test 5

*Deep is defined as achievement of the clinical outcomes of ACR 50 in PsA and ASAS 40 in axSpA:  ACR 50 was achieved by 43.9% (189/431) of biologic-naïve and 43.4% (116/267) of TNFi-IR patients with PsA at Week 16 (primary endpoint in BE OPTIMAL and BE COMPLETE),1–3 54.5% (235/431) and 51.7% (138/267) at Week 52 respectively (NRI analysis).4,5 ASAS 40 was achieved by 47.7% (61/128) of nr-axSpA patients and 44.8% (99/221) of AS patients at Week 16, (primary endpoint in BE MOBILE 1/2);6 60.9% (78/128) and 58.4% (129/221) at Week 52, respectively (NRI analysis).3,6 Rapid onset was demonstrated by numerically higher responder rates (ACR 50) observed when compared with placebo at Week 4 in BE OPTIMAL, 17.6% (76/431), versus 3.2% (9/281); and BE COMPLETE, 16.1% (43/267) versus 1.5% (2/133) respectively.1,2 Rapid separation in ASAS 40 response rates was observed within 1–2 weeks after single a dose of BIMZELX versus placebo; 16.4% (21/128) versus 1.6% (2/126) at Week 1 in BE MOBILE 1, and 16.7% (37/221) versus 7.2% (8/111) at Week 2 in BE MOBILE 2 (NRI analysis).6,7 Reduction of patient limitations was demonstrated using MDA in PsA and ASDAS <2.1 in axSpA. MDA was achieved by 45.0% (194/431) of biologic-naïve and 44.2% (118/267) TNFi-IR patients with PsA at Week 16 (NRI analysis).3 ASDAS <2.1 was achieved by 46.1% (59/128) of nr-axSpA patients and 44.8% (99/221) of AS patients at Week 16, BE MOBILE 1 and BE MOBILE 2 respectively (exploratory endpoint, MI analysis).3

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

achieve consistency

MORE INFORMATION

PSA

PsA

MOA Rheum

MECHANISM OF ACTION

axSpA Rheum

axSpA

Rheum BKZ Resource

RESOURCES

Footnotes

* In PsA, ACR 50 at Week 16 (primary endpoint) was achieved by 43.9% (n=189/431) with BIMZELX, vs 10.0% (n=28/281) as per original publication and (n=28/281) with placebo, of biologic-naïve patients in BE OPTIMAL, and 43.4% (n=116/267) with BIMZELX, vs 6.8% (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 61.3% as per SmPC; (n=133/217) with BIMZELX (vs 2.9% as per SmPC [n=4/140] with placebo) and 47.5% (n=103/217) with BIMZELX (vs 2.1% as per SmPC [n=3/140] with placebo) of biologic-naïve patients, respectively, in BE OPTIMAL, and 68.8% (n=121/176) with BIMZELX (vs 6.8% [n=6/88] with placebo) and 58.5% as per SmPC (n=103/176) with BIMZELX (vs 4.5% [n=4/88] with placebo) of TNFi-inadequate responders, respectively, in BE COMPLETE (NRI analysis); MDA at Week 16 was achieved by 45.0% (n=194/431) of biologic-naïve patients with BIMZELX (vs 13.2% [n=37/281] with placebo) in BE OPTIMAL and 44.2% (n=118/267) of TNFi-inadequate responders with BIMZELX (vs 6.0% [n=8/133] with placebo) in BE COMPLETE (NRI analysis).1-2

**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 (MDA), and complete resolution of enthesitis and dactylitis (49.8% [n=124/249] and 75.6% [n=68/90] at Week 16, respectively, of biologic-naïve and TNFi-inadequate responders with BIMZELX [pooled data, vs 34.9% [n=37/106] and 51.1% [n=24/281], respectively, with placebo; NRI analysis]).1,3

† In axSpA, ASAS 40 at Week 16 (primary endpoint) was achieved by 47.7% (n=61/128) with BIMZELX, vs 21.4% (n=27/126) with placebo, of nr-axSpA patients in BE MOBILE 1, and 44.8% (n=99/221) with BIMZELX, vs 22.5% (n=25/111) with placebo, of AS patients in BE MOBILE 2 (MI analysis);3 ASDAS-LDA at Week 16 was achieved by 46.1% as per reference (n=59/128) of nr-axSpA patients with BIMZELX (vs 21.1% as per reference [n=26/126] with placebo) in BE MOBILE 1 and 44.8% (n=99/221) of AS patients with BIMZELX (vs 17.4% [n=19/111] with placebo) in BE MOBILE 2 (NRI analysis).7

‡ Meaningful efficacy across key domains and manifestations of the full axSpA spectrum is defined by the achievement of high-level efficacy in core axial symptoms (ASAS 40), disease activity (ASDAS-LDA), and complete resolution of enthesitis (achieved by 51.1% (n=48/94) of nr- axSpA patients and 51.5% (n=68/132) of AS patients with BIMZELX at Week 16, vs 23.9% (n=22/92) and 32.8% (n=22/67), respectively, with placebo; NRI analysis).6,8

§ In BE OPTIMAL at Week 16: PASI 90 was achieved by 61.3% (n=133/217) with BIMZELX and 2.9% (n=4/140) with placebo. At Week 52: PASI 90 was achieved by 71.4% (n=155/217) of patients in the BIMZELX treatment arm (NRI analysis).1,3 In BE COMPLETE at Week 16: PASI 90 was achieved by 68.8% (n=121/176) with BIMZELX and 6.8% (n=6/88) with placebo. At Week 52: PASI 90 was achieved by 74.4% (n=131/176) of patients in the BIMZELX treatment arm (NRI analysis).2–4

§ For some patients with plaque psoriasis (including psoriatic arthritis with coexistent moderate to severe psoriasis) and a body weight ≥ 120 kg who did not achieve complete skin clearance at week 16, 320 mg every 4 weeks after week 16 may further improve treatment response.3

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; EULAR, European League Against Rheumatism; 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, Landewe R, Mcinnes IB, et al. Bimekizumab in patients with active psoriatic arthritis and previous inadequate response or intolerance to tumour necrosis factor-a inhibitors: a randomised, double-blind, placebo-controlled, phase 3 trial (BE COMPLETE) Lancet. 2023;401(10370) 38–48.
  3. BIMZELX® SmPC.
  4. Coates L, Landewé RBM, Mcinnes I, et al. POS0231 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. Ann Rheum Dis. 2023;82:346-347.
  5. Ritchlin C, Coates L, McInnes I, et al. Bimekizumab Treatment in Biologic DMARD-Naïve Patients with Active Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3, Randomized, Placebo-Controlled, Active Reference Study [abstract]. Arthritis Rheumatol. 2022;74 (suppl 9).
  6. 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.
  7. UCB Data on file. 2022. AS0010 and AS0011.
  8. Gordon, K.B., et al. Poster P1569/ Presented at the European Academy of Dermatology and Venereology (EADV) meeting, September 7-10 2022; Milan, Italy.
  9. 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.
  10. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed October 2023.
  11. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed October 2023.
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Date of creation: November 2023