BIMZELX is indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults who are candidates for systemic therapy; active psoriatic arthritis (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 non‑radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation as indicated by elevated CRP and/or MRI, in adults who have responded inadequately, or are intolerant, to NSAIDs; active axial spondyloarthritis (AS) in adults who have responded inadequately or are intolerant to conventional therapy; and active moderate to severe hidradenitis suppurativa (HS) in adults with an inadequate response to conventional systemic HS therapy.
Rising To The Challenge of Psoriatic Disease
ACT Now With BIMZELX
Emerging Data
PHASE III/IIIb
BIMZELX demonstrated improved skin efficacy vs three other biologic therapies1–4
These are four separate studies and should not be directly compared. Adapted from references 1–4.
Missing data were imputed with non-responder imputation; p values for the comparison of treatment groups were based on CMH test from the general association.1–4
*The recommended dose for adult patients with plaque PsO is 320 mg (given as two subcutaneous injections of 160 mg or one subcutaneous injection of 320 mg) at Week 0, 4, 8, 12, 16 and every 8 weeks thereafter.5
**The co-primary efficacy endpoints for the pivotal phase III studies BE READY, BE VIVID, and BE SURE were PASI 90 and IGA score of clear or almost clear (IGA 0/1) at Week 16.1–4 †The primary endpoint of BE RADIANT was PASI 100 response at Week 16 with BIMZELX vs secukinumab.4
aRD, adjudicated risk difference; CI, confidence interval; CMH, Cochran-Mantel-Haenszel; PASI 90, ≥90% improvement from baseline in Psoriasis Area and Severity Index; Q1W, once every week; Q2W, every 2 weeks; Q4W, every 4 weeks; Q12W, every 12 weeks.
References: 1. Gordon KB, et al. Lancet. 2021;397:475–486. 2. Reich K, et al. Lancet. 2021;397:487–498. 3. Warren RB, et al. N Engl J Med. 2021;385:130–141. 4. Reich K, et al. N Engl J Med. 2021;385:142–152. 5. BIMZELX SmPC.
Patients receiving BIMZELX had visibly improved skin clearance at 16 weeks1–4
Actual clinical trial patients from BE RADIANT (left)1,2 and BE VIVID (right).3,4 The patients consented to having their photograph taken and used in promotional materials. These are demonstrations of individual patient’s responses. Individual results may vary.
BSA, body surface area; PASI 100, 100% improvement from baseline in Psoriasis Area and Severity Index; Q4W, every 4 weeks; WK, week.
References: 1. Reich K, et al. N Engl J Med. 2021;385:142–152. 2. UCB Data on file. 2020 BE RADIANT – patient photos. 3. Reich K, et al. Lancet. 2021;397:487–498. 4. UCB Data on file. 2020 BE VIVID – patient photos. 5. BIMZELX SmPC.
BIMZELX demonstrated high rates of complete clearance for high-impact sites up to 4 years1
Adapted from Merola 2024.1
Includes patients with IGA ≥3. mNAPSI >10, or pp-IGA ≥3 at baseline. *Data are reported using modified non-responder imputation (mNRI): patients who discontinued due to lack of efficacy or treatment-related adverse events were considered non-responders; multiple imputation was used for other missing data. mNRI for scalp clearance, n=152. mNRI for nail clearance, n=67. mNRI for palmoplantar clearance, n=36. **Week 48/52 data are from Week 48 of BE SURE and BE READY, and Week 52 of BE VIVID, due to differences in assessment schedules.1 Post-hoc analysis of data pooled from BE VIVID (52 weeks), BE READY and BE SURE (56 weeks), and 3 years of their OLE, BE BRIGHT.1 BIMZELX Q4W/Q8W patients received BIMZELX 320 mg Q4W to Week 16, then BIMZELX Q8W throughout the maintenance period and on OLE entry.1 Scalp IGA was a listed original secondary endpoint for BE READY and BE VIVID.2,3 Change in mNAPSI score and pp-IGA response (in patients with nail and palmoplantar psoriasis at baseline) were exploratory endpoints in BE READY and BE VIVID.4,5
IGA, Investigator’s Global Assessment; mNAPSI, modified Nail Psoriasis Severity Index; mNRI, modified non-responder imputation; OLE, open-label extension; pp, palmoplantar psoriasis; Q4W, every 4 weeks; Q8W, every 8 weeks.
References: 1. Merola JF. EADV 2024; P3320. 2. Gordon KB, et al. Lancet. 2021;397(10273):475–486. 3. Reich K, et al. Lancet. 2021;397:487–498. 4. Gordon KB, et al. Lancet. 2021;397(10273):475–486. Supp App. 5. Reich K, et al. Lancet. 2021;397:487–498. Supp App.
Safety Profile
Prescribing
Study details
Prescribing Information for Healthcare Professionals in the United Kingdom, click here
Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk for United Kingdom and www.hpra.ie/homepage/about-us/report-an-issue for Republic of Ireland. Adverse events should also be reported to UCB Pharma Ltd at UCBCares.UK@UCB.com or 0800 2793177 for the UK and UCB (Pharma) Ireland Ltd at UCBCares.IE@UCB.com or 1800 930075 for Republic of Ireland
Prescribing Information for Healthcare Professionals in the Republic of Ireland
Prescribing Information for HCP's in Republic of Ireland
(Please consult the Summary of Product Characteristics (SmPC) before prescribing)
Bimzelx® (bimekizumab)
Active Ingredient: bimekizumab – solution for injection in pre-filled syringe or pre-filled pen: 160 mg of bimekizumab in 1 mL of solution (160 mg/mL), 320 mg of bimekizumab in 2 mL of solution (160 mg/mL).
Indications: Moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Alone or in combination with methotrexate, for active psoriatic arthritis in adults who have had an inadequate response or intolerant to one or more disease-modifying antirheumatic drugs (DMARDs). 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). Adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy. Active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS therapy.
Dosage and Administration: Should be initiated and supervised by a physician experienced in the diagnosis and treatment of conditions for which it is indicated. Recommended dose: Plaque Psoriasis: 320 mg (given as two subcutaneous injections of 160 mg each or 1 subcutaneous injection of 320 mg) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter. Psoriatic arthritis: 160 mg (given as 1 subcutaneous injection of 160 mg) every 4 weeks. For psoriatic arthritis patients with coexistent moderate to severe plaque psoriasis, the recommended dose is the same as for plaque psoriasis. 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 every 4 weeks can be considered. Axial spondyloarthritis (nr-axSpA and AS): 160 mg (given as 1 subcutaneous injection) every 4 weeks. For patients with plaque psoriasis (including psoriatic arthritis with coexistent moderate to severe psoriasis) and a body weight ≥ 120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response. Consider discontinuing if no improvement by 16 weeks of treatment. Hidradenitis suppurativa: 320 mg (given as 2 subcutaneous injections of 160 mg each or 1 subcutaneous injection of 320 mg) every 2 weeks up to Week 16 and every 4 weeks thereafter. Renal or hepatic impairment: No dose adjustment needed. Elderly: No dose adjustment needed.
Administer by subcutaneous injection to thigh, abdomen or upper arm. Rotate injection sites and do not inject into psoriatic plaques or skin that is tender, bruised, erythematous or indurated. Do not shake pre-filled syringe or pre-filled pen. Patients may be trained to self-inject.
Contraindications: Hypersensitivity to bimekizumab or any excipient; Clinically important active infections (e.g. active tuberculosis).
Warnings and Precautions: Record name and batch number of administered product. Infection: Bimekizumab may increase the risk of infections e.g. upper respiratory tract infections, oral candidiasis. Caution when considering use in patients with a chronic infection or a history of recurrent infection. Must not be initiated if any clinically important active infection until infection resolves or is adequately treated. Advise patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection, the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy do not administer bimekizumab until infection resolves. TB: Evaluate for TB infection prior to initiating bimekizumab – do not give if active TB. While on bimekizumab, monitor for signs and symptoms of active TB. Consider anti-TB therapy prior to bimekizumab initiation if past history of latent or active TB in whom adequate treatment course cannot be confirmed. Inflammatory bowel disease: Bimekizumab is not recommended in patients with inflammatory bowel disease. Cases of new or exacerbations of inflammatory bowel disease have been reported. If inflammatory bowel disease signs/symptoms develop or patient experiences exacerbation of pre-existing inflammatory bowel disease, discontinue bimekizumab and initiate medical management. Hypersensitivity: Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, discontinue immediately and treat. Vaccinations: Complete all age appropriate immunisations prior to bimekizumab initiation. Do not give live vaccines to bimekizumab patients. Patients may receive inactivated or non-live vaccinations.
Interactions: A clinically relevant effect on CYP450 substrates with a narrow therapeutic index in which the dose is individually adjusted e.g. warfarin, cannot be excluded. Therapeutic monitoring should be considered.
Fertility, pregnancy and lactation: Women of child-bearing potential should use an effective method of contraception during treatment and for at least 17 weeks after treatment. Avoid use of bimekizumab during pregnancy. It is unknown whether bimekizumab is excreted in human milk, hence a risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Bimzelx therapy. No data available on human fertility. Driving and use of machines: No or negligible influence on ability to drive and use machines.
Adverse Effects: Refer to SmPC for full information. Very Common (≥ 1/10): upper respiratory tract infection; Common (≥ 1/100 to < 1/10): oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis; headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue, Vulvovaginal mycotic infection (including vulvovaginal candidiasis) ; Uncommon (≥ 1/1,000 to < 1/100): mucosal and cutaneous candidiasis (including oesophageal candidiasis), conjunctivitis, neutropenia, inflammatory bowel disease. Storage precautions: Store in a refrigerator (2ºC – 8ºC), do not freeze. Keep in outer carton to protect from light. Bimzelx can be kept at up to 25ºC for a single period of maximum 25 days with protection from light. Product should be discarded after this period or by the expiry date, whichever occurs first.
Legal Category: POM
Marketing Authorisation Numbers: EU/1/21/1575/002 (Pack size of 2 x 1ml Pre-filled Syringes), EU/1/21/1575/006 (Pack size of 2 x 1ml Pre-filled Pens), EU/1/21/1575/009 (Pack size of 1 x 2ml Pre-filled Syringe), EU/1/21/1575/0011 (Pack size of 1 x 2ml Pre-filled Pen).
Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Brussels, Belgium.
Further information is available from: UCB (Pharma) Ireland Ltd, United Drug House, Magna Drive, Magna Business Park, City West Road, Dublin 24, Ireland. Tel: 1800-930075 Email: UCBCares.IE@ucb.com ;
Date of Revision: July 2026 (IE-BK-2600426)
Bimzelx is a registered trademark.
Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie/homepage/about-us/report-an-issue. Adverse events should also be reported to UCB (Pharma) Ireland Ltd at ucbcares.ie@ucb.com or 1800 930075