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Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex (R) Growth Forum Database Experience
Linköping University, Department of Clinical and Experimental Medicine, Division of Clinical Sciences. Linköping University, Faculty of Medicine and Health Sciences.
University of Paris 05, France.
University of Bonn, Germany.
Ipsen Pharma, France.
2015 (English)In: Hormone Research in Paediatrics, ISSN 1663-2818, E-ISSN 1663-2826, Vol. 83, no 5, 345-357 p.Article in journal (Refereed) Published
Abstract [en]

Background/Aims: We report data from the EU Increlex (R) 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 naive 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. (C) 2015 S. Karger AG, Basel

Place, publisher, year, edition, pages
KARGER , 2015. Vol. 83, no 5, 345-357 p.
Keyword [en]
Height; rhIGF-1 therapy; EU IGFD Registry; Short stature; Severe primary insulin-like growth factor-1 deficiency
National Category
Clinical Medicine
URN: urn:nbn:se:liu:diva-120068DOI: 10.1159/000371798ISI: 000355975400007PubMedID: 25824333OAI: diva2:839934

Funding Agencies|Ipsen, France

Available from: 2015-07-06 Created: 2015-07-06 Last updated: 2015-07-06

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