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Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH

Touraine, Philippe ; D'souza, Gwyn a ; Kourides, Ione ; Abs, Roger ; Barclay, Paul ; Xie, Rujia ; Pico, Antonio ; Torres-Vela, Elena and Ekman, Bertil (2009) In European Journal of Endocrinology 161(4). p.533-540
Abstract
Objective: Changes observed during adult GH deficiency (GHD) are most often reversed with the administration of recombinant human GH (rhGH). To avoid daily injections, a long-acting GH molecule has been obtained by covalent binding of polyethylene glycol (PEG) with rhGH (PEG-GH), allowing weekly s.c. injections. This study was designed to assess its efficacy and safety, in adult GHD subjects.
Design and methods: This was a randomized, double-blind, placebo-controlled, multiple-dose, parallel group study. Subjects were recruited from 34 centers. A total of 105 subjects with GHD were assigned a treatment. They received 6 weekly injections of either PEG-GH or placebo. Subjects were randomized into one out of four treatment groups (Groups... (More)
Objective: Changes observed during adult GH deficiency (GHD) are most often reversed with the administration of recombinant human GH (rhGH). To avoid daily injections, a long-acting GH molecule has been obtained by covalent binding of polyethylene glycol (PEG) with rhGH (PEG-GH), allowing weekly s.c. injections. This study was designed to assess its efficacy and safety, in adult GHD subjects.
Design and methods: This was a randomized, double-blind, placebo-controlled, multiple-dose, parallel group study. Subjects were recruited from 34 centers. A total of 105 subjects with GHD were assigned a treatment. They received 6 weekly injections of either PEG-GH or placebo. Subjects were randomized into one out of four treatment groups (Groups A-D) or placebo (Group E). Groups A, B, and C received 1, 3, and 4 mg PEG-GH respectively, for the first 3 weeks followed by 2, 6, and 8 mg PEG-GH respectively, for the remaining 3 weeks. Group D received 4 mg PEG-GH for 6 weeks. Group E received placebo. The study was suspended because of the development of lipoatrophy in certain subjects and restarted with an injection rotation plan, before being terminated due to further subjects developing lipoatrophy.
Results: A total of 13 cases of injection-site lipoatrophy were reported, of which ten were in females and three occurred after the first injection; all cases were independent of PEG-GH dose or IGF1 levels, either basal or under treatment.
Conclusion: The unpredictable occurrence of injection-site lipoatrophy with weekly long-acting pegylated GH molecules may be a limiting factor for their development.
Trial registration: ClinicalTrials.gov NCT00308464. (Less)
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contributor
LU
author collaboration
publishing date
type
Contribution to journal
publication status
published
subject
in
European Journal of Endocrinology
volume
161
issue
4
pages
533 - 540
publisher
Society of the European Journal of Endocrinology
external identifiers
  • scopus:70349780005
ISSN
1479-683X
DOI
10.1530/EJE-09-0422
language
English
LU publication?
no
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038666ea-40dc-4cbe-ba86-ac79d680242d
date added to LUP
2023-11-14 12:01:52
date last changed
2023-11-15 04:02:06
@article{038666ea-40dc-4cbe-ba86-ac79d680242d,
  abstract     = {{Objective: Changes observed during adult GH deficiency (GHD) are most often reversed with the administration of recombinant human GH (rhGH). To avoid daily injections, a long-acting GH molecule has been obtained by covalent binding of polyethylene glycol (PEG) with rhGH (PEG-GH), allowing weekly s.c. injections. This study was designed to assess its efficacy and safety, in adult GHD subjects.<br/>Design and methods: This was a randomized, double-blind, placebo-controlled, multiple-dose, parallel group study. Subjects were recruited from 34 centers. A total of 105 subjects with GHD were assigned a treatment. They received 6 weekly injections of either PEG-GH or placebo. Subjects were randomized into one out of four treatment groups (Groups A-D) or placebo (Group E). Groups A, B, and C received 1, 3, and 4 mg PEG-GH respectively, for the first 3 weeks followed by 2, 6, and 8 mg PEG-GH respectively, for the remaining 3 weeks. Group D received 4 mg PEG-GH for 6 weeks. Group E received placebo. The study was suspended because of the development of lipoatrophy in certain subjects and restarted with an injection rotation plan, before being terminated due to further subjects developing lipoatrophy.<br/>Results: A total of 13 cases of injection-site lipoatrophy were reported, of which ten were in females and three occurred after the first injection; all cases were independent of PEG-GH dose or IGF1 levels, either basal or under treatment.<br/>Conclusion: The unpredictable occurrence of injection-site lipoatrophy with weekly long-acting pegylated GH molecules may be a limiting factor for their development.<br/>Trial registration: ClinicalTrials.gov NCT00308464.}},
  author       = {{Touraine, Philippe and D'souza, Gwyn a and Kourides, Ione and Abs, Roger and Barclay, Paul and Xie, Rujia and Pico, Antonio and Torres-Vela, Elena and Ekman, Bertil}},
  issn         = {{1479-683X}},
  language     = {{eng}},
  month        = {{10}},
  number       = {{4}},
  pages        = {{533--540}},
  publisher    = {{Society of the European Journal of Endocrinology}},
  series       = {{European Journal of Endocrinology}},
  title        = {{Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH}},
  url          = {{http://dx.doi.org/10.1530/EJE-09-0422}},
  doi          = {{10.1530/EJE-09-0422}},
  volume       = {{161}},
  year         = {{2009}},
}