{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T23:13:38Z","timestamp":1789773218295,"version":"4.0.1"},"reference-count":59,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,11,29]],"date-time":"2023-11-29T00:00:00Z","timestamp":1701216000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Evidence on the (long\u2010term) safety of systemic immunomodulating therapies in atopic dermatitis (AD) generated by real\u2010world data is sparse.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>To describe real\u2010world reported adverse drug reactions (AEs) related to systemic immunomodulating therapy in patients with AD and to compare the incidence rates of AEs with the Summaries of Product Characteristics (SmPCs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted an observational prospective multi\u2010centre cohort study, using the TREAT NL registry. All severe AEs, AEs of special interest and serious AEs in adult and paediatric patients on systemic immunomodulating treatment (ciclosporin, methotrexate, azathioprine, mycophenolic acid, dupilumab, tralokinumab, baricitinib and upadacitinib) were assessed. Incidences rates of all (potentially) drug\u2010related AEs were standardized in patient years and compared to the cumulative incidences in the associated SmPCs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>We collected 422 patient years of safety data from 266 patients, of whom 129 (48.5%) reported a total of 224 (potentially) drug\u2010related AEs. Compared to dupilumab's SmPC, higher incidence rates were found for four AEs (reported \u22655 times): eosinophilia, blepharitis, dry eyes and head and neck erythema (i.e. dupilumab facial redness). A higher incidence rate of fatigue was found in patients on oral methotrexate in our cohort compared to the SmPC. Two new drug\u2010related AEs (reported \u22655 times) were found in patients on dupilumab, including non\u2010infectious conjunctivitis and meibomian gland dysfunction.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Real\u2010world reported AEs captured in AD patient registries can add information on the estimated incidence of AEs and benefit clinical decision aids. Future studies using data derived from the TREAT NL registry combined with data from other registries within the TREAT Registry Taskforce will provide more information on (rare) AEs associated with immunomodulating therapy in AD patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.19643","type":"journal-article","created":{"date-parts":[[2023,11,30]],"date-time":"2023-11-30T07:09:15Z","timestamp":1701328155000},"page":"530-542","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Real\u2010world reported adverse events related to systemic immunomodulating therapy in patients with atopic dermatitis: Results from the <scp>TREAT NL<\/scp> (<scp>TREatment<\/scp> of <scp>ATopic<\/scp> eczema, the Netherlands) registry"],"prefix":"10.1111","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6209-4554","authenticated-orcid":false,"given":"A. H.","family":"Musters","sequence":"first","affiliation":[{"name":"Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health, Infection and Immunity University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F. L.","family":"van Lookeren","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health, Infection and Immunity University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. F.","family":"van der Gang","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health, Infection and Immunity University of Amsterdam  Amsterdam The Netherlands"},{"name":"Department of Dermatology and Allergology, National Expertise Center for Atopic Dermatitis University Medical Center Utrecht  Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. A.","family":"Middelkamp\u2010Hup","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health, Infection and Immunity University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6807-6042","authenticated-orcid":false,"given":"A. L.","family":"Bosma","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Amsterdam UMC, location Academic Medical Center, Amsterdam Public Health, Infection and Immunity University of Amsterdam  Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N. T.","family":"Jessurun","sequence":"additional","affiliation":[{"name":"Netherlands' Pharmacovigilance Centre Lareb  's\u2010Hertogenbosch The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Lapeere","sequence":"additional","affiliation":[{"name":"Department of Dermatology Ghent University Hospital  Ghent Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. L.","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Dermatology Leiden University Medical Centre  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Ouwerkerk","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Amsterdam Infection &amp; Immunity Institute, Cancer Centre Amsterdam, Amsterdam UMC University of Amsterdam  Amsterdam The Netherlands"},{"name":"National Heart Centre Singapore  Singapore Singapore"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"de Schepper","sequence":"additional","affiliation":[{"name":"Department of Dermatology Ghent University Hospital  Ghent Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L. A. 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