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PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study

BACKGROUND: Somatrogon is a long-acting recombinant human growth hormone (hGH) currently being developed as a once-weekly subcutaneous injectable treatment for pediatric patients with growth hormone deficiency (GHD). A recent global Phase 3 study compared the efficacy and safety of somatrogon admini...

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Autores principales: Gomez, Roy, Loftus, Jane, Yaworsky, Andrew, Lamoureux, Roger, Polak, Michel, Maghnie, Mohamad, Miller, Bradley S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9625705/
http://dx.doi.org/10.1210/jendso/bvac150.1303
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author Gomez, Roy
Loftus, Jane
Yaworsky, Andrew
Lamoureux, Roger
Polak, Michel
Maghnie, Mohamad
Miller, Bradley S
author_facet Gomez, Roy
Loftus, Jane
Yaworsky, Andrew
Lamoureux, Roger
Polak, Michel
Maghnie, Mohamad
Miller, Bradley S
author_sort Gomez, Roy
collection PubMed
description BACKGROUND: Somatrogon is a long-acting recombinant human growth hormone (hGH) currently being developed as a once-weekly subcutaneous injectable treatment for pediatric patients with growth hormone deficiency (GHD). A recent global Phase 3 study compared the efficacy and safety of somatrogon administered once weekly with Genotropin administered once daily in pediatric patients with GHD (ClinicalTrials.gov: NCT02968004). AIMS: To understand and describe physicians’ experiences using once-weekly somatrogon injections compared with once-daily hGH injections during the Phase 3 study. METHODS: In this quantitative, cross-sectional, observational study, a 14-item multiple choice questionnaire was administered to physicians who were clinical investigators in the Phase 3 study. The questionnaire was designed to assess physicians’ experiences, preferences and satisfaction regarding the use of the once-weekly somatrogon regimen compared with the standard once-daily hGH injection regimen. Survey results were analyzed quantitatively using descriptive statistics. RESULTS: A total of 24 physicians who were part of the global Phase 3 study (mean age [SD]: 58.5 [10.1] years; 10 males, 14 females) in 12 different countries completed the on-line survey. Compared with daily injections, most physicians preferred somatrogon (n=18, 75.0%) and reported that somatrogon was more convenient (n=19, 79.2%), less burdensome (n=19, 79.2%) and that they would be more likely to prescribe somatrogon to patients in the future (n=20, 83.3%). In terms of being more likely to support positive long-term growth outcomes, 37.5% (n=9) of physicians selected somatrogon; the remaining physicians (n=15, 62.5%) reported no difference between treatments. The proportion of physicians who were satisfied or very satisfied with somatrogon was 95.8% (n=23), compared with 87.5% (n=21) for daily hGH injections. Most physicians (n=15, 62.5%) reported that daily hGH injections required more effort/much more effort to monitor adherence, compared with somatrogon. Some physicians (n=7, 29.2%) reported that explaining the device instructions to patient/caregivers required more/much more effort for somatrogon compared with daily hGH injections; more than half (n=14, 58.3%) reported no difference in effort required for either regimen. Physicians were divided as to which treatment needed more/much more effort to: (i) explain the injection regimen (n=7 [29.2%] daily injection; n=7 [29.2%] no difference; n=10 [41.7%] somatrogon), (ii) explain what to do if an injection is missed (n=7 [29.2%] daily injection; n=9 [37.5%] no difference; n=8 [33.3%] somatrogon), and (iii) address patient/caregiver questions (n=8 [33.3%] daily injection; n=11 [45.8%] no difference; n=5 [20.8%] somatrogon). CONCLUSIONS: Overall, physicians from the global Phase 3 study were positive about their experience using somatrogon for the treatment of children with GHD. Physicians generally preferred the once-weekly somatrogon injection regimen, with most physicians reporting somatrogon to be more convenient and less burdensome to patients, indicating that they would be more likely to prescribe somatrogon to their patients in the future. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.
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spelling pubmed-96257052022-11-14 PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study Gomez, Roy Loftus, Jane Yaworsky, Andrew Lamoureux, Roger Polak, Michel Maghnie, Mohamad Miller, Bradley S J Endocr Soc Pediatric Endocrinology BACKGROUND: Somatrogon is a long-acting recombinant human growth hormone (hGH) currently being developed as a once-weekly subcutaneous injectable treatment for pediatric patients with growth hormone deficiency (GHD). A recent global Phase 3 study compared the efficacy and safety of somatrogon administered once weekly with Genotropin administered once daily in pediatric patients with GHD (ClinicalTrials.gov: NCT02968004). AIMS: To understand and describe physicians’ experiences using once-weekly somatrogon injections compared with once-daily hGH injections during the Phase 3 study. METHODS: In this quantitative, cross-sectional, observational study, a 14-item multiple choice questionnaire was administered to physicians who were clinical investigators in the Phase 3 study. The questionnaire was designed to assess physicians’ experiences, preferences and satisfaction regarding the use of the once-weekly somatrogon regimen compared with the standard once-daily hGH injection regimen. Survey results were analyzed quantitatively using descriptive statistics. RESULTS: A total of 24 physicians who were part of the global Phase 3 study (mean age [SD]: 58.5 [10.1] years; 10 males, 14 females) in 12 different countries completed the on-line survey. Compared with daily injections, most physicians preferred somatrogon (n=18, 75.0%) and reported that somatrogon was more convenient (n=19, 79.2%), less burdensome (n=19, 79.2%) and that they would be more likely to prescribe somatrogon to patients in the future (n=20, 83.3%). In terms of being more likely to support positive long-term growth outcomes, 37.5% (n=9) of physicians selected somatrogon; the remaining physicians (n=15, 62.5%) reported no difference between treatments. The proportion of physicians who were satisfied or very satisfied with somatrogon was 95.8% (n=23), compared with 87.5% (n=21) for daily hGH injections. Most physicians (n=15, 62.5%) reported that daily hGH injections required more effort/much more effort to monitor adherence, compared with somatrogon. Some physicians (n=7, 29.2%) reported that explaining the device instructions to patient/caregivers required more/much more effort for somatrogon compared with daily hGH injections; more than half (n=14, 58.3%) reported no difference in effort required for either regimen. Physicians were divided as to which treatment needed more/much more effort to: (i) explain the injection regimen (n=7 [29.2%] daily injection; n=7 [29.2%] no difference; n=10 [41.7%] somatrogon), (ii) explain what to do if an injection is missed (n=7 [29.2%] daily injection; n=9 [37.5%] no difference; n=8 [33.3%] somatrogon), and (iii) address patient/caregiver questions (n=8 [33.3%] daily injection; n=11 [45.8%] no difference; n=5 [20.8%] somatrogon). CONCLUSIONS: Overall, physicians from the global Phase 3 study were positive about their experience using somatrogon for the treatment of children with GHD. Physicians generally preferred the once-weekly somatrogon injection regimen, with most physicians reporting somatrogon to be more convenient and less burdensome to patients, indicating that they would be more likely to prescribe somatrogon to their patients in the future. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m. Oxford University Press 2022-11-01 /pmc/articles/PMC9625705/ http://dx.doi.org/10.1210/jendso/bvac150.1303 Text en © The Author(s) 2022. Published by Oxford University Press on behalf of the Endocrine Society. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (https://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Pediatric Endocrinology
Gomez, Roy
Loftus, Jane
Yaworsky, Andrew
Lamoureux, Roger
Polak, Michel
Maghnie, Mohamad
Miller, Bradley S
PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title_full PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title_fullStr PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title_full_unstemmed PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title_short PMON329 Survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
title_sort pmon329 survey of physician experience with once weekly somatrogon vs once daily somatropin regimen for the treatment of pediatric patients with growth hormone deficiency: results from a cross sectional, observational study
topic Pediatric Endocrinology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9625705/
http://dx.doi.org/10.1210/jendso/bvac150.1303
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