AS-1: A 24-week trial in patients with active AS

AS-1 study design1

Graph representing AS-1 study design

The 24-week double-blind, placebo-controlled trial period was followed by a 24-week dose-blind period during which patients originally randomized to placebo were rerandomized (1:1) to receive CIMZIA 200 mg q2w or CIMZIA 400 mg q4w following 3 loading doses. The trial continued with an open-label period from weeks 48 to 204.

AS-1 was a multicenter, randomized, double-blind, placebo-controlled study in 325 patients ≥18 years of age with adult-onset active axial spondyloarthritis for at least 3 months. The majority of patients in the study had active AS. Patients had active disease as defined by the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and spinal pain ≥4 on a 0 to 10 numeric rating scale (NRS). Patients must have been intolerant to or had an inadequate response to at least 1 nonsteroidal anti-inflammatory drug (NSAID). Patients were treated with a loading dose of CIMZIA 400 mg at weeks 0, 2, and 4 for both treatment arms or placebo followed by either 200 mg q2w or 400 mg q4w or placebo. The primary efficacy variable was the proportion of patients achieving an ASAS20 response at week 12.1