test5 SV

*Efficacy across manifestations means ACR 50 and PASI 90 for PsA, ASAS 40 and ASDAS <2.1 for axSpA. ACR 50 achieved by 43.9% (189/431) biologic-naïve and 43.4% (116/267) TNFi-IR patients with PsA at Week 16 (primary endpoint in BE OPTIMAL and BE COMPLETE; vs 10.0% (28/281) and 6.8% (9/133) with placebo, respectively; p<0.001),1–3 54.5% (235/431) and 51.7% (138/267) at Week 52, respectively (NRI analysis).4,5 ASAS 40 achieved by 47.7% (61/128) nr-axSpA patients and 44.8% (99/221) AS patients at Week 16, (primary endpoint in BE MOBILE 1/2; vs 21.4% (27/126) and 22.5% (25/111) with placebo, respectively; p<0.001);6 60.9% (78/128) and 58.4% (129/221) at Week 52, respectively (NRI analysis).3 Rapid onset demonstrated by numerically higher responder rates (ACR 50) observed vs placebo at Week 4 in BE OPTIMAL, 17.6% (76/431) vs 3.2% (9/281); and in BE COMPLETE, 16.1% (43/267) vs 1.5% (2/133), respectively (both nominal p<0.001).1–3 At Week 4, PASI 90 responses were numerically greater in BIMZELX-treated patients vs placebo in BE OPTIMAL, 19.8% (43/217) vs 4.3% (6/140), and in BE COMPLETE, 26.7% (47/176) vs 0% (0/88), respectively.1,2 At Week 52, PASI 90 achieved by 71.4% (155/217) and 74.4% (131/176) of BIMZELX-treated patients in BE OPTIMAL and BE COMPLETE, respectively (ranked secondary endpoint, NRI analysis; PASI response in patients with psoriasis involving at least 3% BSA at baseline).4,5 Rapid separation in ASAS 40 response rates observed within 1–2 weeks after a single dose of BIMZELX vs placebo; 16.4% (21/128) vs 1.6% (2/126) at Week 1 (nominal p<0.001) in BE MOBILE 1, and 16.7% (37/221) vs 7.2% (8/111) at Week 2 (nominal p=0.019) in BE MOBILE 2 (NRI analysis).3,7,8 At Week 2, ASDAS <2.1 achieved by 19.6% (25/128) of BIMZELX-treated patients vs 7.4% (n=9/126) placebo in BE MOBILE 1 and 24.6% (54/221) vs 8.4% (9/111) in BE MOBILE 2, respectively (MI).7,8 ASDAS <2.1 achieved by 61.6% (79/128) nr-axSpA patients and 57.1% (126/221) AS patients at Week 52 in BE MOBILE 1 and BE MOBILE 2 respectively (exploratory endpoint, MI analysis).3,9

▼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 yellowcard.mhra.gov.uk for the UK and 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.

NICE recommendation

BIMZELX OFFERS THE OPPORTUNITY TO ACHIEVE HIGH TREATMENT TARGETS ACROSS DOMAINS AND MANIFESTATIONS IN axSpA AND PsA2,3,6

 

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*ACR 50 and PASI 90 for PsA, ASAS 40 and ASDAS <2.1 for axSpA

BIMZELX: THE FIRST AND ONLY APPROVED DUAL SELECTIVE INHIBITOR OF IL-17A AND IL-17F FOR USE IN axSpA and PsA1–3,6

 

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.3

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Low rates of uveitis to 2 years in both axSpA and PsA38

MORE INFORMATION

PSA

PsA

MOA Rheum

MECHANISM OF ACTION

axSpA Rheum

axSpA

Rheum BKZ Resource

RESOURCES

Abbreviations

ACR 50, 50% response in the American College of Rheumatology criteria; AE, adverse event; ALT, alanine aminotransferase; AS, ankylosing spondylitis; AST, aspartate aminotransferase; axSpA, axial spondyloarthritis; BSA, body surface area; CfB, change from baseline; CRP, c-reactive protein; DMARDs, disease-modifying antirheumatic drugs; EAIR, exposure-adjusted event rate; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue; HAQ-DI, Health Assessment Questionnaire Disability Index; HS, Hidradenitis suppurativa; IBD, inflammatory bowel disease; IL, interleukin; LEI, Leeds Enthesitis Index; LDI, Leeds Dactylitis Index; MACE, major adverse cardiovascular event; MCID, minimum clinically important difference; MeDRA, Medical Dictionary for Regulatory Activities; MDA, minimal disease activity; mNAPSI, modified Nail Psoriasis Severity Index; mNRI, modified non-responder imputation; MRI, magnetic resonance imaging; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; NSAIDs, non-steroidal anti-inflammatory drugs; OC, observed case; OLE, open-label extension; PASI 100, 100% improvement from baseline in Psoriasis Area Severity Index; PsA, psoriatic arthritis; PsAID, Psoriatic Arthritis Impact of Disease; PsARC, The Psoriatic Arthritis Response Criteria; PtAAP, Patient's Assessment of Arthritis Pain; PY, patient-years; Q2/4/6/8/12W, every 2/4/6/8/12 weeks; SF-36, Short-Form-36 item Health Survey; SIB, suicidal ideation and behaviour; SIJ, sacroiliac joint; SJC, swollen joint count; SmPC, Summary of Product Characteristics; TEAE, treatment-emergent adverse event; TJC, tender joint count; TNFi-IR, tumour necrosis factor inhibitor-inadequate response; ULN, upper limit of normal; VAS, visual analogue scale; vdHmTSS, van der Heijde modified Total Sharp Score; WPAI-SHP, Work Productivity and Activity Impairment Questionnaire – Specific Health Problem.

References

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  2. Gossec, L., Coates, L. C., McInnes, I. B., Mease, P. J., Ritchlin, C. T., Tanaka, Y., Asahina, A., Ink, B., Bajracharya, R., Coarse, J., & Merola, J. F. (2025). Bimekizumab, a dual inhibitor of IL-17A and IL-17F, demonstrated long-term safety and efficacy in biologic DMARD-naïve patients with active psoriatic arthritis: Final 3-year results from the phase 3 BE OPTIMAL study and its open-label extension. EULAR.
  3. Coates, L. C., Husni, M. E., Kishimoto, M., Rahman, P., Sewerin, P., Soriano, E. R., Ink, B., Bajracharya, R., Coarse, J., Mease, P. J., & Nash, P. (2025). Inhibition of radiographic progression with bimekizumab treatment observed in bDMARD-naïve patients with active psoriatic arthritis at 2 years: Results from a phase 3 study and its open-label extension. EULAR.
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  27. Reich, K., Papp, K. A., Blauvelt, A., Langley, R. G., Armstrong, A., Warren, R. B., Gordon, K. B., Merola, J. F., Okubo, Y., Madden, C., Wang, M., Cioffi, C., Vanvoorden, V., & Lebwohl, M. (2021). Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo controlled phase 3 trial. The Lancet, 397(10273), 487–498.
  28. Warren, R. B., Blauvelt, A., Bagel, J., Papp, K. A., Yamauchi, P., Armstrong, A., Langley, R. G., Vanvoorden, V., De Cuyper, D., Cioffi, C., Peterson, L., Cross, N., & Reich, K. (2021). Bimekizumab versus Adalimumab in Plaque Psoriasis. The New England Journal of Medicine, 385(2), 130–141.
  29. Reich, K., Warren, R. B., Lebwohl, M., Gooderham, M., Strober, B., Langley, R. G., Paul, C., De Cuyper, D., Vanvoorden, V., Madden, C., Cioffi, C., Peterson, L., & Blauvelt, A. (2021). Bimekizumab versus Secukinumab in Plaque Psoriasis. The New England Journal of Medicine, 385(2), 142–152.
  30. Baraliakos, X., Deodhar, A., van der Heijde, D., Van den Bosch, F., Magrey, M., Maksymowych, W. P., Tomita, T., Xu, H., Massow, U., Vaux, T., Prajapati, C., Manente, M., Marten, A., & Gensler, L. S. (2025). Long-term safety and efficacy of bimekizumab in axial spondyloarthritis: 2-year results from two phase 3 studies. Rheumatology (Oxford, England), 64(6), 3534–3546.
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  32. van der Horst-Bruinsma, I. E., Brown, M. A., van Gaalen, F., Haroon, N., Gensler, L. S., Marten, A., Manente, M., Stojan, G., Vaux, T., White, K., Deodhar, A., & Rudwaleit, M. (2024, September 1). Low Uveitis Rates in Patients with Axial Spondyloarthritis or Psoriatic Arthritis Treated with Bimekizumab: Long-Term Results from Phase 2b/3 Trials. ACR Meeting Abstracts. https://acrabstracts.org/abstract/low-uveitis-rates-in-patients-with-axial-spondyloarthritis-or-psoriatic-arthritis-treated-with-bimekizumab-long-term-results-from-phase-2b-3-trial/
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Date of creation: October 2025