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BIMZELX IMPROVES OUTCOMES ACROSS KEY DISEASE MANIFESTATIONS AND THE FULL AXSPA SPECTRUM1,2

BIMZELX DELIVERED CLINICALLY SIGNIFICANT EFFICACY, WITH RAPID ONSET AND SUSTAINED ACHIEVEMENT OF HIGH TREATMENT TARGETS IN PATIENTS WITH AXSPA1,2

In two pivotal phase Ill trials, 48% (n=61/128) of patients with nr-axSpA and 45% (n=99/221) of patients with AS achieved the primary endpoint of ASAS 40 at Week 16 with BIMZELX (vs 21% [n=27/126] and 23% [n=25/111] with placebo, respectively; p<0.001 in both trials)1,2

Axial symptoms

BIMZELX PROVIDED CLINICALLY SIGNIFICANT, RAPID, AND SUSTAINED RESPONSES CONSISTENTLY ACROSS THE FULL AXSPA SPECTRUM, AS MEASURED BY ASAS 40*1,3

AXAXIAL1 new
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Disease activity

BIMZELX PROVIDED RAPID (WEEK 16) AND SUSTAINED REDUCTIONS IN DISEASE ACTIVITY AND INFLAMMATION ACROSS THE FULL AXSPA SPECTRUM1,3

AXDisease1
AXDisease2
AXDisease3

Inflammation

BIMZELX PROVIDED A RAPID (WEEK 16) AND SUSTAINED REDUCTION IN INFLAMMATION IN PATIENTS WITH NON-RADIOGRAPHIC AXSPA*1,3

INF1
INF2
INF3

Manifestations

BIMZELX PROVIDED COMPLETE RESOLUTION OF ENTHESITIS FOR MORE THAN 5/10 PATIENTS ACROSS THE FULL AXSPA SPECTRUM3,4,7

MANIFEST1
MANIFEST2
MANIFEST3

FEW EVENTS OF UVEITIS WERE OBSERVED IN THE AXSPA PATIENTS DURING THE PHASE III TRIALS AND THROUGHOUT LONG-TERM EXPOSURE TO BIMZELX2,8

MANIFEST4
Figma5

SAFETY

BIMZELX DEMONSTRATED A CONSISTENT SAFETY PROFILE, WITH LONG-TERM EXPOSURE UP TO 3 YEARS9,10

Long-term exposure observed across 3 years of phase IIb open-label extension studies in PsA and AS,9,10 and phase III trials in PsA, nr-axSpA, AS, and plaque psoriasis1,11–16

RRA
dose1

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 signals.1–4,11,12,17–20

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)**2,17

• Most adverse events were mild to moderate and did not lead to treatment discontinuation1,11,12


• No additional blood monitoring requirements as per the SmPC2,17

 

BIMZELX was generally well tolerated across 52 weeks at a dose of 160 mg Q4W in patients with PsA and axSpA1–4,11,12,17–20

AXSTAB1
AXSTAB2
Rounded axspa

HOW TO USE

DOSING

 

BIMZELX is administered as a single 160 mg injection once every four weeks*2

Dosing2
Axspadosingb

ACCESS

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MORE INFORMATION

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HOMEPAGE

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MODE OF ACTION

PSA Teaser new

PsA

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RESOURCES

Study details

BE MOBILE 1A NEW
BE MOBILE 2A
AXStudy3

Abbreviations

AE, adverse event; AS, ankylosing spondylitis; ASAS 40, ≥40% response in the Assessment of SpondyloArthritis international Society criteria; ASDAS, ankylosing spondylitis disease activity score; ASDAS-ID, ankylosing spondylitis disease activity score-inactive disease; ASDAS-LDA, ankylosing spondylitis disease activity score-low disease activity; ASspiMRI, ankylosing spondylitis spinal magnetic resonance imaging; axSpA, axial spondyloarthritis; BASDAI, Bath ankylosing spondylitis disease activity index; CRP, C-reactive protein; EAIR, exposure-adjusted incidence rate; IBD, inflammatory bowel disease; MASES, Maastricht ankylosing spondylitis enthesitis score; MI, multiple imputation; MoA, mechanism of action; MRI, magnetic resonance imaging; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; OC, observed cases; OLE, open-label extension; PsA, psoriatic arthritis; PY, patient years; Q4W, every four weeks; SAE, serious adverse event; SFU, safety follow-up; SPARCC, Spondyloarthritis Research Consortium of Canada; TB, tuberculosis; TEAE, treatment-emergent adverse event; TNFi-IR, tumour necrosis factor-α inhibitor-inadequate responder; TNFi-naïve, tumour necrosis factor-α inhibitor-naïve; URTI, upper respiratory tract infection

References

  1. 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.
  2. BIMZELX® EU SmPC. Axial spondyloarthritis. https://www.ema.europa.eu/en. Accessed on [MONTH] [YEAR].
  3. Baraliakos. 2022. ACR. Poster L14.
  4. UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report. p13-44.
  5. Aranda-Valera IC, Garrido-Castro JL, Ladehesa-Pineda L, et al. How to calculate ASDAS based on C-reactive protein without individual questions from the BASDAI the BASDAl-based ASDAS formula. Rheumatology (Oxford). 2020;59(7):1545-1549.
  6. Zochling J. Measures of symptoms and disease status in ankylosing spondylitis. Arthritis Care Res (Hoboken). 2011;63(suppl. 11):S47-S58.
  7. 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. Supplementary appendix.
  8. [Author] 2023. EULAR. Abstract [number XX] Submitted for presentation at EULAR.
  9. 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.
  10. 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 llb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1943-1958.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130-141.
  16. Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142-152.
  17. BIMZELX® EU SmPC. Psoriatic arthritis. https://www.ema.europa.eu/en. Accessed on [MONTH] [YEAR].
  18. Ritchlin. 2022. ACR. Oral presentation L02.
  19. Coates. 2023. EULAR. Abstract 1306.
  20. UCB Data on file. 2022. PA0010. Clinical Study Report. p73-77.
  21. 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. Supplementary appendix.

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