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Pharmacovigilance study of the association between peripheral neuropathy and antibody-drug conjugates using the FDA adverse event reporting system.
Chen, Yuheng; Ren, Xiayang; Dai, Yuanyuan; Wang, Yanfeng.
Afiliación
  • Chen Y; Party Committee Office, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Ren X; Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Dai Y; Department of Pharmacy, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
  • Wang Y; Department of Comprehensive Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Chaoyang District, Beijing, 100021, China. wangyf@cicams.ac.cn.
Sci Rep ; 14(1): 21386, 2024 09 13.
Article en En | MEDLINE | ID: mdl-39271716
ABSTRACT
Antibody-drug conjugates (ADCs) are among the fastest-growing classes of anticancer drugs, making it crucial to evaluate their potential for causing peripheral neuropathy. We analyzed data from the FAERS database (January 1, 2014, to June 30, 2023) using disproportionality and Bayesian methods. We identified 3076 cases of ADC-associated peripheral neuropathy. Our study revealed significant signals for all ADCs (ROR 1.82, 95% CI 1.76-1.89). ADCs with tubulin-binding payloads showed significant peripheral neuropathy signals (ROR 2.31, 95% CI 2.23-2.40), whereas those with DNA-targeting (ROR 0.48, 95% CI 0.39-0.59) and topoisomerase 1 inhibitor (ROR 0.56, 95% CI 0.48-0.66) payloads exhibited non-significant signals. Signals for peripheral sensory neuropathy were 4.83, 2.44, 2.74, and 2.21 (calculated based on IC025) for brentuximab vedotin, trastuzumab emtansine, enfortumab vedotin, and polatuzumab vedotin, while signals for peripheral motor neuropathy were 5.31, 0.34, 2.27, and 0.03, respectively. The median time to onset for all ADCs was 127 days (interquartile range 40-457). Tisotumab vedotin had the highest hospitalization rate at 26.67%, followed by brentuximab vedotin at 25.5%. Trastuzumab emtansine had the highest mortality rate ,with 80 deaths (11.96%) among 669 cases. Based on FAERS database, only ADCs with tubulin-binding payloads exhibited significant peripheral neuropathy signals. Brentuximab vedotin and enfortumab vedotin showed similar profiles for peripheral sensory neuropathy and motor neuropathy. Given the delayed time to onset and potentially poor outcomes, ADC-related peripheral neuropathy warrants significant attention.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Sistemas de Registro de Reacción Adversa a Medicamentos / Enfermedades del Sistema Nervioso Periférico / Inmunoconjugados / Farmacovigilancia Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Sci Rep Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: United States Food and Drug Administration / Sistemas de Registro de Reacción Adversa a Medicamentos / Enfermedades del Sistema Nervioso Periférico / Inmunoconjugados / Farmacovigilancia Límite: Female / Humans / Male País/Región como asunto: America do norte Idioma: En Revista: Sci Rep Año: 2024 Tipo del documento: Article País de afiliación: China Pais de publicación: Reino Unido