{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:52Z","timestamp":1789785352447,"version":"4.0.1"},"reference-count":20,"publisher":"S. Karger AG","license":[{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T00:00:00Z","timestamp":1770076800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Res Paediatr"],"abstract":"<jats:p>Introduction: Idiopathic short stature (ISS) is characterized by short stature without identifiable underlying disorders. Long-acting PEGylated recombinant human growth hormone (PEG-rhGH) has emerged as a promising treatment option for ISS children. The objective of this study was to evaluate the long-term efficacy and safety of weekly PEG-rhGH in ISS children. Methods: This multicenter, open-label, uncontrolled extension study (extension phase) followed the initial 52-week trial (main phase). All subjects received once-weekly PEG-rhGH at 0.2 mg\/kg\/week with dose adjustment (up to 0.4 mg\/kg\/week) based on height velocity (HV) and insulin-like growth factor-1 (IGF-1) standard deviation score (SDS). The primary endpoint was change in height SDS (\u0394HT SDS) from baseline; secondary endpoints mainly included HV, changes in bone age\/chronological age ratio, IGF-1 SDS, and average annual prescribed dose. Safety was evaluated through adverse events and clinical findings. Results: Of 280 children enrolled in extension study, 268 completed 52-week treatment. This analysis included results up to week 104, representing 52-week extension phase following the 52-week main phase. At week 104, the least squares means of \u0394HT SDS were 1.52, 1.24, and 1.07 for PEG-rhGH 0.2\/0.2 mg\/kg\/week, 0.1\/0.2 mg\/kg\/week, and 0\/0.2 mg\/kg\/week groups, respectively. The 0.2\/0.2 mg\/kg\/week group maintained significantly greater height improvements. HV was highest in the 0\/0.2 mg\/kg\/week group (9.16 \u00b1 1.33 cm\/year), reflecting typical first-year catch-up growth. Mean IGF-1 SDS remained within 2SDS during 2 years. Conclusion: Once-weekly PEG-rhGH in children with ISS showed sustained efficacy over 2 years in all assessed height-based outcomes. Treatment remained safe and well tolerated with no new safety signals.<\/jats:p>","DOI":"10.1159\/000550510","type":"journal-article","created":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T17:01:49Z","timestamp":1770138109000},"page":"1-11","source":"Crossref","is-referenced-by-count":1,"title":["Long-Acting PEGylated Growth Hormone in Children with Idiopathic Short Stature: 2-Year 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