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).3,6 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. 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.

NICE recommendation

BIMZELX: THE FIRST AND ONLY APPROVED DUAL SELECTIVE INHIBITOR OF IL-17A AND IL-17F FOR USE IN PsA AND axSpA3

 

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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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; ALT, alanine aminotransferase; 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; EAIR, exposure-adjusted event rate; IBD, inflammatory bowel disease; IL, interleukin; MDA, minimal disease activity; MHRA, Medicines and Healthcare products Regulatory Agency; MI, multiple imputation; MRI, magnetic resonance imaging; NICE, The National Institute for Health and Care Excellence; NSAIDs, non-steroidal anti-inflammatory drugs; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; PASI 90, ≥90% improvement from baseline in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; SmPC, summary of product characteristics; PY, patient-years; SIB, suicidal ideation and behaviour; TB, tuberculosis; TEAE, treatment-emergent event; TNFi-IR, tumour necrosis factor inhibitor-inadequate response; UTI, urinary tract infection; Q4W, every 4 weeks; Q8W, every 8 weeks.

References

1. McInnes IB, et al. Lancet. 2023;401(10370):25-37.
2. Merola JF, et al. Lancet. 2023;401(10370):38-48.
3. BIMZELX® SmPC.
4. Coates LC, et al. RMD Open. 2024;10(1):e003855.
5. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414.
6. van der Heijde D, et al. Ann Rheum Dis. 2023;82(4):515-526.
7. UCB Data on file. 2023. AS0010 Clinical Study Report.
8. UCB Data on file. 2023. AS0011 Clinical Study Report.
9. Baraliakos X, et al. Ann Rheum Dis. 2024;83(2):199-213. 
10. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed August 2024
11. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed August 2024.
12. Gordon KB, et al. Poster P1569/ Presented at the European Academy of Dermatology and Venereology (EADV) meeting, September 7-10 2022; Milan, Italy.
13. Gossec L, McGonagle D, Korotaeva T, et al. J Rheumatol. 2018;45(1):6-13.14. 
14. Reich K, Warren RB, Lebwohl M, et al. N Engl J .Med. 2021;385(2):142-152.
15. Ritchlin CT, et al. Ann Rheum Dis. 2023;82(11):1404-1414. Supplementary appendix.
16. Coates LC, et al. 2024. EULAR. Poster POS0969.
17. UCB Data on file. 2022. PA0011/PA0012 Table 8.4.12. p2.
18. Gordon KB, Foley, P, Krueger JG, et al. Lancet. 2021;397(10273):475-486.
19. Reich K, Papp KA, Bauvelt A, et al. Lancet. 2021;397(10273):487-498.
20. Warren RB, Blauvelt A, Bagel, et al. N Eng J Med. 2021;385(2):130-141.
21. McInnes IB, et al. Lancet. 2023;401(10370):25-37. Supplementary appendix.
22. Merola JF, et al. Lancet. 2023;401(10370):38-48. Supplementary appendix.
23. Coates LC, et al. Arthritis Rheumatol. 2022;74;1959-1970. Supplementary appendix.
24. Pope JE, Khanna D, Norrie D, et al. J Rheumatol. 2009;36(2):254-259. 
25. Stanford University School of Medicine. The Health Assessment Questionnaire. Available at: https://www.niehs.nih.gov/research/resources/assets/docs/haq_instructions_508.pdf  Accessed August 2024.
26. Nikiphorou E, Radner H, Chatzidionysiou K, et al. Arthritis Res Ther. 2016;18(1):251.

27. UCB Data on file. 2022. PA0010. Clinical Study Report. p73-77

28. UCB Data on file. 2022. PA0011/PA0012. Table 11.1.1.1.3. pl.

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Date of creation: November 2024