Publications by authors named "N E Reznichenko"
Introduction: SB17 is a biosimilar to reference ustekinumab (UST). We compared the efficacy, safety, and immunogenicity of SB17 to UST up to Week 52, including switching from UST to SB17.
Methods: Subjects were randomized to receive 45 mg of SB17 or UST subcutaneously up to Week 40.
Background: Ustekinumab (UST) is a safe and effective treatment for moderate-to-severe psoriasis.
Objectives: To compare efficacy, safety, pharmacokinetics (PK), and immunogenicity of the proposed UST biosimilar SB17 with reference UST in subjects with moderate-to-severe plaque psoriasis.
Methods: In this randomized double-blind study, subjects were randomized to receive 45 mg of SB17 or UST subcutaneously at week 0, 4, and every 12 weeks.
Article Synopsis
- Immunogenic responses to biologic medicines start at the cellular level, involving T cell activation and B cell maturation, rather than just the final humoral response.
- The study assessed cellular immunogenicity in psoriasis patients who either stayed on the reference product or switched to a different biologic treatment after randomization, collecting and analyzing their immune cells at several time points.
- Results showed comparable cellular immune responses in both treatment groups, suggesting that the switching between biologics does not significantly alter immunogenicity, which is important for determining the safety and effectiveness of these treatments.
Background: CT-P43 is a candidate ustekinumab biosimilar in clinical development.
Objectives: This paper aims to demonstrate equivalent efficacy of CT-P43 to originator ustekinumab in adults with moderate to severe plaque psoriasis.
Methods: This double-blind, phase III trial randomised patients (1:1) to receive subcutaneous CT-P43 or originator ustekinumab (45/90 mg for patients with baseline body weight ≤ 100 kg/> 100 kg) at week 0 and week 4 in Treatment Period I.
Background: This study compared efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity between AVT04 and reference product (RP) ustekinumab (Stelara®) in patients with moderate-to-severe chronic plaque psoriasis (PsO).
Patients And Methods: This multicenter, double-blind, 52-week study randomized patients in 1:2 ratio to AVT04 or RP. At week 16, responsive patients (≥50% improvement in psoriasis area and severity index (PASI)) previously on AVT04 continued on AVT04, while those on RP were re-randomized 1:1 to switch to AVT04 or stay on RP.