Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial

Maniatis, Aristides K; Nadgir, Ulhas M; Saenger, Paul; Reifschneider, Kent; Abuzzahab, Jennifer; Deeb, Larry C.; Fox, Larry A.; Woods, Katie A.; Song, Wenjie; Mao, Meng; Chessler, Steven; Komirenko, Allison; Shu, Aimee D; Casella, Samuel J.; Thornton, Paul

doi:10.1159/000524003

Cited by 8 publications

(11 citation statements)

References 32 publications

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“…Switching to weekly LAGH from daily rhGH is well tolerated and maintains the known high safety profile of daily rhGH, 33 as shown in a recently published study.…”

Section: Discussionmentioning

confidence: 65%

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Long‐acting growth hormone in 2022

Steiner¹,

Frank²,

Saenger³

2023

Pediatric Investigation

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After the isolation of pituitary growth hormone (GH) in 1957, this form of GH, always in limited supply, was the only drug available for the treatment of GH deficiency. In 1985, recombinant GH became available, and the modalities of GH therapies changed dramatically as the supply was unlimited. New indications for GH in pediatrics and adult medicine were developed. Treatment was daily. Now in 2021 long‐acting GH (LAGH) became available the world over making GH therapy more patient‐friendly and even showing slightly greater efficacy than daily GH therapy. We are now entering a new era of LAGH therapy for pediatric and adult use with new formulations of GH, which will predictably be the preferred form of GH therapy for years to come increasing adherence to GH therapy and possibly even efficacy, that is, better growth rate. The continued availability of new safety data will further solidify the use of LAGH in clinical medicine.

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“…Switching to weekly LAGH from daily rhGH is well tolerated and maintains the known high safety profile of daily rhGH, 33 as shown in a recently published study.…”

Section: Discussionmentioning

confidence: 65%

“…Only a low incidence of GHbinding antibodies but no neutralizing antibodies were observed following lonapegsomatropin treatment. 14 Switching to weekly LAGH from daily rhGH is well tolerated and maintains the known high safety profile of daily rhGH, 33 as shown in a recently published study.…”

Section: Discussionmentioning

confidence: 79%

Long‐acting growth hormone in 2022

Steiner¹,

Frank²,

Saenger³

2023

Pediatric Investigation

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“…Although no published data have emerged on the impact of LAGH on adherence from real-world use, a recently published clinical trial demonstrated that treatment burden, as evaluated by life interference, was significantly reduced when patients were treated with somatrogon once weekly compared to once daily Genotropin, and the overall treatment experience for somatrogon was preferred by patients and caregivers ( 19 ). Another recent study found a preference for LAGH and reduced treatment burden in patients that switched from daily somatropin to weekly lonapegsomatropin ( 20 ). A reduced treatment burden and preference for a LAGH should translate into improved adherence and outcomes in the real world; prospective real-world studies which have recently been initiated will aim to evaluate this ( 21 , 22 ).…”

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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“…Children receiving lonapegsomatropin in the extension portions of the phase III trials have continued to show efficacy and safety (13)(14)(15). After completion of the 12 month pivotal randomized trial comparing lonapegsomatropin to DGH (heiGHt) or completion of the 6 month switch trial (fliGHt), children were able to enroll in the enliGHten extension study.…”

Section: Lonapegsomatropinmentioning

confidence: 99%

“…In the phase III fliGHt switch trial, the average IGF-I obtained five days after lonapegsomatropin injection was +1.6 SDS. For subjects who had IGF-I values ≤2 SDS at entry into the fliGHt trial (already receiving DGH therapy), 31.2% of children had IGF-I values five days after lonapegsomatropin injection >+2 SDS at 26 weeks ( 14 ). In the most recently available data for the enliGHten trial, at 130 weeks children had an average IGF-I value five days after lonapegsomatropin injection of +1.46 SDS ( 15 ).…”

Section: Introductionmentioning

confidence: 99%

What do we do now that the long-acting growth hormone is here?

Miller

2022

Front. Endocrinol.

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In standard 52-week phase III clinical trials, once weekly lonapegsomatropin, somatrogon and somapacitan have been found to yield non-inferior height velocities and similar safety profiles to daily GH (DGH) in children with pediatric growth hormone deficiency (PGHD).Lonapegsomatropin, a long-acting GH therapy (LAGH), was approved by the United States Food and Drug Administration (FDA) in August 2021 for the treatment of PGHD and has also been approved in other regions of the world. Somatrogon was approved for the treatment of PGHD beginning in some regions beginning in late 2021. Somapacitan was approved by the FDA for the treatment of Adult GHD in August 2020. The phase III clinical trial of somapacitan for the treatment of PGHD has been completed and demonstrated non-inferiority of somapacitan to DGH.New LAGH products may improve patient adherence, quality of life and clinical outcomes, particularly in patients with poor adherence to daily GH injections in the future. With the availability of new LAGH products, clinicians will need to identify the best candidates for LAGH therapy and understand how to monitor and adjust therapy. Long-term surveillance studies are needed to demonstrate adherence, efficacy, cost-effectiveness and safety of LAGH preparations and to understand how the non-physiological pharmacokinetic and pharmacodynamic profiles following administration of each LAGH product relate to short- and long-term safety and efficacy of LAGH therapy.

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Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial

Cited by 8 publications

References 32 publications

Long‐acting growth hormone in 2022

Long‐acting growth hormone in 2022

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

What do we do now that the long-acting growth hormone is here?

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