Endocrine Abstracts (2017) 51 P057 | DOI: 10.1530/endoabs.51.P057

Analysis of UK patients in PATRO children: a non-interventional study of the long-term safety and efficacy of Omnitrope in children

Shankar Kanumakala1, Helen Johnstone2, Yadlapalli Kumar3, Josephine Heaton4 & Markus Zabransky5


1Department of Paediatrics, Royal Alexandra Children’s Hospital, Brighton, UK; 2Department of Paediatrics, Royal Victoria Infirmary, Newcastle, UK; 3Department of Paediatrics, Royal Cornwall Hospital, Truro, UK; 4Sandoz Ltd, Camberley, UK; 5Sandoz International/Hexal AG, Holzkirchen, Germany.


Introduction: PATRO children is an international, non-interventional, longitudinal study of the long-term safety of a biosimilar recombinant human growth hormone (Omnitrope, Sandoz). In particular, the study assesses the diabetogenic potential of Omnitrope and the risk of malignancies. The long-term efficacy is a secondary objective of the study. Here we present safety and efficacy data of UK patients recruited since 2008, following an interim analysis in May 2017.

Methods: The study population includes infants, children and adolescents receiving Omnitrope therapy according to local prescribing information. All adverse events (AEs) are monitored and recorded for evaluation of Omnitrope safety. Laboratory values (including glucose metabolism) are requested at least once a year. Height standard deviation score (SDS), height velocity and height velocity SDS are calculated using height measurements and UK-specific reference tables to evaluate Omnitrope efficacy.

Results: As of May 2017, 217 patients from 14 sites had been enrolled in the UK. The mean (range) duration of treatment was 32.3 (0.0–106.9) months, with 114 (52.5%) patients completing three years of treatment. To date, 490 AEs have been reported in 119 (54.8%) patients, which were of mild or moderate intensity in 460/490 cases. Overall, 134 AEs in 51 (23.5%) patients were considered serious. Eighteen AEs in 13 (6.0%) patients were suspected to be treatment-related, none of which were considered serious. Twelve treatment-related AEs (TRAEs) were mild in intensity, four moderate and two unrecorded. Headache was the most common TRAE (n=5 patients). Eight TRAEs had resolved and the remaining events were ongoing or unrecorded. There were no reports of diabetes mellitus or malignancies that were suspected to be related to Omnitrope treatment. After three years of treatment, Omnitrope resulted in improvements in most growth parameters across paediatric indications, irrespective of gender and pre-treatment status.

Conclusions: This interim analysis of patients from the UK demonstrates that Omnitrope is safe, well tolerated, and effective across paediatric indications. This analysis provides no evidence of an increased risk of developing diabetes mellitus or malignancies during Omnitrope treatment.

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