Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex® Growth Forum Database Experience.
dc.contributor.author | Bang, P | en_US |
dc.contributor.author | Polak, M | en_US |
dc.contributor.author | Woelfle, J | en_US |
dc.contributor.author | Houchard, A | en_US |
dc.contributor.author | EU IGFD Registry Study Group | en_US |
dc.date.accessioned | 2017-03-31T13:10:14Z | |
dc.date.available | 2014-12-29 | en_US |
dc.date.issued | 2015 | en_US |
dc.date.submitted | 2017-03-23T14:28:57.471Z | |
dc.identifier.uri | http://qmro.qmul.ac.uk/xmlui/handle/123456789/22343 | |
dc.description.abstract | BACKGROUND/AIMS: We report data from the EU Increlex® Growth Forum Database (IGFD) Registry, an ongoing, open-label, observational study monitoring clinical practice use of recombinant human insulin-like growth factor-1 (rhIGF-1) therapy in children. METHODS: Safety and effectiveness data on rhIGF-1 treatment of 195 enrolled children with growth failure were collected from December 2008 to September 2013. RESULTS: Mean ± SD (95% CI) height velocity during first year of rhIGF-1 treatment was 6.9 ± 2.2 cm/year (6.5; 7.2) (n = 144); in prepubertal patients naïve to treatment, this was 7.3 ± 2.0 cm/year (6.8; 7.7) (n = 81). Female sex, younger age at start of rhIGF-1 therapy, and lower baseline height SDS predicted first-year change in height SDS. The most frequent targeted treatment-emergent adverse events (% patients) were hypoglycemia (17.6%, predictors: young age, diagnosis of Laron syndrome, but not rhIGF-1 dose), lipohypertrophy (10.6%), tonsillar hypertrophy (7.4%), injection site reactions (6.4%), and headache (5.9%). Sixty-one serious adverse events (37 related to rhIGF-1 therapy) were reported in 31 patients (16.5%). CONCLUSION: Safety and effectiveness data on use of rhIGF-1 in a 'real-world' setting were similar to those from controlled randomized trials. Severe growth phenotype and early start of rhIGF-1 improved height response and predicted risk of hypoglycemia. | en_US |
dc.format.extent | 345 - 357 | en_US |
dc.language | eng | en_US |
dc.language.iso | en | en_US |
dc.relation.ispartof | Horm Res Paediatr | en_US |
dc.rights | CC-BY | |
dc.subject | Adolescent | en_US |
dc.subject | Child | en_US |
dc.subject | Child, Preschool | en_US |
dc.subject | Databases, Factual | en_US |
dc.subject | Europe | en_US |
dc.subject | Female | en_US |
dc.subject | Growth Disorders | en_US |
dc.subject | Humans | en_US |
dc.subject | Insulin-Like Growth Factor I | en_US |
dc.subject | Male | en_US |
dc.subject | Recombinant Proteins | en_US |
dc.title | Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex® Growth Forum Database Experience. | en_US |
dc.type | Article | |
dc.rights.holder | © 2015 S. Karger AG, Basel | |
dc.identifier.doi | 10.1159/000371798 | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/25824333 | en_US |
pubs.issue | 5 | en_US |
pubs.notes | Not known | en_US |
pubs.publication-status | Published | en_US |
pubs.volume | 83 | en_US |
dcterms.dateAccepted | 2014-12-29 | en_US |