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Analysis of the association between Janus kinase inhibitors and malignant skin tumors using the Food and Drug Administration Adverse Event Reporting System

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Abstract

Background

Malignant skin tumors are adverse events of concern regarding Janus kinase (JAK) inhibitors.

Aim

This study aimed to evaluate the association between JAK inhibitors and adverse events of malignant skin tumors, and to characterize the main features.

Method

Data (2012–2021) were collected using the US Food and Drug Administration Adverse Event Reporting System (FAERS). Adverse event cases of JAK inhibitors as the primary suspected drug were extracted for further analysis. Disproportionality analysis evaluated the association between JAK inhibitors and malignant skin tumor events by estimating the reporting odds ratio (ROR) and the information component (IC) with 95% confidence intervals (95% CI).

Results

A total of 142,673 cases with JAK inhibitors as a primary suspected drug were collected, including 1400 malignant skin tumor events. Ruxolitinib, upadacitinib, tofacitinib, and baricitinib were included in the disproportionality analysis. Three JAK inhibitors were associated with malignant skin tumor events, namely ruxolitinib (ROR 5.40, 95% CI 5.03–5.81; IC 2.39, 95% CI 2.14–2.62), upadacitinib (ROR 4.79, 95% CI 4.03–5.71; IC 2.24, 95% CI 1.62–2.77), and tofacitinib (ROR 1.67, 95% CI 1.53–1.83; IC 0.73, 95% CI 0.43–1.02). The median time to onset time was 378.5 days.

Conclusion

We found association between malignant skin tumors and ruxolitinib, upadacitinib, and tofacitinib. More attention should be paid to these events when prescribing JAK inhibitors in clinical practice.

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Acknowledgements

This research was supported by National Key Clinical Specialties Construction Program.

Funding

This study was supported by the 1·3·5 projects for disciplines of excellence-Clinical Research Incubation Project, West China Hospital, Sichuan University (2018HXFH050) of the National Key Clinical Specialties Construction Program.

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Author notes

  1. Tianqi Liu and Ruonan Gao have contributed equally to this work.

Authors and Affiliations

  1. Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, 610041, China

    Tianqi Liu, Ruonan Gao, Li Li, Bin Wu & Fengbo Wu

  2. West China School of Pharmacy, Sichuan University, Chengdu, 610041, China

    Tianqi Liu & Ruonan Gao

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  1. Tianqi Liu
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Liu, T., Gao, R., Li, L. et al. Analysis of the association between Janus kinase inhibitors and malignant skin tumors using the Food and Drug Administration Adverse Event Reporting System. Int J Clin Pharm 45, 1483–1491 (2023). https://doi.org/10.1007/s11096-023-01634-5

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