TY - JOUR
T1 - Adherence and growth outcomes in children with growth disorders
T2 - results from the Easypod™ Connect Observational Study (ECOS) in Indonesia, Singapore, and Taiwan
AU - Pulungan, Aman Bhakti
AU - Yap, Fabian
AU - Chao, Mei Chyn
AU - Loke, Kah Yin
AU - Yang, Chen
AU - Ma, Tianrong
AU - Ovbude, Leroy
AU - Su, Pen Hua
N1 - Funding Information:
ECOS was funded by Merck KGaA, Darmstadt, Germany.
Funding Information:
The authors would like to thank Dr. Peter Bates, Cambridge Medical Writing Services, UK, for medical writing assistance, funded by Merck Serono PTE Ltd, Singapore.
Publisher Copyright:
© 2022, Indonesian Pediatric Society Publishing House. All rights reserved.
PY - 2022/3
Y1 - 2022/3
N2 - Background Non-objective assessments indicate poor patient adherence to growth hormone (GH) prescribed for growth failure, with sub-optimal growth response. The easypod™ connect device for GH administration enables real-time, objective assessment of adherence. Objective To examine adherence with pediatric GH therapy in Asia-Pacific countries and relationship with growth outcomes. Methods Subjects were children in Indonesia, Singapore, Taiwan enrolled in the multi-national, open-label Easypod Connect Observational Study (ECOS). Adherence during follow-up was the primary endpoint and a relationship with 1-year growth outcomes was assessed by Spearman’s product-moment correlations. Results Over a 1-year time frame, median overall patient adherence was ≥89%; rates were similar for children with GH deficiency (GHD; n=17) and those born small-for-gestational age (SGA; n=5), except that median adherence dropped between 9 months (94%) and 1 year (83%) for SGA subjects. Median initial GH dose was 42.3 µg/kg/day for GHD subjects and 31.4 µg/kg/day for SGA subjects. Median age (12 years) and bone age (13 years) indicated that most children had entered puberty at treatment onset. Clinically meaningful improvements in growth were observed at 1 year in the GHD group, but not the SGA group. Statistically significant correlations between adherence and height change (P=0.039) as well as height velocity (P=0.004) were observed. Conclusions Children in Asia-Pacific countries show high adherence over the first year of GH therapy with easypod. The easypod study also shows that adherence is correlated to good growth outcomes.
AB - Background Non-objective assessments indicate poor patient adherence to growth hormone (GH) prescribed for growth failure, with sub-optimal growth response. The easypod™ connect device for GH administration enables real-time, objective assessment of adherence. Objective To examine adherence with pediatric GH therapy in Asia-Pacific countries and relationship with growth outcomes. Methods Subjects were children in Indonesia, Singapore, Taiwan enrolled in the multi-national, open-label Easypod Connect Observational Study (ECOS). Adherence during follow-up was the primary endpoint and a relationship with 1-year growth outcomes was assessed by Spearman’s product-moment correlations. Results Over a 1-year time frame, median overall patient adherence was ≥89%; rates were similar for children with GH deficiency (GHD; n=17) and those born small-for-gestational age (SGA; n=5), except that median adherence dropped between 9 months (94%) and 1 year (83%) for SGA subjects. Median initial GH dose was 42.3 µg/kg/day for GHD subjects and 31.4 µg/kg/day for SGA subjects. Median age (12 years) and bone age (13 years) indicated that most children had entered puberty at treatment onset. Clinically meaningful improvements in growth were observed at 1 year in the GHD group, but not the SGA group. Statistically significant correlations between adherence and height change (P=0.039) as well as height velocity (P=0.004) were observed. Conclusions Children in Asia-Pacific countries show high adherence over the first year of GH therapy with easypod. The easypod study also shows that adherence is correlated to good growth outcomes.
KW - easypod connect
KW - growth hormone deficiency
KW - growth outcomes
KW - pediatric GH therapy adherence
KW - small for gestational age
UR - http://www.scopus.com/inward/record.url?scp=85129653957&partnerID=8YFLogxK
U2 - 10.14238/pi62.2.2022.79-85
DO - 10.14238/pi62.2.2022.79-85
M3 - Article
AN - SCOPUS:85129653957
SN - 0030-9311
VL - 62
SP - 79
EP - 85
JO - Paediatrica Indonesiana(Paediatrica Indonesiana)
JF - Paediatrica Indonesiana(Paediatrica Indonesiana)
IS - 2
ER -