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The adverse events of toripalimab in nasopharyngeal carcinoma based on FAERS database and bibliometric analysis
Qian Guo1, Dong Dong1, Zihan Dang2
1Department of Rhinology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Background:
Toripalimab, a monoclonal antibody designed to target PD-1, has recently received approval from the U.S. Food and Drug Administration (FDA) for use as a first-line treatment in adults diagnosed with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC). The purpose of this study is to utilize the FAERS database and bibliometric analysis to examine adverse events associated with toripalimab in real-world settings, thereby enhancing the safety management of clinical medications.
Methods:
This research implemented a disproportionality analysis to assess the safety of toripalimab by reviewing all adverse event reports from the FAERS database dating back to 2004, wherein toripalimab was recognized as the main suspected medication. Various statistical techniques were applied in the analysis, such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network (BCPNN), to evaluate the adverse events linked to toripalimab. CiteSpace is utilized to search for authors, countries, keywords, and various indicators within research fields, facilitating the identification of research hotspots and future trends.
Results:
From 2004 to 2024, 441 AEs linked to toripalimab were recorded across 27 SOCs. The top five SOCs were procedural complications, investigations, blood/lymphatic disorders, gastrointestinal disorders, and skin/subcutaneous disorders. At the PT level, the top five AEs by ROR were myelosuppression (n = 192, ROR 687.41), decreased granulocyte count (n = 11, ROR 515.72), immune-mediated hepatic disorder (n = 7, ROR 343.20), immune-mediated myocarditis (n = 3, ROR 214.68), and bicytopenia (n = 3, ROR 117.49). Additionally, 91.62% of AEs occurred within the first 30 days, and immune-related AEs were highlighted in bibliometric analysis.
Conclusion:
This research provides initial safety information regarding the real-world application of toripalimab, affirming previously acknowledged adverse effects and concurrently uncovering new possible risks. These results could act as important cautionary evidence for healthcare professionals and pharmacists engaged in administering toripalimab for NPC.
Insights
This study analyzed real-world adverse events for toripalimab, a PD-1 inhibitor for nasopharyngeal carcinoma (NPC). It identified myelosuppression and immune-mediated hepatic disorders as key safety concerns, particularly within the first 30 days of treatment.
Area of Science:
- Oncology
- Immunotherapy
- Pharmacovigilance
Background:
- Toripalimab, a PD-1 inhibitor, is FDA-approved for metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC).
- Real-world safety data is crucial for effective clinical use and risk management of newly approved therapies.
Purpose of the Study:
- To investigate the real-world adverse event (AE) profile of toripalimab using the FAERS database.
- To identify potential safety signals and trends associated with toripalimab treatment in NPC patients.
Main Methods:
- Disproportionality analysis of FAERS data (2004-2024) for toripalimab-related AEs.
- Statistical methods including ROR, PRR, MGPS, and BCPNN were employed.
- Bibliometric analysis using CiteSpace to identify research trends and hotspots.
Main Results:
- 441 AEs reported across 27 Standardized SOCs, with top categories including procedural complications, investigations, and blood/lymphatic disorders.
- Myelosuppression (ROR 687.41), decreased granulocyte count (ROR 515.72), and immune-mediated hepatic disorder (ROR 343.20) were prominent AEs.
- 91.62% of AEs occurred within 30 days; bibliometric analysis highlighted immune-related AEs.
Conclusions:
- This study provides initial real-world safety insights for toripalimab in NPC treatment.
- Findings confirm known adverse effects and suggest potential new risks, including myelosuppression and immune-mediated disorders.
- Results offer critical safety information for healthcare professionals managing toripalimab therapy.
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