Other adverse events were headache, extremity pain, arthralgia, and musculoskeletal pain.
Although the numbers were small overall, reports did increase after all the children were switched to the 3.5-mg/kg dose.
Overall, somavaratan induced a rapid and dramatic increase in IGF-1 that tailed off over 30 days.
By day 8 after injection, IGF-1 had risen from a mean baseline of -1 SDs to more than 2 SDs above. The response to the fifth injection was identical to that of the first, Dr. Response varied somewhat by cohort, with the younger, mixed-gender group responding the most dramatically, with a mean increase of about 4 SDs from baseline.
All subjects received one injection per month for 5 months.
Cohort A comprised 21 men and women aged 35 years or older, who took 0.6 mg/kg per month.
The pediatric study reported 3-year data on the cohort, which began treatment of children at a mean age of 7 years.
At baseline, the children were about 2.6 standard deviations (SDs) below their expected height, and their mean IGF-1 levels, about 1.7 SDs below.
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– An extended-release human growth hormone formulation proved safe and effective in both children and adults, offering the prospect of a less-rigorous dosing schedule and potentially better patient compliance with treatment.