{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T18:21:10Z","timestamp":1790965270286,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,10,6]],"date-time":"2020-10-06T00:00:00Z","timestamp":1601942400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acad Dermatol Venereol"],"published-print":{"date-parts":[[2021,2]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Janus kinase (JAK) inhibition is a new mode of action in atopic dermatitis (AD); clarity about drug class safety considerations in the context of AD is important. Baricitinib, an oral, reversible, selective inhibitor of JAK1\/JAK2, is in late\u2010stage development for adult patients with moderate\u2010to\u2010severe AD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To report pooled safety data for baricitinib in patients with moderate\u2010to\u2010severe AD in the clinical development program including long\u2010term extension (LTE) studies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This analysis included patient\u2010level safety data from six double\u2010blinded, randomized, placebo\u2010controlled studies (one phase 2 and five phase 3), one double\u2010blinded, randomized, LTE study and one open\u2010label LTE study, reported in three data sets: placebo\u2010controlled, 2\u2010mg \u2013 4\u2010mg extended and All\u2010bari AD. Safety outcomes include treatment\u2010emergent adverse events, adverse events of special interest and abnormal laboratory changes. Proportions of patients with events and incidence rates were calculated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Data were collected for 2531 patients who were given baricitinib for 2247 patient\u2010years (median duration 310\u00a0days). The frequency of serious infections, opportunistic infections and conjunctival disorders was low and similar between treatment groups in the placebo\u2010controlled period. The most common serious infections were eczema herpeticum [<jats:italic>n<\/jats:italic>\u00a0=\u00a011, incidence rates (IR)\u00a0=\u00a00.5], cellulitis (<jats:italic>n<\/jats:italic>\u00a0=\u00a06, IR\u00a0=\u00a00.3) and pneumonia (<jats:italic>n<\/jats:italic>\u00a0=\u00a03, IR\u00a0=\u00a00.1). There were four opportunistic infections (IR\u00a0=\u00a00.2). No malignancies, gastrointestinal perforations, positively adjudicated cardiovascular events or tuberculosis were reported in the placebo\u2010controlled period in baricitinib\u2010treated patients. Frequency of herpes simplex was higher in the 4\u2010mg group (6.1%) vs. the 2\u2010mg (3.6%) and placebo group (2.7%); IRs in the extended data set (2\u2010mg IR\u00a0=\u00a09.6; 4\u2010mg IR\u00a0=\u00a014.5) were lower vs. the placebo\u2010controlled data set (2\u2010mg IR\u00a0=\u00a012.4; 4\u2010mg IR\u00a0=\u00a021.3). In the All\u2010bari AD data set, there were two positively adjudicated major adverse cardiovascular events (2\u2010mg group): two venous thrombosis events (4\u2010mg group) and one death.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This integrated safety analysis in patients with moderate\u2010to\u2010severe AD confirms the established safety profile of baricitinib.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jdv.16948","type":"journal-article","created":{"date-parts":[[2020,9,18]],"date-time":"2020-09-18T07:36:52Z","timestamp":1600414612000},"page":"476-485","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":144,"title":["Pooled safety analysis of baricitinib in adult patients with atopic dermatitis from 8 randomized clinical trials"],"prefix":"10.1111","volume":"35","author":[{"given":"T.","family":"Bieber","sequence":"first","affiliation":[{"name":"University Hospital of Bonn Bonn Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3770-1743","authenticated-orcid":false,"given":"J.P.","family":"Thyssen","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Allergy Herlev\u2010Gentofte Hospital University of Copenhagen Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5248-4332","authenticated-orcid":false,"given":"K.","family":"Reich","sequence":"additional","affiliation":[{"name":"University Med Cen Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.L.","family":"Simpson","sequence":"additional","affiliation":[{"name":"Oregon Health &amp; 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