ESPE Abstracts (2014) 82 P-D-3-2-850

A Follow-up Study up to Adult Height of the Patients Included in the Phase iii Clinical Trial with the Biosimilar Human Recombinant GH (omnitrope®) on the Treatment of Spanish Children with GH Deficit

Victoria Borrasa, Juan Pedro Lopez Siguerob, Gabriela Martinezc, Raquel Corripiod, Juan Fernanadeze, Jose Labartaf, Marta Ferrerf, Nuria Cabrinetyg, Pablo Prietoh, Marta Ramoni, Jordi Boschj, Rafael Espinok & Margarida Palla Garcial

aHospital General Granolers, Barcelona, Spain; bHospital Universitario Carlos Haya, Malaga, Spain; cHospital Ciudad de Jaén, Jaen, Spain; dCorporación Sanitaria Parc Tauli, Barcelona, Spain; eHospital San Cecilio, Granada, Spain; fHospital Universitario Miguel Servet, Zaragoza, Spain; gHospital Sacrat Cor, Barcelona, Spain; hHospital Universitario de Salamanca, Salamanca, Spain; iHospital San Joan de Deu, Barcelona, Spain; jHospital Universitario Arnau Villanova, Lérida, Spain; kHospital Nuestra Sra Valme, Sevilla, Spain; lSandoz Farmacéutica, Madrid, Spain

Introduction: The results of the phase III clinical trial that evaluated the efficacy and safety of the biosimilar recombinant human GH - rhGH - (Omnitrope®, Sandoz) on the treatment of Spanish children with GH deficiency were published in 2011. At the end of the study those patients that were still growing remained on treatment within the usual clinical practice.

Objective: To know the values of adult height of the children who participated in the Spanish phase III clinical trial. To ascertain the long term safety of treatment with Omnitrope®.

Method: This study was a multicentre, observational, retrospective follow-up study of the patients that participated in the Spanish phase III clinical trial (70 patients recruited). Height data up to adult height was obtained from 39 patients.

Results: Data from 27 men and 12 women was gathered. The mean age of the patients was 18.5+2.7 years (men 18.5±2.8; women 18.5±2.6). At the end of the phase III clinical trial the mean height was 144.8±13.9 cm (men 145.1±14.3, women144.1±13.3) and the height SDS was −1.16±0.63 (men −1.11±0.69, women −1.26±0.50). The mean adult height was 163.1±7.6 cm (n=36; men165.5±7.8, women 157.6±3.2) and the adult height SDS was −1.01±0.59 (n=36; men −1.07±0.52, women −0.86±0.72). Two patients have not yet reached adult height and in one patient adult height could not be measured. 23.1% of patients (9) changed from Omnitrope® to an original rhGH. No adverse events were reported.

Conclusions: The patients recruited in the Spanish phase III clinical trial had a positive growth achieving an adult height SDS of −1.01+0.59 (men: −1.07±0.52 and women: −0.86±0.72). No adverse events were reported.