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Bimzelx®▼

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

For adult patients with plaque psoriasis, high treatment targets act as a surrogate marker for systemic inflammatory control and may modify psoriatic disease progression.1–3
Aim for complete skin clearance.

Windown of opportunity

Figure adapted from references 2,4-6.

Abbreviations: CLCI, cumulative life course impairment

References: 1. Arancio LMH, et al. Clin Exp Dermatol. 2024;49:1525–1531. 2. Schäkel K, et al. 2024. AAD. Poster 50236. 3. Angsana J, et al. 2023. ISID. Poster 587. 4. Carter L, et al. J Invest Dermatol. 2022;142:944–50. 5. Felix PAO, et al. Front Med (Lausanne). 2022;9:1027347. 6. Martorell A, et al. Actas Dermosifiliogr. 2016;107:32–42.

The Missed Moment:
Are We Waiting Too Long To Treat Psoriasis?

Watch Dr Christos Kasparis, Consultant Dermatologist, Circle Healthcare Wolverhampton, debate the impact of time on the management of psoriasis and psoriatic disease.
Dr Kasparis
 

ACT Now With BIMZELX

BIMZELX enables timely intervention within the ‘window of opportunity’, helping eligible patients with plaque PsO improve their quality-of-life and minimise the impacts of psoriatic disease through: 1–9

KSM part1 KSM part2 KSM part3
KSM

To understand more about our Phase III trial programme and its findings click here.

*BIMZELX vs ustekinumab, PASI 90 at Week 16: 85.0% (273/321) vs 49.7% (81/163), respectively (p<0.0001; coprimary endpoint).6

BIMZELX vs adalimumab, PASI 90 at Week 16: 86.2% (275/319) vs 47.2% (75/159), respectively (p<0.001; coprimary endpoint).7

BIMZELX vs secukinumab, PASI 100 at Week 16: 61.7% (230/373) vs 48.9% (181/370), respectively (p<0.001; primary endpoint).8

After 5 years of BIMZELX use, in a pooled analysis of three Phase III trials and their OLE, rates of PASI 90 and PASI 100 were 88.5% and 76.9%, respectively, for those receiving the licensed dose of BIMZELX (N=52).9

**The pivotal Phase III trials for BIMZELX in PsA were BE OPTIMAL and BE COMPLETE. Their primary endpoints were ACR 50 at Week 16.10,11

References: 1. BIMZELX SmPC. 2. Cole S, et al. Front Immunol. 2020;11:585134. 3. Glatt S, et al. Ann Rheum Dis. 2018;77:523–32. 4. Lacour JP, et al. Dermatol Ther (Heidelb). 2020;11:1099–1109. 5. Carter L, et al. J Invest Dermatol. 2022;142:944–50. 6. Reich K, et al. Lancet. 2021;397:487–498. 7. Warren RB, et al. N Engl J Med. 2021;385:130–141. 8. Reich K, et al. N Engl J Med. 2021;385:142–152. 9. Blauvelt. 2025. AAD Presentation 62275. 10. McInnes IB, et al. Lancet. 2023;401:25–37. 11. Merola JF, et al. Lancet. 2023;401(10370):38–48. 12. Mease PJ, et al. Arthritis Rheum. 2005;52(10):3279–89. 13. NCT00646178. Available at: clinicaltrials.gov/study/NCT00646178 (accessed December 2025). 14. Mease PJ, et al. Lancet. 2000;356(9227):3875–90. 15. Mease PJ, et al. Arthritis Rheum. 2019;71(7):1112–1124. 16. Mease PJ, et al. Arthritis Rheum. 2004;50(7):2264–72. 17. Antoni C, et al. Ann Rheum Dis. 2005;64(8):1150–7. 18. Kavanaugh A, et al. Ann Rheum Dis. 2007;66(4):498–505. 19. Rossini M, et al. Biol Ther. 2013;3(2):83–107. 20. Kavanaugh A, et al. Arthritis Rheum. 2017;69(11):2151–2161. 21. Kavanaugh A, et al. Arthritis Rheum. 2009;60(4):976–86. 22. Mease PJ, et al. Ann Rheum Dis. 2013;73(1):48–55. 23. NCT01087788. Available at: clinicaltrials.gov/study/NCT01087788 (accessed December 2025). 24. Yang K, et al. Am J Clin Dermatol. 2020;10(2):173–192. 25. McInnes IB, et al. Lancet. 2013;382(9894):780–9. 26. Ritchlin C, et al. Ann Rheum Dis. 2014;73(6):990–999. 27. Nash P, et al. Arthritis Res Ther. 2018;20:47. 28. Mease P, e al. Ann Rheum Dis. 2018;77(6):890–897. 29. Mease PJ, et al. N Engl J Med. 2015;373(14):1329–39. 30. McInnes IB, et al. Lancet. 2015;586(9999):1137–46. 31. Mease PJ, et al. Ann Rheum Dis. 2016;76(1):79–87. 32. Van der Heijde D, et al. J Rheumatol. 2018;45(3):367–377. 33. Ritchlin CT, et al. RMD Open. 2022;8(1):e002195. 34. Deodhar A, et al. Lancet. 2020;395(10230):1115–1125. 35. Mease PJ, et al. Lancet. 2020;395(10230):1126–1136.

Emerging Data

Precision Meets Ambition:
Can Bimzelx Help Us Aim Higher In Psoriatic Care?

With growing evidence that early intervention with immune‑modulating therapy may help reduce long‑term health impacts—there has been increasing focus on concepts such as disease remission and minimising cumulative disease burden amongst the dermatology community.1-4

Hear from Dr Maria‑Angeliki Gkini, Consultant Dermatologist at Barts Health NHS Trust, as she explores the value of BIMZELX® across the full spectrum of psoriatic disease, drawing on key insights from emerging data.

Dr Gkini

Important Notice: The emerging data presented are results from post‑hoc, exploratory analysis that were not part of the primary study objectives and was not adjusted for multiplicity. The findings should be interpreted with caution, are hypothesis‑generating, and require confirmation in prospectively designed studies.
 

References: 1. Yi RC, et al. J Clin Med. 2025; 14(4): 1312. 2. Arancio LMH, et al. Clin Exp Dermatol. 2024;49:1525–31. 3. Carter L, et al. J Invest Dermatol. 2022;142:944–50. 4. Felix PAO, et al. Front Med (Lausanne). 2022;9:1027347. 5. Martorell A, et al. Actas Dermosifiliogr. 2016;107:32–42. 6. Merola JF et al. EADV 2025. Poster P2785. 7. Warren RB et al. EADV 2025. Poster P2120.

PHASE III/IIIb

BIMZELX demonstrated improved skin efficacy vs three other biologic therapies1–4

Phase III

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.

BIMZELX demonstrated lasting skin efficacy that was rapid in onset

Pooled analysis of three Phase III trials

To understand more about our Phase III study designs, please click here

*Patients who completed BE SURE, BE VIVID, or BE READY were eligible to enrol in BE BRIGHT, an OLE study designed to assess long-term safety, tolerability, and efficacy of BIMZELX. US/Canadian patients who completed the BE BRIGHT OLE (4 years’ total treatment), could enter a second 48-week OLE (OLE2). The mean weight of US/Canadian patients in OLE2 was numerically higher than the global BE BRIGHT population (mean weight was 88.5 ± 20.8 kg [BIMZELX Q4W/Q8W]). **BE VIVID lasted 52 weeks and BE SURE and BE READY lasted 56 weeks; to pool data across studies, Week 56 data were not included. In this graph, the period after Week 52 (or Week 48/52) corresponds to the BE BRIGHT OLE.

(m)NRI, (modified) non-responder imputation: OLE, open-label extension; PASI 90/100, ≥90/100% improvement from baseline in Psoriasis Area and Severity Index; Q4W, every 4 weeks; Q8W, every 8 weeks.

Reference: Blauvelt. 2025. AAD Presentation 62275.

Patients receiving BIMZELX had visibly improved skin clearance at 16 weeks1–4

week0 - week 16

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

Proportion of patients achieve complete regional clearance up to 4 years with BIMZELX Q4W/Q8W

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.

Actual clinical trial from BE VIVID Actual clinical trial from BE VIVID

Safety Profile

BIMZELX demonstrated a consistent safety profile over 4 years among patients with PsO1

In a pooled analysis of three Phase III trials (BE VIVID, BE READY and BE SURE) and their OLE BE BRIGHT, and the phase Illb trial and OLE study BE RADIANT, EAIR per 100 PY of serious and severe TEAEs were low with BIMZELX treatment over longer-term treatment exposure1

Consistent BIMZELXs safety profile

Some patients may not be suitable for BIMZELX. You are strongly advised to read the prescribing information, which can be accessed via this advert and the Summary of Product Characteristics. BIMZELX is contraindicated in patients with clinically important active infections (e.g. active tuberculosis) or known hypersensitivity to the active substance or any excipients listed in Section 6.1. Please refer to the Summary of Product Characteristics for further information.

Contraindictions
Bimekizumab is contraindicated in patients with clinically important active infections (e.g., active tuberculosis) or known hypersensitivity to the active substance or any excipients listed in section 6.1 of the SmPC.

Warnings and precautions
Bimekizumab may increase the risk of infections, including upper respiratory tract infections and oral candidiasis. Use with caution in patients with chronic or recurrent infections, and do not start treatment in those with active, clinically significant infections until resolved. Patients should seek medical advice if infection symptoms occur. If an infection develops, monitor closely and discontinue treatment if it becomes serious or unresponsive to standard therapy.

Additional Warnings and Precautions
Bimekizumab has been associated with new or worsening cases of inflammatory bowel disease (IBD) and is not recommended for patients with IBD. If signs or symptoms of IBD occur or existing IBD worsens, discontinue treatment and initiate appropriate medical care.

  • Traceability: Record product name and batch number to ensure traceability.
  • Tuberculosis (TB): Screen for TB before starting. Do not use in active TB. Monitor for TB symptoms during treatment; consider prophylaxis if past TB treatment is uncertain.
  • Vaccinations: Complete all age-appropriate immunisations before starting. Avoid live vaccines during treatment; inactivated vaccines are permitted.
  • Excipients: Contains polysorbate 80 (may cause allergies) and is essentially sodium-free.

You are advised to refer to the SmPC for full details and further information.

*All patients were switched to BIMZELX 320 mg Q8W at the next scheduled clinic visit on or after the Week 64/Week 104 visit (BE RADIANT/BE BRIGHT, respectively) following protocol amendment. **Entire pooled study period. †Total BIMZELX exposure over 4 years is greater than the sum of BIMZELX exposure in individual years, as data beyond Week 208 are not included due to the use of a cutoff date. ‡The EAIR of TEAEs over 4 years was numerically lower in patients receiving BIMZELX Q8W vs Q4W (115.4/100 PY vs 224.4/100 PY). §The rate of serious TEAEs over 4 years is lower than the rate in any individual year due to time not accounted for in the individual year summaries.

Cl, confidence interval; EAIR, exposure-adjusted incidence rate; PY, patient-year; Q4W, every 4 weeks; Q8W, every 8 weeks; TEAE, treatment-emergent adverse event.

References: 1. Gordon. 2024. AAD. Presentation 52671. 2. BIMZELX SmPC.
 

Prescribing

Six to seven maintenance doses a year for your patients with moderate-to-severe plaque PsO1

2 devide options

The recommended BIMZELX 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. This equates to 9 doses in Year 1 then 6 or 7 doses per year thereafter.

Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment. Overweight patients: For some patients with a body weight ≥120 kg who do not achieve complete skin clearance at Week 16, BIMZELX 320 mg Q4W after Week 16 may further improve treatment response.1

References: 1. BIMZELX SmPC.
 

Study details

BIMZELX was assessed across four Phase III/IIIb trials in adult patients with moderate-to-severe PsO1–4

Patients who finished

Open-label extension data are also available for all trials. The bimekizumab clinical trials included some off-label treatment arms. Please refer to the SmPC for the licenced doses.

*After Week 16, patients receiving BKZ achieving PASI 90 were re-allocated (1:1:1) to receiving BKZ 320 mg Q4W, Q8W, or placebo for Weeks 16–56.1

**Patients received 45/90 mg at Weeks 0 and 4, then Q12W. UST dosing was based on weight plan: patients ≤100 kg at baseline received one UST 45 mg injection; patients >100 kg at baseline received two.2

†ADA was dosed 80 mg at Week 0 and 40 mg at Week 1, then Q2W until Week 24 where the patient was switched to BKZ 320 mg Q4W.3

‡The Q8W maintenance dosing regimen was added via protocol amendment, with the first re-randomisation occurring ~7 months after the trial began, after 82 patients had completed Week 16.

§SEC was administered weekly until Week 4 and then monthly.

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.

Prescribing Information for Healthcare Professionals in the United Kingdom, click here

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. 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)