Treatment Produces Clinically Meaningful Response in Active Ankylosing Spondylitis

In a double-blind, Phase 3 trial of adults with active ankylosing spondylitis who had an inadequate response to at least two nonsteroidal anti-inflammatory drugs (NSAIDS), the oral Janus kinase inhibitor tofacitinib demonstrated significantly greater efficacy than placebo. Researchers published their findings online ahead of print in the Annals of the Rheumatic Diseases. 

“Currently, the unmet need for treatment options is high in patients with ankylosing spondylitis, including a need for effective oral treatment options following NSAIDs and a need for additional mechanisms of action,” researchers wrote. “If approved by regulatory agencies, tofacitinib could be one of a new class of drugs for use in ankylosing spondylitis, providing an additional treatment option for patients with this disease.” 

The study randomized 133 patients to tofacitinib 5 mg two times per day and 136 patients to placebo for 16 weeks. Afterward, all patients received open-label tofacitinib until week 48.

After 16 weeks of treatment, 56.4% of patients receiving tofacitinib achieved Assessment of SpondyloArthritis international Society (ASAS) ≥20% improvement compared with 29.4% of patients receiving placebo, according to the study, and 40.6% of patients receiving tofacitinib achieved ASAS ≥40% improvement compared with 12.5% of patients receiving placebo. 

In patients who switched from placebo to tofacitinib after week 16, clinical response improved through week 24 and was sustained until the study’s end at week 48. 

The study identified no new potential safety risks with tofacitinib. 

“Adverse events were more frequent with tofacitinib versus placebo, consistent with the phase II study of tofacitinib in patients with ankylosing spondylitis,” researchers reported. “The safety profile of tofacitinib, including laboratory changes, in patients with ankylosing spondylitis in this study was consistent with the established safety profile of tofacitinib 5 mg two times per day across all clinical programs.” 

—Jolynn Tumolo

Reference:

Deodhar A, Sliwinska-Stanczyk P, Xu H, et al. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study [published online ahead of print, 2021 Apr 27]. Ann Rheum Dis. 2021;annrheumdis-2020-219601. doi:10.1136/annrheumdis-2020-219601