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Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial
BACKGROUND/OBJECTIVE: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab can...
Autores principales: | , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9245232/ https://www.ncbi.nlm.nih.gov/pubmed/35773713 http://dx.doi.org/10.1186/s13075-022-02840-8 |
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author | Jamshidi, Ahmadreza Vojdanian, Mahdi Soroush, Mohsen Akbarian, Mahmoud Aghaei, Mehrdad Hajiabbasi, Asghar Mirfeizi, Zahra Khabbazi, Alireza Alishiri, Gholamhosein Haghighi, Anousheh Salimzadeh, Ahmad Karimzadeh, Hadi Shirani, Fatemeh Fard, Mohammad Reza Hatef Nazarinia, MohammadAli Soroosh, Soosan Anjidani, Nassim Gharibdoost, Farhad |
author_facet | Jamshidi, Ahmadreza Vojdanian, Mahdi Soroush, Mohsen Akbarian, Mahmoud Aghaei, Mehrdad Hajiabbasi, Asghar Mirfeizi, Zahra Khabbazi, Alireza Alishiri, Gholamhosein Haghighi, Anousheh Salimzadeh, Ahmad Karimzadeh, Hadi Shirani, Fatemeh Fard, Mohammad Reza Hatef Nazarinia, MohammadAli Soroosh, Soosan Anjidani, Nassim Gharibdoost, Farhad |
author_sort | Jamshidi, Ahmadreza |
collection | PubMed |
description | BACKGROUND/OBJECTIVE: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients. METHODS: In this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L(1)-L(4)), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs). RESULTS: A total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of − 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [− 1.34 to 2.11], 0.04 [− 1.61 to 1.69], and 0.41 [− 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs. CONCLUSION: The efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03293108; Registration date: 2017–09-19. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13075-022-02840-8. |
format | Online Article Text |
id | pubmed-9245232 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-92452322022-07-01 Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial Jamshidi, Ahmadreza Vojdanian, Mahdi Soroush, Mohsen Akbarian, Mahmoud Aghaei, Mehrdad Hajiabbasi, Asghar Mirfeizi, Zahra Khabbazi, Alireza Alishiri, Gholamhosein Haghighi, Anousheh Salimzadeh, Ahmad Karimzadeh, Hadi Shirani, Fatemeh Fard, Mohammad Reza Hatef Nazarinia, MohammadAli Soroosh, Soosan Anjidani, Nassim Gharibdoost, Farhad Arthritis Res Ther Research BACKGROUND/OBJECTIVE: Osteoporosis is a global health concern with an increasing prevalence worldwide. Denosumab is an antiresoptive agent that has been demonstrated to be effective and safe in osteoporotic patients. This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients. METHODS: In this randomized, double-blind, active-controlled, noninferiority trial, postmenopausal osteoporotic patients received 60 mg of subcutaneous Arylia or Prolia® at months 0, 6, and 12 and were followed up for 18 months. The primary endpoint was the noninferiority of the biosimilar product to the reference product in the percentage change of bone mineral density (BMD) in 18 months at the lumbar spine (L(1)-L(4)), total hip, and femoral neck. The secondary endpoints were safety assessment, the incidence of new vertebral fractures, and the trend of bone turnover markers (BTMs). RESULTS: A total of 190 patients were randomized to receive either biosimilar (n = 95) or reference (n = 95) denosumab. In the per-protocol (PP) analysis, the lower limits of the 95% two-sided confidence intervals of the difference between Arylia and Prolia® in increasing BMD were greater than the predetermined noninferiority margin of − 1.78 at the lumbar spine, total hip, and femoral neck sites (mean differences [95% CIs] of 0.39 [− 1.34 to 2.11], 0.04 [− 1.61 to 1.69], and 0.41 [− 1.58 to 2.40], respectively). The two products were also comparable in terms of safety, new vertebral fractures, and trend of BTMs. CONCLUSION: The efficacy of the biosimilar denosumab was shown to be noninferior to that of the reference denosumab, with a comparable safety profile at 18 months. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03293108; Registration date: 2017–09-19. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13075-022-02840-8. BioMed Central 2022-06-30 2022 /pmc/articles/PMC9245232/ /pubmed/35773713 http://dx.doi.org/10.1186/s13075-022-02840-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Jamshidi, Ahmadreza Vojdanian, Mahdi Soroush, Mohsen Akbarian, Mahmoud Aghaei, Mehrdad Hajiabbasi, Asghar Mirfeizi, Zahra Khabbazi, Alireza Alishiri, Gholamhosein Haghighi, Anousheh Salimzadeh, Ahmad Karimzadeh, Hadi Shirani, Fatemeh Fard, Mohammad Reza Hatef Nazarinia, MohammadAli Soroosh, Soosan Anjidani, Nassim Gharibdoost, Farhad Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title | Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title_full | Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title_fullStr | Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title_full_unstemmed | Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title_short | Efficacy and safety of the biosimilar denosumab candidate (Arylia) compared to the reference product (Prolia®) in postmenopausal osteoporosis: a phase III, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
title_sort | efficacy and safety of the biosimilar denosumab candidate (arylia) compared to the reference product (prolia®) in postmenopausal osteoporosis: a phase iii, randomized, two-armed, double-blind, parallel, active-controlled, and noninferiority clinical trial |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9245232/ https://www.ncbi.nlm.nih.gov/pubmed/35773713 http://dx.doi.org/10.1186/s13075-022-02840-8 |
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