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

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Johannsson, G, Feldt-Rasmussen, U, Håkonsson, IH, Biering, H, Rodien, P, Tahara, S, Toogood, A, Rasmussen, MH & REAL 2 Study Group 2018, 'Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial' European Journal of Endocrinology, vol. 178, no. 5, pp. 491-499. https://doi.org/10.1530/EJE-17-1073

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Author

Johannsson, Gudmundur ; Feldt-Rasmussen, Ulla ; Håkonsson, Ida Holme ; Biering, Henrik ; Rodien, Patrice ; Tahara, Shigeyuki ; Toogood, Andrew ; Rasmussen, Michael Højby ; REAL 2 Study Group. / Safety and convenience of once-weekly somapacitan in adult GH deficiency : a 26-week randomized, controlled trial. In: European Journal of Endocrinology. 2018 ; Vol. 178, No. 5. pp. 491-499.

Bibtex

@article{f1d8bc27bab24cf4be85e4e0c0a9ed78,
title = "Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial",
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{\circledR}. 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.",
keywords = "Adult, Aged, Cholelithiasis/chemically induced, Drug Administration Schedule, Dwarfism, Pituitary/blood, Female, Human Growth Hormone/administration & dosage, Humans, Male, Middle Aged, Serum Albumin/metabolism",
author = "Gudmundur Johannsson and Ulla Feldt-Rasmussen and H{\aa}konsson, {Ida Holme} and Henrik Biering and Patrice Rodien and Shigeyuki Tahara and Andrew Toogood and Rasmussen, {Michael H{\o}jby} and {REAL 2 Study Group}",
note = "{\circledC} 2018 The authors.",
year = "2018",
month = "5",
doi = "10.1530/EJE-17-1073",
language = "English",
volume = "178",
pages = "491--499",
journal = "European Journal of Endocrinology",
issn = "0804-4643",
publisher = "BioScientifica Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - Safety and convenience of once-weekly somapacitan in adult GH deficiency

T2 - a 26-week randomized, controlled trial

AU - Johannsson, Gudmundur

AU - Feldt-Rasmussen, Ulla

AU - Håkonsson, Ida Holme

AU - Biering, Henrik

AU - Rodien, Patrice

AU - Tahara, Shigeyuki

AU - Toogood, Andrew

AU - Rasmussen, Michael Højby

AU - REAL 2 Study Group

N1 - © 2018 The authors.

PY - 2018/5

Y1 - 2018/5

N2 - 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.

AB - 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.

KW - Adult

KW - Aged

KW - Cholelithiasis/chemically induced

KW - Drug Administration Schedule

KW - Dwarfism, Pituitary/blood

KW - Female

KW - Human Growth Hormone/administration & dosage

KW - Humans

KW - Male

KW - Middle Aged

KW - Serum Albumin/metabolism

U2 - 10.1530/EJE-17-1073

DO - 10.1530/EJE-17-1073

M3 - Journal article

VL - 178

SP - 491

EP - 499

JO - European Journal of Endocrinology

JF - European Journal of Endocrinology

SN - 0804-4643

IS - 5

ER -

ID: 55074469