Clinical Experience with Recombinant Authentic Human Growth Hormone in Growth Hormone Deficient Children

Results from four multicenter studies are presented. A total of 150 children with hGH deficiency were treated for 3 months and 80 of them for 6 months with recombinant authentic hGH. All children increased their growth rate. The results from the four different studies differ somewhat regarding mean height velocity in naive patients: Japan 7.4cm/year (n=21), Sweden-Finland 13.9cm/year (n=18), West Germany 13.3cm/year (n=9) calculated from 6 months height measurements and France 9.3cm/year (n=24) calculated from 3 months height measurements. The studies differ regarding doses: 0.5U/kg, 0.7U/kg, 12U/m2 and 0.6U/kg, respectively; weekly frequency of injections: 3, 7, 6, 3 injections/week, respectively; regimens: i. m. in Japan and s. c. in other countries, and mean age of the children: 10.8y, 6.1y, 8.2y and 13.4y, respectively. Thus, the best growth rate was found in children of the Swedish-Finnish study. These children were the youngest, were treated with s. c. injection of the highest frequency (7) and dose (0.7U/kg and week).None of the previously GH treated patients (47 at 3 months and 18 at 6 months) had developed measurable anti-GH antibodies. Among the previously untreated patients, one out of 74 children at 3 months and one out of 34 children at 6 months developed measurable anti-GH antibodies with a binding capacity of 0.02mg/litre. The growth velocity of these children remained as good as the others. No consistent changes in levels of antibodies to Escherichia coli protein were detected. No other allergic manifestations and systemic side effect were demonstrable.In conclusions, the high efficiency and safety of recombinant authentic hGH as a therapeutic agent in GH deficient children has been confirmed.