Disproportionality analysis of satralizumab in FDA adverse event reporting system and Japanese adverse drug event report: a pharmacovigilance study

The adverse risks associated with satralizumab are notable. Our findings provide evidence to support risk assessment in clinical practice; however, high-quality clinical studies are still needed to validate these results and to further explore the long-term safety and efficacy of the drug.

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Publication Details

Journal
Frontiers in Immunology
Published
2026-01-14
DOI
https://doi.org/10.3389/fimmu.2025.1647306
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
0.00

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Disproportionality analysis of satralizumab in FDA adverse event reporting system and Japanese adverse drug event report: a pharmacovigilance study

Rong Yan, Linhai Zhang, Zucai Xu
Frontiers in Immunology
Pharmacovigilance and Adverse Drug Reactions
article

Disproportionality analysis of satralizumab in FDA adverse event reporting system and Japanese adverse drug event report: a pharmacovigilance study

Rong Yan, Linhai Zhang, Zucai Xu
article en

Abstract

The adverse risks associated with satralizumab are notable. Our findings provide evidence to support risk assessment in clinical practice; however, high-quality clinical studies are still needed to validate these results and to further explore the long-term safety and efficacy of the drug.

Frontiers in ImmunologyVol. 16
Zunyi Medical University (CN), VIB-KU Leuven Center for Brain & Disease Research (BE)
National Natural Science Foundation of China, U.S. Food and Drug Administration
Openalex Percentile: Top 89%
Pharmacovigilance and Adverse Drug Reactions
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