Welcome to the BIMZELX®▼ (bimekizumab) European website for healthcare professionals
Approved across five eligible patient populations
BIMZELX®▼ (bimekizumab) is approved to treat FIVE eligible patient populations.1
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Approved therapeutic indications1
Plaque psoriasis (PSO)
BIMZELX® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Psoriatic arthritis (PsA)
BIMZELX®, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
Axial spondyloarthritis
Non-radiographic axial spondyloarthritis (nr-axSpA)
BIMZELX® is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs).
Ankylosing spondylitis (AS, radiographic axial spondyloarthritis, r-axSpA)
BIMZELX® is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.
Hidradenitis suppurativa (HS)
BIMZELX® is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
Dosing and administration1
BIMZELX® is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which BIMZELX® is indicated and is available in the following formulations:
- BIMZELX® 160 mg solution for injection in pre-filled syringe or pre-filled pen each containing 160 mg of bimekizumab in 1 mL
- BIMZELX® 320 mg solution for injection in pre-filled syringe or pre-filled pen each containing 320 mg bimekizumab in 2 mL
Plaque psoriasis
The recommended dose for adult patients is 320 mg (given as 2 SC injections of 160 mg or 1 SC injection of 320 mg) at week 0, 4, 8, 12, 16 and Q8W thereafter.
Psoriatic arthritis
The recommended dose for adult patients is 160 mg (given as 1 SC injection of 160 mg) Q4W.
For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, the recommended dose is the same as for plaque psoriasis which is 320 mg (given as 2 SC injections of 160 mg or 1 SC injection of 320 mg) at week 0, 4, 8, 12, 16 and Q8W thereafter]. After 16 weeks, regular assessment of efficacy is recommended and if a sufficient clinical response in joints cannot be maintained, a switch to 160 mg Q4W can be considered.
Axial spondyloarthritis (nr-axSpA and AS)
The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as 1 SC injection of 160 mg) Q4W.
Hidradenitis suppurativa
The recommended dose for adult patients with hidradenitis suppurativa is 320 mg (given as 2 SC injections of 160 mg or 1 SC injection of 320 mg) Q2W up to Week 16 and Q4W thereafter.
For above indications, consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.
Summary of safety profile1
The most frequently reported adverse reactions were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS respectively).
Abbreviations
Q2W, every 2 weeks; Q4W, every 4 weeks; Q8W, every 8 weeks, SC, subcutaneous.
References
-
BIMZELX® EU SmPC. https://www.ema.europa.eu/en/documents/product-in!formation/BIMZELX-epar-product information_en.pdf. Last accessed August 2025.
Access EU BIMZELX® SmPC
The most frequently reported adverse reactions were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively).1
BIMZELX® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate, in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs; active non-radiographic axial spondyloarthritis in adults with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging who have responded inadequately or are intolerant to nonsteroidal anti-inflammatory drugs; active ankylosing spondylitis in adults who have responded inadequately or are intolerant to conventional therapy and active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.1
▼This medication is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to https://www.ucb.com/UCBCares.
Please refer to the Summary of Product Characteristics (SmPC) before prescribing.1
EU-BK-2500051
Date of preparation: November 2025
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