{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T11:37:27Z","timestamp":1791459447323,"version":"4.3.4"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2023,1,7]],"date-time":"2023-01-07T00:00:00Z","timestamp":1673049600000},"content-version":"vor","delay-in-days":37,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2022,10,26]],"date-time":"2022-10-26T00:00:00Z","timestamp":1666742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T00:00:00Z","timestamp":1669852800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100008271","name":"LEO Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008271","id-type":"DOI","asserted-by":"publisher"}]},{"name":"MedImmune LLC"},{"DOI":"10.13039\/501100008271","name":"LEO Pharma Research Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100008271","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2022,12,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Tralokinumab is a fully human monoclonal antibody that neutralizes the activity of interleukin-13, a key pathogenic driver of atopic dermatitis (AD). Clinical trials including adults with moderate-to-severe AD, of up to 52 weeks\u2019 duration, showed tralokinumab was efficacious and well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To characterize the safety profile of tralokinumab for the treatment of moderate-to-severe AD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Safety and laboratory measures were assessed in pooled analyses of phase II and III placebo-controlled clinical trials of tralokinumab in moderate-to-severe AD (NCT02347176, NCT03562377, NCT03131648, NCT03160885, NCT03363854).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In total, 2285 patients were randomized in the initial treatment periods up to 16 weeks (1605 tralokinumab, 680 placebo). The frequencies of any adverse event (AE) were 65\u00b77% for tralokinumab and 67\u00b72% for placebo. The respective rates were 640 and 678 events per 100 patient-years of exposure (ep100PYE); rate ratio 1\u00b70, 95% confidence interval (CI) 0\u00b79\u20131\u00b71. Serious AEs occurred in 2\u00b71% of patients with tralokinumab and 2\u00b78% with placebo (7\u00b74 and 11\u00b79 ep100PYE; rate ratio 0\u00b77, 95% CI 0\u00b74\u20131\u00b72). The most common AEs occurring at a higher frequency and rate with tralokinumab vs. placebo were: viral upper respiratory tract infection (15\u00b77% vs. 12\u00b72%; 65\u00b71 vs. 53\u00b75 ep100PYE); upper respiratory tract infection (5\u00b76% vs. 4\u00b78%; 20\u00b78 vs. 18\u00b75 ep100PYE); conjunctivitis (5\u00b74% vs. 1\u00b79%; 21\u00b70 vs. 6\u00b79 ep100PYE); and injection-site reaction (3\u00b75% vs. 0\u00b73%; 22\u00b79 vs. 4\u00b70 ep100PYE). Some events in safety areas of interest occurred at a lower frequency and rate with tralokinumab vs. placebo: skin infections requiring systemic treatment (2\u00b76% vs. 5\u00b75%; 9\u00b77 vs. 22\u00b78 ep100PYE), eczema herpeticum (0\u00b73% vs. 1\u00b75%; 1\u00b72 vs. 5\u00b72 ep100PYE), opportunistic infections (3\u00b74% vs. 4\u00b79%; 13\u00b70 vs. 21\u00b73 ep100PYE) and serious infections (0\u00b74% vs. 1\u00b71%; 1\u00b73 vs. 3\u00b77 ep100PYE). AEs did not increase with continued maintenance and open-label treatment, including rates of common or serious AEs and AEs leading to study drug discontinuation. No clinically meaningful changes in mean laboratory measures were observed with treatment up to 1 year.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Across the AD population pool from five clinical trials, tralokinumab was well tolerated, with consistent safety findings during treatment of patients with moderate-to-severe AD. The safety profile during prolonged tralokinumab treatment was consistent with that during the initial treatment period; the frequency of events did not increase over time.<\/jats:p>\n                    <jats:p>What is already known about this topic? \u00a0Tralokinumab is a fully human monoclonal antibody that specifically neutralizes interleukin-13, a key cytokine driving skin inflammation and epidermal barrier dysfunction in atopic dermatitis (AD).In clinical trials in moderate-to-severe AD, tralokinumab provided significant and early improvements in the extent and severity of AD and was well tolerated, with an overall safety profile comparable with placebo over 52 weeks.<\/jats:p>\n                    <jats:p>What does this study add? \u00a0We report the frequency and rate of adverse events (AEs) from pooled observations of over 2000 patients from five phase II and phase III placebo-controlled clinical trials of tralokinumab in moderate-to-severe AD.During initial treatment up to 16 weeks, the frequencies of any AE and of serious AEs were similar for tralokinumab and placebo. AE rates did not increase with continued treatment up to 52 weeks.Common AEs occurring more frequently with tralokinumab vs. placebo were viral and upper respiratory tract infection, conjunctivitis and injection-site reaction. Some events occurred at a lower frequency and rate with tralokinumab vs. placebo, such as skin infections requiring systemic treatment, eczema herpeticum and opportunistic and serious infections.No clinically meaningful changes in mean laboratory measures were observed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bjd.21867","type":"journal-article","created":{"date-parts":[[2022,9,9]],"date-time":"2022-09-09T13:25:27Z","timestamp":1662729927000},"page":"888-899","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":81,"title":["Safety of tralokinumab in adult patients with moderate-to-severe atopic dermatitis: pooled analysis of five randomized, double-blind, placebo-controlled phase II and phase III trials"],"prefix":"10.1093","volume":"187","author":[{"given":"Eric L.","family":"Simpson","sequence":"first","affiliation":[{"name":"Department of Dermatology Oregon Health & Science University Portland OR 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