Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis
Abstract Aims The objective of this study was to analyze immune-related adverse events (irAEs) in a real-world data sample and examine the differences in incidence between affected organ systems, irAE severity, therapeutic agent, and gender. Methods We retrospectively analyzed all consecutive patien...
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BMC
2025-08-01
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| Online Access: | https://doi.org/10.1186/s12885-025-14733-5 |
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| author | Lauris Annatha Mariam Auch Chloé Sieber Dirk Lehnick Balthasar L. Hug |
| author_facet | Lauris Annatha Mariam Auch Chloé Sieber Dirk Lehnick Balthasar L. Hug |
| author_sort | Lauris Annatha Mariam Auch |
| collection | DOAJ |
| description | Abstract Aims The objective of this study was to analyze immune-related adverse events (irAEs) in a real-world data sample and examine the differences in incidence between affected organ systems, irAE severity, therapeutic agent, and gender. Methods We retrospectively analyzed all consecutive patients treated with anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibodies, anti-programmed death 1 (PD-1) inhibitors, and programmed death-ligand 1 (PD-L1) inhibitors between January 2020 and May 2023 in a tertiary referral center in Switzerland. IrAEs documented in the electronic health records (EHR) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) and analyzed descriptively. Results Among the 500 patients, 196 (39.2%) were female. Treatments included pembrolizumab (51.2%), atezolizumab (20.2%), nivolumab (14.4%), durvalumab (6.4%), ipilimumab in combination with nivolumab (4.8%), cemiplimab (1.4%), avelumab (1.2%), and ipilimumab (0.4%). N = 216 (43.2%) patients had ≥ 1 irAEs (females: 47.4%; males: 40.5%). Severe (≥ grade 3) irAEs were reported in 13.6% of patients. The following irAE incidences were found: dermatological (15.2%), gastrointestinal (13.0%), endocrine (10.8%), musculoskeletal (4.8%), pulmonary (3.8%), systemic (3.6%), neurological (2.6%), cardiac (1.4%), renal (1.4%), hematological (0.6%), and ocular (0.2%). Conclusion Nearly half of the patients experienced ≥ 1 irAEs, of which one-third severe. Females experienced more irAEs than males, above all due to a higher incidence of grade 1 irAEs. Only about half of the irAEs were reported as coded diagnosis. Further prospective studies on irAEs are warranted using structured documentation. |
| format | Article |
| id | doaj-art-e78fa567610e4b1bb7774da015dcc18b |
| institution | Kabale University |
| issn | 1471-2407 |
| language | English |
| publishDate | 2025-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj-art-e78fa567610e4b1bb7774da015dcc18b2025-08-20T03:46:09ZengBMCBMC Cancer1471-24072025-08-0125111110.1186/s12885-025-14733-5Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysisLauris Annatha Mariam Auch0Chloé Sieber1Dirk Lehnick2Balthasar L. Hug3Faculty of Health Sciences and Medicine, University of LucerneFaculty of Health Sciences and Medicine, University of LucerneFaculty of Health Sciences and Medicine, University of LucerneFaculty of Health Sciences and Medicine, University of LucerneAbstract Aims The objective of this study was to analyze immune-related adverse events (irAEs) in a real-world data sample and examine the differences in incidence between affected organ systems, irAE severity, therapeutic agent, and gender. Methods We retrospectively analyzed all consecutive patients treated with anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibodies, anti-programmed death 1 (PD-1) inhibitors, and programmed death-ligand 1 (PD-L1) inhibitors between January 2020 and May 2023 in a tertiary referral center in Switzerland. IrAEs documented in the electronic health records (EHR) were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) and analyzed descriptively. Results Among the 500 patients, 196 (39.2%) were female. Treatments included pembrolizumab (51.2%), atezolizumab (20.2%), nivolumab (14.4%), durvalumab (6.4%), ipilimumab in combination with nivolumab (4.8%), cemiplimab (1.4%), avelumab (1.2%), and ipilimumab (0.4%). N = 216 (43.2%) patients had ≥ 1 irAEs (females: 47.4%; males: 40.5%). Severe (≥ grade 3) irAEs were reported in 13.6% of patients. The following irAE incidences were found: dermatological (15.2%), gastrointestinal (13.0%), endocrine (10.8%), musculoskeletal (4.8%), pulmonary (3.8%), systemic (3.6%), neurological (2.6%), cardiac (1.4%), renal (1.4%), hematological (0.6%), and ocular (0.2%). Conclusion Nearly half of the patients experienced ≥ 1 irAEs, of which one-third severe. Females experienced more irAEs than males, above all due to a higher incidence of grade 1 irAEs. Only about half of the irAEs were reported as coded diagnosis. Further prospective studies on irAEs are warranted using structured documentation.https://doi.org/10.1186/s12885-025-14733-5Immune checkpoint inhibitorsImmune-related adverse eventsAnti-CTLA-4Anti-PD-1Anti-PD-L1Real-world data |
| spellingShingle | Lauris Annatha Mariam Auch Chloé Sieber Dirk Lehnick Balthasar L. Hug Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis BMC Cancer Immune checkpoint inhibitors Immune-related adverse events Anti-CTLA-4 Anti-PD-1 Anti-PD-L1 Real-world data |
| title | Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis |
| title_full | Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis |
| title_fullStr | Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis |
| title_full_unstemmed | Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis |
| title_short | Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis |
| title_sort | adverse drug events of immune checkpoint inhibitors a retrospective descriptive real world data analysis |
| topic | Immune checkpoint inhibitors Immune-related adverse events Anti-CTLA-4 Anti-PD-1 Anti-PD-L1 Real-world data |
| url | https://doi.org/10.1186/s12885-025-14733-5 |
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