Because of the high incidence of antibodies after HGH therapy in our hypopituitary patients, we have studied the plasma of all HGH-treated children with a sensitive radioimmunological method. We found antibodies to HGH in 12 out of 21 children who were initially treated with a cloudy preparation of HGH Raben, and in only 2 out of 14 children treated with HGH Roos. Growth was not inhibited in 4 children with low and in 2 out of 4 children with medium-high antibody titers. In one patient, antibodies in medium-high concentrations inhibited the growth response to administered HGH and seemed to suppress also the effect of endogenous GH. Replacement of the cloudy preparation by a clear solution of HGH Raben or by HGH Roos led to a decrease or the disappearance of antibodies, and, in the absence of antibodies, growth response to therapy returned. Thus, the quality of the HGH preparation might account for the appearance of antibodies in low and medium-high titers. In 6 children with isolated GH deficiency, antibodies developed in high concentrations independent of the quality of the HGH preparation used. Antibodies were still present 2–5 yr after discontinuation of HGH therapy, and their titers rose immediately to very high levels after resuming therapy with HGH Roos. Four of these children are related to each other. These patients can be distinguished from others with isolated growth hormone deficiency by their typical appearance, shortness at birth, early onset of growth retardation resulting in extreme dwarfism, and by a strong anabolic action of HGH before antibodies appear. These observations suggest that these 6 patients suffer from a hereditary prenatal GH deficiency, and that the antibody formation is due to a lack of immunotolerance to homologous human GH.
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R Illig (1970) studied this question.