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Author: Medical team doctors report NMT NMT ENDO compile reports, please do not reprint without authorization.
Introduction: The 2021 American Endocrine Society Annual Meeting (ENDO) released a number of research advances on the "treatment of pediatric growth hormone deficiency".
Dr.
Reiko Horikawa from the National Center for Children’s Health and Development in Tokyo, Japan, introduced us to “In Japanese children with growth hormone deficiency (pGHD), the use of long-acting human growth hormone (somatrogon) once a week versus daily The use of human growth hormone (Genotropin) efficacy and adverse reactions" Phase 3 clinical study.
What is Somatrogon? Somatrogon is a long-acting recombinant human growth hormone that contains the natural sequence of human growth hormone, and contains one copy at the N-terminus and 2 copies at the C-terminus of human chorionic gonadotropin (hCG) β-chain C-terminal peptide (CTP).
), CTP can extend the half-life of the molecule.
Designed to be used once a week, developed for the treatment of childhood growth hormone deficiency (pGHD).
Study Design This is a 12-month, open-label, randomized, active drug control, phase 3 clinical study with parallel groups.
A total of 44 Japanese pGHD patients (aged 3 to 11 years old) were randomly divided into two groups at a ratio of 1:1.
One group was given somatrogon (dose 0.
66mg/kg/wk), and the other group was given Genotropin (0.
025mg /kg/d) Subcutaneous injection, the course of treatment is 12 months.
Patients receiving Somatrogon treatment underwent pharmacokinetic evaluation in the first 6 weeks, according to 0.
25, 0.
48, and 0.
66 mg/kg/wk gradually increasing doses, and each stage was maintained for 2 weeks.
During the remaining 46 weeks, the patient continued to receive the drug dose of 0.
66 mg/kg/wk. The main endpoint of the study was the annual avatar height growth rate (HV) at 12 months.
Research results 1.
Yearly incarnation height growth rate The baseline characteristics of the two groups are comparable.
The HV least squares method at 12 months in the Somatrogon group was 9.
65 cm/y; the figure in the Genotropin group was 7.
87 cm/y (Figure 1A).
The estimated treatment difference was +1.
79 cm/y (95%CI 0.
97, 2.
60), and the Somatrogon group was better.
Similar results were also observed in the HV annualized data at the 6th month.
The point estimate is greater than the predetermined average treatment difference "-1.
8cm/y", indicating that it is comparable.
2.
The standard deviation of average height at 6 months and 12 months, the standard deviation unit (SDS) (-2.
02 and -1.
64) of the average height of the Somatrogon group was higher than that of the Genotropin group (-2.
23 and -2.
03) (Figure 1B) .
At 6 months and 12 months, the average change in height SDS in the Somatrogon group was 0.
58 and 0.
94, respectively, which were higher than those in the Genotropin group (0.
31 and 0.
52).
3.
Bone age progression does not exceed age progression The average bone development maturity (defined as the ratio of BA to CA) at 12 months in the two treatment groups is less than 1.
0 (Somatrogon group: 0.
80; Genotropin group: 0.
80), that is, bone age progression ( BA) Progression not beyond age (CA).
4.
Safety There was no significant difference in the safety of the two treatment groups.
Most of the adverse events were mild to moderate in severity, and the most common adverse reactions were nasopharyngitis, injection site pain and influenza (Table 1).
The incidence of serious adverse reactions in both groups was low.
However, pain at the injection site was more common in the somatrogon group (72.
7% vs.
13.
6%). Conclusion This phase 3 trial in Japanese patients with pGHD showed that weekly somatrogon is as effective as daily Genotropin.
After 12 months of treatment, the annual HV of the somatrogon was higher than that of the Genotropin group, and the Somatrogon group was well tolerated.
The changes in bone maturity of the two treatment groups were similar, and the progression of bone age did not exceed the progression of age.
Introduction: The 2021 American Endocrine Society Annual Meeting (ENDO) released a number of research advances on the "treatment of pediatric growth hormone deficiency".
Dr.
Reiko Horikawa from the National Center for Children’s Health and Development in Tokyo, Japan, introduced us to “In Japanese children with growth hormone deficiency (pGHD), the use of long-acting human growth hormone (somatrogon) once a week versus daily The use of human growth hormone (Genotropin) efficacy and adverse reactions" Phase 3 clinical study.
What is Somatrogon? Somatrogon is a long-acting recombinant human growth hormone that contains the natural sequence of human growth hormone, and contains one copy at the N-terminus and 2 copies at the C-terminus of human chorionic gonadotropin (hCG) β-chain C-terminal peptide (CTP).
), CTP can extend the half-life of the molecule.
Designed to be used once a week, developed for the treatment of childhood growth hormone deficiency (pGHD).
Study Design This is a 12-month, open-label, randomized, active drug control, phase 3 clinical study with parallel groups.
A total of 44 Japanese pGHD patients (aged 3 to 11 years old) were randomly divided into two groups at a ratio of 1:1.
One group was given somatrogon (dose 0.
66mg/kg/wk), and the other group was given Genotropin (0.
025mg /kg/d) Subcutaneous injection, the course of treatment is 12 months.
Patients receiving Somatrogon treatment underwent pharmacokinetic evaluation in the first 6 weeks, according to 0.
25, 0.
48, and 0.
66 mg/kg/wk gradually increasing doses, and each stage was maintained for 2 weeks.
During the remaining 46 weeks, the patient continued to receive the drug dose of 0.
66 mg/kg/wk. The main endpoint of the study was the annual avatar height growth rate (HV) at 12 months.
Research results 1.
Yearly incarnation height growth rate The baseline characteristics of the two groups are comparable.
The HV least squares method at 12 months in the Somatrogon group was 9.
65 cm/y; the figure in the Genotropin group was 7.
87 cm/y (Figure 1A).
The estimated treatment difference was +1.
79 cm/y (95%CI 0.
97, 2.
60), and the Somatrogon group was better.
Similar results were also observed in the HV annualized data at the 6th month.
The point estimate is greater than the predetermined average treatment difference "-1.
8cm/y", indicating that it is comparable.
2.
The standard deviation of average height at 6 months and 12 months, the standard deviation unit (SDS) (-2.
02 and -1.
64) of the average height of the Somatrogon group was higher than that of the Genotropin group (-2.
23 and -2.
03) (Figure 1B) .
At 6 months and 12 months, the average change in height SDS in the Somatrogon group was 0.
58 and 0.
94, respectively, which were higher than those in the Genotropin group (0.
31 and 0.
52).
3.
Bone age progression does not exceed age progression The average bone development maturity (defined as the ratio of BA to CA) at 12 months in the two treatment groups is less than 1.
0 (Somatrogon group: 0.
80; Genotropin group: 0.
80), that is, bone age progression ( BA) Progression not beyond age (CA).
4.
Safety There was no significant difference in the safety of the two treatment groups.
Most of the adverse events were mild to moderate in severity, and the most common adverse reactions were nasopharyngitis, injection site pain and influenza (Table 1).
The incidence of serious adverse reactions in both groups was low.
However, pain at the injection site was more common in the somatrogon group (72.
7% vs.
13.
6%). Conclusion This phase 3 trial in Japanese patients with pGHD showed that weekly somatrogon is as effective as daily Genotropin.
After 12 months of treatment, the annual HV of the somatrogon was higher than that of the Genotropin group, and the Somatrogon group was well tolerated.
The changes in bone maturity of the two treatment groups were similar, and the progression of bone age did not exceed the progression of age.