Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study.

ABSTRACT:

Objective

To assess the efficacy/safety of tofacitinib in adult patients with active ankylosing spondylitis (AS).

Methods

This phase III, randomised, double-blind, placebo-controlled study enrolled patients aged ≥18 years diagnosed with active AS, meeting the modified New York criteria, with centrally read radiographs, and an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs. Patients were randomised 1:1 to receive tofacitinib 5 mg two times per day or placebo for 16 weeks. After week 16, all patients received open-label tofacitinib until week 48. The primary and key secondary endpoints were Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) and ≥40% improvement (ASAS40) responses, respectively, at week 16. Safety was

SUBMITTER: Deodhar A 

PROVIDER: S-EPMC8292568 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature