ESPE Abstracts (2016) 86 P-P1-594

Somapacitan, a Once-Weekly Reversible Albumin-Binding Growth Hormone (GH) Derivative, Is Well Tolerated and Convenient in Adults with GH Deficiency (AGHD): Results from a 26-Week Randomised, Controlled Phase 3 Trial

Gudmunder Johannssona, Ulla Feldt-Rasmussenb, Ida Holme Haakonssonc, Henrik Bieringd, Patrice Rodiene, Shigeyuki Taharaf, Andrew Toogoodg & Michael Højbyc

aDepartment of Internal Medicine, University of Gothenburg, Göteborg, Sweden; bRigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; cGlobal Development, Novo Nordisk A/S, Søborg, Denmark; dMediCover Berlin-Mitte MVZ, Berlin, Germany; eService d’Endocrinologie-Diabétologie-Nutrition, Centre de référence des maladies rares de la réceptivité hormonale, CHU d’Angers, Angers, France; fDepartment of Neurosurgery, Nippon Medical School, Tokyo, Japan; gDepartment of Endocrinology, Queen Elizabeth Hospitals Birmingham, Birmingham, UK

Background: Growth hormone (GH) replacement as daily s.c. injections for patients with adults with GH deficiency (AGHD) can be cumbersome. Somapacitan (Novo Nordisk), a once-weekly reversible albumin-binding GH derivative, has been shown in short-term trials to be well tolerated in healthy adults and in patients with AGHD.

Objective and hypotheses: This trial was a multinational, multicentre, randomised (2:1), open-label, active-controlled trial (NCT02382939; REAL 2) investigating the safety, tolerability and treatment satisfaction of once-weekly somapacitan versus once-daily hGH (human GH; somatropin) in patients with AGHD.

Method: Ninety-two patients (diagnosed with AGHD, previously treated with somatropin for ≥6 months, male or female, aged 18–79 years) were randomised to once-weekly somapacitan or once-daily somatropin. During the first 8 weeks, somapacitan and somatropin doses were titrated according to serum insulin-like growth factor-I (IGF-I) SDS levels in order to achieve IGF-I levels within the normal range and preferably between 0 and 2 SDS; a fixed dose was received for the remaining 18-week period. Treatment satisfaction was assessed using the Treatment Satisfaction Questionnaire for Medication-9.

Results: A similar pattern and rate of adverse events (AEs) and serious AEs was observed with the two treatments. The most frequently occurring AEs for somapacitan and somatropin were nasopharyngitis, headache and fatigue. Mild and transient injection site reactions were observed only in the somapacitan group. After dose titration, the IGF-I levels were maintained in both treatment groups. No anti-somapacitan or anti-hGH antibodies were detected. A statistically significant difference between treatment arms in convenience score was observed with once-weekly somapacitan being more convenient than once-daily somatropin. Effectiveness and global satisfactions scores were similar in both groups.

Conclusion: Somapacitan was well tolerated and no safety issues were identified. These data indicate that somapacitan may serve as a well-tolerated, once-weekly treatment for AGHD and be more convenient than once-daily treatment.