title: Effectiveness and Safety of rhIGF-1 Therapy in Children: The European Increlex® Growth Forum Database Experience.
abstract: OBJECTIVE
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Pediatrics, Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Bang
authors.forename: Michel
authors.initials: M
authors.lastname: Polak
authors.forename: Joachim
authors.initials: J
authors.lastname: Woelfle
authors.forename: Aude
authors.initials: A
authors.lastname: Houchard
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D005060:Europe; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011994:Recombinant Proteins; D007334:Insulin-Like Growth Factor I