{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T09:49:15Z","timestamp":1791539355761,"version":"4.3.4"},"reference-count":25,"publisher":"The Endocrine Society","issue":"11","license":[{"start":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T00:00:00Z","timestamp":1791504000000},"content-version":"vor","delay-in-days":4,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015851","name":"OPKO Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015851","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,10,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This open-label extension (OLE) study aimed to evaluate the long-term efficacy and safety of once-weekly somatrogon in pediatric patients with growth hormone deficiency (GHD) following up to 5 years of somatrogon treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Patients who had previously completed 12 months of treatment (somatrogon or somatropin) in a phase 3, randomized, active-controlled study (NCT02968004) were eligible to enroll into this OLE study; somatropin-treated patients were switched to somatrogon (0.66\u2005mg\/kg\/week), and somatrogon-treated patients received somatrogon at their previous dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 212 patients entered the OLE. Mean annualized height velocity at the end of OLE Year 1 (Y1), Y2, Y3, and Y4 was 8.11, 7.91, 7.02, and 6.56\u2005cm\/year, respectively. Mean height SDS increased in each year of the OLE and approached 0 SDS by OLE Y4. Mean (SD) IGF-I SDS was positive and within the normal range throughout the OLE. The incidence of adverse events (AEs) was 53.8% to 72.3%, with most being mild to moderate. The incidence of serious AEs in each year was low (0-4.7%), and none were related to treatment. The most common treatment-related AEs were injection-site pain and injection-site erythema. The presence of antidrug antibodies did not appear to impact safety or efficacy outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Based on the final data from the largest cohort of somatrogon-treated patients to date, once-weekly somatrogon demonstrated sustained efficacy and an acceptable safety profile during the OLE period. Once-weekly somatrogon constitutes a valuable long-term alternative to once-daily somatropin, offering potentially improved adherence and treatment outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/jendso\/bvag175","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T11:57:10Z","timestamp":1791374230000},"source":"Crossref","is-referenced-by-count":0,"title":["Up to 5 years of weekly somatrogon in children with growth hormone deficiency: final data from the global phase 3 study"],"prefix":"10.1210","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0508-2186","authenticated-orcid":false,"given":"Renata","family":"Stawerska","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Metabolic Diseases, Polish Mother's Memorial Hospital\u2014Research Institute , 93-338 Lodz ,","place":["Poland"]},{"name":"Department of Paediatric and Adults Endocrinology, Medical University of Lodz , 93-338 Lodz 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