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Somavaratan improved height, IGF-I in prepubertal children with GH deficiency
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Prepubertal children treated with the long-acting recombinant human growth hormone somavaratan saw significant improvement in height velocity over 6 months, with no significant differences between assigned dose regimens, according to research in The Journal of Clinical Endocrinology & Metabolism.
In a randomized, open-label trial comparing the treatment effects of three dosing regimens in children with GH deficiency, researchers also found that somavaratan (VRS-317, Versartis), a recombinant human GH fusion protein designed to reduce the dosing frequency of daily recombinant human GH, increased insulin-like growth factor I levels and was well tolerated.
Wayne V. Moore, MD, PhD, of Children’s Mercy Hospital and the department of endocrinology and diabetes at the University of Missouri-Kansas City, and colleagues analyzed data from 64 prepubertal children with GH deficiency (mean age, 7 years) who were naive to treatment from 25 pediatric endocrinology centers in the United States. All children received single subcutaneous doses of somavaratan (0.8, 1.2, 1.8, 2.7, 4 or 6 mg/kg) during an ascending 30-day dose-finding phase. Researchers then randomly assigned children to somavaratan 1.15 mg/kg weekly, 2.5 mg/kg twice monthly or 5 mg/kg monthly for 6 months. Researchers measured 6-month height velocity; IGF-I was measured by liquid chromatography-mass spectroscopy; safety and efficacy data were collected at baseline, 1, 3 and 6 months.
Researchers found that a single dose of somavaratan sustained IGF-I responses for up to 1 month; no somavaratan or IGF-I accumulation occurred with repeat dosing.
The mean annualized height velocity was 7.86 cm/year in the monthly group; 8.61 cm/year in the twice-monthly group and 7.58 cm/year in the weekly group.
Adverse events were mild and transient and comparable to daily GH therapy, according to researchers, with no reported cases of injection-site lipoatrophy or nodule formation. One patient withdrew from the twice-monthly group after experiencing chronic hives. – by Regina Schaffer
Disclosure: Versartis funded the study. Two of the study researchers are employees of Versartis, and two others report serving as consultants.
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