| アブストラクト | Cutaneous immune-related adverse events (cirAEs) are the most prevalent complication to arise from immunotherapy and cause significant morbidity. We aimed to determine the spectrum, timing, clinical features, and outcomes of cirAEs by conducting an observational pharmacovigilance study using VigiBase, the World Health Organization's global database of individual case safety reports from over 130 member countries (ClinicalTrials.gov, number NCT04898751). We compared adverse event reporting in patients who received immune checkpoint inhibitors (91,323 adverse events) with those of the full reporting database (18,919,358 adverse events). There were 10,933 cases of cirAEs within 51 distinct dermatologic types, with 27 specific eruptions with disproportionate signal represented (information component [IC](025) > 0). Of these 27 eruptions, there were eight cirAEs with n > 100 reports, including vitiligo (IC(025) = 4.87), bullous pemphigoid (IC(025) = 4.08), lichenoid dermatitis (IC(025) = 3.69), erythema multiforme (IC(025) = 1.03), toxic epidermal necrolysis (IC(025) = 0.95), Stevens‒Johnson syndrome (IC(025) = 0.41), drug eruption (IC(025) = 0.11), and eczematous dermatitis (IC(025) = 0.11). There were differences in time to onset after immune checkpoint inhibitor initiation, with a median of approximately 1 month (erythema multiforme, Stevens‒Johnson syndrome, and toxic epidermal necrolysis), 2 months (drug eruption and eczematous dermatitis), 4 months (lichenoid dermatitis), and 5 E months (bullous pemphigoid and vitiligo). CirAEs are diverse, dependent on cancer type, and have distinct and different onset times that are linked to the cirAE subtype. |
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| 投稿者 | Le, Thomas K; Brown, Isabelle; Goldberg, Rebecca; Taylor, Matthew T; Deng, Junwen; Parthasarathy, Varsha; Bordeaux, Zachary A; Alphonse, Martin Prince; Kwatra, Madan M; Naranbhai, Vivek; Gusev, Alexander; Alhariri, Jihad; LeBoeuf, Nicole R; Reynolds, Kerry L; Cappelli, Laura C; Naidoo, Jarushka; Brahmer, Julie R; Kang, Sewon; Semenov, Yevgeniy R; Kwatra, Shawn G |
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| 組織名 | Department of Dermatology, Johns Hopkins University School of Medicine,;Baltimore, Maryland, USA.;Baltimore, Maryland, USA; Department of Anesthesiology, Duke University Medical;Center, Durham, North Carolina, USA.;Department of Anesthesiology, Duke University Medical Center, Durham, North;Carolina, USA.;Department of Oncology, Mass General Cancer Center, Massachusetts General;Hospital, Boston, Massachusetts, USA; Department of Medicine, Dana-Farber Cancer;Institute, Boston, Massachusetts, USA.;Department of Medicine, Dana-Farber Cancer Institute, Boston, Massachusetts, USA.;Department of Dermatology, Massachusetts General Hospital, Boston, Massachusetts,;USA; Department of Cutaneous Oncology, Dana Farber Cancer Institute, Harvard;Medical School, Boston, Massachusetts, USA.;Division of Hematology and Oncology, Massachusetts General Hospital, Harvard;Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore,;Maryland, USA.;Department of Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns;Hopkins University School of Medicine, Baltimore, Maryland, USA; The;Bloomberg-Kimmel Institute for Cancer Immunotherapy, The Sidney Kimmel;Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, USA.;USA.;Baltimore, Maryland, USA; Department of Oncology, The Sidney Kimmel Comprehensive;Cancer Center, Johns Hopkins University School of Medicine, Baltimore, Maryland,;USA. Electronic address: skwatra1@jhmi.edu. |
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