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Tofacitinib in Ankylosing Spondylitis

Apr 28, 2021 6:55 pm

A phase III trial assessing the efficacy and safety of tofacitinib in adults with with active ankylosing spondylitis (AS) shows that JAK inhibitiion was superior to placebo in a 48 week study.

A total of 269 adult AS patients with a prior an inadequate response or intolerance to ≥2 non-steroidal anti-inflammatory drugs, were randomised to receive either tofacitinib (n=133) or placebo (n=136) for 48 weeks. The primary endpoint was the Assessment of SpondyloArthritis international Society ≥20% improvement (ASAS20) response at week 16.

The week 16 ASAS20 and ASAS 40 response rates were:

  Tofacitinib Placebo p Value
ASAS 20 56.4% 29.4% p<0.0001 
ASAS 40 40.6% 12.5%  

Adverse events were equal between treatment groups with a low rate of serious adverse events (1.5% vs. 0.7%).  By week 48, tofacitinib had low rates of adjudicated hepatic events (2.3%), non-serious herpes zoster (2.3%) and serious infection (0.8%). There were no deaths, malignancies, major adverse cardiovascular events, thromboembolic events or opportunistic infections.

Tofacitinib appears to be a potentially effective intervention in patients with AS.

The author has no conflicts of interest to disclose related to this subject

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