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rhIGF-1/rhIGFBP-3 in Preterm Infants: A Phase 2 Randomized Controlled Trial

David Ley¹, Boubou Hallberg², Ingrid Hansen-Pupp¹

¹Skane University Hospital, Department of Clinical Sciences Lund, Pediatrics, Lund University, Lund, Sweden.

The Journal of Pediatrics

|November 26, 2018

Insights

Recombinant human insulin-like growth factor 1 complexed with its binding protein (rhIGF-1/rhIGFBP-3) did not prevent retinopathy of prematurity but reduced severe bronchopulmonary dysplasia in extremely preterm infants.

Area of Science:

Neonatal Medicine
Pediatric Endocrinology
Critical Care Medicine

Background:

Retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) are significant morbidities in extremely preterm infants.
Recombinant human insulin-like growth factor 1 complexed with its binding protein (rhIGF-1/rhIGFBP-3) has been investigated for its potential to mitigate these complications.

Purpose of the Study:

To evaluate the efficacy of rhIGF-1/rhIGFBP-3 in preventing ROP and other prematurity-related complications in extremely preterm infants.

Main Methods:

A phase 2 randomized trial involving infants born between 23 and 27 weeks gestational age.
Infants received either rhIGF-1/rhIGFBP-3 infusion or standard neonatal care, with follow-up to 40 weeks postmenstrual age.
Primary endpoint was ROP severity; secondary endpoints included BPD, intraventricular hemorrhage (IVH), and growth.

Main Results:

rhIGF-1/rhIGFBP-3 did not reduce ROP severity or occurrence.
A significant reduction in severe BPD was observed (53% decrease in the full analysis set, 89% in the evaluable set).
A trend towards decreased severe IVH (grades 3-4) was noted, but no effect on discharge time or growth.

Conclusions:

rhIGF-1/rhIGFBP-3 therapy did not impact ROP development.
The treatment demonstrated a significant benefit in reducing severe bronchopulmonary dysplasia in extremely preterm infants.
A potential, though not statistically significant, reduction in severe intraventricular hemorrhage was observed.

Read full analysis

Abstract

Objective:

To investigate recombinant human insulin-like growth factor 1 complexed with its binding protein (rhIGF-1/rhIGFBP-3) for the prevention of retinopathy of prematurity (ROP) and other complications of prematurity among extremely preterm infants.

Study Design:

This phase 2 trial was conducted from September 2014 to March 2016. Infants born at a gestational age of 23^0/7 weeks to 27^6/7 weeks were randomly allocated to rhIGF-1/rhIGFBP-3 (250 µg/kg/ 24 hours, continuous intravenous infusion from <24 hours of birth to postmenstrual age 29^6/7 weeks) or standard neonatal care, with follow-up to a postmenstrual age of 40^4/7 weeks. Target exposure was ≥70% IGF-1 measurements within 28-109 µg/L and ≥70% intended therapy duration. The primary endpoint was maximum severity of ROP. Secondary endpoints included time to discharge from neonatal care, bronchopulmonary dysplasia, intraventricular hemorrhage, and growth measures.

Results:

Overall, 61 infants were allocated to rhIGF-1/rhIGFBP-3, 60 to standard care (full analysis set); 24 of 61 treated infants achieved target exposure (evaluable set). rhIGF-1/rhIGFBP-3 did not decrease ROP severity or ROP occurrence. There was, however, a 53% decrease in severe bronchopulmonary dysplasia in the full analysis set (21.3% treated vs 44.9% standard care), and an 89% decrease in the evaluable set (4.8% vs 44.9%; P = .04 and P = .02, respectively) for severity distribution between groups. There was also a nonsignificant trend toward decrease in grades 3-4 intraventricular hemorrhage in the full analysis set (13.1% vs 23.3%) and in the evaluable set (8.3% vs 23.3%). Fatal serious adverse events were reported in 19.7% of treated infants (12/61) and 11.7% of control infants (7/60). No effect was observed on time to discharge from neonatal care/growth measures.

Conclusions:

rhIGF-1/rhIGFBP-3 did not affect development of ROP, but decreased the occurrence of severe bronchopulmonary dysplasia, with a nonsignificant decrease in grades 3-4 intraventricular hemorrhage.

Trial Registration:

ClinicalTrials.gov: NCT01096784.

Keywords:

bronchopulmonary dysplasia intraventricular hemorrhage neonatology retinopathy of prematurity

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