SB16 versus reference denosumab in postmenopausal women with
osteoporosis: 18-month outcomes of a phase III randomized
clinical trial

J 2025

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial

CHUNG, Yoon-Sok; Bente LANGDAHL; Rafal PLEBANSKI; Edward CZERWINSKI; Eva DOKOUPILOVÁ et al.

Základní údaje

Originální název

SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial

Autoři

Vydání

Bone, NEW YORK, Elsevier, 2025, 8756-3282

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30100 3.1 Basic medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 3.600 v roce 2024

Označené pro přenos do RIV

Ano

Kód RIV

RIV/00216224:14160/25:00143965

Organizační jednotka

Farmaceutická fakulta

Klíčová slova anglicky

Biosimilar; Bone mineral density; Denosumab; Clinical trials; Postmenopausal osteoporosis; SB16

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 13. 3. 2026 17:16, Mgr. Irena Doubková

Anotace

V originále

Purpose: This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16. Methods: 457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period. Results: Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.

Citovat

CHUNG, Yoon-Sok; Bente LANGDAHL; Rafal PLEBANSKI; Edward CZERWINSKI; Eva DOKOUPILOVÁ; Jerzy SUPRONIK; Jan ROSA; Andrzej MYDLAK; Rafal SAPULA; Anna ROWINSKA-OSUCH; Ki-Hyun BAEK; Audrone URBONIENE; Robert MORDAKA; Sohui AHN; Young Hee RHO; Jisuk BAN a Richard EASTELL. SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial. Bone. NEW YORK: Elsevier, 2025, roč. 192, neuvedeno, s. 1-9. ISSN 8756-3282. Dostupné z: https://doi.org/10.1016/j.bone.2024.117371.

@article{2560242,
   author = {Chung, YoonandSok and Langdahl, Bente and Plebanski, Rafal and Czerwinski, Edward and Dokoupilová, Eva and Supronik, Jerzy and Rosa, Jan and Mydlak, Andrzej and Sapula, Rafal and RowinskaandOsuch, Anna and Baek, KiandHyun and Urboniene, Audrone and Mordaka, Robert and Ahn, Sohui and Rho, Young Hee and Ban, Jisuk and Eastell, Richard},
   article_location = {NEW YORK},
   article_number = {neuvedeno},
   doi = {https://doi.org/10.1016/j.bone.2024.117371},
   keywords = {Biosimilar; Bone mineral density; Denosumab; Clinical trials; Postmenopausal osteoporosis; SB16},
   language = {eng},
   issn = {8756-3282},
   journal = {Bone},
   title = {SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial},
   url = {https://www.sciencedirect.com/science/article/pii/S8756328224003600?pes=vor&utm_source=clarivate&getft_integrator=clarivate},
   volume = {192},
   year = {2025}
}

TY  - JOUR
ID  - 2560242
AU  - Chung, Yoon-Sok - Langdahl, Bente - Plebanski, Rafal - Czerwinski, Edward - Dokoupilová, Eva - Supronik, Jerzy - Rosa, Jan - Mydlak, Andrzej - Sapula, Rafal - Rowinska-Osuch, Anna - Baek, Ki-Hyun - Urboniene, Audrone - Mordaka, Robert - Ahn, Sohui - Rho, Young Hee - Ban, Jisuk - Eastell, Richard
PY  - 2025
TI  - SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial
JF  - Bone
VL  - 192
IS  - neuvedeno
SP  - 1-9
EP  - 1-9
PB  - Elsevier
SN  - 87563282
KW  - Biosimilar
KW  - Bone mineral density
KW  - Denosumab
KW  - Clinical trials
KW  - Postmenopausal osteoporosis
KW  - SB16
UR  - https://www.sciencedirect.com/science/article/pii/S8756328224003600?pes=vor&utm_source=clarivate&getft_integrator=clarivate
N2  - Purpose: This study evaluated the efficacy, safety, pharmacodynamics (PD), pharmacokinetics (PK), and immunogenicity of SB16 versus reference denosumab (DEN) up to 18 months in postmenopausal osteoporosis (PMO) patients, and assessed outcomes after switching from DEN to SB16 compared to those who continued with DEN or SB16. Methods: 457 PMO patients were initially randomized, with 407 re-randomized at Month 12 to either continue DEN (DEN+DEN), switch to SB16 (DEN+SB16), or continue SB16 (SB16 + SB16) through Month 18. Efficacy was assessed by the percent change from baseline in bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck. Safety, PD, PK, and immunogenicity were evaluated throughout the study period. Results: Mean percent changes from baseline in lumbar spine, total hip, and femoral neck BMD at Month 18 were comparable across treatment groups, indicating comparable efficacy between SB16 and DEN. The mean percent change in lumbar spine BMD was 6.8 % (SB16 + SB16), 6.2 % (DEN+SB16), and 6.8 % (DEN+DEN). Total hip BMD increased by 4.4 %, 3.5 %, and 4.0 %, and femoral neck BMD by 3.4 %, 3.1 %, and 2.7 % for SB16 + SB16, DEN+SB16, and DEN+DEN, respectively. Safety profiles were similar among groups, with no new safety concerns identified after switching. Only one patient in the DEN+SB16 group developed non-neutralizing anti-drug antibodies by Month 18, indicating a low immunogenicity risk for SB16.
ER  -

CHUNG, Yoon-Sok; Bente LANGDAHL; Rafal PLEBANSKI; Edward CZERWINSKI; Eva DOKOUPILOVÁ; Jerzy SUPRONIK; Jan ROSA; Andrzej MYDLAK; Rafal SAPULA; Anna ROWINSKA-OSUCH; Ki-Hyun BAEK; Audrone URBONIENE; Robert MORDAKA; Sohui AHN; Young Hee RHO; Jisuk BAN a Richard EASTELL. SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial. \textit{Bone}. NEW YORK: Elsevier, 2025, roč.~192, neuvedeno, s.~1-9. ISSN~8756-3282. Dostupné z: https://doi.org/10.1016/j.bone.2024.117371.

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