{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,20]],"date-time":"2026-07-20T10:29:33Z","timestamp":1784543373919,"version":"3.55.0"},"reference-count":25,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,5,15]],"date-time":"2021-05-15T00:00:00Z","timestamp":1621036800000},"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":["Allergy"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The standardized quality (SQ) tree sublingual immunotherapy (SLIT)\u2010tablet has recently been approved for treatment of tree pollen allergy. Healthcare workers should be provided with detailed safety data for clinical use.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To assess the tolerability and safety of the SQ tree SLIT\u2010tablet (12 SQ\u2010Bet) in adults and adolescents.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Safety data were pooled from three double\u2010blinded, randomized, placebo\u2010controlled trials (2 phase\u2010II\/1 phase\u2010III) including adults and adolescents 12\u201365\u00a0years with allergic rhinitis and\/or conjunctivitis treated before and during one pollen season once\u2010daily with 12 SQ\u2010Bet (<jats:italic>n<\/jats:italic>\u00a0=\u00a0471) or placebo (<jats:italic>n\u00a0=<\/jats:italic>\u00a0458): EudraCT no: 2012\u2010000031\u201059; NCT02481856; EudraCT 2015\u2010004821\u201015.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The most frequently reported investigational medicinal product (IMP)\u2010related AEs with 12 SQ\u2010Bet were oral pruritis (39% of subjects) and throat irritation (29%). IMP\u2010related AEs were mainly mild or moderate in severity, and the majority resolved without treatment and did not lead to treatment interruption\/discontinuation. With 12 SQ\u2010Bet, oral pruritus was more frequent among subjects with pollen food syndrome (PFS) (45%) than without PFS (29%). The 12 SQ\u2010Bet did not seem to induce an increased risk of asthma: 7 events were reported in 7 subjects with 12 SQ\u2010Bet and 11 in 10 subjects with placebo. No differences were seen in the risk of moderate\u2010to\u2010severe IMP\u2010related AEs regardless of age, PFS status and asthma medical history.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The 12 SQ tree SLIT\u2010tablet was well tolerated in tree pollen allergic subjects with no major safety concerns detected. This safety profile supports daily at\u2010home sublingual administration once the first dose is tolerated when administered under medical supervision.<\/jats:p><\/jats:sec>","DOI":"10.1111\/all.14882","type":"journal-article","created":{"date-parts":[[2021,4,27]],"date-time":"2021-04-27T15:49:33Z","timestamp":1619538573000},"page":"3733-3742","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials"],"prefix":"10.1111","volume":"76","author":[{"given":"Tilo","family":"Biedermann","sequence":"first","affiliation":[{"name":"Department of Dermatology and Allergology Technical University of Munich  Munich Germany"},{"name":"Clinical Unit Allergology Helmholtz Zentrum Munich German Research Center for Environmental Health GmbH  Munich 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