axSpA

▼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 DELIVERED HIGH TREATMENT TARGETS ACROSS THE FULL axSpA SPECTRUM1,2

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

EFFICACY

BIMZELX DELIVERED EFFICACY IN AXSPA PATIENTS, SUSTAINED OVER TIME (to week 52)1,2

 

In two pivotal phase Ill trials, 47.7% (n=61/128) of patients with nr-axSpA and 44.8% (n=99/221) of patients with AS achieved the primary endpoint of ASAS 40 at Week 16 with BIMZELX (vs 21.4% [n=27/126] and 22.5% [n=25/111] with placebo, respectively; p<0.001 in both trials)1,2

Axial symptoms
BIMZELX PROVIDED DEEP AND SUSTAINED RESPONSES CONSISTENTLY ACROSS THE FULL axSpA SPECTRUM (TO WEEK 52)*1–3

*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

 

Non-radiographic axSpA and ankylosing spondylitis

 ""

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

Ankylosing spondylitis

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 
 

     

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

 

*In BE MOBILE 1, ASAS 40 was achieved by 16.4% (n=21/128) with BIMZELX at Week 1 (vs 1.6% [n=2/126] with placebo),2,4 47.7% (n=61/128) at Week 16 (vs 21.4% [n=27/126] with placebo, p<0.001), and 60.9% (n=78/128) at Week 52 of patients with nr-axSpA in the BIMZELX treatment arm (NRI analysis).1,3 **In BE MOBILE 2, ASAS 40 was achieved by 16.7% (n=37/221) with BIMZELX at Week 2 (vs 7.2% [n=8/111] with placebo),2,4 44.8% (n=99/221) at Week 16 (vs 22.5% [n=25/111] with placebo, p<0.001), and 58.4% (n=129/221) at Week 52 of patients with AS in the BIMZELX treatment arm (NRI analysis);1,3 In BE MOBILE 1, 86.6% (n=220/254) of patients with nr-axSpA who completed 16 weeks of treatment remained on BIMZELX at Week 52.3 In BE MOBILE 2, 89.8% (n=298/332) of patients with AS who completed 16 weeks of treatment remained on BIMZELX at Week 52.3

Disease Activity
BIMZELX PROVIDED SUSTAINED REDUCTIONS IN DISEASE ACTIVITY AND INFLAMMATION ACROSS THE FULL axSpA SPECTRUM (TO WEEK 52)1–3

 

 

Non-radiographic axSpA

 

ASDAS measures disease activity using patient-reported outcomes and an objective sign of inflammation (CRP)*5,6

""

 

Adapted from Baraliakos. X, et al.

After Week 16 all patients were aware that they were receiving active treatment, which may have affected the results. 

 

 

Ankylosing spondylitis

 

ASDAS measures disease activity using patient-reported outcomes and an objective sign of inflammation (CRP)*5,6

 

Adapted from Baraliakos. X, et al. 2022.

After Week 16 all patients in BE MOBILE 1 & BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results.

 

Non-radiographic axSpA and ankylosing spondylitis
ASDAS measures disease activity using patient-reported outcomes and an objective sign of inflammation (CRP)*5,6

 

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

*In BE MOBILE 1, ASDAS <2.1 was achieved by 46.1% (n=59/128) at Week 16 (vs 21.1% [n=26/126] with placebo) and 61.6% (n=79/128) at Week 52 of nr-axSpA patients in the BIMZELX treatment arm (MI analysis).3 In BE MOBILE 2, ASDAS <2.1 was achieved by 44.8% (n=99/221) at Week 16 (vs 17.4% [n=20/111] with placebo) and 57.1% (n=126/221) at Week 52 of AS patients in the BIMZELX treatment arm (MI analysis).3 ASDAS-MI response at Weeks 24 and 52 was an exploratory endpoint.1,3

o

 

Inflammation
BIMZELX PROVIDED A SUSTAINED REDUCTION IN INFLAMMATION ACROSS THE FULL axSpA SPECTRUM (TO WEEK 52)*1–3

 

 

 

 

 

 

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

*In BE MOBILE 1, inflammation of the sacroiliac joints, measured via SPARCC MRI, was reduced from a baseline mean score of 8.0 in the BIMZELX treatment arm and 9.8 in the placebo treatment arm to 2.0 and 9.0 at Week 16, respectively, nominal p<0.001 (OC).3,4 In BE MOBILE 2, inflammation of the spine, measured via ASspiMRI-a Berlin, was reduced from a baseline mean score of 5.4 in the BIMZELX treatment arm and 3.8 in the placebo treatment arm to 1.4 and 4.5 at Week 16, respectively, nominal p<0.001 (OC);3,4 **In BE MOBILE 1, Week 52 SPARCC MRI was reduced to a mean score of 1.0 (OC).3 In BE MOBILE 2, Week 52 ASspiMRI-a Berlin was reduced to a mean score of 0.8 (OC).3

Manifestations
BIMZELX PROVIDED COMPLETE RESOLUTION OF ENTHESITIS FOR MORE THAN 50% OF PATIENTS ACROSS THE FULL axSpA SPECTRUM BY WEEK 523,4,7

 

Non-radiographic axSpA

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

Ankylosing spondylitis

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

 

Non-radiographic axSpA and ankylosing spondylitis

Adapted from Baraliakos. 2022. ACR. Poster L14, UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report, and van der Heide D, et al. Ann Rheum Dis. 2023. Supplementary appendix [ePub).

 

After Week 16 patients in BE MOBILE 1 and BE MOBILE 2 were aware that they were receiving active treatment, which may have affected the results. 

 

*In BE MOBILE 1, complete resolution of enthesitis, measured via MASES=0, was achieved by 51.1% (n=48/94) in the BIMZELX treatment arm versus 23.9% (n=22/92) in the placebo arm at Week 16, nominal p<0.001 (NRI analysis).7 In BE MOBILE 2, complete resolution of enthesitis, measured via MASES=0, was achieved by 51.5% (n=68/132) in the BIMZELX treatment arm versus 32.8% (n=22/67) in the placebo arm at Week 16, nominal p<0.001 (NRI analysis);7 **In BE MOBILE 1 and BE MOBILE 2, complete resolution of enthesitis (MASES=0) was achieved by 54.3% (n=51/94) of patients with nr-axSpA and 50.8% (n=67/132) of patients with AS at Week 52.3,4

 

LESS THAN 1% OF PATIENTS WUTH NR-AXSPA AND AS DEVELOPED UVEITIS DURING THE PHASE III TRIALS AND THROUGHOUT LONG TERM EXPOSURE TO BIMZELX 2,8

*Of 349 patients randomised to BIMZELX treatment across BE MOBILE 1 and BE MOBILE 2, 14.9% (n=52) had a history of uveitis at baseline (pooled data);8 **Of 848 patients randomised to BIMZELX across the phase IIb and phase III trials (pooled data), 15.3% (n=130) had a history of uveitis at baseline;8 †All uveitis events were mild to moderate, and only one event led to discontinuation.8

axspa-asdas-explained
SAFETY

BIMZELX WAS GENERALLY WELL TOLERATED IN PSA AND AXSPA PATIENTS, 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 moderate-to-severe plaque psoriasis1,11–16

 

 

Safety

Across all four 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 moderate-to-severe plaque psoriasis, 14.6%

in PsA, and 16.3% in axSpA) and oral candidiasis (7.3% in moderate-to-severe plaque psoriasis, 2.3% in PsA, and 3.7% in axSpA)**2

 

  • Most adverse events were mild to moderate and most did not lead to treatment discontinuation1,11,12
  • No additional blood monitoring requirements2 

 

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

axspa safety
axspa safety2

 

*4,821 patients treated in blinded and open-label clinical studies in PsA, nr-axSpA, AS, and plaque psoriasis;2 **Data shown here are from the placebo-controlled period of the phase III trials in plaque psoriasis, PsA, and axSpA; †Week 52 data are from the BE MOBILE 1 and BE MOBILE 2 open-label maintenance phases.3 

HOW TO USE

SIMPLICITY 2

 

BIMZELX is administered as a single 160 mg subcutaneous injection once every 4 weeks*2

dose
INJECTION CHART

*The recommended dose for adult patients with axial spondyloarthritis is 160 mg (given as one subcutaneous injection) every four weeks. Consideration should be given to discontinuing treatment in patients who have shown no improvement by 16 weeks of treatment.2

Pivotal phase III study design: BE MOBILE 1
 
Patients with nr-axSpA (TNFi-naïve and TNFi-inadequate responders)7
Be Mobile

Adapted from van der Heijde D, et al. Ann Rheum Dis. 2023 (ePub). Supplementary appendix

Pivotal phase III study design: BE MOBILE 2
 
Patients with AS (TNFi-naïve and TNFi-inadequate responders)7
Be Mobile 2

Adapted from van der Heijde D, et al. Ann Rheum Dis. 2023 (ePub). Supplementary appendix

Phase IIb and open-label extension study design: BE AGILE

 

Patients with AS20
Be agile

Adapted from van der Heijde D, et al. Ann Rheum Dis. 2023 (ePub). Supplementary appendix

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® (bimekizumab) SmPC. 
  3. 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 Studies [abstract]. Arthritis Rheumatol. 2022; 74 (suppl 9).
  4. UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report.
  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. Coates L, et al 2023. EULAR. Abstract 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. Ritchlin. 2022. ACR. Oral presentation L02.
  18. 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.
  19. UCB Data on file. 2022. PA0010. Clinical Study Report.
  20. 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.
  21. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed October 2023.
  22. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed October 2023.
logo

IE-BK-2400125

Date of creation: October 2023