡

Health Service Department, Naval Hospital of Eastern Theater of PLA, Zhejiang Province, Zhoushan, China

‡Authors contributed equally

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Yinghong Zhai‡

Clinical Research Unit, School of Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai JiaoTong University, Shanghai, China

‡Authors contributed equally

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Xia Ye‡

Ophthalmology Department, Naval Hospital of Eastern Theater of PLA, Zhejiang Province, Zhoushan, China

‡Authors contributed equally

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Yiming Ruan

Health Service Department, The First Naval Hospital of Southern Theater of PLA, Guangdong Province, Zhanjiang, China

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Zhen Liu

Ophthalmology Department, Naval Hospital of Eastern Theater of PLA, Zhejiang Province, Zhoushan, China

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Zhiyan Wang

Ophthalmology Department, Naval Hospital of Eastern Theater of PLA, Zhejiang Province, Zhoushan, China

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Wei Shen

*Author for correspondence:

E-mail Address: shenwei@smmu.edu.cn

Ophthalmology Department, The First Affiliated Hospital of Naval Medical University, Shanghai, China

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Lei Yuan

**Author for correspondence:

E-mail Address: yuanleigz@163.com

Department of Health Management, Faculty of Military Health Service, Naval Medical University, Shanghai, China

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Published Online:21 Dec 2023https://doi.org/10.2217/imt-2023-0220

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Abstract

Aim: The purpose of this study was to comprehensively explore the ocular toxicity associated with chimeric antigen receptor (CAR) T-cell therapy. Materials & methods: Data were assembled from the US FDA's Adverse Event Reporting System (FAERS) database from 2017 to 2023. Information component and reporting odds ratio methods were used for signal detection in total/categorized CAR T-cell therapy. Results: A total of 17 positive signals (preferred term) were detected, yet none of them were documented in the product information. Some adverse events were with death outcomes and overlapped a lot with cytokine-release syndrome. Conclusion: The ocular adverse events associated with CAR-T cell therapy are noteworthy, and it is imperative to maintain increased alertness and institute early intervention strategies.

Plain language summary

CAR-T-cell therapy is a highly effective treatment for blood cancers that has gained significant attention as a promising therapy in recent years. However, a complete analysis of its side effects on eyes has not been determined. In this study, we examined eye-related adverse events with five US Food and Drug Administration (FDA)-approved CAR T-cell therapies by using data from the FDA. We found that certain eye issues such as dilated pupils, impaired pupillary light reflex and eye surface bleeding deserve attention. Surprisingly, these problems were not mentioned in the product information. Since some adverse events can have severe outcomes, it is important to be vigilant and take early action.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

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Vol. 16, No. 3

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History

Received 2 September 2023

Accepted 22 November 2023

Published online 21 December 2023

Published in print February 2024

Information

Keywords

Supplementary data

To view the supplementary data that accompany this paper please visit the journal website at: www.futuremedicine.com/doi/suppl/10.2217/imt-2023-0220

Author contributions

N Zhao and F Hu designed the study; W Shen, X Ye, Z Liu and Z Wang contributed to the data collection and organization. N Zhao, Y Zhai, Y Ruan, F Hu and L Yuan collaborated on data analysis. Each author has made an equitable contribution to the manuscript's composition. The final manuscript has been thoroughly reviewed, vetted and unanimously approved by all authors.

Financial disclosure

This study was supported by multiple funding sources, including The National Social Science Fund of China (2022-SKJJ-C-033; 2022), Zhoushan Medical and Health Science and Technology Program for the Military and Local (2022JYB05), Zhoushan Medical and Health Science and Technology Program for the Military and Local (2023JYB05) and Project of Hospital Management (no. YGA202308) from Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Data sharing statement

The datasets generated and analyzed during the course of this study can be accessed via the FAERS repository [https://fis.fda.gov/extensions/FPD-QDE-FAERS/FPD-QDE-FAERS.html]. All sensitive and individual clinical data has been duly identified, and all data utilized within our research is publicly accessible in accordance with FAERS guidelines.

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