Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial

Johannsson, Gudmundur ; Feldt-Rasmussen, Ulla ; Håkonsson, Ida holme ; Biering, Henrik ; Rodien, Patrice ; Tahara, Shigeyuki ; Toogood, Andrew and Rasmussen, Michael Højby (2018) In European Journal of Endocrinology 178(5). p.491-499
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... (More)
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. (Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; and
contributor
LU
author collaboration
publishing date
type
Contribution to journal
publication status
published
subject
in
European Journal of Endocrinology
volume
178
issue
5
pages
491 - 499
publisher
Society of the European Journal of Endocrinology
external identifiers
  • scopus:85046120724
ISSN
1479-683X
DOI
10.1530/EJE-17-1073
language
English
LU publication?
no
id
1b656b5f-b876-4f95-9f35-ac7d6e3f0f95
date added to LUP
2023-11-13 11:46:20
date last changed
2023-11-14 04:09:13
@article{1b656b5f-b876-4f95-9f35-ac7d6e3f0f95,
  abstract     = {{Objective<br/>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.<br/>Design<br/>26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).<br/>Methods<br/>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).<br/>Results<br/>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).<br/>Conclusions<br/>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.}},
  author       = {{Johannsson, Gudmundur and Feldt-Rasmussen, Ulla and Håkonsson, Ida holme and Biering, Henrik and Rodien, Patrice and Tahara, Shigeyuki and Toogood, Andrew and Rasmussen, Michael Højby}},
  issn         = {{1479-683X}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{5}},
  pages        = {{491--499}},
  publisher    = {{Society of the European Journal of Endocrinology}},
  series       = {{European Journal of Endocrinology}},
  title        = {{Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial}},
  url          = {{http://dx.doi.org/10.1530/EJE-17-1073}},
  doi          = {{10.1530/EJE-17-1073}},
  volume       = {{178}},
  year         = {{2018}},
}