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** Annals of the Rheumatic Diseases Publishes Results from Two Bimekizumab =
Phase 3 Studies in Axial Spondyloarthritis
------------------------------------------------------------
=C2=B7 Publication of 24-week results from the BE MOBILE 1 and BE MOBILE 2 =
studies, evaluating bimekizumab, an IL-17A and IL-17F inhibitor, across the=
full spectrum of axial spondyloarthritis=C2=A0
=C2=A0
Brussels (Belgium), 18 January 2023 =E2=80=93 07:00 (CET) =E2=80=93 UCB, a =
global biopharmaceutical company, today announced that Annals of the Rheuma=
tic 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), includ=
ing active non-radiographic axial spondyloarthritis (nr-axSpA; BE MOBILE 1)=
and active ankylosing spondylitis (AS; BE MOBILE 2), also known as radiogr=
aphic axSpA.^1
=E2=80=9CBE 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 a=
cross the spectrum of axSpA. In both studies, treatment with bimekizumab re=
sulted 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 pot=
ential new treatment option across the full spectrum of the disease,=E2=80=
=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions =
and Head of U.S., UCB.=C2=A0
The two phase 3 studies, BE MOBILE 1 and BE MOBILE 2, met all primary and r=
anked secondary endpoints at Week 16.^1 In both studies, a significantly hi=
gher 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 internat=
ional Society =E2=89=A540 percent improvement (ASAS40) response at Week 16 =
compared with placebo (p<0.001).^1 In patients who received bimekizumab fro=
m baseline, the proportion of patients achieving ASAS40 response continued =
to increase to Week 24, and in patients who switched from placebo to bimeki=
zumab at Week 16, the ASAS40 responses at Week 24 reached similar levels to=
those seen in bimekizumab-randomized patients.^1 The safety profile of bim=
ekizumab 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 (https://www.ucb.com/stories-me=
dia/Press-Releases/article/The-Lancet-Publishes-Results-from-Two-Bimekizuma=
b-Phase-3-Studies-in-Psoriatic-Arthritis) in December 2022 that The Lancet =
published two articles detailing results from two Phase 3 studies evaluatin=
g bimekizumab in adult patients with active psoriatic arthritis (PsA).=C2=
=A0
In September 2022, UCB announced (https://www.ucb.com/stories-media/Press-R=
eleases/article/European-Medicine-Agency-Accepts-Marketing-Authorization-Ap=
plications-for-Bimekizumab-in-Psoriatic-Arthritis-and-Axial-Spondyloarthrit=
is) that the European Medicines Agency had accepted for regulatory review t=
he marketing authorization application for bimekizumab for the treatment of=
adult patients with active axSpA and active PsA. The efficacy and safety o=
f bimekizumab in the treatment of axSpA and PsA have not been established a=
nd it is not approved for the treatment of active axSpA or active PsA by an=
y regulatory authority worldwide.
Notes to editors:
About BE MOBILE 1 =C2=A0 =C2=A0
BE MOBILE 1 was a randomized, multicenter, double-blind, placebo-controlled=
, parallel-group, Phase 3 study designed to evaluate the efficacy and safet=
y of bimekizumab in the treatment of adult patients with active=C2=A0nr-axS=
pA. For additional details on the study, see article published in Annals of=
the Rheumatic Diseases.^1=C2=A0
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 safet=
y of bimekizumab in the treatment of adult patients with active AS. =C2=A0F=
or additional details on the study, see article published in Annals of the =
Rheumatic Diseases.^1=C2=A0
About Axial Spondyloarthritis
Axial Spondyloarthritis (axSpA), which includes both non-radiographic axSpA=
(nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axS=
pA (r-axSpA), is a chronic, immune-mediated, inflammatory disease.^2=C2=A0 =
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 conditi=
on that primarily affects the spine and the joints linking the pelvis and l=
ower spine (sacroiliac joints).^2 The leading symptom of axSpA in a majorit=
y of patients is inflammatory back pain that improves with exercise, but no=
t with rest.^2 Other common clinical features frequently include anterior u=
veitis, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel dis=
ease and dactylitis.^2 The overall prevalence of axSpA is 0.3 percent to 1.=
3 percent of adults.^3,4=C2=A0 Approximately half of all patients with axSp=
A are patients with nr-axSpA.^2 axSpA onset usually occurs before the age o=
f 45.^2 Approximately 10 to 40 percent of patients with nr-axSpA progress t=
o AS over 2 to 10 years.^2=C2=A0
About bimekizumab
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F)=
, two key cytokines driving inflammatory processes.^5,6 In August 2021, bim=
ekizumab was approved in the European Union (EU)/European Economic Area (EE=
A) and in Great Britain, for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.^6,7=C2=A0The labe=
l information may differ in other countries. Please check local prescribing=
information.
About BIMZELX^=C2=AE=E2=96=BC (bimekizumab) in the EU/EEA
In the EU/EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate to=
severe plaque psoriasis in adults who are candidates for systemic therapy.=
^6
BIMZELX^=C2=AE=E2=96=BC(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 (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).=C2=A0
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 m=
edical 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 wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
Cases of new or exacerbations of inflammatory bowel disease have been repor=
ted with bimekizumab. Bimekizumab is not recommended in patients with infla=
mmatory bowel disease. If a patient develops signs and symptoms of inflamma=
tory bowel disease or experiences an exacerbation of pre-existing inflammat=
ory bowel disease, bimekizumab should be discontinued and appropriate medic=
al management should be initiated. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld be discontinued immediately and appropriate therapy initiated.=C2=A0
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.euro=
pa.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.
=E2=96=BC=C2=A0This 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=C2=A0
For further information, contact UCB:=C2=A0
Investor Relations
Antje Witte
T +32.2.559.94.14=C2=A0
email antje.witte@ucb.com=C2=A0
Corporate Communications
Laurent Schots=C2=A0
T +32.2.559.92.64=C2=A0
email laurent.schots@ucb.com
Brand Communications
Eimear O=E2=80=99Brien
T +32.2.559.92.71
email eimear.obrien@ucb.com=C2=A0
About UCB=C2=A0
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company =
focused on the discovery and development of innovative medicines and soluti=
ons to transform the lives of people living with severe diseases of the imm=
une system or of the central nervous system. With approximately 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
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UCB is providing this information, including forward-looking statements, on=
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UCB is following the worldwide developments diligently to assess the financ=
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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 ra=
ndomized 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 c=
are. Am J Manag Care. 2019;25:S319=E2=80=93S330.
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=E2=80=93910.
4. Hamilton L, Macgregor A, Toms A, et al. The prevalence of axial spondylo=
arthritis in the UK: A cross-sectional cohort study. BMC Musculoskelet Diso=
rd. 2015;21(16):392.
5. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, 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=
=E2=80=931001.
6. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. =C2=
=A0https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-=
product-information_en.pdf. Last Accessed: January 2023.
7. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: http://www.medicines.org.uk/emc/product/12834/smpc#gref Last Acce=
ssed: January 2023.
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