Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. Issue 5 (May 2018)

• Record Type: Journal Article
• Authors: Johannsson, Gudmundur; Feldt-Rasmussen, Ulla; Håkonsson, Ida Holme; Biering, Henrik; Rodien, Patrice; Tahara, Shigeyuki; Toogood, Andrew; Rasmussen, Michael Højby
• Other Names: author non-byline.; Biering Henrik author non-byline.; Karges Wolfram author non-byline.; Mann Alexander author non-byline.; Christiansen Jens Sandahl author non-byline.; Hansen Troels Krarup author non-byline.; Andersen Marianne author non-byline.; Feldt-Rasmussen Ulla author non-byline.; Borresen Sine author non-byline.; Rodien Patrice author non-byline.; Borson-Chazot Françoise author non-byline.; Kerlan Véronique author non-byline.; Cariou Bertrand author non-byline.; Verges Bruno author non-byline.; Tahara Shigeyuki author non-byline.; Matsuno Akira author non-byline.; Takano Koji author non-byline.; Tagami Tetsuya author non-byline.; Takahashi Yutaka author non-byline.; Takahashi Toshikazu author non-byline.; Yamamoto Masahiro author non-byline.; Johannsson Gudmundur author non-byline.; Höybye Charlotte author non-byline.; Erfurth Eva-Marie author non-byline.; Drake William author non-byline.; Higham Claire author non-byline.; Murray Robert author non-byline.; Toogood Andrew author non-byline.; Brooke Antonia author non-byline.
• Is Part Of: European journal of endocrinology. Volume 178:Issue 5(2018)
• Page Start: 491
• Page End: 499
• Publication Date: 2018-05
• Subjects: Endocrinology -- Periodicals; 616.4005
• DOI: 10.1530/EJE-17-1073
• Languages: English
• ISSNs: 0804-4643

Abstract

Abstract : Objective: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin ® . Local tolerability and treatment satisfaction were also assessed. Design: 26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939). Methods: Male or female patients aged 18–79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan ( n = 61) or once-daily Norditropin ( n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results: Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin ( P = 0.0171). Conclusions: In this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.