[Somatropin therapy in Italy during 2019-2022: prevalence and incidence rates estimated by data from the national register and regional health sources.]

Introduction: The availability of epidemiological data relating to the therapy with somatropin (recombinant Growth Hormone, rGH) is scarce and mostly limited to specific clinical conditions. In Italy, the National Register of rGH users (Registro nazionale degli assuntori dell'ormone della crescita - Rnaoc) has been established since 2004 as recommended by the Italian medicine agency (Aifa). However, prevalence (P) and incidence (I) estimates in the Italian population are lacking.

Methods: Data from the Rnaoc and a questionnaire submitted to all the Italian regions have been used to calculate P and I rates of rGH treatment exposure in the Italian paediatric (0-17 years) and adult (≥18 years) population during 2019-2022; P and I rates of growth hormone deficiency (GHD) in paediatric patients have been estimated as well. Results from the two data sources have been compared.

Results: In 2019-2022, the estimated P rate in the paediatric population was 13,4/10.000, in adults 0,7/10.000 inhabitants; the I rate was 2,3/10.000 and 0,06/10.000 inhabitants, correspondingly. The estimated P rate of paediatric GHD was 8,9/10.000, the I rate was 1,5/10.000 inhabitants, respectively.

Conclusion: Study results showed a better reliability of data collected via questionnaire because more consistent with Italian regional resident populations.