Endocrinology · Pediatrics · 3 h ago
Weekly somapacitan maintained growth outcomes in children born SGA over two years
Two phase 3 studies assessed once-weekly somapacitan in children and adolescents born small for gestational age (SGA). In the larger study, 139 of 142 randomized, treatment-naïve children completed 104 weeks; growth outcomes were maintained after participants initially assigned daily growth hormone (GH) switched to weekly treatment.
- Weekly treatment maintained height velocity through 104 weeks in REAL8.
- Most participants switching from daily GH preferred weekly somapacitan.
- REAL9 included 12 participants and had no control group.
Children born SGA who do not show spontaneous catch-up growth may receive GH, but daily injections can be burdensome. REAL8 was a randomized, multinational, open-label phase 3 study: 142 prepubertal, GH-treatment-naïve children were assigned to weekly somapacitan or daily GH for 52 weeks, then all received weekly somapacitan through week 104. A second open-label, uncontrolled phase 3 study, REAL9, enrolled 12 children and adolescents, including participants previously treated with GH, for 26 weeks of weekly somapacitan.
In REAL8, annualized height velocity during weeks 52–104 was 8.5–8.8 cm/year across the original treatment groups, and height standard deviation scores continued to increase. In REAL9, height velocity increased in GH-naïve participants and was maintained in those previously treated. The studies reported that somapacitan was well tolerated, with mostly mild adverse events and infrequent injection-site reactions; most participants switching from daily GH preferred weekly treatment. These findings support sustained growth outcomes over two years in the studied population, but REAL9 was small and uncontrolled, and the supplied abstract does not provide detailed comparative estimates or establish regulatory status. The findings alone do not establish a need to change treatment practice.
In practice
For children born small for gestational age who require growth hormone, the phase 3 results indicate that once-weekly somapacitan maintained growth outcomes through two years, including after switching from daily GH; most switchers preferred the weekly regimen. The evidence is not sufficient on its own to establish a practice change: the supplied abstract lacks detailed comparative estimates, REAL9 was small and uncontrolled, and it does not state the treatment's regulatory status.
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The Journal of Clinical Endocrinology & Metabolism: Somapacitan Treatment in Children and Adolescents Born SGA: Two-Year Efficacy and Preference Over Daily GH ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.