The following article is part of our coverage of the Endocrine Society’s annual meeting (ENDO 2021) that is being held virtually from March 20-23, 2021. Endocrinology Advisor‘s staff will report on the top research in hormone science and clinical care. Check back for the latest news from ENDO 2021.
A real-world data analysis suggested that treatment of growth hormone (GH) in children born small for gestational age (SGA) may be safe and effective regardless of patient age at treatment initiation. Safety and efficacy data that evaluated the long-term effectiveness and safety of Norditropin (somatropin; Novo Nordisk) was presented at Endocrine Society’s ENDO 2021 conference, held virtually from March 20 to 23, 2021.
Study authors reviewed data from the NordiNet IOS (Clinicaltrials.gov Identifier: NCT00960128) and ANSWER (Clinicaltrials.gov Identifier: NCT01009905) clinical trials to assess the long-term effectiveness and safety of GH in real-life clinical practice and whether age mattered at the time of treatment initiation.
In this study, children (N=3351) born SGA were grouped according to age of GH initiation (<4 years of age [n=389]; 4-6 years of age [n=1048]; ≥6 years of age [n=1914]). Study authors analyzed characteristics at birth, characteristics at GH initiation, auxological measurements, and adverse events. The proportion of patients born pre-term varied in the 3 groups (<4 years of age, 38.6%; 4-6 years of age, 36.1%; ≥6 years of age, 28.2%).
At baseline, all groups had similar mean birth length (<4 years of age, -2.9±1.6; 4-6 years of age, -2.8±1.3; ≥6 years of age, -2.5±1.4) and birth weight (<4 years of age, -2.3±1.2; 4-6 years of age, -2.2±1.1; ≥6 years of age, -2.0±1.2). The mean age of GH initiation was 3.1±0.7 years in participants less than 4 years of age at initiation, 4.9±0.6 years in participants 4 to 6 years at initiation, and 9.3±2.2 years in participants at least 6 years of age at initiation.
The mean GH therapy duration and daily doses did not differ significantly among the 3 groups. Study authors also measured the mean height SDS (HSDS) at GH initiation (<4 years of age, -3.3±1.2; 4-6 years of age, -3.1±0.9; ≥6 years of age, -2.8±0.8).
After 4 years of treatment, the mean HSDS from baseline was 1.7±0.7 in the less than 4 years of age group, 1.6±0.7 in the 4 to 6 years of age group, and 1.3±0.7 in the at least 6 years of age group.
After 8 years of treatment, the mean HSDS from baseline was 2.5±0.6 in the less than 4 years of age group, 2.2±0.8 in the 4 to 6 years of age group, and 1.7±0.6 in the at least 6 years of age group. When the investigators looked those patients who reached near-adult height in the study, the found the mean HSDS was -1.9±0.6 in the less than 4 years of age group (n=3), -1.9±0.8 in the 4 to 6 years of age group (n=10), and -1.8±1.0 in the at least 6 years of age group (n=220).
A separate analysis of safety included 5643 patients and it showed the most commonly reported non-serious adverse events (AE) were headache (n=20) and arthralgia (n=5). Common, but serious, AEs reported were headache (n=3) and epiphysiolysis (n=4). There were no significant differences between the 3 groups in terms of both non-serious AEs and serious AEs.
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
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Juul A, Pietropoli A, Kelepouris N, Geffner ME. Effectiveness and safety of early growth hormone treatment in children born small for gestational age: long-term data from Nordinet® International Outcome Study (IOS) and ANSWER program. Presented at: ENDO 2021; March 20-23, 2021. Session P33.