Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in
Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

J 2024

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

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

Základní údaje

Originální název

Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12

Autoři

Vydání

JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, WASHINGTON, ENDOCRINE SOC, 2024, 0021-972X

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30202 Endocrinology and metabolism

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Odkazy

URL

Impakt faktor

Impact factor: 5.100

Kód RIV

RIV/00216224:14160/24:00139084

Organizační jednotka

Farmaceutická fakulta

DOI

https://doi.org/10.1210/clinem/dgae611

UT WoS

001322022600001

Klíčová slova anglicky

menopause; metabolic bone disease; osteoporosis; clinical trials

Štítky

rivok, ÚFT

Příznaky

Mezinárodní význam, Recenzováno

Změněno: 17. 3. 2025 11:16, Ing. Richard Heger, Ph.D.

Anotace

V originále

Context SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).Objective This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).Design The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.Methods The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.Results The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.Conclusion The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.

Citovat

LANGDAHL, Bente; Yoon-Sok CHUNG; Rafal PLEBANSKI; Edward CZERWINSKI; Eva DOKOUPILOVÁ; Jerzy SUPRONIK; Jan ROSA; Andrzej MYDLAK; Anna ROWINSKA-OSUCH; Ki-Hyun BAEK; Audrone URBONIENE; Robert MORDAKA; Sohui AHN; Young Hee RHO; Jisuk BAN a Richard EASTELL. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM. WASHINGTON: ENDOCRINE SOC, 2024, Neuveden, Neuveden, s. 1-8. ISSN 0021-972X. Dostupné z: https://doi.org/10.1210/clinem/dgae611.

@article{2484661,
   author = {Langdahl, Bente and Chung, YoonandSok and Plebanski, Rafal and Czerwinski, Edward and Dokoupilová, Eva and Supronik, Jerzy and Rosa, Jan and Mydlak, Andrzej 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 = {WASHINGTON},
   article_number = {Neuveden},
   doi = {https://doi.org/10.1210/clinem/dgae611},
   keywords = {menopause; metabolic bone disease; osteoporosis; clinical trials},
   language = {eng},
   issn = {0021-972X},
   journal = {JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM},
   title = {Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12},
   url = {https://www.webofscience.com/wos/woscc/full-record/WOS:001322022600001},
   volume = {Neuveden},
   year = {2024}
}

TY  - JOUR
ID  - 2484661
AU  - Langdahl, Bente - Chung, Yoon-Sok - Plebanski, Rafal - Czerwinski, Edward - Dokoupilová, Eva - Supronik, Jerzy - Rosa, Jan - Mydlak, Andrzej - Rowinska-Osuch, Anna - Baek, Ki-Hyun - Urboniene, Audrone - Mordaka, Robert - Ahn, Sohui - Rho, Young Hee - Ban, Jisuk - Eastell, Richard
PY  - 2024
TI  - Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12
JF  - JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
VL  - Neuveden
IS  - Neuveden
SP  - 1-8
EP  - 1-8
PB  - ENDOCRINE SOC
SN  - 0021972X
KW  - menopause
KW  - metabolic bone disease
KW  - osteoporosis
KW  - clinical trials
UR  - https://www.webofscience.com/wos/woscc/full-record/WOS:001322022600001
N2  - Context SB16 is a proposed biosimilar to reference denosumab (DEN; brand name: Prolia).Objective This phase 3 randomized, double-blind, multicenter study evaluated the biosimilarity of SB16 to DEN in women with postmenopausal osteoporosis (NCT04664959).Design The study included 457 postmenopausal osteoporosis patients who had a lumbar spine or total hip T-score between -2.5 and -4. Patients were randomized in a 1:1 ratio to receive either 60 mg of SB16 or DEN subcutaneously at month 0 and month 6. At month 12, patients were rerandomized to continue with the assigned treatment or switch from DEN to SB16 up to month 18. This report includes results up to month 12.Methods The primary endpoint was the percent change from baseline in lumbar spine bone mineral density (BMD) at month 12. Secondary endpoints including the percent change from baseline in BMD of the lumbar spine (except for month 12), total hip, and femoral neck; pharmacokinetic, pharmacodynamic (serum C-telopeptide of type I collagen, and procollagen type I N-terminal propeptide), safety, and immunogenicity profiles were measured up to month 12.Results The least-squares mean differences in percent change from baseline in lumbar spine BMD at month 12 were 0.33% (90% CI, -0.25 to 0.91) in the full analysis set and 0.39% (95% CI, -0.36 to 1.13) in the per-protocol set; both within the predefined equivalence margin. The secondary endpoints were comparable between the 2 treatment groups.Conclusion The reported efficacy, pharmacokinetic, pharmacodynamic, safety, and immunogenicity data support the biosimilarity of SB16 to DEN.
ER  -

LANGDAHL, Bente; Yoon-Sok CHUNG; Rafal PLEBANSKI; Edward CZERWINSKI; Eva DOKOUPILOVÁ; Jerzy SUPRONIK; Jan ROSA; Andrzej MYDLAK; Anna ROWINSKA-OSUCH; Ki-Hyun BAEK; Audrone URBONIENE; Robert MORDAKA; Sohui AHN; Young Hee RHO; Jisuk BAN a Richard EASTELL. Proposed Denosumab Biosimilar SB16 vs Reference Denosumab in Postmenopausal Osteoporosis: Phase 3 Results Up to Month 12. \textit{JOURNAL OF CLINICAL ENDOCRINOLOGY \&{}amp; METABOLISM}. WASHINGTON: ENDOCRINE SOC, 2024, Neuveden, Neuveden, s.~1-8. ISSN~0021-972X. Dostupné z: https://doi.org/10.1210/clinem/dgae611.

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