Efficacy, Safety and Immunogenicity of AVT02 Versus Originator Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis: A Multicentre, Double-Blind, Randomised, Parallel Group, Active Control, Phase III Study.

ABSTRACT:

Background

AVT02 (adalimumab) is a proposed biosimilar to Humira^®. AVT02 is produced at a 100 mg/mL concentration with a citrate-free formulation.

Objectives

The aim of this study was to compare the efficacy, safety and immunogenicity of AVT02 versus Humira^® in subjects with moderate to severe chronic plaque psoriasis.

Methods

This double-blind, randomised, parallel group, active control study of adult subjects compared (at a 1:1 ratio) AVT02 with originator adalimumab 80 mg subcutaneously in Week 1, then 40 mg every other week. At Week 16, subjects who had received originator adalimumab were re-randomised at a 1:1 ratio to continue receiving originator adalimumab, or to switch to AVT02, every other week until Week 48, with final efficacy endpoin

SUBMITTER: Feldman SR 

PROVIDER: S-EPMC8520467 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature