{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,6]],"date-time":"2026-11-06T21:55:17Z","timestamp":1794002117131,"version":"4.8.0"},"reference-count":31,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T00:00:00Z","timestamp":1784851200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004735","name":"Natural Science Foundation of Hunan Province","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004735","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>The combination of enfortumab vedotin and pembrolizumab (EV+P) has revolutionized advanced urothelial carcinoma treatment, yet their combined real-world safety profile remains insufficiently characterized. This study aimed to quantitatively compare the adverse event (AE) landscapes of EV+P and EV monotherapy using the FAERS data.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A case\/non-case study design was conducted on FAERS data from 2020 Q4 to 2025 Q3. Disproportionality signals were evaluated at the System Organ Class (SOC), High-Level Group Term (HLGT), and Preferred Term (PT) levels. Time-to-onset was analyzed using the Kaplan\u2013Meier method, and narrative review was performed to validate pneumonitis signals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>We identified 3, 004 and 2, 265\u00a0AE reports for EV and EV+P, respectively. EV+P demonstrated significantly higher risks across nine SOCs, most notably in endocrine (OR: 5.88), immune system (OR: 2.03), and respiratory (OR: 1.71) disorders. At the PT level, EV+P was strongly associated with hepatitis (OR: 14.79), immune-mediated enterocolitis (OR: 11.77), adrenal insufficiency (OR: 9.14), and pneumonitis (OR: 2.75). Potential novel signals like hearing disorders (OR: 10.64) and dental\/gingival conditions (OR: 9.31) were noted but lacked statistical robustness post-correction. Literature validation confirmed a higher incidence of any-grade pneumonitis with EV+P (10% vs. 3.5%). Furthermore, EV+P suggested a potentially earlier onset for several toxicities, including eye (FDR P\u00a0=\u00a00.047) and skin disorders (FDR P\u00a0=\u00a00.011).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>EV + P demonstrates a broader and more intense AE spectrum than EV monotherapy, driven largely by immune-related toxicities and potential synergistic organ injury. These findings emphasize the need for vigilant clinical monitoring and early intervention when employing this combination therapy.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1831172","type":"journal-article","created":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T05:37:09Z","timestamp":1784871429000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["The real-world safety profile of enfortumab vedotin with or without pembrolizumab: insights from a comparative analysis of FAERS"],"prefix":"10.3389","volume":"17","author":[{"given":"Heng","family":"Chen","sequence":"first","affiliation":[{"name":"Department of Pharmacy, The First Hospital of Changsha (The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University)","place":["Changsha, Hunan, 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