High incidence of anti-GH antibodies in subjects treated with the GH clinical preparation available in Italy

We have characterized the GH clinical preparation available in Italy (Grorm, Serono) by gel chromatography and immunoreactivity. Only 50-60% of this preparation can be identified with the active GH monomeric form. Both higher and lower molecular weight compounds are present as well. Then, using a radioimmunoassay technique, we looked for anti-GH antibodies in 21 subjects under Grorm treatment and found them in 6 paitents (28.6%). Two subjects having anti-GH antibodies with high affinity had a lower growth rate. These data suggest that anti-GH antibodies measurement is clinically useful in patients treated with this GH preparation. A more purified preparation should be used when a slowing down of the growth rate is observed in the presence of anti-GH antibodies.