| アブストラクト | In 2022, the FDA approved nivolumab-relatlimab for the treatment of unresectable or metastatic melanoma. In the present study, we conducted a living pharmacovigilance study, integrating data from clinical trials and the FDA Adverse Event Reporting System (FAERS) database, to assess the safety profile of nivolumab-relatlimab. Treatment related adverse events (TRAEs) in trials of nivolumab-relatlimab available in electronic databases were systematically searched. The outcomes included were all-grade (grades 1-5) and high-grade (grades 3-5) TRAEs, considering both overall and individual aspects. Meta-analysis was conducted to calculate the incidence and risk ratio of TRAEs associated with nivolumab-relatlimab. Certainty of evidence was assessed using the GRADE system. Adverse events reports were extracted from the FAERS database, and a disproportionality analysis was carried out to estimate the safety signals of AEs associated with nivolumab-relatlimab. A total of 12 trials were included, the incidence of all-grade and high-grade TRAEs for nivolumab-relatlimab was 74.11 % and 38.05 %, respectively. Compared with nivolumab monotherapy, therapy with nivolumab-relatlimab was associated with a significantly increased risk of high-grade TRAEs, and some individual specified all-grade TRAEs, including hypothyroidism/thyroiditis, rash, diarrhea/colitis, hepatitis, adrenal insufficiency, hypophysitis, arthralgia and myalgia. Disproportionality analyses of FAERS pharmacovigilance data identified 39 positive signals, with 18 AEs not mentioned in the drug label. Nivolumab-relatlimab showed significantly higher reporting frequencies for 15 AEs than nivolumab monotherapy. Our study provides valuable insights into the potential safety profile of nivolumab-relatlimab, the results of this living study will be updated to incorporate new, robust evidence as it becomes available. |
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| ジャーナル名 | European journal of pharmacology |
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| Pubmed追加日 | 2025/7/29 |
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| 投稿者 | Zhu, Jianhong; Wu, Qian; Yang, Ziwen; Wu, Chengmi; Zhou, Jingyi; Li, Sha; Wu, Junyan; Jiang, Jie |
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| 組織名 | College of Pharmacy, Jinan University, Guangzhou, China; Department of Pharmacy,;Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China; Shenshan;Medical Center, Memorial Hospital of Sun Yat-Sen University, Shanwei, Guangdong,;China.;College of Pharmacy, Jinan University, Guangzhou, China.;College of Pharmacy, Jinan University, Guangzhou, China; State Key Laboratory of;Bioactive Molecules and Druggability Assessment, Jinan University, Guangzhou,;China. Electronic address: tlisha@jnu.edu.cn.;Department of Pharmacy, Sun-Yat-Sen Memorial Hospital, Sun Yat-sen University,;Guangzhou, China. Electronic address: wujunyan@mail.sysu.edu.cn.;China. Electronic address: jiangjie@jnu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40716631/ |
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