Publications by authors named "Paul Duijzings"
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.
Article Synopsis
- - This study examined the pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a potential biosimilar to the reference product ustekinumab (Stelara®).
- - A total of 298 healthy subjects received either AVT04 or the reference products; results showed that the PK parameters met the predetermined bioequivalence criteria, indicating similarity.
- - The findings also revealed that AVT04 had comparable safety and immunogenicity profiles to the reference products, supporting its potential use as a biosimilar.