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▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare Professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk for the UK and hpra.ie/homepage/about-us/report-an-issue for Ireland Or, via the MHRA Yellow Card App in the Google Play or Apple App Store. Adverse events should also be reported to UCB Pharma Limited at UCBCares.UK@ucb.com or 0800 2793177.
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NICE GUIDANCE
Bimekizumab alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis* in adults who have not responded to or cannot tolerate DMARDs.1**
Bimekizumab is recommended as an option in adults for treating active AS when conventional therapy has not worked well enough or is not tolerated, or active nr-axSpA with objective signs of inflammation (shown by elevated C-reactive protein or MRI) when NSAIDs have not worked well enough or are not tolerated.2
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PSA
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Bimekizumab is recommended after two conventional DMARDs and at least one biological DMARD or if TNFis are contraindicated.
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The response to bimekizumab should be assessed after 16 weeks of treatment.
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Treatment should only be continued if there is clear evidence of a response (defined as an improvement in at least 2 of the 4 Psoriatic Arthritis Response Criteria (PsARC), one of which must be joint tenderness or swelling score, with no worsening in any of the four criteria.
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If the PsARC response is not adequate but there is a PASI75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.
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If bimekizumab is considered one of a range of suitable treatments (including ixekizumab and secukinumab), after discussing the advantages and disadvantages of the options, the least expensive drug should be used.
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Treatment decisions should take account of administration costs, dosage, price per dose and commercial arrangements.
Results of an indirect comparison suggest that bimekizumab is as effective as ixekizumab, and likely has similar safety.
*Active PsA is defined as peripheral arthritis with three or more tender joints and three or more swollen joints **DMARD, disease-modifying antirheumatic drug. †Bimekizumab has not been compared directly with ixekizuma
AS and nr-axSpA
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Bimekizumab is recommended only if TNFis are not suitable or do not control the condition well enough.2
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The response to bimekizumab should be assessed after 16 weeks of treatment.2
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Treatment should only be continued if there is clear evidence of a 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).2
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If bimekizumab is considered one of a range of suitable treatments, after discussing the advantages and disadvantages of the options, the least expensive drug should be used.2
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Treatment decisions should take account of administration costs, dosage, price per dose and commercial arrangements.2
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FORMULARY PACK
This document is intended to provide a starting point for healthcare professionals wishing to submit a local formulary application or business case for bimekizumab in the treatment of psoriatic arthritis or axial spondyloarthritis.
The formulary pack provides some suggested answers to common questions that appear on local NHS formulary application forms. It also includes information to support business case creation. Further information is available from the UCB Medical Information department.
BIMZELX® (bimekizumab) is indicated for the treatment of: active PsA, alone or in combination with methotrexate, in adults who have had an inadequate response or who have been intolerant to one or more DMARDs; active nr-axSpA, in adults with objective signs of inflammation as indicated by elevated CRP and/or MRI, who have responded inadequately or are intolerant to NSAIDs; and active AS, in adults who have responded inadequately or are intolerant to conventional therapy.1
BIMZELX phase 3 clinical trials in axial spondyloarthritis and psoriatic arthritis can be accessed via the links below. These documents should be able to support you when applying for access to this therapy for eligible patients.
Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials (BE MOBILE 1 & 2)
Bimekizumab in patients with psoriatic arthritis, naïve to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL)
Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-α inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE)
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IE-BK-2400116
Date of creation: March 2024