{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T20:56:37Z","timestamp":1790110597146,"version":"4.0.1"},"reference-count":35,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2023,3,8]],"date-time":"2023-03-08T00:00:00Z","timestamp":1678233600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Questions remain regarding the safety of swallowed topical corticosteroids in eosinophilic oesophagitis (EoE).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To assess the safety of an investigational formulation of budesonide (budesonide oral suspension; BOS) from six trials.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Safety data were integrated from six trials (healthy adults: SHP621\u2010101 [phase 1]; patients with EoE: MPI 101\u201001 and MPI 101\u201006 [phase 2]; SHP621\u2010301, SHP621\u2010302 and SHP621\u2010303 [phase 3]) for participants who received \u22651 dose of study drug (BOS 2.0\u00a0mg twice\u00a0daily\u00a0[b.i.d.], BOS any dose [including BOS 2.0\u00a0mg b.i.d.] and placebo). Adverse events (AEs), laboratory testing, bone density and adrenal AEs were assessed. Exposure\u2010adjusted incidence rates were calculated for AEs and AEs of special interest (AESIs).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 514 unique participants were included (BOS 2.0\u00a0mg b.i.d., <jats:italic>n<\/jats:italic>\u00a0=\u2009292; BOS any dose, <jats:italic>n<\/jats:italic>\u00a0=\u2009448; placebo, <jats:italic>n<\/jats:italic>\u00a0=\u2009168). The BOS 2.0\u00a0mg b.i.d., BOS any dose and placebo groups totalled 93.7, 122.4 and 25.0 participant\u2010years of exposure (PY), respectively. Proportions of treatment\u2010emergent AEs (TEAEs) and AESIs (any) reported were higher for BOS than placebo; however, most were mild\/moderate in severity. The most commonly reported AESIs (exposure\u2010adjusted incidence rates [per 100 PY]) in the BOS 2.0\u00a0mg b.i.d., BOS any dose and placebo groups were infections (133.5, 154.4 and 136.2,\u00a0respectively) and gastrointestinal AEs (84.3, 80.9 and 92.1,\u00a0respectively). Adrenal AEs were more frequent with BOS 2.0\u00a0mg b.i.d. and BOS any dose than placebo (44.8, 34.3 and 24.0,\u00a0respectively). TEAEs and AESIs related to study drug or leading to discontinuation were infrequent.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>BOS was well\u2010tolerated; most TEAEs with BOS were mild\/moderate in severity.<\/jats:p><\/jats:sec><jats:sec><jats:title><jats:styled-content style=\"fixed-case\">ClinicalTrials<\/jats:styled-content>.gov numbers<\/jats:title><jats:p>SHP621\u2010101 (no clinical trials registration number), MPI 101\u201001 (NCT00762073), MPI 101\u201006 (NCT01642212), SHP621\u2010301 (NCT02605837), SHP621\u2010302 (NCT02736409) and SHP621\u2010303 (NCT03245840).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.17430","type":"journal-article","created":{"date-parts":[[2023,3,9]],"date-time":"2023-03-09T04:00:05Z","timestamp":1678334405000},"page":"1117-1130","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1\u20133 clinical trials"],"prefix":"10.1111","volume":"57","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7688-9377","authenticated-orcid":false,"given":"Ikuo","family":"Hirano","sequence":"first","affiliation":[{"name":"Division of Gastroenterology and Hepatology Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan S.","family":"Dellon","sequence":"additional","affiliation":[{"name":"Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep K.","family":"Gupta","sequence":"additional","affiliation":[{"name":"Section of Pediatric Gastroenterology, Hepatology and Nutrition Indiana University School of Medicine, Riley Hospital for Children at Indiana University Health  Indianapolis Indiana USA"},{"name":"Community Health Network  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2307-2317","authenticated-orcid":false,"given":"David A.","family":"Katzka","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology Columbia University Medical Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret H.","family":"Collins","sequence":"additional","affiliation":[{"name":"Department of Pathology and Laboratory Medicine Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine  Cincinnati Ohio USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abigail M.","family":"Wojtowicz","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc.  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"Terreri","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc.  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenwen","family":"Zhang","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mena","family":"Boules","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals USA, Inc.  Lexington Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siddharth","family":"Bhatia","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals International Co.  Cambridge Massachusetts USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nirav K.","family":"Desai","sequence":"additional","affiliation":[{"name":"Takeda Development Center Americas, Inc.  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