Abstract
Anti-ECP (E.Coli Polypeptide) and anti-GH antibodies (Ab) were analyzed on a total of 88 blood samples withdrawn from 73 patients. 24 samples belonged to 22 children who were never treated with hGH (Control Group). The remaining 64 samples were obtained from 51 patients treated with GH for at least 12 months. The 64 samples belonged to 4 groups according to the type of GH used (Table). A code number was assigned to each one of the 88 samples, thereby fulfilling the conditions for a singlo-blind-control study. The determination of the anti-GH Ab was performed with a radioimmuno-precipitation assay while the determination of antibodies to ECP was performed using an ELISA method.
Results: Anli-GH Ab were positive in 3 samples of 2 patients: 1 of the 2 patients was treated with Met-GH who stopped growing. The same child, 6 months after transfer to mammalian-derived GH, had a positive anti-GH titer but a normal growht-rate. The results of the Anti-ECP Ab are shown in the table.
Conclusion: Of the 2 patients (3 samples) with positive anti-GH Ab in the GH treated groups, only one had a reduction in growth rate (the Met-GH patient); following transfer to a mammalian-derived GH, resumption of growth rate was observed although anti-GH antibody titer was not completely reduced. The presence of anti-ECP Ab in all groups including the control group suggests that this determination is of no value in the GH treated child. Since in the one patient who developed neutralizing anti-GH Ab to the Met-GH no antibodies to ECP were found, ECP contamination is apparently not the cause for the immunogenicity of this particular GH molecule.
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Cohen, A., Lavagetto, A., Morchio, A. et al. ANTI-ECP & ANTI-GH ANTIBODIES IN PATIENTS TREATED WITH MAMMALIAN vs E.COLI-DERIVED hGH: A SINGLE BLIND CONTROL STUDY. Pediatr Res 33 (Suppl 5), S63 (1993). https://doi.org/10.1203/00006450-199305001-00358
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DOI: https://doi.org/10.1203/00006450-199305001-00358