The Food and Drug Administration's Adverse Event Reporting System reveals that nearly 50% of significant dermatologic adverse events linked to anticancer therapies are associated with targeted therapies, according to a recent analysis.

The study reviewed FAERS data from January 2013 to September 2022, encompassing 3,399,830 reports involving 3,084 drugs and 16,348 unique adverse events (AEs). Researchers identified 10,698 drug-skin AE pairs, of which 676 were significant, involving 113 anticancer drugs and 144 types of skin AEs. Rash and dry skin were the most frequently reported AEs, followed by alopecia, inflammatory conditions, and nonspecific dermatitis. Significant associations with targeted therapies comprised 49% of the pairs, followed by cytotoxic chemotherapies (35.9%) and immunotherapies (11%).

Methotrexate and mechlorethamine were most associated with distinct AEs, with 34 and 33 significant associations, respectively. Vemurafenib, a targeted therapy, had 24 significant associations and the highest percentage of skin-related AEs among drugs reviewed (38.9%). Additionally, 50% of significant drug-AE pairs had a reporting odds ratio exceeding 10, indicating a strong likelihood of these drugs being linked to dermatologic toxicities.

Newer therapies, such as enfortumab vedotin, were also notable, with 28.3% of its reported AEs being skin-related. The study, published in the Journal of the American Academy of Dermatology, employed Fisher’s exact test and the Bonferroni correction to control for false positives, ensuring robust statistical validity. While under-reporting remains a limitation, the methodology effectively identifies potential safety signals for post-marketing surveillance.

The findings underscore the importance of monitoring dermatologic AEs in patients receiving anticancer therapies to better understand potential skin toxicities and inform clinical decision-making. Full disclosures and methodologies are available in the Journal of the American Academy of Dermatology publication.