Real-World Treatment Patterns and Outcomes of Growth Hormone Treatment Among Children in Israel Over the Past Decade (2004–2015)

Ben-Ari, Tal; Chodick, Gabriel; Shalev, Varda; Goldstein, Dalit; Gomez, Roy; Landau, Zohar

doi:10.3389/fped.2021.711979

Cited by 9 publications

(11 citation statements)

References 38 publications

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“…If GH treatment had been continued for more than 3 years, the height SDS at the 3 rd year increased by 1.46 compared to baseline in both boys and girls (height SDS, boys: −2.48–−1.02, girls: −2.58–−1.12). These results were consistent with those of previous studies in which the height SDS increased by 0.40 to 0.57 from 6 months to the 1 st year after GH treatment and by 0.96–1.05 at the 3 rd year ( 4 , 5 , 30 – 32 ).…”

Section: Discussionsupporting

confidence: 93%

“…When considering both GH dose and the efficacy results comprehensively, GH treatment efficacy in this study was enough compared with that of previous studies, although the average GH dose in this study was lower than the recommended GH treatment dose. This revealed that the GH dose administered in a Korean clinical setting is lower than the recommended dose ( 29 , 30 , 33 , 34 ) and that effective treatment is possible even without prescribing a high dose of GH to children with ISS. Although the dose initially approved in Korea (0.067 mg/kg/day, 0.37 mg/kg/week, 0.40 mg/kg/week) is lower that the dose recommended in international guidelines (0.47 mg/kg/week), the phenomenon of administering less than the approved dose for patients with ISS was also seen in previous Korean studies by Nam HK et al in 2019 and Jeong HR et al in 2014, which showed significantly improved growth outcomes even with low doses ( 35 – 40 ).…”

Section: Discussionmentioning

confidence: 99%

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Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

et al. 2022

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ObjectivesGrowth hormone (GH) therapy’s capacity to increase height velocity and height at the end of the study in children with idiopathic short stature (ISS) is controversial. We aimed to investigate the height standard deviation score (SDS) and height velocity of patients with ISS in Korea who received GH treatment.MethodsWe retrospectively reviewed and performed linear mixed model and survival analyses on data from 12 tertiary hospitals in Korea, including subjects diagnosed with ISS from January 2009 to September 2019, treated with GH therapy for more than 6 months, and who were at a pre-pubertal state at the time of diagnosis.ResultsWe included 578 children (330 boys and 248 girls). The mean daily dose of GH in this study was 0.051 mg/kg, which was lower than the approved dose in Korea of 0.062 - 0.067 mg/kg. Height SDS was higher in patients who started treatment before the age of 6 years. The probability of reaching the target SDS (-1 SDS) from the beginning of treatment to 2–3 years after its start was higher in children starting treatment before the age of 6 years. The hazard ratio to reach the target SDS (-1 SDS) when using automatic pen or electronic devices was 1.727 times higher than that when using the needle and syringe device.ConclusionISS patients should start GH treatment at an early age, and even lower-than-recommended drug doses may be effective. The selection of automatic pen or electronic device can have a positive effect on reaching the target height SDS.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionmentioning

confidence: 99%

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

et al. 2022

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“…21,23,24 The main indications for treatment in our study were ISS and GH deficiency, similar to a previous cohort study from Israel, comprising 2379 children. 25 Univariate analysis of our rhGH treatment group demonstrated that male gender, older age at initiation of rhGH treatment and high SES were associated with increased risks for scoliosis. The higher SES may be explained by a bias resulting from differences in seeking medical evaluation and treatment behaviours according to SES.…”

Section: Discussionmentioning

confidence: 84%

Growth hormone treatment and the risk of adolescent scoliosis: A large matched cohort study

et al. 2023

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Aim:We aimed to evaluate the risk of developing adolescent scoliosis among recipients of recombinant human growth hormone (rhGH).Methods: This registry-based cohort study included 1314 individuals who initiated rhGH treatment since 2013, treated during 10-18 years of age for at least 6 months. This group was matched to a comparison group of 6570 individuals not treated with rhGH. Demographic and clinical information was extracted from the electronic database. The results are presented using hazard ratios (HR) and 95% confidence intervals (CI).Results: During a median follow-up of 4.2 years, 59 (4.5%) rhGH recipients and 141 individuals (2.1%) from the comparison group were diagnosed with adolescent scoliosis. The age at diagnosis did not differ between the groups (14.7 versus 14.3 years, p = 0.095). Patients treated with rhGH were more likely diagnosed with scoliosis (HR 2.12, 95% CI 1.55-2.88, p < 0.001). Among males, the risk was about three times greater in the treated versus the comparison group (HR 3.15, 95% CI 2.12-4.68, p < 0.001), while in females the risk was not increased (HR 1.12, 95% CI 0.72-2.04, p = 0.469). Conclusions:Recombinant human growth hormone treatment was associated with an increased risk to be diagnosed with adolescent scoliosis in males. Scoliosis development should be monitored appropriately in rhGH recipients. K E Y W O R D S adolescents, recombinant human growth hormone, scoliosis, side effects 1 | INTRODUC TI ON Scoliosis, a three-dimensional spinal deformity, is the most common spinal disorder in children and adolescents. It is defined as a lateral curvature of the spine that is 10° or greater, according to measurement by the Cobb angle. In paediatric patients, scoliosis can be classified by aetiology into congenital, neuromuscular, syndrome-related and idiopathic. Idiopathic

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“…Persistence studied using the Easypod autoinjector found median persistence with treatment to be 2.1 years ( 11 ). A retrospective database study of children initiating GH treatment in Israel found mean persistence of 3.6 ± 1.6 years, and 3.7% of children discontinued (gap of 365 years without treatment) ( 12 ). A recent US-based study found that 42.2% of pGHD children discontinued somatropin therapy (gap of >60 days without treatment) within 48 months of follow-up ( 13 ).…”

Section: Discussionmentioning

confidence: 99%

Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in the UK

Loftus

Wogen²,

Oliveri³

et al. 2022

Front. Endocrinol.

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BackgroundChildren with growth hormone deficiency (GHD) are treated with daily somatropin injections; however, poor treatment persistence and adherence have been recognized previously and have been shown to negatively impact growth outcomes. A recent real-world study of a US pediatric GHD population found that a substantial proportion of children discontinued somatropin therapy, but similar data for a real-world UK population are lacking.ObjectivesTo describe the discontinuation of, and persistence with, daily somatropin treatment among children with GHD in the UK.MethodsThis was a retrospective cohort study of children (≥3 and <16 years old) with ≥1 medication prescription for daily injectable somatropin from 1 July 2000 to 31 December 2020 in the IQVIA Medical Research DATA (IMRD) database. Early persistence was defined as the proportion of children prescribed ≥1 somatropin refill (≥2 prescriptions). Discontinuation was defined as the first date at which a medication gap for somatropin (of >60 or >90 days between prescriptions) occurred. Kaplan–Meier methods were used to evaluate persistence (non-discontinuation) over time to assess time to first discontinuation event. Cox proportional hazards models were used to evaluate the relationship between patient characteristics and time to medication discontinuation.ResultsAmong the cohort identified in this study (n = 117), the majority (n = 84, 71.8%) had 48 months of available follow-up; 56.4% were boys and the mean (median) age was 8.6 (8.0) years. About 98% exhibited early persistence, but persistence over the follow-up period decreased with follow-up duration. Using the conservative 90-day gap definition of persistence, an estimated 72.4%, 52.8%, and 43.3% were persistent at 12, 36, and 48 months. Lower persistence rates were observed using the 60-day definition. No significant patient predictors of time to discontinuation were identified.ConclusionsDespite high early persistence with somatropin, a high percentage of children with GHD were increasingly non-persistent over time. More than 1 in 4 were non-persistent at 12 months and more than 1 in 2 were non-persistent at 48 months of follow-up. These results suggest that strategies to support improved medication-taking behavior among children with GHD in the UK are warranted.

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Real-World Treatment Patterns and Outcomes of Growth Hormone Treatment Among Children in Israel Over the Past Decade (2004–2015)

Cited by 9 publications

References 38 publications

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

Height outcomes in Korean children with idiopathic short stature receiving growth hormone treatment

Growth hormone treatment and the risk of adolescent scoliosis: A large matched cohort study

Persistence with daily growth hormone among children and adolescents with growth hormone deficiency in the UK

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