medwireNews: The Janus kinase (JAK) inhibitor tofacitinib is a promising treatment option for people with ankylosing spondylitis (AS), suggest phase 3 trial findings presented at the ACR Convergence 2020 virtual meeting.
If tofacitinib is approved for this indication, it “will be a very welcome addition for us to have an oral agent available to treat ankylosing spondylitis once the nonsteroidal anti-inflammatory drugs [NSAIDs] have failed to work,” lead investigator Atul Deodhar (Oregon Health & Science University, Portland, USA) told medwireNews.
Lead investigator Atul Deodhar: Tofacitinib shows promise for ankylosing spondylitis (5:36)
The study included 269 adult patients with AS and an inadequate response to two or more NSAIDs who were randomly assigned to receive oral tofacitinib 5 mg twice daily or placebo. The majority of participants (79–87%) in both groups were men, with an average age of 40–42 years, and 77% of participants had no prior exposure to biologic DMARDs.
Deodhar told delegates that at the 16-week follow-up, 56.4% of the 133 patients treated with tofacitinib achieved the primary endpoint of ASAS20 response, compared with 29.4% of the 136 participants given placebo, a significant difference. Similarly, ASAS40 response rates at week 16 were significantly greater in the tofacitinib compared with the placebo arm, at 40.6% versus 12.5%.
Moreover, Deodhar reported that improvements in a range of secondary endpoints, including ASDAS, high-sensitivity C-reactive protein levels, and FACIT fatigue scores, were significantly greater with tofacitinib versus placebo at week 16.
He also highlighted that “patients had a rapid clinical response to tofacitinib,” with significantly greater ASAS20 response rates among tofacitinib- versus placebo-treated patients seen as early as the 2-week follow-up (28.6 vs 10.3%).
In all, 54.1% of patients given the JAK inhibitor and 51.5% of those given placebo experienced adverse events (AEs) from baseline to week 16, most commonly upper respiratory tract infection and nasopharyngitis. A total of 1.5% and 0.0% of patients in the tofacitinib and placebo arms, respectively, experienced serious AEs, and a corresponding 2.3% and 0.7% discontinued treatment due to AEs.
Deodhar said that the AE profile of tofacitinib in AS patients was “consistent with the known safety profile in patients with rheumatoid arthritis and psoriatic arthritis,” with “no new potential safety risks” identified during the 16-week placebo controlled period or the extension period from week 16–48, in which all participants were switched to open-label tofacitinib treatment. No cases of malignancy or venous thromboembolism were reported.
Marina Magrey on the potential impact of tofacitinib on AS treatment (4:24)
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