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BIMZELX DELIVERS EFFICACY ACROSS KEY DISEASE DOMAINS OF PsA1–4

EFFICACY

BIMZELX PROVIDED CLINICALLY SIGNIFICANT EFFICACY, WITH RAPID ONSET AND SUSTAINED ACHIEVEMENT OF HIGH TREATMENT TARGETS IN PATIENTS WITH PSA1–4

 

In two pivotal phase III trials, 44 % (n = 189/431) of biologic-naïve and 43 % (n = 116/267) of TNFi-inadequate responder patients achieved the primary endpoint of ACR 50 at Week 16 with BIMZELX (versus 10 % [n = 28/281] and7 % [n = 9/133] with placebo, respectively; p < 0.0001 in both trials)1,2

Joint efficacy

BIMZELX PROVIDED CLINICALLY SIGNIFICANT, RAPID, AND SUSTAINED EFFICACY IN THE JOINTS IN PSA PATIENTS AS MEASURED BY ACR 50*1–4

 

Primary endpoint: ACR 50 at Week 16 (p < 0.0001 vs placebo)1

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Skin efficacy

BIMZELX PROVIDED SUSTAINED ALMOST COMPLETE OR COMPLETE SKIN CLEARANCE, AS MEASURED BY PASI 90 OR PASI 100*1,2,4,5

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Disease activity

BIMZELX DELIVERED CLINICALLY SIGNIFICANT, RAPID, AND SUSTAINED EFFICACY ACROSS MULTIPLE DISEASE DOMAINS IN PSA PATIENTS, AS MEASURED BY MDA*1,2,4–7

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SAFETY

BIMZELX DEMONSTRATED A CONSISTENT SAFETY PROFILE, WITH LONG-TERM EXPOSURE UP TO 3 YEARS12,13

Long-term exposure observed across 3 years of phase IIb open-label extension studies in PsA and AS,1,2 and phase III trials in PsA, nr-axSpA, AS (r-axSpA), and plaque psoriasis3–9

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Across all phase III trials in PsA and axSpA, rates of TEAEs and AEs of special monitoring were low, and there were no new safety signals1,2,14–18

Most frequently reported adverse reactions were upper respiratory tract infections (14.5 % in plaque psoriasis, 14.6 % in PsA, and 16.3 % in axSpA) and oral candidiasis (7.3 % in plaque psoriasis, 2.3 % in PsA, and 3.7 % in axSpA)**10,11

• Most adverse events were mild to moderate and did not lead to treatment discontinuation3–5

• No additional blood monitoring requirements as per the SmPC10,11

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HOW TO USE

DOSING REGIMEN

 

BIMZLEX: One 160 mg dose once every 4 weeks

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MORE INFORMATION

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HOMEPAGE

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MODE OF ACTION

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axSpA

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RESOURCES

Study details

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BE COMPLETE B
BE ACTIVEB

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; EAIR, exposure-adjusted incidence rate; HAQ-DI, Health Assessment Questionnaire Disability Index; IBD, inflammatory bowel disease; MACE, major adverse cardiovascular event; MDA, minimal disease activity; MoA, mechanism of action; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; OLE, open-label extension; PASI 90/100, ≥90/100% improvement from baseline in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; Q2W, every two weeks; Q4W, every four weeks; SAE, serious adverse event; SFU, safety follow-up; SIB, suicidal ideation and behaviour; SmPC, Summary of Product Characteristics; TB, tuberculosis; TEAE, treatment-emergent adverse event; TNFi-IR, tumour necrosis factor-α inhibitor-inadequate responder; ULN, upper limit of normal; URTI, upper respiratory tract infection; UTI, urinary tract infection; VAS, visual analogue scale; vdHmTSS, van der Heijde modified Total Sharp Score.

References

  1. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37.
  2. Merola JF, Landewé R, McInnes IB, et al. 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). Lancet. 2023;401(10370):38-48.
  3. BIMZELX® EU SmPC. Psoriatic arthritis. https://www.ema.europa.eu/en. Accessed on [MONTH] [YEAR].
  4. Coates. 2023. EULAR. Abstract 1306.
  5. Ritchlin CT, Coates LC, McInnes IB, et al. 2022. ACR. Oral presentation L02.
  6. UCB Data on file. 2022. PA0010. Clinical Study Report. p49-77.
  7. UCB Data on file. 2022. PA0011/PA0012. Table 8.4.12. p2.
  8. Gossec L, McGonagle D, Korotaeva T, et al. Minimal disease activity as a treatment target in psoriatic arthritis: a review of the literature. J Rheumatol. 2018;45(1):6-13.
  9. Pope JE, Khanna D, Norrie D, et al. The minimally important difference for the health assessment questionnaire in rheumatoid arthritis clinical practice is smaller than in randomized controlled trials. J Rheumatol. 2009;36(2):254-259.
  10. 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: March 2023.
  11. Nikiphorou E, Radner H, Chatzidionysiou K, et al. Patient global assessment in measuring disease activity in rheumatoid
arthritis: a review of the literature. Arthritis Res Ther. 2016;18(1):251.
  12. Coates LC, McInnes IB, Merola JF, et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: three-year results from a phase IIb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1959-1970.
  13. Baraliakos X, Deodhar A, Dougados M, et al. Safety and efficacy of bimekizumab in patients with active ankylosing spondylitis: three-year results from a phase lIb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1943-1958.
  14. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of bimekizumab in axial spondyloarthritis: results of two parallel phase 3 randomised controlled trials. Ann Rheum Dis. 2023. 82(4):515–526.
  15. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.
  16. Reich K, Papp KA, Blauvelt A, et al. 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. Lancet. 2021;397(10273):487-498.
  17. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130-141.
  18. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142-152.
  19. BIMZELX® EU SmPC. Axial spondyloarthritis. https://www.ema.europa.eu/en. Accessed on [MONTH] [YEAR].
  20. Baraliakos. 2022. ACR. Poster L14.
  21. UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report. p36-44.
  22. UCB Data on file. 2022. PA0011/PA0012. Table 11.1.1.1.3. p1.
  23. UCB Data on file. 2022. PA0011/PA0012. Table 11.1.2.1.3. p1-12.
  24. UCB Data on file. 2022. PA0011/PA0012. Table 11.2.9.10.3. p2.
  25. UCB Data on file. 2022. PA0011/PA0012. Table 11.1.5.1.3. p50.
  26. UCB Data on file. 2022. PA0011/PA0012. Table 11.2.1.1.3. p2.
  27. UCB Data on file. 2022. PA0011/PA0012. Table 11.2.9.4.3. p1.
  28. UCB Data on file. 2022. PA0011/PA0012. Table 11.2.3.1.3. p1-2.
  29. McInnes IB, Asahina A, Coates LC, et al. Bimekizumab in patients with psoriatic arthritis, naive to biologic treatment: a randomised, double-blind, placebo-controlled, phase 3 trial (BE OPTIMAL). Lancet. 2023;401(10370):25-37. Supplementary appendix.
  30. Merola JF, Landewé R, McInnes IB, et al. 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). Lancet. 2023;401(10370):38-48. Supplementary appendix.
  31. Coates LC, McInnes IB, Merola JF, et al. Safety and efficacy of bimekizumab in patients with active psoriatic arthritis: three-year results from a phase llb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1959-1970. Supplementary appendix.
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SE-P-BK-axSpA-2300028

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