Emerging treatments
Ustekinumab
Ustekinumab is a fully humanised monoclonal antibody that inhibits the bioactivity of interleukin (IL)-12 and IL-23. Randomised controlled trials have failed to demonstrate that ustekinumab is effective in patients with axSpA.[222]
Apremilast
Apremilast is an oral phosphodiesterase 4 inhibitor. A phase 2 proof-of-concept trial showed absolute improvements in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Metrology Index (BASMI) over 12 weeks in patients with active ankylosing spondylitis (AS), although this did not attain statistical significance.[223] No clinical benefit was observed following 16 weeks of treatment with apremilast in one phase 3 randomised controlled trial of 490 patients with active AS.[224]
Bimekizumab
Bimekizumab, a monoclonal antibody which selectively inhibits IL-17F, IL-17A, and IL-17AF, has demonstrated sustained efficacy and was well tolerated up to 3 years in patients with active AS in the phase 2b BE AGILE trial and its open-label extension.[225] Two parallel trials provide the first phase 3 data for the dual inhibition of IL-17A and IL-17F with bimekizumab, and cover the full spectrum of axSpA in patients with non-radiographical (nr)-axSpA (BE MOBILE 1) and radiographic ®-axSpA (BE MOBILE 2).[226] Inhibition of IL-17F in addition to IL-17A with bimekizumab resulted in rapid, clinically relevant improvements in efficacy outcomes compared with placebo. Improvements started after 1-2 weeks and treatment was well tolerated.[226] Bimekizumab is approved for the treatment of plaque psoriasis in some countries, but it is not approved for the treatment of AS.
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