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@article{2428280, author = {Jeka, Slawomir and Dokoupilová, Eva and Kivitz, Alan and Zuchowski, Pawel and Vogg, Barbara and Krivtsova, Natalia and Sekhar, Susmit and Banerjee, Samik and Schwebig, Arnd and Poetzl, Johann and Body, JeanandJacques and Eastell, Richard}, article_location = {Hoboken}, article_number = {3}, doi = {http://dx.doi.org/10.1093/jbmr/zjae016}, keywords = {diseases and disorders of/related to bone: osteoporosis; clinical trials; bone modeling and remodeling: biochemical markers of bone turnover}, language = {eng}, issn = {0884-0431}, journal = {Journal of bone and mineral research}, title = {Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study}, url = {https://watermark.silverchair.com/zjae016.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA2YwggNiBgkqhkiG9w0BBwagggNTMIIDTwIBADCCA0gGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMXnLf_ibAi5W763kFAgEQgIIDGTLW7HAwZxncFjr5930K4JP9kA_ZoHMZtCtl9TFxfRG_1D}, volume = {39}, year = {2024} }
TY - JOUR ID - 2428280 AU - Jeka, Slawomir - Dokoupilová, Eva - Kivitz, Alan - Zuchowski, Pawel - Vogg, Barbara - Krivtsova, Natalia - Sekhar, Susmit - Banerjee, Samik - Schwebig, Arnd - Poetzl, Johann - Body, Jean-Jacques - Eastell, Richard PY - 2024 TI - Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study JF - Journal of bone and mineral research VL - 39 IS - 3 SP - 202-210 EP - 202-210 PB - Wiley SN - 08840431 KW - diseases and disorders of/related to bone: osteoporosis KW - clinical trials KW - bone modeling and remodeling: biochemical markers of bone turnover UR - https://watermark.silverchair.com/zjae016.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA2YwggNiBgkqhkiG9w0BBwagggNTMIIDTwIBADCCA0gGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMXnLf_ibAi5W763kFAgEQgIIDGTLW7HAwZxncFjr5930K4JP9kA_ZoHMZtCtl9TFxfRG_1D N2 - Denosumab is a monoclonal antibody used to reduce risk of fractures in osteoporosis. ROSALIA was a multicenter, double-blind, randomized, integrated phase I/phase III study comparing the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and safety of proposed biosimilar denosumab GP2411 with reference denosumab (REF-DMAb) (Prolia (R); Amgen). Postmenopausal women with osteoporosis were randomized 1:1 to 2 60-mg doses of GP2411 or REF-DMAb, one at study start and one at week 26. At week 52, the REF-DMAb group was re-randomized 1:1 to a third dose of REF-DMAb or switch to GP2411. The primary efficacy endpoint was percentage change from baseline (%CfB) in LS-BMD at week 52. Secondary efficacy endpoints were %CfB in LS-BMD, FN-BMD, and TH-BMD at weeks 26 and 78 (and week 52 for FN-BMD and TH-BMD). Primary PK and PD endpoints were the area under the serum concentration-time curve extrapolated to infinity and maximum drug serum concentration at week 26, and the area under the effect-time curve of the %CfB in serum CTX at week 26. Secondary PK and PD endpoints included drug serum concentrations and %CfB in serum CTX and P1NP during the study period. Similar efficacy was demonstrated at week 52, with 95% CIs of the difference in %CfB in LS-BMD between treatment groups fully contained within prespecified equivalence margins. Similarity in PK and PD was demonstrated at week 26. Immunogenicity was similar between groups and was not impacted by treatment switch. The rate of new vertebral fractures was comparable. Treatment-emergent adverse events were comparable between groups (63.6% [GP2411/GP2411]; 76.0% [REF-DMAb/REF-DMAb]; 76.6% [REF-DMAb/GP2411]). In conclusion, ROSALIA showed similar efficacy, PK and PD, and comparable safety and immunogenicity of GP2411 to REF-DMAb in postmenopausal osteoporosis. ER -
JEKA, Slawomir, Eva DOKOUPILOVÁ, Alan KIVITZ, Pawel ZUCHOWSKI, Barbara VOGG, Natalia KRIVTSOVA, Susmit SEKHAR, Samik BANERJEE, Arnd SCHWEBIG, Johann POETZL, Jean-Jacques BODY and Richard EASTELL. Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study. \textit{Journal of bone and mineral research}. Hoboken: Wiley, 2024, vol.~39, No~3, p.~202-210. ISSN~0884-0431. Available from: https://dx.doi.org/10.1093/jbmr/zjae016.
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