Tofacitinib in Ankylosing Spondylitis Save
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:
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.