{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T20:01:04Z","timestamp":1791576064272,"version":"4.3.4"},"reference-count":18,"publisher":"Walter de Gruyter GmbH","issue":"3","license":[{"start":{"date-parts":[[2023,2,3]],"date-time":"2023-02-03T00:00:00Z","timestamp":1675382400000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100015851","name":"OPKO Health","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015851","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,3,28]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_jpem-2022-0359_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      Somatrogon is a long-acting recombinant human growth hormone (GH) employed as a once-weekly treatment for children with GH deficiency (GHD). A 12-month, phase 2 study of once-weekly somatrogon vs. once-daily GH (Genotropin\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) was initiated, after which participants could enroll into an open-label extension (OLE) evaluating the safety and efficacy of long-term somatrogon treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_jpem-2022-0359_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>There were five study periods, Periods I and II were 6 months each while Periods III, IV, and V were 12 months each. In the main study (Periods I and II), 53 prepubertal children with GHD were randomized to once-weekly somatrogon (0.25, 0.48, or 0.66 mg\/kg\/week) or once-daily Genotropin (0.034 mg\/kg\/day); 48 continued into the OLE, consisting of Period III (original somatrogon dose; Genotropin recipients randomized to one of three somatrogon doses), Period IV (somatrogon 0.66 mg\/kg\/week), and Period V (prefilled somatrogon pen [0.66 mg\/kg\/week]).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_jpem-2022-0359_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>At the end of Period III, the mean \u00b1 SD annual height velocity (HV) for 0.25, 0.48, and 0.66 mg\/kg\/week somatrogon groups was 7.73 \u00b1 1.89, 7.54 \u00b1 1.28, and 8.81 \u00b1 1.12 cm\/year, respectively; HV was sustained during Periods IV\/V. Height SD scores (SDS) showed progressive improvement throughout the OLE, regardless of initial cohort assignment, approaching the normal range (\u22120.69 \u00b1 SD 0.87) at the end of Period V Year 1. Mild or moderate treatment-emergent adverse events were reported in 81.3% of participants, most unrelated to study drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_jpem-2022-0359_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Up to 5 years of once-weekly somatrogon was well tolerated and resulted in sustained improvement in height SDS and delta height SDS in prepubertal short children with GHD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/jpem-2022-0359","type":"journal-article","created":{"date-parts":[[2023,2,2]],"date-time":"2023-02-02T22:07:47Z","timestamp":1675375667000},"page":"261-269","source":"Crossref","is-referenced-by-count":39,"title":["An open-label extension of a phase 2 dose-finding study of once-weekly somatrogon vs. once-daily Genotropin in children with short stature due to growth hormone deficiency: results following 5 years of treatment"],"prefix":"10.1515","volume":"36","author":[{"given":"Zvi","family":"Zadik","sequence":"first","affiliation":[{"name":"Pediatric Endocrinology , Kaplan Medical Center , Rehovot , Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nataliya","family":"Zelinska","sequence":"additional","affiliation":[{"name":"Ukrainian Scientific and Practical Center of Endocrine Surgery, Transplantation Endocrine Organs and Tissues of the Ministry of Health of Ukraine , Kyiv , Ukraine"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Violeta","family":"Iotova","sequence":"additional","affiliation":[{"name":"Department of Pediatrics , Medical University of Varna, UMHAT \u201cSv. Marina\u201d , Varna , Bulgaria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yulia","family":"Skorodok","sequence":"additional","affiliation":[{"name":"Saint-Petersburg State Pediatric Medical University , Saint-Petersburg , Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oleg","family":"Malievsky","sequence":"additional","affiliation":[{"name":"Bashkirian State Medical University , Ufa , Russia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nelly","family":"Mauras","sequence":"additional","affiliation":[{"name":"Nemours Children\u2019s Health , Jacksonville , FL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srinivas Rao","family":"Valluri","sequence":"additional","affiliation":[{"name":"Pfizer Inc , New York , NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandra","family":"Pastrak","sequence":"additional","affiliation":[{"name":"OPKO Health , Toronto , ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron","family":"Rosenfeld","sequence":"additional","affiliation":[{"name":"Oregon Health and Science University , Portland , OR , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2023,2,3]]},"reference":[{"key":"2023033123251294198_j_jpem-2022-0359_ref_001","doi-asserted-by":"crossref","unstructured":"Collett-Solberg, PF, Jorge, AAL, Boguszewski, MCS, Miller, BS, Choong, CSY, Cohen, P, et al.. 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