Bimekizumab for treating axial spondyloarthritis
Bimekizumab (BKZ) is a humanised monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A (1)
- preclinical studies suggest superior efficacy of BKZ in reducing inflammation and pathological bone formation compared with IL-17Ai alone (1)
- cytokines interleukin (IL)-17A and IL-17F have been implicated in the pathogenesis of axSpA (ankylosing spondylitis)
- although IL-17A is considered to be more biologically active, IL-17F is enriched in the skin and synovial tissue of patients with spondyloarthritis
- several types of innate-like immune cells, which are thought to be drivers of axSpA pathogenesis, also demonstrate high levels of IL-17F expression
- BKZ has also demonstrated superior clinical efficacy, versus an interleukin 17A inhibitors (IL-17Ai), in a head-to-head clinical trial in plaque psoriasis
- in a 52-week study
- dual inhibition of IL-17A and IL-17F with BKZ resulted in sustained efficacy across the axSpA spectrum; the safety profile was consistent with the known safety of BKZ (1)
NICE state:
- Bimekizumab is recommended as an option in adults for treating active ankylosing spondylitis (AS) when conventional therapy has not worked well enough or is not tolerated, or active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation (shown by elevated C-reactive protein or MRI) when non-steroidal anti-inflammatory drugs (NSAIDs), have not worked well enough or are not tolerated. It is recommended only if:
- tumour necrosis factor (TNF)-alpha inhibitors are not suitable or do not control the condition well enough, and
- the company provides it according to the commercial agreement
- Assess response to bimekizumab after 16 weeks of treatment. Continue treatment only if there is clear evidence of response, defined as:
- a reduction in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to 50% of the pre-treatment value or by 2 or more units, and
- a reduction in the spinal pain visual analogue scale (VAS) by 2 cm or more
The NICE committee noted:
- "..usual treatment for AS and nr-axSpA is TNF-alpha inhibitors. People may have 1or more TNF-alpha inhibitors before being offered secukinumab or ixekizumab. Bimekizumab works in a similar way to these 2 treatments and would be offered to the same population.
- Clinical trial evidence shows that bimekizumab is more effective than placebo. Bimekizumab has not been compared directly with secukinumab and ixekizumab. But the results of an indirect comparison suggest that it is as effective as secukinumab and ixekizumab.."
Reference:
- Baraliakos et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies.Annals of the Rheumatic Diseases Published Online First: 04 October 2023. doi: 10.1136/ard-2023-224803.
- NICE (October 2023). Bimekizumab for treating axial spondyloarthritis