Endocrine Abstracts

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.