UCB VIRTUAL BRIEFING
BIMZELX® (bimekizumab)
Four-Year Data in
Moderate to Severe
Plaque Psoriasis
Capital Market Call
12th March 2024
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Proprietary and Confidential Property of UCB
GL-BK-2400026| Date of preparation: March 2024 | 2 |
About BIMZELX® in the United States (U.S.) and in the European Union (EU)
In the U.S.
BIMZLEX® (bimekizumab-bkzx) is approved for the treatment of
In the EU
Approved indications for BIMZELX ®▼ (bimekizumab) are:
moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1
Plaque
Psoriasis
Psoriatic
Arthritis
Axial Spondyloarthritis
Bimekizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.2
Bimekizumab, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).2
Bimekizumab is indicated for the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP), and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidalanti-inflammatory drugs (NSAIDs), and for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.2
Proprietary and Confidential Property of UCB
The label information may differ in other countries where approved. Please check local prescribing information.
▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
References: 1. BIMZELX® (bimekizumab-bkzx) U.S. PI. www.ucb-usa.com/bimzelx-prescribing-information.pdf. Accessed March 2024; 2. BIMZELX® (bimekizumab) EU | |
GL-BK-2400026| Date of preparation: March 2024 | SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Accessed March 2024. |
3 |
Introduction
Emmanuel Caeymaex
Executive Vice President
Immunology Solutions & Head of U.S.
Proprietary and Confidential Property of UCB
GL-BK-2400026| Date of preparation: March 2024 | 4 |
Antje Witte
Head of Investor Relations, UCB
Emmanuel Caeymaex
Executive Vice President
Immunology Solutions & Head of U.S.
Agenda
Dr. Andrew Blauvelt
Blauvelt Consulting, LLC
Lake Oswego, OR, USA
Emmanuel Caeymaex
Executive Vice President
Immunology Solutions & Head of U.S.
WELCOME
INTRODUCTION
BIMZELX®
Four-Year Data in Moderate to Severe Plaque Psoriasis
SUMMARY
Proprietary and Confidential Property of UCB
Q & A Session Facilitated by Antje Witte
GL-BK-2400026| Date of preparation: March 2024 | 5 |
BIMZELX® is the first and only approved biologic to selectively target IL-17F in addition to IL-17A
Approvals in Moderate to Severe Plaque Psoriasis
12 | 41 | >20,000 |
REGULATORY AUTHORITIES | COUNTRIES | PATIENTS ± |
Approvals in Psoriatic Arthritis (PsA) and/or Axial Spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA)and Ankylosing Spondylitis (AS)
European | Great | Japan3 | United Arab | Saudi | Canada6 |
(PsA) | |||||
Union1 | Britain2 | Emirates4 | Arabia5 | ||
References: 1. BIMZELX® (bimekizumab) EU SmPC. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last Accessed March 2024; 2. BIMZELX GB Prescribing
Information GB.https://www.medicines.org.uk/emc/product/12834/smpchttps://www.medicines.org.uk/emc/product/12833/smpcLast accessed: March 2024; 3. BIMZELX Japan Prescribing Information -
https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0001.html. .Last accessed: March 2024; 4.https://mohap.gov.ae/en/services/registered-medical-product-directory.Last
accessed: March 2024; 5. https://www.sfda.gov.sa/enLast accessed: March 2024; 6. BIMZELX Canada Prescribing Information https://pdf.hres.ca/dpd_pm/00064702.PDF. Last accessed: March 2024.;
GL-BK-2400026| Date of preparation: March 2024
Proprietary and Confidential Property of UCB
6
IL-17 plays a pivotal role in the pathogenesis of immune-mediated inflammatory diseases
Innate immunity driven pathology5
Innate lymphocytes5 IL-175
Adaptive immunity driven pathology1
and Confidential Property of UCB
IL-235
Adaptive IL-175 lymphocytes5
Proprietary
IL-17 production by innate lymphocytes
can be independent of IL-236,7
†U.S. prevalence.
References: 1. National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Last accessed: March 2024; 2. Gladman DD, et al. Ann Rheum Dis. 2005; 64 (Suppl 2): ii14-7; 3. Reveille JD. AM J Med Sci. 2013; 345(6):431-36. 4. Calao M et al. PLoS ONE. 2018;13(7):e0200683. 5. Tsukazaki H, Kaito T. Int J Mol Sci. 2020;21(17):6401. 6. Cole S et al. Front Immunol. 2020;11:585134. 7. Łukasik Z, et al. Rheumatology (Oxford). 2021;60(Suppl 4):iv16-iv2
GL-BK-2400026| Date of preparation: March 2024
IL-17F/F5
IL-17A/F5
IL-17A/A5
7
In Phase 3 clinical studies in moderate to severe plaque psoriasis bimekizumab demonstrated rapid, complete and maintained response
Patients with moderate to severe plaque psoriasis place a high value on treatment which provides*1
- Clear skin
- Sustained response
- Rapid onset of action
Rapid | >7 out of 10 | achieved PASI 75 | at Week 4 after |
patients | 1 dose 2,3,4 |
Complete | ~6 out of 10 | achieved PASI 100 at Week 16 2,3,4 |
patients |
Maintained | >6 out of 10 | achieved PASI 100 up to Year 1† 2,4 |
patients |
The most frequently reported treatment-emergent adverse event in bimekizumab-treated patients were nasopharyngitis, oral candidiasis, and upper respiratory tract infection*2,3
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- U.S. Cross Sectional Patient Survey (N=500); Attributes are not exclusive
† 52-56 weeks - Reported in more than 5% of bimekizumab-treated patients
References: 1. Gorelick J, et al. Dermatol Ther (Heidelb). 2019;9: 785-797. 2. Reich K, et al. Lancet. 2021;397(10273):487-498. 3. Gordon KB, et al. Lancet. 2021; 397(10273):475-486. 4. Warren RB, et al. N Engl J Med. 2021; 385(2):130-141.
The primary endpoints in the three Phase 3 studies were PASI 90 at week 16 and IGA 0/1 at week 16
GL-BK-2400026| Date of preparation: March 2024 | 8 |
In post-hoc analyses bimekizumab demonstrated high levels of skin clearance in patients with an inadequate response to other therapies
PASI 100 with bimekizumab in patients with an inadequate response to secukinumab, ustekinumab or adalimumab PASI 90 (post hoc analyses)
Proportion of patients achieving PASI100 (%)
100 | PASI 100 responses among | ||
PASI 90 non-responders (mNRI) | |||
75 | 70% | 70% | |
58% | |||
50 | 42% | 51% |
25 | 33% | |||||||||||||||||||
21% | ||||||||||||||||||||
ADA/BKZ Q4W/BKZ (N=54) | ||||||||||||||||||||
UST/BKZ (N=44) | ||||||||||||||||||||
0 | SEC/BKZ (N=53) | |||||||||||||||||||
4 | 8 | 12 | 16 | 20 | 24 | 28 | 32 | 36 | 40 | 44 | 48 | 52 | 56 | 60 | 64 | 68 | 72 | 76 | 80 | |
0 | ||||||||||||||||||||
Weeks since switch |
Proprietary and Confidential Property of UCB
Figure adapted from reference 1. Clinical responses in PASI 90 non-responders initially treated with ADA, UST or SEC who switched to BKZ (mNRI). In BE SURE, patients switched from ADA to BKZ at Week 24. In BE VIVID, patients switched from UST to BKZ upon entry to the BE BRIGHT OLE at Week 52. In BE RADIANT, patients switched from SEC to BKZ upon entry to the BE RADIANT OLE at Week 48. On entering the OLEs, PASI 90 non-responders received BKZ 320 mg Q4W and could switch to Q8W during the OLE according to study designs. For mNRI, patients with missing data following treatment discontinuation due to lack of efficacy were considered non-responders, whereas all other missing data were imputed using multiple imputation.; ADA, adalimumab; BKZ, bimekizumab; mNRI, modified non-responder imputation; OLE, open-label extension; PASI, Psoriasis Area and Severity Index; Q4W, every 4 weeks; Q8W, every 8 weeks; SEC, secukinumab; UST, ustekinumab.
1. Kokolakis G, et al. Br J Dermatol. 2023;188(3):330-40.
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Dr. Andrew Blauvelt
Blauvelt Consulting, LLC Lake Oswego, OR, USA
BIMZELX®
Four-Year Data in Moderate to Severe Plaque Psoriasis
Proprietary and Confidential Property of UCB
GL-BK-2400026| Date of preparation: March 2024 | 10 |
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UCB SA published this content on 13 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 March 2024 09:01:05 UTC.