Effective GH Replacement With Somapacitan in Children With GH Deficiency (GHD): REAL4 2-year Results and After Switch From Daily GH
An erratum to this article was published (J Clin Endocrinol Metab, 17 Nov 2023 ↗)
Authors' conclusion
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.
Study context
- Population
- Treatment-naïve prepubertal children with GHD; 85 sites across 20 countries194 completed 2 years
- Participants
- 200 children
- Comparison
- Somapacitan vs daily GH in year 1, then all switched to somapacitan
- Primary endpoint
- HV (cm/year)
- Follow-up
- Week 104
Methodological detailsmultinational, open-labelled, controlled parallel group, phase 3, 52-week main phase and 3-year safety extension
- Multinational
- Open-labelled
- Controlled parallel group
- Phase 3
- 52-week main phase and 3-year safety extension
Primary result
As reported in the abstract
HV between weeks 52 and 104
Further findings
Secondary height-related endpoints
- Supported sustained growth
Mean IGF-I SD score (SDS) during year 2
- Similar between groups and within normal range (−2 to +2)
Preference for once-weekly somapacitan over daily GH among those switching · year 2
- Patients and caregivers who switched preferring somapacitan
- 90%
Safety
- Somapacitan well tolerated, no safety or tolerability issues identified
Original publication
Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH. J Clin Endocrinol Metab. Published 5 July 2023. doi:10.
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