Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .
Pharmacokinetic and Pharmacodynamic Modeling of MOD-4023, a Long-Acting Human Growth Hormone, in Growth Hormone Deficiency Children
Background / Aims : MOD-4023 is a long-acting human growth hormone ( hGH ) in clinical trials for the treatment of growth hormone deficiency ( GHD ) . A key goal is maintenance of serum concentrations of insulin-like growth factor ( IGF ) 1 within normal range throughout GH dosing . The study aim ed to develop a pharmacokinetic model for MOD-4023 and a pharmacodynamic model for the effect of MOD-4023 on IGF-1 to allow estimation of peak and mean IGF-1 and to identify the optimal IGF-1 sampling day . Methods : MOD-4023 ( 0.25 , 0.48 , or 0.66 mg/kg ) was administered weekly for 12 months to 41 GH-naive GHD children ( age 3–11 years ) . The control group ( n = 11 , age 4–9 years ) received daily recombinant human growth hormone ( r-hGH ; 34 µg/kg ) . Sparse sample s ( 4/subject ) were obtained to determine serum concentrations of MOD-4023 or r-hGH and IGF-1 . Results : A 2-compartment pharmacokinetic model with first-order absorption fit MOD-4023 data well ; a 1-compartment model was appropriate for r-hGH . For both , weight-normalized systemic parameters were preferred over allometric scaling . For MOD-4023 , an indirect model fit IGF-1 SDS data well ; baseline IGF-1 increased over time . At steady state , sample s obtained 4 days following dose administration predicted mean IGF-1 SDS during the dosing interval well . Conclusion : The IGF-1 profile is consistent with the weekly dosing interval . Sampling 4 days following dose administration allows estimation of mean IGF-1 SDS during the dosing interval in GHD patients
Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .