Tildrakizumab No Better Than Placebo for Ankylosing Spondylitis

A 48-week trial of tildrakizumab in patients with ankylosing spondylitis was terminated early after a 24-month interim analysis showed a lack of efficacy. Researchers published findings from the study online ahead of print in the Journal of Clinical Rheumatology.

“Tildrakizumab is an anti-interleukin-23p19 monoclonal antibody approved to treat moderate to severe plaque psoriasis. This study evaluated the efficacy and safety of tildrakizumab in patients with ankylosing spondylitis,” wrote corresponding author Eric Peters, MD, of Arizona Arthritis and Rheumatology Associates PC in Phoenix, and study coauthors.

The multinational, double-blind, phase 2a trial randomized 101 patients with active ankylosing spondylitis, per modified New York criteria and Bath Ankylosing Spondylitis Disease Activity Index Score of 4 or higher, to tildrakizumab 200 mg or placebo every 4 weeks over 24 weeks. At that point, study plans called for all patients to receive tildrakizumab 200 mg every 4 weeks until week 48.

At week 24, the proportion of patients achieving 20% improvement from baseline by Assessment in SpondyloArthritis International Society criteria (ASAS20) was 74% with tildrakizumab compared with 80.4% with placebo, according to the study.

When researchers looked at treatment effect by subgroups, they found no noteworthy differences with prior treatment experience, weight, age, or sex. No unexpected safety findings were observed with tildrakizumab.

“Tildrakizumab treatment was generally well tolerated,” researchers concluded, “but did not improve ASAS20 response rate versus placebo in patients with ankylosing spondylitis.”

Due to tildrakizumab’s lack of efficacy in participants, the study was called off.

Reference: 
Peters E, Chou RC, Rozzo SJ, Yao SL, Fructuoso FJG. A randomized, double-blind, placebo-controlled phase 2a study of tildrakizumab efficacy and safety in patients with active ankylosing spondylitis. J Clin Rheumatol. Published online May 10, 2023. doi:10.1097/RHU.0000000000001973