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*ACR 50 was achieved by 44% of biologic-naïve and 43% of TNFi-IR patients with PsA at Week 16 (primary endpoint in both studies);1,2 18% and 16% at Week 4; 55% and 52% at Week 52, respectively (NRI analysis).1-4 ASAS 40 was achieved by 48% of nr-axSpA patients and 45% of AS patients at Week 16 (primary endpoint in both studies);5 16% and 17% at Week 1 and 2; 61% and 58% at Week 52, respectively (NRI analysis).6,7 Reduction of patient limitations was demonstrated using MDA in PsA and ASDAS <2.1 in axSpA. MDA was achieved by 45% of biologic-naïve patients and 44% of TNFi-IR patients with PsA at Week 16 (NRI analysis).1,2 ASDAS <2.1 was achieved by 46% of nr-axSpA patients and 45% of AS patients at Week 16 (MI analysis).5

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BIMZELX® (bimekizumab) is indicated for the treatment of: moderate to severe plaque psoriasis, in adults who are candidates for systemic therapy; 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.7

BIMZELX: THE FIRST AND ONLY APPROVED DUAL SELECTIVE INHIBITOR OF IL-17A AND IL-17F FOR USE IN PsA AND axSpA1-7

Bimzelx was generally well tolerated with long-term exposure up to 3 years12,13

Consistent safety profile demonstrated in 4,821 patients across all indications

8,733 patient-years across PsA, nr-axSpA, AS and plaque psoriasis7

Brief Important Safety Information

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); most adverse events were mild to moderate and did not lead to treatment discontinuation.7

Expert opinions

Watch the video below to hear expert rheumatologists Prof. Frank Behrens, Prof. Laure Gossec, Prof. Xenofon Baraliakos and Prof. Lars Erik Kristensen share their first impressions of BIMZELX, its efficacy and mode of action.

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PSA

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AXSPA

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MOA

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Abbreviations

ACR 50, ≥50% response in the American College of Rheumatology criteria; AS, ankylosing spondylitis; ASAS 40, ≥40% response in the Assessment of SpondyloArthritis international Society criteria; ASDAS, ankylosing spondylitis disease activity score; ASDAS-LDA, ankylosing spondylitis disease activity score-low disease activity; axSpA, axial spondyloarthritis; CRP, C-reactive protein; DMARD, disease-modifying anti-rheumatic drug; IGA, Investigator’s Global Assessment; IL, interleukin; MDA, minimal disease activity; MI, multiple imputation; MoA, mechanism of action; MRI, magnetic resonance imaging; nr-axSpA, non-radiographic axial spondyloarthritis; NRI, non-responder imputation; NSAID, non-steroidal anti-inflammatory drug; PASI 90/100, ≥90/100% improvement from baseline in Psoriasis Area and Severity Index; PsA, psoriatic arthritis; TNFi-IR, tumour necrosis factor-α inhibitor-inadequate responder.

Footnotes

*Three head-to-head phase III trials were carried out in plaque psoriasis. These were independent to the phase III trials carried out in PsA and axSpA, which included entirely separate patient populations. No head-to-head trials have been carried out with BIMZELX in patients with PsA or axSpA. Superior skin clearance was demonstrated across the phase III studies BE SURE (BIMZELX vs adalimumab, co-primary endpoints of PASI 90 and IGA 0/1 at Week 16), BE RADIANT (BIMZELX vs secukinumab, primary endpoint of PASI 100 at Week 16) and BE VIVID (BIMZELX vs ustekinumab, co-primary endpoints of PASI 90 and IGA 0/1 at Week 16).8-10 BE SURE: BIMZELX vs adalimumab, 86% (n=275/319) vs 47% (n=75/159) achieved PASI 90, respectively (p<0.001), and 61% (n=194/319) vs 24% (n=38/159) achieved PASI 100, respectively (p<0.001).9 BE RADIANT: BIMZELX vs secukinumab, 86% (n=319/373) vs 74% (n=275/370) achieved PASI 90, respectively, and 62% (n=230/373) vs 49% (n=181/370) achieved PASI 100, respectively (p<0.001).10 BE VIVID: BIMZELX vs ustekinumab vs placebo, 85% (n=273/321) vs 50% (n=81/163) vs 5% (n=4/83) achieved PASI 90, respectively (p<0.0001), and 59% (n=188/321) vs 21% (n=34/163) vs 0% (n=0/83) achieved PASI 100, respectively (p<0.0001).8

**In PsA, ACR 50 at Week 16 (primary endpoint) was achieved by 44% (n=189/431) with BIMZELX, vs 10% (n=28/281) with placebo, of biologic-naïve patients in BE OPTIMAL, and 43% (n=116/267) with BIMZELX, vs 7% (n=9/133) with placebo, of TNFi-inadequate responders in BE COMPLETE (NRI analysis); PASI 90 and PASI 100 at Week 16 were achieved by 61% (n=133/217) with BIMZELX (vs 3% [n=4/140] with placebo) and 47% (n=103/217) with BIMZELX (vs 2% [n=3/140] with placebo) of biologic-naïve patients, respectively, in BE OPTIMAL, and 69% (n=121/176) with BIMZELX (vs 7% [n=6/88] with placebo) and 59% (n=103/176) with BIMZELX (vs 5% [n=4/88] with placebo) of TNFi-inadequate responders, respectively, in BE COMPLETE (NRI analysis); MDA at Week 16 was achieved by 45% (n=194/431) of biologic-naïve patients with BIMZELX (vs 13% [n=37/281] with placebo) in BE OPTIMAL and 44% (n=118/267) of TNFi-inadequate responders with BIMZELX (vs 6% [n=8/133] with placebo) in BE COMPLETE (NRI analysis). **In BE OPTIMAL, ACR 50 was achieved by 44% (n=189/431) at Week 16 (vs 10% [n=28/281] with placebo, p<0.0001), and 55% (n=235/431) at Week 52 of biologic-naïve patients in the BIMZELX treatment arm (NRI analysis).1,3 In BE COMPLETE, ACR 50 was achieved by 43% (n=116/267) at Week 16 (vs 7% [n=9/133] with placebo, p<0.0001), and 52% (n=138/267) at Week 52 of TNFi-IR patients in the BIMZELX treatment arm (NRI analysis).2,4 In BE OPTIMAL, at Week 16: PASI 90 was achieved by 61% (n=133/217) with BIMZELX and 3% (n=4/140) with placebo, and PASI 100 was achieved by 47% (n=103/217) with BIMZELX and 2% (n=3/140) with placebo; at Week 52: PASI 90 was achieved by 71% (n=155/217) and PASI 100 was achieved by 61% (n=132/217) of patients in the BIMZELX treatment arm (NRI analysis).1,3 In BE COMPLETE, at Week 16: PASI 90 was achieved by 69% (n=121/176) with BIMZELX and 7% (6/88) with placebo, and PASI 100 was achieved by 59% (n=103/176) with BIMZELX and 5% (n=4/88) with placebo; at Week 52: PASI 90 was achieved by 74% (n=131/176) and PASI 100 was achieved by 66% (n=116/176) of patients in the BIMZELX treatment arm (NRI analysis).2,4 In BE OPTIMAL, MDA was achieved by 45% (n=194/431) at Week 16 (vs 13% [n=37/281] with placebo, p<0.0001), and 55% (n=237/431) of patients in the BIMZELX treatment arm at Week 52 (NRI analysis).1,3 In BE COMPLETE, MDA was achieved by 44% (n=118/267) at Week 16 (vs 6% [n=8/133] with placebo, p<0.0001), and 47% (n=126/267) of patients in the BIMZELX treatment arm at Week 52 (NRI analysis).2,4

†In BE MOBILE 1, ASAS 40 was achieved by 48% (n=61/128) at Week 16 (vs 21% [n=27/126] with placebo, p<0.001), and 61% (n=78/128) at Week 52 of patients with nr-axSpA in the BIMZELX treatment arm (NRI analysis).5,6,14 In BE MOBILE 2, ASAS 40 was achieved by 45% (n=99/221) at Week 16 (vs 23% [n=25/111] with placebo, p<0.001), and 58% (n=129/221) at Week 52 of patients with AS in the BIMZELX treatment arm (NRI analysis).5,6,14 In BE MOBILE 1, ASDAS <2.1 was achieved by 46% (n=59/128) at Week 16 (vs 21% [n=26/126] with placebo) and 62% (n=79/128) at Week 52 of nr-axSpA patients in the BIMZELX treatment arm (MI analysis).5,6,14 In BE MOBILE 2, ASDAS <2.1 was achieved by 45% (n=99/221) at Week 16 (vs 18% [n=20/111] with placebo) and 57% (n=126/221) at Week 52 of AS patients in the BIMZELX treatment arm (MI analysis).5,6,14

‡Meaningful efficacy across key domains and manifestations in PsA is defined by the achievement of high-level efficacy in joints (ACR 50), skin (PASI 100), minimal disease activity, and complete resolution of enthesitis and dactylitis (50% and 76% at Week 16, respectively, of biologic-naïve and TNFi-inadequate responders with BIMZELX [pooled data, vs 35% and 51%, respectively, with placebo; and 57% and 80% at Week 52, respectively, with BIMZELX; NRI analysis]).1,3

§Meaningful efficacy across key domains and manifestations of the full axSpA spectrum is defined by the achievement of high-level efficacy in core symptoms (ASAS 40), disease activity (ASDAS-LDA), and complete resolution of enthesitis (achieved by 51% of nr‑axSpA patients and 52% of AS patients with BIMZELX at Week 16 vs 24% and 33%, respectively, with placebo; and 54% of nr-axSpA patients and 51% of AS patients at Week 52. NRI analysis).5,6,11

4,821 patients treated in blinded and open-label clinical studies in PsA, nr-axSpA, AS, and plaque psoriasis.7

References
  • 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.
  • 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.
  • Ritchlin CT, Coates LC, McInnes IB, et al. 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. Ann Rheum Dis. 2023;82:1404–14.
  • Coates L, et al. Sustained Efficacy and Safety of Bimekizumab in Patients with Active Psoriatic Arthritis and Prior Inadequate Response to Tumour Necrosis Factor Inhibitors: Results from the Phase 3 BE COMPLETE Study and its Open-Label Extension up to 1 Year. EULAR. 2023. Abstract POS0231.
  • 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):515–26.
  • Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab treatment in patients with active axial spondyloarthritis: 52-week efficacy and safety from the randomised parallel phase 3 BE MOBILE 1 and BE MOBILE 2 studies. Ann Rheum Dis. 2023;0:1–15. doi:10.1136/ard-2023-224803.
  • BIMZELX® EU SmPC. Psoriatic arthritis and axial spondyloarthritis. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed: March 2024.
  • 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):487–98.
  • Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–41.
  • Reich K, Warren RB, Lebwohl M, et al. Bimekizumab versus secukinumab in plaque psoriasis. N Engl J Med. 2021;385(2):142–52.
  • 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):515–26. Supplementary appendix.
  • 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):1959–70.
  • 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 IIb randomized controlled trial and its open-label extension study. Arthritis Rheumatol. 2022;74(12):1943–58.
  • Baraliakos X, Deodhar A, van der Heijde D, et al. Bimekizumab Maintains Improvements in Efficacy Endpoints and Has a Consistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Parallel Phase 3 Studues, 2022. ACR. Abstract L14.