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- Title
Serious Cutaneous Toxicities with Immune Checkpoint Inhibitors in the U.S. Food and Drug Administration Adverse Event Reporting System.
- Authors
Raschi, Emanuel; Antonazzo, Ippazio Cosimo; La Placa, Michelangelo; Ardizzoni, Andrea; Poluzzi, Elisabetta; De Ponti, Fabrizio
- Abstract
Cutaneous toxicities frequently occurred with immune checkpoint inhibitors (ICIs), although clinical and pharmacological features are incompletely characterized. The U.S. Food and Drug Administration Adverse Event Reporting System was queried to describe ICI‐related cutaneous toxicities, focusing on severe cutaneous adverse reactions (SCARs): Stevens‐Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome. As compared with other anticancer drugs, a higher proportion of death (11.3% vs. 8.7%) and serious reports (42.7% vs. 34.6%) emerged for ICIs (p <.05). A higher frequency of coreported allopurinol and antiepileptics was recorded among 2,525 total SCARs (17% vs. 10%, ICIs and anticancer agents, respectively; p <.05). Mean times to onset were 47, 48, and 40 days (SJS, TEN, and DRESS, respectively), with comparable mean latency between monotherapy and combination regimens (41 days). This immune‐related pattern advocates for long‐lasting monitoring by oncologists and dermatologists. Immune checkpoint inhibitors can cause unique immune‐related adverse events. This article focuses on severe cutaneous immune‐related adverse events.
- Subjects
COMBINATION drug therapy; DRUG eruptions; IMMUNOTHERAPY; SKIN diseases; TOXIC epidermal necrolysis; UNITED States. Food &; Drug Administration; STEVENS-Johnson Syndrome; ADVERSE health care events; DESCRIPTIVE statistics; DRESS syndrome
- Publication
Oncologist, 2019, Vol 24, Issue 11, pe1228
- ISSN
1083-7159
- Publication type
Article
- DOI
10.1634/theoncologist.2019-0250