Is Bone Formation Observed in Patients with Ankylosing Spondylitis Related to Clinical Signs and Symptoms?
Purpose: In all clinical trials conducted with TNF antagonists in patients with ankylosing spondylitis (AS), patients experienced radiographic progression characterized by bone formation as assessed by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) at a similar rate and frequency as patients from a historical cohort of AS patients without treatment with TNF antagonists.13 We determined whether there is a link between the level of signs and symptoms in the patients during follow-up visits and the radiographic outcome. Methods: ATLAS was a Phase III, randomized, placebo-controlled trial of adalimumab in patients with AS. After the 24-week double-blind period, placebo-treated patients switched to adalimumab and enter an open-label extension phase and receive up to 4 years of follow up. Patients were categorized by the degree of radiographic progression (DmSASSS >2 over 2 years). Patients were also evaluated by clinical response measures between baseline and Week 208, inclu
