Endocrine Abstracts

Introduction: PATRO Adults is an ongoing, longitudinal, noninterventional study assessing the long-term safety and efficacy of Omnitrope^® (Sandoz; recombinant human growth hormone [rhGH]), among adults with severe growth hormone deficiency (GHD) treated in routine clinical practice in European countries. Omnitrope^® was approved by the European Medicines Agency (EMA) in 2006, representing the first biosimilar approved by the EMA. We report the latest safety data from PATRO Adults, focusing on diabetes risk.

Methods: Adult patients receiving treatment with Omnitrope^® and providing informed consent were eligible for inclusion, regardless of prior treatment with another rhGH. This interim analysis was performed using data available as of 30^th November 2018.

Results: At the interim analysis timepoint, 1324 patients had been enrolled since 2007, including 1106 (83.5%) with adulthood-onset and 206 (15.6%) with childhood-onset GHD. In total, 665 (50.2%) patients had previously received another rhGH. Mean age at baseline was 49.2 years (standard deviation [SD]: 15.4), with mean BMI of 29.5 kg/m² (S.D.: 6.4). Overall, 4287 adverse events (AEs) were reported by 934 (70.5%) patients; 812 of these events (among 400 [30.2%] patients) were serious AEs (SAEs). One hundred and sixty-nine AEs in 102 (7.7%) patients were suspected to be treatment-related, with musculoskeletal/connective tissue disorders (36 patients), general disorders/administration site conditions (27 patients), and nervous system disorders (24 patients) most commonly reported. Twenty-eight SAEs (among 21 patients [1.6%]) were suspected to be treatment-related, resulting in treatment discontinuation in 7 patients. Overall, 349 (26.4%) patients have discontinued the study, 83 (6.3%) due to AEs (31 [2.3%] due to treatment-related AEs). Twenty-eight cases of diabetes have been reported as AEs (24 in combined GHD patients; 27 in adulthood-onset GHD); 14 cases were SAEs, of which 3 were suspected to be treatment-related. These three cases included: diabetes in a 29-year-old male with childhood-onset combined GHD, following ~11 years’ GH therapy, in whom Omnitrope^® treatment was not changed; diabetes mellitus aggravation in a 45-year-old male with adulthood-onset combined GHD, following 4–6 months’ GH therapy, in whom treatment was discontinued; and worsening of diabetes in a 72-year-old male with adulthood-onset combined GHD, following 19 years’ GH therapy, in whom treatment was interrupted.

Conclusions: This interim analysis indicates that Omnitrope^® is well tolerated in routine clinical practice, including among those previously receiving GH. The ongoing PATRO Adults study will provide further insights into the overall safety and diabetogenic potential of long-term GH.