{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:54Z","timestamp":1789785354227,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,2,18]],"date-time":"2024-02-18T00:00:00Z","timestamp":1708214400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Somapacitan is a long\u2010acting\u00a0growth hormone (GH) derivative developed for the treatment of GH deficiency (GHD). This study evaluates the efficacy and tolerability of somapacitan in Japanese children with GHD after 104 weeks of treatment and after switch from daily GH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Subanalysis on Japanese patients from a randomised, open\u2010labelled, controlled parallel\u2010group phase 3 trial (REAL4, NCT03811535).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Measurements<\/jats:title>\n                    <jats:p>Thirty treatment\u2010na\u00efve patients were randomised 2:1 to somapacitan (0.16\u2009mg\/kg\/week) or daily GH (0.034\u2009mg\/kg\/day) up to Week 52, after which all patients received somapacitan. Height velocity (HV; cm\/year) at Weeks 52 and 104 were the primary measurements. Additional assessments included HV SD score (SDS), height SDS, bone age, insulin\u2010like growth factor\u2010I\u00a0(IGF\u2010I) SDS, and observer\u2010reported outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At Week 52, observed mean HV\u00a0was similar between treatment groups (10.3 vs. 9.8\u2009cm\/year for somapacitan and daily GH, respectively). Similar HVs between groups were also observed at Week 104: 7.4\u2009cm\/year after continuous somapacitan treatment (soma\/soma) and 7.9\u2009cm\/year after 1\u2010year somapacitan treatment following switch from daily GH (switch). Other height\u2010related endpoints supported continuous growth. IGF\u2010I SDS increased in both groups with mean IGF\u2010I SDS within \u22122 and +2 during the study. Somapacitan was well tolerated, one mild injection site reaction was reported, with no reports of injection site pain. Patient preference questionnaires showed that most patients and their caregivers (90.9%) who switched treatment at Week 52 preferred once\u2010weekly somapacitan over daily GH treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Somapacitan showed sustained efficacy in Japanese children with GHD over 104 weeks and for 52 weeks after switching from daily GH. Somapacitan was well tolerated and preferred over daily GH.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/cen.15025","type":"journal-article","created":{"date-parts":[[2024,2,18]],"date-time":"2024-02-18T12:09:31Z","timestamp":1708258171000},"page":"389-398","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Effective growth hormone replacement with once\u2010weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial"],"prefix":"10.1111","volume":"100","author":[{"given":"Jun","family":"Mori","sequence":"first","affiliation":[{"name":"Division of Pediatric Endocrinology and Metabolism Children's Medical Center, Osaka City General Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhisa","family":"Ohata","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Osaka University Graduate School of Medicine Suita Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuko","family":"Fujisawa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Hamamatsu University School of Medicine Hamamatsu Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihito","family":"Sato","sequence":"additional","affiliation":[{"name":"Rare Disease Group Novo Nordisk Pharma Ltd. 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