According to the retrieved meta-analysis studies, it was observed that
long acting once weekly LAGH therapy provided better efficacy compared with
daily growth hormone DGH injections with better safety profiles [6-16]. Several
systemic reviews and meta-analysis results were studied for different available
LAGH, mainly Sogroya® (somapacitan), Skytrofa® (lonapegsomatropin, TransCon
hGH), NGENLA® (somatrogon) and
Jintrolong®, a polyethylene glycol LAGH (PEG-LAGH) as an alternative,
once weekly treatment, for the management of growth hormone deficiency in
children. Hence, In one meta-analysis study (Tsurayya G et al.) six randomized
controlled trials were included, with 289 pre-pubertal children diagnosed with
GHD, with 206 males and 83 females, for maximum of 208 weeks (4.3 years).
Somapacitan was administered at doses ranging from 0.02 to 0.16 mg/kg/week. The
average age of the children was 6.58 ± 2.29 years (including five countries in
Eurpe, North America, Asia and Middle East) [17]. During analysing data for
meta-analysis, a daily growth hormone injection with a control dose of 0.034
mg/kg/day were utilized with the selected studies. Meta-analysis focuses specifically
on the 0.16 mg/kg/week Somapacitan dosage, with the prediction of achieving
higher insulin-like growth factor-I (IGF-I) levels compared to daily human
growth hormones [18,19]. The results
revealed similar outcomes in height velocity, height SDs, IGF-I SDs, and
chronological age vs. bone age. Non-inferiority was observed in height velocity
SDs (MD = ?0.71 (95% CI: ?1.53, 0.10); p = 0.09). Safety profiles were similar
between the two groups, with an overall adverse event OR of 1.49 (95% CI: 0.85,
2.60; p = 0.16; I2 = 0%). Treatment adherence is three times higher in the
Somapacitan group compared to Norditropin (OR = 3.02 (95% CI: 1.12, 8.13); p =
0.03). Similarly, in another meta-analysis (Zhu J et al.) has evaluated the
relative efficacy and safety of long-acting growth hormone (LAGH) with total of
1,899 patients. It was concluded according to the forest plot that PEG-LAGH
exhibited better efect on HV (MD: -0.031, 95% CrI: -0.278, 0.215) than
somatrogon (MD: 0.105, 95% CrI: -0.419, 0.636), somapacitan (MD: 0.802, 95%
CrI: -0.451, 2.068) and lonapegsomatropin (MD: 1.335, 95% CrI: -0.3, 2.989)
when compared with DGH. PEG-LAGH ranked the highest in SUCRA (0.78), followed
by DGH (0.72), somatrogon (0.61), somapacitan (0.26) and lonapegsomatropin (0.12)
[?20]. Furthermore, another research trial done by Mori J et al. has
demonstrated the efficacy of somapacitan [21]. The main pharmacodynamic
endpoint was IGF?ISDS, height velocity (HV; cm/year), HV SD score (SDS), height
SDS, and bone age. Somapacitan was shown to be well?tolerated. During Weeks
0–52, mean adherence for the somapacitan group and the daily GH group was 98.2%
and 94.8%, respectively. IGF?I SDS had a marginally higher mean baseline level.
Observed mean (SD) HV during Weeks 0–52 was 10.3 (2.0) cm/year for the
somapacitan group and 9.8 (2.6) cm/year for the daily GH group. IGF?I SDS from
baseline to Week 52, and Weeks 52–104 was similar between treatment groups (2.0
(0.9) and 1.9 (1.5) and 1.4 (0.5) and 1.8 (0.9) for both somapacitan and daily GH
respectively. The authors have recommended the utilization of LAGH for the
management of growth hormone deficiency for beeter compliance and
efficacy. Additionally, in another
meta-analysis, it was demonstrated that all LAGH were well tolerated and were
associated with an elevated IGF-I level compared to daily GH [22] similarly,
several other clinical trials, systemic reviews and meta-analysis have
demonstrated safety and efficacy of LAGH for achieving higher IGF-1 levels,
growth and height velocity, as mentioned in the references section.