Efficacy and safety of mirikizumab in psoriasis: results from a 52-week, double-blind, placebo-controlled, randomized withdrawal, phase III trial (OASIS-1).

ABSTRACT:

Background

Interleukin-23 inhibitors are effective and safe for treating moderate-to-severe plaque psoriasis.

Objectives

To evaluate the efficacy and safety of mirikizumab in adult patients with moderate-to-severe plaque psoriasis through 52 weeks in a phase III randomized controlled trial.

Methods

OASIS-1 (NCT03482011) was a double-blind, placebo-controlled, randomized withdrawal, phase III trial. Patients (n = 530, randomized 4 : 1) received subcutaneous mirikizumab 250 mg or placebo every 4 weeks (Q4W) through week 16. Coprimary endpoints were superiority of mirikizumab vs. placebo on static Physician's Global Assessment (sPGA; score of 0 or 1 with ≥ 2-point improvement) and ≥ 90% improvement in Psoriasis Area and Severity Index (PASI 90, responders) at week 16. Mi

SUBMITTER: Blauvelt A 

PROVIDER: S-EPMC10087045 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature