Brussels (Belgium), 18 January 2023 – 07:00 (CET) – UCB, a global biopharmaceutical company, today announced that Annals of the Rheumatic Diseases has published 24-week results from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, evaluating the efficacy and safety of bimekizumab in the treatment of adults with active axial spondyloarthritis (axSpA), including active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1) and active ankylosing spondylitis (AS; BE MOBILE 2), also known as radiographic axSpA.¹

“BE MOBILE 1 and BE MOBILE 2 represent the first phase 3 studies to evaluate the inhibition of IL-17F in addition to IL-17A with bimekizumab across the spectrum of axSpA. In both studies, treatment with bimekizumab resulted in rapid and clinically relevant improvements in outcomes, compared with placebo. The observed depth of response as well as the consistency of results in nr-axSpA and AS reinforce our confidence in bimekizumab as a potential new treatment option across the full spectrum of the disease,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. 

The two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, met all primary and ranked secondary endpoints at Week 16.¹ In both studies, a significantly higher proportion of patients treated with bimekizumab achieved statistically significant and clinically meaningful improvements in nr-axSpA and AS, as defined by the primary endpoint of Assessment of SpondyloArthritis international Society ≥40 percent improvement (ASAS40) response at Week 16 compared with placebo (p<0.001).¹ In patients who received bimekizumab from baseline, the proportion of patients achieving ASAS40 response continued to increase to Week 24, and in patients who switched from placebo to bimekizumab at Week 16, the ASAS40 responses at Week 24 reached similar levels to those seen in bimekizumab-randomized patients.¹ The safety profile of bimekizumab was consistent with safety data seen in previous studies, with no new observed safety signals.¹

The publication of results from two Phase 3 axSpA studies in Annals of the Rheumatic Diseases closely follows UCB news in December 2022 that The Lancet published two articles detailing results from two Phase 3 studies evaluating bimekizumab in adult patients with active psoriatic arthritis (PsA). 

In September 2022, UCB announced that the European Medicines Agency had accepted for regulatory review the marketing authorization application for bimekizumab for the treatment of adult patients with active axSpA and active PsA. The efficacy and safety of bimekizumab in the treatment of axSpA and PsA have not been established and it is not approved for the treatment of active axSpA or active PsA by any regulatory authority worldwide.

Notes to editors:

About BE MOBILE 1    

BE MOBILE 1 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active nr-axSpA. For additional details on the study, see article published in Annals of the Rheumatic Diseases.¹ 

About BE MOBILE 2

BE MOBILE 2 was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, Phase 3 study designed to evaluate the efficacy and safety of bimekizumab in the treatment of adult patients with active AS.  For additional details on the study, see article published in Annals of the Rheumatic Diseases.¹ 

About Axial Spondyloarthritis

Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA (r-axSpA), is a chronic, immune-mediated, inflammatory disease.²  nr-axSpA is defined clinically by the absence of definitive x-ray evidence of structural damage to the sacroiliac joints.² axSpA is a painful condition that primarily affects the spine and the joints linking the pelvis and lower spine (sacroiliac joints).² The leading symptom of axSpA in a majority of patients is inflammatory back pain that improves with exercise, but not with rest.² Other common clinical features frequently include anterior uveitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease and dactylitis.² The overall prevalence of axSpA is 0.3 percent to 1.3 percent of adults.^3,4  Approximately half of all patients with axSpA are patients with nr-axSpA.² axSpA onset usually occurs before the age of 45.² Approximately 10 to 40 percent of patients with nr-axSpA progress to AS over 2 to 10 years.² 

About bimekizumab

Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.^5,6 In August 2021, bimekizumab was approved in the European Union (EU)/European Economic Area (EEA) and in Great Britain, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.^6,7 The label information may differ in other countries. Please check local prescribing information.

About BIMZELX^®▼ (bimekizumab) in the EU/EEA

In the EU/EEA, BIMZELX^® is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.⁶

BIMZELX^®▼(bimekizumab) EU/EEA Important Safety Information in Psoriasis6

The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%) (most frequently nasopharyngitis) and oral candidiasis (7.3%). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headache, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.

Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis). 
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be administered in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB and patients receiving bimekizumab should be monitored for signs and symptoms of active TB. 

Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated. Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated. 

Live vaccines should not be given in patients treated with bimekizumab.

Please consult the summary of product characteristics in relation to other side effects, full safety and prescribing information. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf

EU summary of product characteristics date of revision December 2022.

Last accessed: January 2023.

▼ 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 

For further information, contact UCB: 

Investor Relations
Antje Witte
T +32.2.559.94.14 
email antje.witte@ucb.com 

Corporate Communications
Laurent Schots 
T +32.2.559.92.64 
email laurent.schots@ucb.com

Brand Communications
Eimear O’Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com 

About UCB 
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,600 people in approximately 40 countries, the company generated revenue of €5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news.

Forward looking statements 
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UCB is providing this information, including forward-looking statements, only as of the date of this press release and it does not reflect any potential impact from the evolving COVID-19 pandemic, unless indicated otherwise. UCB is following the worldwide developments diligently to assess the financial significance of this pandemic to UCB. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. 
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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 randomized controlled trials Ann Rheum Dis Epub ahead of print: 2023; doi:10.1136/ard-2022-223595
2. Deodhar A. Understanding axial spondyloarthritis: A primer for managed care. Am J Manag Care. 2019;25:S319–S330.
3. Reveille J, Witter J, Weisman M. Prevalence of axial spondylarthritis in the United States: Estimates from a cross-sectional survey. Arthritis Care Res. 2012;64(6):905–910.
4. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondyloarthritis in the UK: A cross-sectional cohort study. BMC Musculoskelet Disord. 2015;21(16):392.
5. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991–1001.
6. BIMZELX^® (bimekizumab) EU Summary of Product Characteristics.  https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-information_en.pdf. Last Accessed: January 2023.
7. BIMZELX^® (bimekizumab) GB Summary of Product Characteristics. Available at: http://www.medicines.org.uk/emc/product/12834/smpc#gref Last Accessed: January 2023.

Sourcwe:- UCB