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31st August 2023
Bimekizumab is now approved for use by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with active psoriatic arthritis (PsA) and active axial spondyloarthritis (axSpA), its manufacturer UCB has announced.
The MHRA approval of bimekizumab (brand name Bimzelx) makes the drug the first approved treatment both both conditions that works as a dual IL-17A and IL-17F inhibitor, both of which have ben implicated in driving the inflammatory processes associated with PsA and axSpA.
Bimekizumab can be used alone or in combination with methotrexate, for the treatment of adults with active PsA who have had an inadequate response or who have been intolerant to one or more disease-modifying anti-rheumatic drugs.
The AxSpA indication spans both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA).
For adults with nr-axSpA, bimekizumab can be used where there are objective signs of inflammation, as indicated by elevated C-reactive protein and/or magnetic resonance imaging, or for those who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs. It can also be used for the treatment of adults with active r-axSpA who have responded inadequately or are intolerant to conventional therapy.
Claire Brading, managing director UK and Ireland at UCB, said: ‘The approval of Bimzelx in psoriatic arthritis and axial spondyloarthritis is a significant milestone for the rheumatology community in the UK.‘
She added: ‘We are extremely proud to be able to bring a new dual action biological treatment option to a broad range of people living with psoriatic arthritis and axial spondyloarthritis in the UK.‘
The MHRA approval for use in PsA was based on the findings of two randomised, double-blind, placebo-controlled phase 3 trials, BE OPTIMAL and BE COMPLETE. In both studies, bimekizumab met the primary endpoint of a 50% or greater improvement in American College of Rheumatology criteria (ACR50) at week 16 and all ranked secondary endpoints.
Consistent results were seen across both biologic-naive and TNF-inhibitor (TNFi) inadequate responder populations and the clinical responses achieved at Week 16 were sustained up to Week 52 in BE OPTIMAL.
In addition, among biological DMARD-naive and TNFi patients with an inadequate response, 47% and 59% of patients with baseline psoriasis affecting ≥ 3% body surface area receiving bimekizumab achieved a PASI100 at Week 16, respectively compared to only 2% and 5% receiving placebo.
The approval for axSpA was also based on the findings of two phase 3 trials, BE MOBILE 1 (nr-axSpA) and BE MOBILE 2 (AS). Bimekizumab met the primary endpoint of Assessment of SpondyloArthritis international Society ≥40% improvement response at Week 16 compared to placebo and all ranked secondary endpoints.
Indeed, the drug showed improvements compared to placebo in signs, symptoms and disease activity across the spectrum of disease.
Commenting on bimekizumab’s approval, Professor Karl Gaffney, rheumatologist at the Norfolk and Norwich University NHS Foundation Trust, said: ‘Psoriatic arthritis and axial spondyloarthritis are chronic, painful conditions with no cure. The unfortunate reality for many patients is that they will have to cycle through a number of treatments before eventually finding one that works for them.
‘I welcome the possibility of a new, dual-action, biologic treatment option to potentially improve the quality of life of people living with psoriatic arthritis and axial spondyloarthritis.‘
Earlier this year, bimekizumab was found to provide clinical benefit in patients with moderate to severe hidradenitis suppurativa.
2nd March 2023
Use of bimekizumab in patients with both radiographic and non-radiographic axial spondyloarthritis produced significant and rapid improvements in disease outcomes in two parallel randomised trials by a European research group.
Axial spondyloarthritis (axSpA) represents a chronic inflammatory disease involving the axial skeleton that gives rise to chronic back pain and spinal stiffness but which may also include peripheral and extra-musculoskeletal manifestations. The term includes two forms of the condition, those with either radiographic and non-radiographic disease, with patients in this latter group representing those who are symptomatic but no evidence of definitive damage seen on pelvic radiographs.
It has become recognised that the interleukin-17A (IL-17A) pathway is implicated in the pathogenesis of axial spondyloarthritis although IL-17F has also been shown to induce similar inflammatory changes to IL-17 in joints. In fact, use of bimekizumab, which is a dual IL-17A and IL-17F blocker, is effective in psoriatic arthritis, which can also present with axial involvement in up to 50% of patients.
With data from a phase 2IIb trial in active ankylosing spondylitis, proving that bimekizumab was effective, in the current study, researchers undertook two parallel randomised, double-blind, placebo-controlled phase 3 trials of the drug in patients with both forms, i.e., non-radiographic (nr-disease) and radiographic (r-disease) axial spondyloarthritis. Participants with active nr-disease were randomised 1:1 and 2:1 (r-disease) to bimekizumab 160 mg every 4 weeks and from week 16 through to 52, all patients received bimekizumab 160 mg every 4 weeks. The primary endpoint was based on the Assessment of SpondyloArthritis international Society ≥40% improvement (ASAS40), i.e., a 40% improvement is disease severity.
Bimekizumab and disease improvement
At baseline virtually all patients (> 97.6%) had high or very high disease activity. In total, 254 patients with nr-disease and a mean age of 39.4 years (54.3% male) and 332 with r-disease and a mean age 40.1 years (72.2% male) with were included in the analysis.
At week 16, there was a significantly higher proportion of participants achieving an ASAS40 in both trials (nr-disease 47.7% vs 21.4% and r-disease 44.8% vs 22.5%, p<0.001 in both cases). Moreover, improvements became apparent within one to two weeks after starting bimekizumab in both trials.
The most frequent treatment emergent adverse events (i.e. occurring in > 3% of patients) with bimekizumab included nasopharyngitis, upper respiratory tract infection, pharyngitis, diarrhoea, headache and oral candidiasis.
The authors concluded that the use of the dual IL-17A and IL-17F inhibitor bimekizumab gave rise to significant and rapid improvements in patients with both radiographic and non-radiographic axial spondyloarthritis and was well tolerated.
van de Heijde D et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis 2023