PMID- 17848841
OWN - NLM
STAT- MEDLINE
DCOM- 20071025
LR  - 20220321
IS  - 1720-8386 (Electronic)
IS  - 0391-4097 (Linking)
VI  - 30
IP  - 7
DP  - 2007 Jul-Aug
TI  - Efficacy and safety of a new ready-to-use recombinant human growth hormone 
      solution.
PG  - 578-89
AB  - We report 24-month interim results of two multicenter phase III studies in 
      previously untreated children with growth failure secondary to GH deficiency 
      (GHD) that were paramount to the development of a new recombinant human GH (rh- 
      GH, somatropin), approved as the first 'biosimilar' in Europe. Study 1 consisted 
      of 3 parts performed in 89 children. The objective was to compare efficacy and 
      safety of the lyophilized formulation of the new somatropin [Somatropin Powder 
      (Sandoz)] with a licensed reference rhGH preparation and the liquid formulation 
      of the new somatropin [Somatropin Solution (Sandoz)] and to assess long-term 
      efficacy and safety of this ready-to-use Somatropin Solution. Study 2 was 
      performed in 51 children and designed to demonstrate efficacy and safety of 
      Somatropin Powder and to confirm its low immunogenic potential; rhGH was given sc 
      at a daily dose of 0.03 mg/kg. Primary [body height, height SD score (HSDS), 
      height velocity, and height velocity (HV) SD score (HVSDS)] and secondary [IGF-I 
      and IGF binding protein 3 (IGFBP-3)] efficacy endpoints and safety parameters 
      were assessed regularly. In study 1, all treatments showed comparable increases 
      in growth. The baseline-adjusted difference between Somatropin Powder and the 
      reference rhGH product in mean HV was -0.20 cm/yr (95% confidence interval (CI) 
      [-1.34;0.94]) and in mean HVSDS was 0.76 (95% CI [-0.57;2.10]) after 9 months. 
      These very small differences demonstrate comparable therapeutic efficacy between 
      the two treatments. The results of study 2 were consistent with those seen in 
      study 1. Equivalent therapeutic efficacy and clinical comparability in terms of 
      safety and immunogenicity between Somatropin Powder and the reference rhGH 
      product and between Somatropin Powder and Somatropin Solution was demonstrated. 
      The safety and immunogenicity profiles were similar and as expected from 
      experience with rhGH preparations.
FAU - Romer, T
AU  - Romer T
AD  - Department of Endocrinology, Children's Memorial Health Institute, Warsaw, 
      Poland.
FAU - Peter, F
AU  - Peter F
FAU - Saenger, P
AU  - Saenger P
FAU - Starzyk, J
AU  - Starzyk J
FAU - Koehler, B
AU  - Koehler B
FAU - Korman, E
AU  - Korman E
FAU - Walczak, M
AU  - Walczak M
FAU - Wasik, R
AU  - Wasik R
FAU - Ginalska-Malinowska, M
AU  - Ginalska-Malinowska M
FAU - Solyom, E
AU  - Solyom E
FAU - Berghout, A
AU  - Berghout A
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Italy
TA  - J Endocrinol Invest
JT  - Journal of endocrinological investigation
JID - 7806594
RN  - 0 (IGFBP3 protein, human)
RN  - 0 (Insulin-Like Growth Factor Binding Protein 3)
RN  - 0 (Insulin-Like Growth Factor Binding Proteins)
RN  - 0 (Powders)
RN  - 0 (Recombinant Proteins)
RN  - 0 (Solutions)
RN  - 12629-01-5 (Human Growth Hormone)
RN  - 67763-96-6 (Insulin-Like Growth Factor I)
SB  - IM
MH  - Age Determination by Skeleton
MH  - Body Height/drug effects
MH  - Child
MH  - Child, Preschool
MH  - Female
MH  - Follow-Up Studies
MH  - Growth Disorders/*drug therapy
MH  - Human Growth Hormone/*administration & dosage/adverse effects
MH  - Humans
MH  - Insulin-Like Growth Factor Binding Protein 3
MH  - Insulin-Like Growth Factor Binding Proteins/blood
MH  - Insulin-Like Growth Factor I/analysis
MH  - Male
MH  - Powders
MH  - Recombinant Proteins/administration & dosage/adverse effects
MH  - Solutions
MH  - Treatment Outcome
EDAT- 2007/09/13 09:00
MHDA- 2007/10/27 09:00
CRDT- 2007/09/13 09:00
PHST- 2007/09/13 09:00 [pubmed]
PHST- 2007/10/27 09:00 [medline]
PHST- 2007/09/13 09:00 [entrez]
AID - 3917 [pii]
AID - 10.1007/BF03346352 [doi]
PST - ppublish
SO  - J Endocrinol Invest. 2007 Jul-Aug;30(7):578-89. doi: 10.1007/BF03346352.