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Multicenter Study
. 2021 May 25:12:676083.
doi: 10.3389/fendo.2021.676083. eCollection 2021.

Effectiveness and Overall Safety of NutropinAq® for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq® European Registry (iNCGS)

Regis Coutant  1 , Jordi Bosch Muñoz  2 , Cristina Patricia Dumitrescu  3 , Dirk Schnabel  4 , Caroline Sert  5 , Valerie Perrot  5 , Mehul Dattani  6
Affiliations
Multicenter Study

Effectiveness and Overall Safety of NutropinAq® for Growth Hormone Deficiency and Other Paediatric Growth Hormone Disorders: Completion of the International Cooperative Growth Study, NutropinAq® European Registry (iNCGS)

Regis Coutant et al. Front Endocrinol (Lausanne). .

Abstract

Objective: The International Cooperative Growth Study, NutropinAq® European Registry (iNCGS) (NCT00455728) monitored long-term safety and effectiveness of recombinant human growth hormone (rhGH; NutropinAq® [somatropin]) in paediatric growth disorders.

Methods: Open-label, non-interventional, post-marketing surveillance study recruiting children with growth disorders. Endpoints included gain in height standard deviation score (SDS), adult height, and occurrence of adverse events (AEs).

Results: 2792 patients were enrolled. 2082 patients (74.6%) had growth hormone deficiency (GHD), which was isolated idiopathic in 1825 patients (87.7%). Non-GHD diagnoses included Turner syndrome (TS) (n=199), chronic renal insufficiency (CRI) (n=10), other non-GHD (n=498), and missing data for three participants. Improvements from baseline height SDS occurred at all time points to Month 132, and in all subgroups by disease aetiology. At Month 12, mean (95% CI) change in height SDS by aetiology was: idiopathic GHD 0.63 (0.61;0.66), organic GHD 0.71 (0.62;0.80), TS 0.59 (0.53; 0.65), CRI 0.54 (-0.49;1.56), and other non-GHD 0.64 (0.59;0.69). Mean height ( ± SD) at the last visit among the 235 patients with adult or near-adult height recorded was 154.0 cm ( ± 8.0) for girls and 166.7 cm ( ± 8.0) for boys. The most frequent biological and clinical non-serious drug-related AEs were increased insulin-like growth factor concentrations (314 events) and injection site haematoma (99 events). Serious AEs related to rhGH according to investigators were reported (n=30); the most frequent were scoliosis (4 events), epiphysiolysis (3 events), and strabismus (2 events).

Conclusions: There was an improvement in mean height SDS in all aetiology subgroups after rhGH treatment. No new safety concerns were identified.

Keywords: NutropinAq® (somatropin); growth hormone deficiency; paediatric GH disorders; rhGH, recombinant human GH; safety.

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Conflict of interest statement

RC received honoraria for lectures and for the scientific organization of meetings from Sandoz, Ipsen, Novo Nordisk, Lilly, and Pfizer. JB-M received honoraria for lectures from Lilly, Merck Ferring, Sandoz and Ipsen and participated in Ipsen advisory board. DS served in advisory boards for Kyowa Kirin, Ipsen, Merck Serono, Novo Nordisk; received honoraria for lectures and for the scientific organization of meetings from, Hexal/Sandoz Ipsen, Merck Serono, Novo Nordisk and Pfizer; and received research grants from Hexal/Sandoz, Kyowa Kirin and Pfizer. MD received honoraria for lectures and for the scientific organization of meetings from Sandoz, Ipsen, Novo Nordisk and Pfizer. CS and VP are employees of Ipsen. The authors declare that this study received funding from Ipsen. The funder contributed to study design, data collection and analysis, decision to publish, and funded editorial support for preparation of the manuscript. The authors take full responsibility for the entire content of this submitted manuscript and approved submission. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
International Cooperative Growth Study, NutropinAq® European Registry participant flow chart.
Figure 2
Figure 2
Evolution of height SDS from baseline to month 132 – Registry population (n=2714).
Figure 3
Figure 3
Change in height SDS from baseline in treatment-naïve patients over 48 months, according to disease aetiology – Registry population (n=2314).
See this image and copyright information in PMC

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