Characterization of Adverse Drug Effects for Three Radiopharmaceuticals: A Descriptive Analysis from WHO-VigiAccess.
This analysis reveals distinct adverse drug reaction profiles for Lutathera, Pluvicto, and Xofigo, emphasizing the importance of individualized risk assessment in clinical use.
Where it sits
this study against the rest of the vipivotide corpusSummary and findings
This study analyzed adverse drug reactions (ADRs) associated with three radiopharmaceuticals: Lutathera, Pluvicto, and Xofigo. A total of 17,743 ADR reports were examined, revealing distinct safety profiles among the drugs. Notably, Pluvicto showed a higher frequency of general systemic disorders and fatal outcomes.
Abstract
<h4>Background</h4>Radiopharmaceuticals are being used more frequently to treat neuroendocrine tumors and advanced prostate cancer; however, their clinical application is associated with adverse drug reactions (ADRs) that may affect patient safety. Real-world data from spontaneous reporting systems such as the World Health Organization's (WHO's)-VigiAccess can aid in assessing safety after the drugs have been marketed.<h4>Materials and methods</h4>A retrospective descriptive analysis was conducted using ADR reports from the WHO-VigiAccess database up to November 2024. Reports related to lutetium (<sup>177</sup>Lu) dotatate (Lutathera<sup>®</sup>), lutetium (<sup>177</sup>Lu) vipivotide tetraxetan (Pluvicto<sup>®</sup>), and radium (<sup>223</sup>Ra) dichloride (Xofigo<sup>®</sup>) were extracted and analyzed with respect to patient demographics, geographic distribution, and ADRs classified by MedDRA System Organ Class and Preferred Terms. Descriptive statistics were used to compare safety profiles.<h4>Results</h4>A total of 17,743 ADR reports were analyzed. Lutathera was predominantly associated with gastrointestinal disorders and skin or subcutaneous tissue reactions. In contrast, Pluvicto demonstrated a higher frequency of general systemic disorders and a disproportionately higher number of fatal outcomes, a finding consistent with its indication for the treatment of advanced prostate cancer. Xofigo was primarily linked to hematological and musculoskeletal toxicities. In addition to 169 ADRs that were common to all three agents, distinct drug-specific reaction patterns were also observed.<h4>Conclusions</h4>WHO-VigiAccess data reveal clearly differentiated ADR profiles among Lutathera, Pluvicto, and Xofigo. These results highlight the necessity for individualized risk assessment, careful monitoring, and further prospective investigations to optimize the safe clinical application of radiopharmaceuticals.
Background
This paper addresses the safety profiles of radiopharmaceuticals used in treating neuroendocrine tumors and advanced prostate cancer. Previous studies have indicated that these treatments can lead to adverse drug reactions (ADRs), which may compromise patient safety. Understanding the ADRs associated with these drugs is crucial for optimizing their clinical application and ensuring patient safety.
Methods
A retrospective descriptive analysis was conducted using ADR reports from the WHO-VigiAccess database up to November 2024. Reports related to lutetium-177 dotatate, lutetium-177 vipivotide tetraxetan, and radium-223 dichloride were extracted for analysis. Descriptive statistics were employed to compare the safety profiles of these agents.
Results
A total of 17,743 ADR reports were analyzed. Pluvicto demonstrated a higher frequency of general systemic disorders and a disproportionately higher number of fatal outcomes. Lutathera was predominantly associated with gastrointestinal disorders and skin or subcutaneous tissue reactions, while Xofigo was primarily linked to hematological and musculoskeletal toxicities.
Interpretation
The findings indicate that each radiopharmaceutical has a distinct ADR profile, which is consistent with their clinical indications. While the statistical differences in ADRs are significant, the clinical implications of these findings require careful consideration, especially regarding the higher fatality rates associated with Pluvicto. Limitations include reliance on spontaneous reporting data, which may not fully capture the scope of ADRs.
Key findings
- 17,743 ADR reports analyzed.
- Pluvicto associated with a disproportionately higher number of fatal outcomes.
- Lutathera predominantly linked to gastrointestinal disorders and skin reactions.
- Xofigo primarily connected to hematological and musculoskeletal toxicities.
- 169 ADRs common to all three agents.
Limitations
- Retrospective analysis may miss unreported ADRs.
- Data sourced from spontaneous reporting may not reflect true incidence rates.
- No clinical trial data to corroborate findings.
- Potential for reporting bias in ADR documentation.