Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14160%2F24%3A00137009" target="_blank" >RIV/00216224:14160/24:00137009 - isvavai.cz</a>

Result on the web

<a href="https://watermark.silverchair.com/zjae016.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA2YwggNiBgkqhkiG9w0BBwagggNTMIIDTwIBADCCA0gGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMXnLf_ibAi5W763kFAgEQgIIDGTLW7HAwZxncFjr5930K4JP9kA_ZoHMZtCtl9TFxfRG_1D" target="_blank" >https://watermark.silverchair.com/zjae016.pdf?token=AQECAHi208BE49Ooan9kkhW_Ercy7Dm3ZL_9Cf3qfKAc485ysgAAA2YwggNiBgkqhkiG9w0BBwagggNTMIIDTwIBADCCA0gGCSqGSIb3DQEHATAeBglghkgBZQMEAS4wEQQMXnLf_ibAi5W763kFAgEQgIIDGTLW7HAwZxncFjr5930K4JP9kA_ZoHMZtCtl9TFxfRG_1D</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/jbmr/zjae016" target="_blank" >10.1093/jbmr/zjae016</a>

Result language

angličtina

Original language name

Equivalence trial of proposed denosumab biosimilar GP2411 and reference denosumab in postmenopausal osteoporosis: the ROSALIA study

Original language description

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.

Czech name

—

Czech description

—

Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30202 - Endocrinology and metabolism (including diabetes, hormones)

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2024

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of bone and mineral research

ISSN

0884-0431

e-ISSN

1523-4681

Volume of the periodical

39

Issue of the periodical within the volume

3

Country of publishing house

US - UNITED STATES

Number of pages

9

Pages from-to

202-210

UT code for WoS article

001205748100001

EID of the result in the Scopus database

2-s2.0-85191103875