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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Pharmacoepidemiology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1440907

Adverse Drug Events (ADEs) Risk Signal Mining Related to Eculizumab Based on the FARES Database

Provisionally accepted
Xifeng Wang Xifeng Wang 1Luri Bao Luri Bao 2*Tala Hu Tala Hu 3*Ruifeng Xu Ruifeng Xu 3*Wuniri Gao Wuniri Gao 3*Jingyuan Wang Jingyuan Wang 2Jianrong Zhao Jianrong Zhao 3*Shufang Wang Shufang Wang 4*Yan Meng Yan Meng 3*
  • 1 Department of Nephrology, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
  • 2 Inner Mongolia Medical University, Hohhot, Inner Mongolia Autonomous Region, China
  • 3 Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
  • 4 Other, Hohhot, China

The final, formatted version of the article will be published soon.

    Eculizumab is a C5 complement inhibitor approved by the FDA for the targeted treatment of four rare diseases, paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and aquaporin-4 immunoglobulin G-positive optic neuromyelitis optica spectrum disorders (AQP4-IgG+NMOSD). The current study was conducted to assess realworld adverse events (AEs) associated with eculizumab through data mining of the FDA Adverse Event Reporting System (FAERS).: Disproportionality analyses, including Reporting Ratio Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms were used to quantify the signals of eculizumab-associated AEs. Results: A total of 46,316 eculizumab-related ADEs reports were identified by analyzing 19,418,776 reports in the U.S. Food and Drug Administration AdverseEvent Reporting System (FAERS) database. A total of 461 PTs were identified as satisfying by all four algorithms. These PTs reported adverse reactions consistent with the specifications, such as fatigue, nasopharyngitis, meningococcal infection, fever, and anemia. Some PTs, such as aplastic anemia, gene mutation, mastication disorder, kidney fibrosis, BK virus infection, abnormal neutrophil count, C3 glomerulopathy, neuroblastoma, and glomerulonephritis membranoproliferative, were also detected outside the instructions. The median time to onset of eculizumab adverse events was 159 days (interquartile range [IQR] 11~738 days). In addition, at the PT level, 51 PTs were determined to have an imbalance in the occurrence of ADEs between the sexes.Conclusions: These findings provide valuable insights into the occurrence of ADEs following the use of eculizumab and could support clinical monitoring and risk identification efforts.

    Keywords: Eculizumab, FAERS, Adverse drug events, Adverse drug reaction monitoring, ADRM

    Received: 30 May 2024; Accepted: 18 Dec 2024.

    Copyright: © 2024 Wang, Bao, Hu, Xu, Gao, Wang, Zhao, Wang and Meng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence:
    Luri Bao, Inner Mongolia Medical University, Hohhot, Inner Mongolia Autonomous Region, China
    Tala Hu, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
    Ruifeng Xu, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
    Wuniri Gao, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
    Jianrong Zhao, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China
    Shufang Wang, Other, Hohhot, China
    Yan Meng, Affiliated Hospital, Inner Mongolia Medical University, Hohhot, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.