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*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 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

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or, via the MHRA Yellow Card App in the Google Play or Apple App Store for the UK and www.hpra.ie/homepage/about-us/report-an-issue for the ROI. Adverse events should also be reported to UCB Pharma Ltd. Email: UCBCares.UK@UCB.com or 0800 2793177 for the UK or UCBCares.IE@UCB.com or 1800 930075 for the ROI.

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

axSpA Rheum

axSpA

Rheum BKZ Resource

RESOURCES

MOA Rheum

MECHANISM OF ACTION

Abbreviations

ACR 50, ≥50% response in the American College of Rheumatology criteria; AS, ankylosing spondylitis; ASAS 40, ≥40% improvement in the Assessment of SpondyloArthritis International Society criteria; ASDAS, Ankylosing Spondylitis Disease Activity Score; axSpA, axial spondyloarthritis; BSA, body surface area; CRP, c-reactive protein; DMARDs, disease-modifying antirheumatic drugs; HS, hidradenitis suppurativa; IL, interleukin; MHRA, Medicines and Healthcare products Regulatory Agency; MI, multiple imputation; MOA, mechanism of action; MRI, magnetic resonance imaging; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; NSAIDs, non-steroidal anti-inflammatory drugs; PASI, Psoriasis Area and Severity Index; PASI 90, >90 improvement from baseline in Psoriasis Area Severity Index; PsA, psoriatic arthritis; r-axSpA, radiographic axial spondyloarthritis; TNFi-IR, tumour necrosis factor inhibitor-inadequate response.

References

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  2. Merola, J. F., Landewé, R., McInnes, I. B., Mease, P. J., Ritchlin, C. T., Tanaka, Y., Asahina, A., Behrens, F., Gladman, D. D., Gossec, L., Gottlieb, A. B., Thaçi, D., Warren, R. B., Ink, B., Assudani, D., Bajracharya, R., Shende, V., Coarse, J., & Coates, L. C. (2023). 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). The Lancet, 401(10370), 38–48. 
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  5. Ritchlin, C. T., Coates, L. C., McInnes, I. B., Mease, P. J., Merola, J. F., Tanaka, Y., Asahina, A., Gossec, L., Gottlieb, A. B., Warren, R. B., Ink, B., Bajracharya, R., Shende, V., Coarse, J., & Landewé, R. B. (2023). Bimekizumab treatment in biologic DMARD-naïve patients with active psoriatic arthritis: 52-week efficacy and safety results from the phase III, randomised, placebo-controlled, active reference BE OPTIMAL study. Annals of the Rheumatic Diseases, 82(11), 1404– 1414. 
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  38. 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. 
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  40. 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.
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Date of creation: July 2026