hrp0082p1-d3-161 | Growth (2) | ESPE2014

Safety and Effectiveness of Increlex® Therapy in Children Enrolled in the Increlex® Growth Forum Database in Europe: 4 Years Interim Results

Polak Michel , Woelfle Joachim , Bang Peter , Sicsic Aude , Fiorentino Bruno

Background: The post-authorization registry, European Increlex® (Mecasermin (rDNA Origin) injection) growth forum database (EU-IGFD) was initiated in Dec 2008 to collect data on children with growth failure treated with Increlex®.Objective: To report 4-year safety and effectiveness data.Methods: Multicenter, open-label observational study, eCRF data collection.Results: As of 30...

hrp0082p3-d2-857 | Growth (3) | ESPE2014

Differences in Personality of Monozygotic Twins can be Predicted by Difference in Birth Weight in Teen Monozygotic Twins

Wimmer Lioba , Woelfle Joachim , Bartmann Peter , Schulte Sandra , Gohlke Bettina

Background: Low birth weight and unfavourable intrauterine conditions are associated with long-term effects on life. The influence of intrauterine conditions on personality might be underestimated.Objective and hypotheses: In a longitudinal study we followed genetically identical twins with intra-twin birth-weight (bw) differences due to twin–twin transfusion syndrome (ttts) from birth until puberty.Method: 23 pairs of monozyg...

hrp0084fc7.1 | Growth-promoting therapies | ESPE2015

Safety and Effectiveness of Increlex® Therapy in Children with Laron Syndrome and Enrolled in the European Increlex® Growth Forum Database in Europe

Bang Peter , Polak Michel , Woelfle Joachim , Houchard Aude , Sert Caroline

Background: The post-authorisation registry, European Increlex® Growth Forum Database (EU-IGFD), initiated in December 2008, collects data in children receiving Increlex (mecasermin (rDNA origin) injection) for growth failure, including Laron syndrome (LS) (severe primary IGF1 deficiency with confirmed GH-receptor mutation).Objective and hypotheses: Report safety and effectiveness data in children with LS.Method: Multicentre, ...

hrp0084p2-420 | GH & IGF | ESPE2015

Hypoglycaemic Adverse Events Reported in Children Enrolled in the European Increlex® Growth Forum Database in Europe (5-Year Interim Data)

Woelfle Joachim , Polak Michel , Bang Peter , Houchard Aude , Sert Caroline

Background: The post-authorisation registry, European Increlex® (mecasermin (rDNA origin) injection) Growth European Increlex Growth Forum Database (EU-IGFD), initiated in December 2008, collects safety and efficacy data in children receiving Increlex® for growth failure. Hypoglycaemia has been reported as a common adverse event (AE) during any IGF1 replacement therapy in randomised clinical trials, and is therefore of interest in real-life sett...

hrp0084p2-499 | Perinatal | ESPE2015

Postnatal Catch-Down Growth is not Associated with Disturbances in Metabolic Parameters in Large-for-Gestational-Age Infants at the Age of 8 Years

Peters Julia , Woelfle Joachim , Joergens Susanne , Bartmann Peter , Gohlke Bettina

Background: Children born small-for-gestational-age (SGA) especially when they experience rapid catch-up growth have an increased risk for obesity and metabolic disturbances later in life.Aims and objectives: Little is known about the effect of catch-down (c-d) growth and its effect on metabolic parameters in children born large-for-gestational-age (LGA).Patients and methods: 101 pre-pubertal children with a birth-weight and/or len...

hrp0095fc10.3 | GH and IGFs | ESPE2022

Near final height in 62 twin pairs with twin-to-twin transfusion syndrome is not associated with the GHRd3 genotype

Schreiner Felix , Schulte Sandra , Kasner Charlotte , Bartmann Peter , Woelfle Joachim , Bettina Gohlke

Background: Alterations of pre- and early postnatal growth can have long lasting impact on adult height, body composition and metabolic health throughout life. In monozygotic twins discordant for prenatal growth due to twin-to-twin transfusion syndrome (TTTS), we previously demonstrated lower cord blood IGF-I concentrations and earlier pubertal maturation, indicative of prenatal programming of endocrine systems, to be linked to reduced final height of the form...

hrp0095p1-313 | Growth and Syndromes | ESPE2022

Pathway to assess severe primary IGF-1 deficiency diagnosis in a real-life setting: data from the Global Increlex® Registry

Bang Peter , Polak Michel , Bossowski Artur , De Schepper Jean , Sert Caroline , Perrot Valérie , Woelfle Joachim

Background: Severe primary insulin-like growth factor-1 deficiency (SPIGFD) is a rare condition for which replacement therapy with recombinant human insulin-like growth factor-1 (rhIGF 1; mecasermin [Increlex®]) is approved for treatment in Europe and the USA. SPIGFD is defined as a height standard deviation score (HtSDS) ≤-3, and baseline IGF-1 <2.5th percentile (European indication) or ≤-3 SDS (USA indication) for age and gender, desp...

hrp0092p1-212 | GH and IGFs (1) | ESPE2019

Hypoglycaemia Adverse Events in SPIGFD: Association with Patient Diagnosis, Age, Time-Course and Dosage of Mecasermin: 10-year Data from the European Increlex® Growth Forum Database in Europe (EU-IGFD)

Woelfle Joachim , Polak Michel , Bang Peter , Perrot Valérie , Sert Caroline

Background: In Europe, Increlex® (mecasermin) is approved for treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (SPIGFD). We present 10-year data (up to October 2018) from the European Increlex® Growth Forum Database (EU-IGFD) registry (NCT00903110) on the frequency, predictive factors, and the potential impact of hypoglycaemia on efficacy outcomes....

hrp0092p1-214 | GH and IGFs (1) | ESPE2019

The European Increlex® Growth Forum Database (EU-IGFD) Registry: Do Treatment Practices Differ Between European Countries?

Bang Peter , Polak Michel , Woelfle Joachim , Perrot Valérie , Sert Caroline

Background: In the European Union, Increlex® (mecasermin) is approved for the treatment of growth failure in children with severe primary insulin-like growth factor-1 deficiency (SPIGFD).Methods: The European Increlex® Growth Forum Database (EU-IGFD) registry (NCT00903110) is an ongoing, multicentre, open-label, observational study monitoring the safety and efficacy of mecasermin in childr...

hrp0089fc7.6 | Fetal, Neonatal Endocrinology and Metabolism | ESPE2018

TSH-Resistance and Remaining Low-T4 in Former Low-Birthweight Infants – A Study in Monozygotic Twins with Intra-Twin Birth-Weight-Differences

Schulte Sandra , Woelfle Joachim , Bartmann Peter , Schreiner Felix , Panou Evangelia , Vollbach Heike , Gohlke Bettina

Background: Low birth-weight (bw) and unfavourable intrauterine conditions are associated with a subsequent impact on the endocrine system. However, very little is known about the impact on thyroid function.Objective and hypotheses: We observed genetically identical twins with intra-twin bw-differences from birth until adolescence to objectify the impact of a lower bw on development and health in later life.Method: Bw-difference of...