Cited 0 times in
Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH
DC Field | Value | Language |
---|---|---|
dc.contributor.author | 김호성 | - |
dc.date.accessioned | 2024-05-30T06:43:28Z | - |
dc.date.available | 2024-05-30T06:43:28Z | - |
dc.date.issued | 2023-11 | - |
dc.identifier.issn | 0021-972X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/199305 | - |
dc.description.abstract | Context Somapacitan is a long-acting GH derivative for treatment of GH deficiency (GHD). Objective Evaluate the efficacy and tolerability of somapacitan in children with GHD after 2 years of treatment and after the switch from daily GH. Design A randomized, multinational, open-labelled, controlled parallel group phase 3 trial, comprising a 52-week main phase and 3-year safety extension (NCT03811535). Setting Eighty-five sites across 20 countries. Patients A total of 200 treatment-naive prepubertal patients were randomized and exposed; 194 completed the 2-year period. Interventions Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (0.034 mg/kg/d) during the first year, after which all patients received somapacitan 0.16 mg/kg/wk. Main outcome measures Height velocity (HV; cm/year) at week 104. Additional assessments included HV SD score (SDS), height SDS, IGF-I SDS, and observer-reported outcomes. Results HV was sustained in both groups between 52 and 104 weeks. At week 104, mean (SD) for HV between weeks 52 and 104 was 8.4 (1.5) cm/year after continuous somapacitan treatment and 8.7 (1.8) cm/year after 1 year of somapacitan treatment following switch from daily GH. Secondary height-related endpoints also supported sustained growth. Mean IGF-I SDS during year 2 was similar between groups and within normal range (-2 to +2). Somapacitan was well tolerated, with no safety or tolerability issues identified. GH patient preference questionnaire results show that most patients and their caregivers (90%) who switched treatment at year 2 preferred once-weekly somapacitan over daily GH treatment. Conclusions Somapacitan in children with GHD showed sustained efficacy and tolerability for 2 years, and after switching from daily GH. Patients/caregivers switching from daily GH expressed a preference for somapacitan. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Endocrine Society | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Body Height | - |
dc.subject.MESH | Child | - |
dc.subject.MESH | Dwarfism, Pituitary* / drug therapy | - |
dc.subject.MESH | Growth Disorders / drug therapy | - |
dc.subject.MESH | Growth Hormone / therapeutic use | - |
dc.subject.MESH | Human Growth Hormone* / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Insulin-Like Growth Factor I | - |
dc.title | Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아과학교실) | - |
dc.contributor.googleauthor | Bradley S Miller | - |
dc.contributor.googleauthor | Joanne C Blair | - |
dc.contributor.googleauthor | Michael Højby Rasmussen | - |
dc.contributor.googleauthor | Aristides Maniatis | - |
dc.contributor.googleauthor | Jun Mori | - |
dc.contributor.googleauthor | Volker Böttcher | - |
dc.contributor.googleauthor | Ho-Seong Kim | - |
dc.contributor.googleauthor | Rikke Beck Bang | - |
dc.contributor.googleauthor | Michel Polak | - |
dc.contributor.googleauthor | Reiko Horikawa | - |
dc.identifier.doi | 10.1210/clinem/dgad394 | - |
dc.contributor.localId | A01184 | - |
dc.relation.journalcode | J01318 | - |
dc.identifier.eissn | 1945-7197 | - |
dc.identifier.pmid | 37406251 | - |
dc.subject.keyword | growth hormone | - |
dc.subject.keyword | growth hormone deficiency | - |
dc.subject.keyword | growth hormone replacement therapy | - |
dc.subject.keyword | long-acting growth hormone | - |
dc.subject.keyword | somapacitan | - |
dc.contributor.alternativeName | Kim, Ho Seong | - |
dc.contributor.affiliatedAuthor | 김호성 | - |
dc.citation.volume | 108 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 3090 | - |
dc.citation.endPage | 3099 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, Vol.108(12) : 3090-3099, 2023-11 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.