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Guillain–Barré syndrome in patients treated with immune checkpoint inhibitors

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Abstract

Objective

Guillain–Barré syndrome (GBS) induced by immune checkpoint inhibitors (ICIs) has been occasionally reported in randomized clinical trials (RCTs), but the post-marketing data are quite limited. This study aimed to comprehensively examine GBS events secondary to ICI treatments in the real-world patients based on the Food and Drug Administration Adverse Event Reporting System (FAERS).

Methods

Reports from January 2004 to March 2020 were extracted from the FAERS. GBS cases related to ICIs were identified to characterize their clinical features. The disproportionality and Bayesian analysis were performed for the detection of GBS signals associated with ICIs.

Results

In total, 149 GBS reports with ICIs as suspect drugs were screened out. These events were found to be more prevalent in adults ≥ 45 years (63.09%) and males (63.09%). The onsets of GBS were variable with a median time of 38 (range 0–628) days after ICI initiation. The outcomes tended to be severe with 61.74% hospitalization and 22.82% death. GBS events were most commonly reported in ipilimumab plus nivolumab treatment (24.83%), and this combination therapy also yielded stronger signal for GBS than other therapies based on the highest reporting odds ratio (ROR = 12.43, two-sided 95% CI = 8.62, 17.93), proportional reporting ratio (PRR = 12.39, χ2 = 300.90), information component (IC = 3.62, IC025 = 2.51) and empirical Bayes geometric mean (EBGM = 12.28, EBGM05 = 9.04).

Conclusion

As complements to the safety data from RCTs, the current pharmacovigilance research helps establish a more detailed overview of ICI-related GBS, which facilitates the understanding of this rare adverse drug effect.

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Data availability

All data have been presented in the manuscript. Other related information is available under request to the corresponding author.

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Funding

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Authors and Affiliations

  1. Department of Pharmacy, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, No.1 Shuaifuyuan, Dongcheng District, Beijing, 100730, China

    Qianqian Fan, Yang Hu & Bin Zhao

  2. Department of Medical Oncology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China

    Xiang Wang

Authors
  1. Qianqian Fan
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  2. Yang Hu
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  3. Xiang Wang
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  4. Bin Zhao
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Contributions

QF designed the research, collected and analyzed the data, and wrote the manuscript draft; YH participated in the data collection and analysis; XW contributed to the quality assessment; BZ designed and directed the research, and corrected the manuscript.

Corresponding author

Correspondence to Bin Zhao.

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Conflicts of interest

The authors declare no conflict of interest.

Ethical approval

Ethical approval was waived by the Institutional Review Board of Peking Union Medical College Hospital because this was an observational study based on the FAERS, which is a public anonymized database.

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Fan, Q., Hu, Y., Wang, X. et al. Guillain–Barré syndrome in patients treated with immune checkpoint inhibitors. J Neurol 268, 2169–2174 (2021). https://doi.org/10.1007/s00415-021-10404-0

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  • DOI: https://doi.org/10.1007/s00415-021-10404-0

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