AURIEL-PsO: a randomized, double-blind phase III equivalence trial to demonstrate the clinical similarity of the proposed biosimilar MSB11022 to reference adalimumab in patients with moderate-to-severe chronic plaque-type psoriasis.

ABSTRACT:

Background

MSB11022 is a proposed adalimumab biosimilar.

Objectives

To compare the efficacy, safety and immunogenicity of MSB11022 with reference adalimumab.

Methods

AURIEL-PsO was a double-blind randomized controlled equivalence trial, in which patients with moderate-to-severe chronic plaque-type psoriasis were randomized 1 : 1 to MSB11022 or reference adalimumab. The primary end point was ≥ 75% improvement in Psoriasis Area and Severity Index (PASI 75) at week 16, with a prespecified equivalence interval of ± 18%. Patients with a ≥50% improvement in PASI at week 16 were eligible to enter a double-blind extension period: patients receiving MSB11022 continued treatment, and patients receiving reference adalimumab were rerandomized 1 : 1 either to continue reference ad

SUBMITTER: Hercogova J 

PROVIDER: S-EPMC7027805 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature