This interim analysis of the first 100 patients receiving long-acting growth hormone therapy in the INSIGHTS-GHT registry provides early real-world evidence on patient selection and physician preferences, finding that a majority of pediatric patients received starting doses below manufacturer recommendations and about half were switch patients from daily therapy.
Key Findings
Methods
The INSIGHTS-GHT registry enrolled 70 pediatric patients from 15 German centers and 31 adult patients from 6 German centers receiving long-acting growth hormone (LAGH) therapy.
INSIGHTS-GHT is described as the first product-independent registry to document real-world use of recombinant human growth hormone replacement therapy within the labelling.
Three LAGH products were available following market launch in Germany: lonapegsomatropin, somapacitan, and somatrogon.
This report represents an interim analysis of the registry.
Results
The majority of pediatric patients receiving LAGH therapy were male, with a mean age of 9.2 years at LAGH initiation.
76% of pediatric patients were male.
Mean age at LAGH initiation was 9.2 years.
About half of the pediatric patients (54%) were switch patients transitioning from daily GH therapy.
Before start of GH therapy, mean IGF-I (SDS) was -2.1 ± 1.1 SDS and mean IGFBP-3 (SDS) was -2.0 ± 1.5 SDS.
Results
The majority of pediatric patients received a LAGH starting dose below the manufacturer's recommendation.
82% of pediatric patients received a LAGH starting dose below the manufacturer's recommendation.
The median dose administered was 92% of the recommended level.
Results
All adult patients switched from daily GH therapy to LAGH, with over half receiving the manufacturer's recommended starting dose.
100% of adult patients were switch patients transitioning from daily GH therapy.
65% of adult patients were male, with a mean age of 38.2 years at LAGH initiation.
More than half (55%) received the LAGH starting dose according to the manufacturer's recommendation.
41% of adult patients began with a lower-than-recommended dose.
Conclusions
The registry findings highlight the need for continued follow-up to evaluate long-term efficacy, adherence, and safety of LAGH therapy in real-world settings.
The development of LAGH formulations is described as offering a promising approach to reduce injection frequency and improve adherence in growth hormone deficiency treatment.
The authors note that this interim analysis provides only an 'initial picture on patient selection and physician preferences outside of clinical trials.'
Continued follow-up is identified as necessary to evaluate long-term outcomes.