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

YS. Chung, B. Langdahl, R. Plebanski, E. Czerwinski, E. Dokoupilova, J. Supronik, J. Rosa, A. Mydlak, R. Sapula, A. Rowińska-Osuch, KH. Baek, A. Urboniene, R. Mordaka, S. Ahn, YH. Rho, J. Ban, R. Eastell

. 2025 ; 192 (-) : 117371. [pub] 20241212

Language English Country United States

Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase III, Comparative Study

Persistent link   https://www.medvik.cz/link/bmc25009731

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. CONCLUSION: Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.

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$a Chung, Yoon-Sok $u Department of Endocrinology and Metabolism, Ajou University School of Medicine, Suwon, Republic of Korea; Institute on Aging, Ajou University Medical Center, Suwon, Republic of Korea. Electronic address: yschung@ajou.ac.kr
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$a SB16 versus reference denosumab in postmenopausal women with osteoporosis: 18-month outcomes of a phase III randomized clinical trial / $c YS. Chung, B. Langdahl, R. Plebanski, E. Czerwinski, E. Dokoupilova, J. Supronik, J. Rosa, A. Mydlak, R. Sapula, A. Rowińska-Osuch, KH. Baek, A. Urboniene, R. Mordaka, S. Ahn, YH. Rho, J. Ban, R. Eastell
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$a 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. CONCLUSION: Switching from DEN to SB16 demonstrated comparable efficacy, safety, PD, PK, and immunogenicity in PMO patients relative to those who continued DEN. SB16 was well tolerated over 18 months, demonstrating comparable outcomes to DEN.
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$a Langdahl, Bente $u Department of Endocrinology, Aarhus University Hospital and Department of Clinical Medicine, Aarhus University, Aarhus, Denmark. Electronic address: bente.langdahl@aarhus.rm.dk
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$a Plebanski, Rafal $u Klinika Zdrowej Kosci, Lodz, Poland
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$a Czerwinski, Edward $u Krakowskie Centrum Medyczne sp z oo, Krakow, Poland. Electronic address: edward.czerwinski@futuremeds.com
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$a Dokoupilova, Eva $u MEDICAL PLUS sro, Uherske Hradiste, Czech Republic; Masaryk University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Brno, Czech Republic
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$a Supronik, Jerzy $u OsteoMedic sc A Racewicz J Supronik, Bialystok, Poland
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$a Rosa, Jan $u Affidea Praha, s.r.o., Praha, Czech Republic. Electronic address: rosaj@affidea-praha.cz
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$a Mydlak, Andrzej $u ETG Siedlce, Siedlce, Poland. Electronic address: a.mydlak@etg-network.com
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$a Sapula, Rafal $u Zamosc Rehabilitation Clinic, The Academy od Zamosc, Zamosc, Poland. Electronic address: r.sapula@etg-network.com
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$a Rowińska-Osuch, Anna $u ETG Warszawa, Warszawa, Poland. Electronic address: a.rowinskaosuch@etg-network.com
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$a Baek, Ki-Hyun $u Division of Endocrinology and Metabolism, Department of Internal Medicine, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea. Electronic address: drbkh@catholic.ac.kr
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$a Urboniene, Audrone $u JSC Saules seimos medicinos centras, kaunas, Lithuania. Electronic address: a.urboniene@ssmc.lt
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$a Mordaka, Robert $u Santa Sp. z o.o., Lodz, Poland. Electronic address: robert.mordaka@swietarodzina.com.pl
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$a Ahn, Sohui $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea. Electronic address: sohui.ahn@samsung.com
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$a Rho, Young Hee $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea. Electronic address: younghee.rho@samsung.com
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$a Ban, Jisuk $u Samsung Bioepis Co., Ltd., Incheon, Republic of Korea. Electronic address: jisuk.ban@samsung.com
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$a Eastell, Richard $u University of Sheffield, Sheffield, United Kingdom. Electronic address: r.eastell@sheffield.ac.uk
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