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Endocrine Abstracts (2018) 56 P749 | DOI: 10.1530/endoabs.56.P749

ECE2018 Poster Presentations: Pituitary and Neuroendocrinology Neuroendocrinology (28 abstracts)

Latest safety outcomes from the PATRO adults study of omnitrope® for the treatment of adult patients with growth hormone deficiency

Paolo Beck-Peccoz 1 , Charlotte Höybye 2 , Robert Murray 3 , Suat Simsek 4 , Markus Zabransky 5 , Hichem Zouater 5 & Günter Stalla 6


1Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore Policlinico, Milan, Italy; 2Karolinska University Hospital, Stockholm, Sweden; 3St James’s University Hospital, Leeds, UK; 4Medisch Centrum Alkmaar, Alkmaar, Netherlands; 5Sandoz International GmbH, Holzkirchen, Germany. 6Max Planck Institute of Psychiatry, Munich, Germany.


Introduction: Omnitrope® (Sandoz) is a recombinant human growth hormone (rhGH) and was the first biosimilar medicine approved by the European Medicines Agency. PATRO Adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope® in adults treated in routine clinical practice. The study provides data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here we present safety data from an interim analysis.

Methods: The study includes adult patients who are receiving treatment with Omnitrope® and have provided informed consent. Patients treated with another rhGH before starting Omnitrope® therapy are also eligible for inclusion. The current interim analysis aims to provide data on the risk of glucose intolerance and diabetes.

Results: As of December 2017, 1236 patients had been enrolled on the study; 1038 (84.0%) had adulthood-onset GHD and 188 (15.2%) had childhood-onset GHD. Overall, 629 (50.9%) patients had been pre-treated with another rhGH. Mean (standard deviation (S.D.)) age was 49.4 (15.3) years, and mean (S.D.) BMI was 29.5 (6.3) kg/m2. In total 3420 adverse events (AEs) in 801 patients have been reported, with 622 (321 (26.0%) patients) of these regarded as serious. One hundred and fifty AEs in 88 (7.1%) patients were suspected to be related to Omnitrope®; these included general disorders/administration site conditions in 20 patients, nervous system disorders in 25 patients and musculoskeletal/connective tissue disorders in 33 patients. A total of 26 serious AEs (SAEs) in 18 (1.5%) patients were suspected to be related to Omnitrope®, leading to treatment discontinuation in six patients. Treatment-related SAEs included two incidences of diabetes. The first case was diabetes mellitus aggravation in a 45 year old male with adulthood-onset GHD, following 4–6 months of GH therapy; Omnitrope® was permanently discontinued. The second case was worsening of diabetes mellitus in a male aged 72 years with adulthood-onset GHD, following 19 years of GH therapy; Omnitrope® treatment was interrupted. Since the start of the study, 263 patients discontinued treatment, of which 25 (9.5%) were due to AEs related to rhGH treatment.

Conclusions: Based on this interim analysis, Omnitrope® treatment in adults with GHD is well tolerated in a real-life clinical practice setting, irrespective of pre-treatment status. The ongoing PATRO Adults study will provide further data on the diabetogenic potential and overall safety of long-term GH treatment in this population.

Volume 56

20th European Congress of Endocrinology

Barcelona, Spain
19 May 2018 - 22 May 2018

European Society of Endocrinology 

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