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 image 02.jpg
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.2

EFFICACY
BIMZELX DELIVERED EFFICACY IN AXSPA PATIENTS, SUSTAINED OVER TIME (TO WEEK 104)4

 

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 SUSTAINED EFFICACY (ASAS 40) CONSISTENTLY ACROSS THE FULL axSpA SPECTRUM TO WEEK 1041,3,4

 

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. 1

 

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. 1

 

 

*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 the open-label treatment period, ASAS 40 was achieved by 49.2% (125/254) of patients with nr-axSpA receiving BIMZELX at Week 104 (NRI analysis). 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);3 In the open-label treatment period, ASAS 40 was achieved by 53.9% (179/332) of patients with AS receiving BIMZELX at Week 104 (NRI analysis).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. 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 
**Includes patients originally randomised to placebo.3

Disease Activity
BIMZELX PROVIDED SUSTAINED REDUCTIONS IN DISEASE ACTIVITY AND INFLAMMATION ACROSS THE FULL axSpA SPECTRUM (TO WEEK 104)4

 

 

Non-radiographic axSpA

 

ASDAS-LDA and ID (ASDAS <2.1) was sustained in 61.2% (155/254) and 63.4% (210/332) of BIMZELX-treated patients in the BE MOBILE 1 and BE MOBILE 2 studies, respectively, at Week 1044

 

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

 

 

Adapted from Baraliakos X, et al. 2022. ACR Poster L14 and Baraliakos X, et al. 2024. EULAR. Poster POS0806.

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

 

 

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. ACR Poster L14 and Baraliakos X, et al. 2024. EULAR. Poster POS0806.

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.1

 

 

Week 104 data includes patients originally randomised to placebo.4


*ASDAS <2.1 values shown next to bars for Week 104 data are manually calculated from ASDAS state response rates.4 In BE MOBILE 1, ASDAS <2.1 was achieved by 61.2% (n=155/254) of patients with nr-axSpA at Week 104.4 In BE MOBILE 2, ASDAS <2.1 was achieved by 63.4% (n=210/332) of patients with AS at Week 104.4 ASDAS-MI response at Weeks 24 and 52 was an exploratory endpoint.1

 

Inflammation
BIMZELX PROVIDED A SUSTAINED REDUCTION IN INFLAMMATION ACROSS THE FULL axSpA SPECTRUM (TO WEEK 104)4

 

57.7% (30/52) of patients with nr-axSpA and 61.3%) (19/31) of patients with AS achieved MRI remission at Weeks 104 (OC)*
These are two separate studies and should not be compared directly

 

 

 

*MRI sub-study enrolling patients receiving BIMZELX with baseline MRI SIJ SPARCC ≥2 (nr-axSpA; n=52) or baseline Berlin MRI spine score >2 (AS; n=31) MRI remission is defined as MRI SIJ SPARCC <2 or Berlin MRI spine score ≤2.4

Manifestations
BIMZELX PROVIDED COMPLETE RESOLUTION OF ENTHESITIS FOR MORE THAN 50% OF PATIENTS ACROSS THE FULL axSpA SPECTRUM BY WEEK 523,8,9

 

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.1

 

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. 1

 

*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).8,9 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);8,9 **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

 

LESS THAN 1% OF PATIENTS WITH NR-AXSPA AND AS DEVELOPED UVEITIS DURING THE PHASE III TRIALS AND THROUGHOUT LONG TERM EXPOSURE TO BIMZELX 1,2,10

 

 

*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).1

axspa-asdas-explained
Bimzelx
Bimzelx

Most common TEAES (>5.0% in BE MOBILE 1 and BE MOBILE 2) with BIMZELX across 52 weeks were:
• Nasopharyngitis (12.3%, n=30/244, and 9.1%, n=30/330), oral candidiasis (7.4%, n=18/244, and 6.1%, n=20/330), and URTIS (9.4%, n=23/244, and 6.4%, n=21/330) in BE MOBILE 1 and BE MOBILE 2, respectively3

 

Most frequent TEAEs to Week 104 by preferred term (EAIR/100 PY) were COVID-19 Infection (13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0),22Most frequent TEAEs to Week 104 by preferred term (EAIR/100 PY)  were COVID-19 infection (13.2), nasopharayngitis (10.2), and upper respiratory tract infection (6.0).4


*Patient population is pooled and includes patients from both BE MOBILE 1 and BE MOBILE 2 who received a dose of BIMZELX, including those originally randomised to placebo, events are reported after switch only.4

Bimzelx

Most common TEAES (>5.0% in BE MOBILE 1 and BE MOBILE 2) with BIMZELX across 52 weeks were:
• Nasopharyngitis (12.3%, n=30/244, and 9.1%, n=30/330), oral candidiasis (7.4%, n=18/244, and 6.1%, n=20/330), and URTIS (9.4%, n=23/244, and 6.4%, n=21/330) in BE MOBILE 1 and BE MOBILE 2, respectively3

 

Most frequent TEAEs to Week 104 by preferred term (EAIR/100 PY) were COVID-19 Infection (13.2), nasopharyngitis (10.2), and upper respiratory tract infection (6.0),22Most frequent TEAEs to Week 104 by preferred term (EAIR/100 PY)  were COVID-19 infection (13.2), nasopharayngitis (10.2), and upper respiratory tract infection (6.0).4


*Patient population is pooled and includes patients from both BE MOBILE 1 and BE MOBILE 2 who received a dose of BIMZELX, including those originally randomised to placebo, events are reported after switch only.4

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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)9
Be Mobile

Adapted from van der Heijde D, et al. Ann Rheum Dis. 2023; 82(4):515-526. Supplementary appendix.

Pivotal phase III study design: BE MOBILE 2

Patients with AS (TNFi-naïve and TNFi-inadequate responders)9
Be Mobile 2

Adapted from van der Heijde D, et al. Ann Rheum Dis. 2023; 82(4):515-526. Supplementary appendix.

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

Patients with AS19
Be agile

Adapted from Baraliakos X, et al. Arthritis Rheumatol. 2022; 71(q12): 1943-58. 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-MI, Ankylosing Spondylitis Disease Activity Score - major improvement; 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; HS, hidradenitis suppurativa; 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; SIJ, sacroiliac joint; 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; Q4W, every 4 weeks.

References

1. van der Heijde D, et al. Ann Rheum Dis. 2023; 82(4):515-526.
2. BIMZELX® (bimekizumab) SmPC. 
3. Baraliakos X, et al. Ann Rheum Dis. 2024;83:199-213.
4. Baraliakos X, et al. 2024. EULAR Poster POS0806.
5. Aranda-Valera IC, et al. Rheumatology (Oxford). 2020;59(7):1545-1549.
6. Zochling J. Arthritis Care Res (Hoboken). 2011;63 Suppl 11:S47-58.
7. Baraliakos X, et al. 2022. ACR. Poster L14.
8. UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report. p29.
9. van der Heijde D, et al. Ann Rheum Dis. 2023; 82(4):515-526. Supplementary appendix.
10. Rudwaleit M, et al. Ann Rheum Dis. 2023;82:614-615.
11. Zochling J. Arthritis Care Res (Hoboken). 2011;63(suppl. 11):S47-S58.
12. McInnes IB, et al. Lancet. 2023;401(10370):25-37.
13. Merola JF, et al. Lancet. 2023;401(10370):38-48.
14. Gordon KB, et al. Lancet. 2021;397(10273):475-486.
15. Reich K, et al. Lancet. 2021;397(10273):487-498.
16. Warren RB, et al. N Engl J Med. 2021;385(2):130-141.
17. Reich K, et al. N Engl J Med. 2021;385(2):142-152.
18. UCB Data on file. 2022. AS0010 and AS0011. Clinical Study Report. p36-44.
19. Baraliakos X, et al. Arthritis Rheumatol. 2022;74(12):1943-58. Supplementary appendix.
20. Update to PsA NICE, 2023. https://www.nice.org.uk/guidance/ta916. Accessed August 2024.
21. Update to axSpA NICE, 2023. https://www.nice.org.uk/guidance/indevelopment/gid-ta11347. Accessed August 2024.

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Date of creation: September 2024