Publications by authors named "E Dokoupilova"
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.
Objective: Our goal was to assess the efficacy and safety of intravenous (IV) secukinumab for the treatment of adults with active axial spondyloarthritis (axSpA) in INVIGORATE-1.
Methods: INVIGORATE-1 (NCT04156620) was a randomized, double-blind, parallel-group, phase 3 trial in patients with active axSpA (either radiographic or nonradiographic). Patients were randomized one to one to receive IV secukinumab (6 mg/kg at baseline followed by 3 mg/kg every four weeks) or IV placebo for 16 weeks.
Article Synopsis
- SB16 is a proposed biosimilar to denosumab (Prolia) aimed at treating postmenopausal osteoporosis in women, studied through a phase 3 randomized trial.
- The study involved 457 patients, assessing the effectiveness of SB16 compared to DEN by measuring changes in bone mineral density over 12 months.
- Results demonstrated that SB16's efficacy and safety profiles were comparable to DEN, confirming its biosimilarity.
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®; 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.
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- * It was found that after two doses of the Pfizer/BioNTech mRNA vaccine, those treated with the original drug maintained stable antibody levels, whereas those on the biosimilar showed a significant decrease in antibody levels over time.
- * A strong statistical difference was observed in SARS-CoV-2 antibody levels between patients receiving biological treatment (both original and biosimilar) and those not receiving any biological treatment, indicating that the type of treatment rather than other factors like age