Expert opinion on drug safety · 2025
Peripheral neuropathies induced by BRAF+MEK inhibitor combinations: a real-world study based on FAERS database 2011-2022.
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Wang Yuting, Zheng Jingping, Zhang Zhenpo, Mai Haiyan, Su Ling
Аннотация
BACKGROUND: BRAF/MEK inhibitors (BRAFi+MEKi) like may cause peripheral neuropathies (PN). This study analyzes FAERS data to assess PN signals across BRAFi+MEKi combinations.
RESEARCH DESIGN AND METHODS: Disproportionality analysis was conducted to quantify the signals of BRAFi+MEKi-associated PN on FAERS database from January 2011 to December 2022. Additionally, we examined the onset times and prognosis of BRAFi+MEKi-associated PN.
RESULTS: A total of 268 reports of BRAFi+MEKi-associated PN were identified in the study, with a median age range of 60.00 to 69.00 years. All three combination therapies exhibited positive signals for PN, and notably, Encorafenib and Binimetinib (E+B) displayed the strongest association with PN (ROR 3.05[2.47,3.76], IC1.57[1.26]). The associations between PN and different BRAFi+MEKi combinations remained persisted in the gender and age stratification analysis, with all three combination therapies showing an elevated number of disproportionality signals in males compared to females.
CONCLUSION: According to our findings, BRAFi+MEKi-associated PN tends to occur several months after initiation and may lead to serious outcomes. Male sex is more likely to be a risk factor associated with PN. Prompt identification and intervention for BRAFi+MEKi-associated PN are crucial, and additional fundamental research is required to validate the underlying mechanism as observed in our study.
RESEARCH DESIGN AND METHODS: Disproportionality analysis was conducted to quantify the signals of BRAFi+MEKi-associated PN on FAERS database from January 2011 to December 2022. Additionally, we examined the onset times and prognosis of BRAFi+MEKi-associated PN.
RESULTS: A total of 268 reports of BRAFi+MEKi-associated PN were identified in the study, with a median age range of 60.00 to 69.00 years. All three combination therapies exhibited positive signals for PN, and notably, Encorafenib and Binimetinib (E+B) displayed the strongest association with PN (ROR 3.05[2.47,3.76], IC1.57[1.26]). The associations between PN and different BRAFi+MEKi combinations remained persisted in the gender and age stratification analysis, with all three combination therapies showing an elevated number of disproportionality signals in males compared to females.
CONCLUSION: According to our findings, BRAFi+MEKi-associated PN tends to occur several months after initiation and may lead to serious outcomes. Male sex is more likely to be a risk factor associated with PN. Prompt identification and intervention for BRAFi+MEKi-associated PN are crucial, and additional fundamental research is required to validate the underlying mechanism as observed in our study.