Adverse drug events of immune checkpoint inhibitors - a retrospective, descriptive real-world data analysis
Lauris Annatha Mariam Auch, Chloé Sieber, Dirk Lehnick, Balthasar L. Hug
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.