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** UCB Presents New Five-Year Data on BIMZELX^=C2=AE=E2=96=BC(bimekizumab) =
in Ankylosing Spondylitis at ACR Convergence 2023
------------------------------------------------------------
=C2=B7 Long-term data on bimekizumab in the treatment of adults with ankylo=
sing spondylitis showed sustained improvements for up to five years with th=
e safety profile consistent with previous observations=C2=A0
=C2=A0
Brussels (Belgium), 10th November 2023 =E2=80=93 07:00 (CEST) =E2=80=93 UCB=
, a global biopharmaceutical company, today announced new long-term data fr=
om the BIMZELX^=C2=AE (bimekizumab) Phase 2b study BE AGILE and its open la=
bel extension (OLE). Patients with ankylosing spondylitis (AS), also known =
as radiographic axial spondyloarthritis (r-axSpA), treated with bimekizumab=
, an IL-17A and IL-17F inhibitor, showed sustained improvements in signs an=
d symptoms, disease activity, physical function and health-related quality =
of life for up to five years, with a consistent safety profile through five=
years of treatment.^1 These data are being presented this week at the Amer=
ican College of Rheumatology (ACR) Convergence 2023 in San Diego, U.S., Nov=
ember 10=E2=80=9315.=C2=A0
=E2=80=9CThere is a need for additional treatment options for people living=
with ankylosing spondylitis since many people do not achieve long-term dis=
ease control. The five-year bimekizumab data in ankylosing spondylitis demo=
nstrated sustained improvements across multiple domains of disease and a sa=
fety profile consistent with previous observations,=E2=80=9D said Emmanuel =
Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., =
UCB. =C2=A0
=E2=80=9CThis is the first report of ASAS40 five-year data in patients with=
ankylosing spondylitis to use a conservative non-responder imputation anal=
ysis. Using this method, the data showed that at least half of the patients=
treated with bimekizumab achieved sustained improvements through five year=
s of treatment,=E2=80=9D said Professor Atul Deodhar, Professor of Medicine=
, Oregon Health & Science University, Division of Arthritis and Rheumatic D=
iseases, Portland, OR, U.S.
Bimekizumab is not approved in the U.S. for the treatment of AS. In the U.S=
., the efficacy and safety of bimekizumab for the treatment of AS have not =
been established. =C2=A0In the U.S., bimekizumab is approved for the treatm=
ent of moderate to severe plaque psoriasis in adults who are candidates for=
systemic therapy or phototherapy.^2=C2=A0
In the European Union (EU), bimekizumab is approved for the treatment of mo=
derate to severe plaque psoriasis in adults who are candidates for systemic=
therapy.^3 In the EU, bimekizumab, alone or in combination with methotrexa=
te, is also indicated for the treatment of active psoriatic arthritis in ad=
ults who have had an inadequate response or who have been intolerant to one=
or more disease-modifying antirheumatic drugs.^3 Bimekizumab is also indic=
ated in the EU for the treatment of adults with active non radiographic axi=
al spondyloarthritis with objective signs of inflammation as indicated by e=
levated C reactive protein, and/or magnetic resonance imaging who have resp=
onded inadequately or are intolerant to non-steroidal anti inflammatory dru=
gs, and for the treatment of adults with active ankylosing spondylitis who =
have responded inadequately or are intolerant to conventional therapy.^3
Highlights from the BE AGILE five-year data in AS=C2=A0
Of 255/303 (84.2 percent) patients who entered the OLE at Week 48, and rece=
ived =E2=89=A51 bimekizumab dose, 202/255 (79.2 percent) completed to Week =
256. Clinical improvements were sustained across the endpoints detailed bel=
ow through Week 256 in patients receiving bimekizumab.^1=C2=A0
=C2=B7 ASAS40: At the OLE entry visit (Week 48), 51.7 percent of patients w=
ho started the dose-blind period (n=3D296) achieved ASAS40, a 40 percent im=
provement response according to Assessment of Spondyloarthritis Internation=
al Society (ASAS) criteria, and 49.7 percent of patients achieved ASAS40 at=
five years (Week 256; non-responder imputation).^1 Of patients who entered=
the OLE at Week 48 (n=3D249), 59.8 percent achieved ASAS40 at Week 48 and =
59.0 percent at five years (Week 256; non-responder imputation).^1=C2=A0
=C2=B7 Disease Activity: Mean reduction from baseline to Week 48 in Ankylos=
ing Spondylitis Disease Activity Score (ASDAS, 3.9 to 2.1, respectively) in=
patients who entered the dose-blind period were sustained at five years (2=
.1, multiple imputation). At Week 48, 49.3 percent who started the dose-bli=
nd period (n=3D296) achieved low disease activity (LDA) status, as measured=
by ASDAS<2.1 and 41.6 percent of patients had ASDAS LDA at five years (Wee=
k 256; non-responder imputation).^1 Of patients who entered the OLE at Week=
48 (n=3D249), 57.3 percent achieved ASDAS LDA at Week 48 with 66.0 percent=
at five years (Week 256; multiple imputation).^1=C2=A0
Mean reductions from baseline to Week 48 in the Bath Ankylosing Spondylitis=
Disease Activity Index (BASDAI, 6.5 to 3.0, respectively) in patients who =
entered the dose-blind period were sustained or further decreased to 2.5 at=
five years (Week 256; multiple imputation).^1 Responses for patients who e=
ntered the OLE were similar.^1
=C2=B7 Physical Function & Quality of Life: Improvements in physical functi=
on, measured by the Bath Ankylosing Spondylitis Functional Index (BASFI) an=
d mean improvements in quality of life measured by the Ankylosing Spondylit=
is Quality of Life questionnaire (ASQoL) were sustained to Week 256.^1
Over five years, exposure adjusted incidence rates (EAIRs) per 100 patient =
years were 134.6 for any treatment emergent adverse event (TEAE) and 5.2 fo=
r serious TEAEs. The EAIR of Candida infections over 256 weeks at 2.6 was l=
ower than in weeks 0=E2=80=9348 (7.5). All Candida infections were mild or =
moderate, and none were systemic.1
=E2=96=BC This medicinal product is subject to additional monitoring. This =
will allow quick identification of new safety information. Healthcare profe=
ssionals are asked to report any suspected adverse reactions.
Notes to editors:
About BE AGILE=C2=A0
The dose ranging BE AGILE study consisted of a 12-week double-blind, placeb=
o-controlled period, then a dose blind period to Week 48 where patients rec=
eived bimekizumab 160 mg or 320 mg every four weeks (Q4W).^1 Patients compl=
eting Week 48 were eligible to enter the open label extension (OLE) where a=
ll patients received bimekizumab 160 mg Q4W to Week 256.^1=C2=A0
About Axial Spondyloarthritis (axSpA)
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.^4 nr axS=
pA is defined clinically by the absence of definitive X-ray evidence of str=
uctural damage to the sacroiliac joints.^4 AxSpA is a painful condition tha=
t primarily affects the spine and the joints linking the pelvis and lower s=
pine (sacroiliac joints).^4 The leading symptom of axSpA in a majority of p=
atients is inflammatory back pain that improves with exercise, but not with=
rest.^4 Other common clinical features frequently include anterior uveitis=
, enthesitis, peripheral arthritis, psoriasis, inflammatory bowel disease a=
nd dactylitis.^4 The overall prevalence of axSpA is 0.3 percent to 1.4 perc=
ent of adults.^5,6=C2=A0 Approximately half of all patients with axSpA are =
patients with nr-axSpA.^4 axSpA onset usually occurs before the age of 45.^=
4 Approximately 10 to 40 percent of patients with nr-axSpA progress to anky=
losing spondylitis over 2 to 10 years.^4
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.^7=C2=A0
Bimekizumab is not approved in the U.S. for the treatment of AS. In the U.S=
., the efficacy and safety of bimekizumab for the treatment of AS have not =
been established.=C2=A0In the U.S., bimekizumab is approved for the treatme=
nt of moderate to severe plaque psoriasis in adults who are candidates for =
systemic therapy or phototherapy.^2
The therapeutic indications in the European Union are:
=C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode=
rate to severe plaque psoriasis in adults who are candidates for systemic t=
herapy.^3=C2=A0
=C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho=
trexate, is indicated for the treatment of active psoriatic arthritis in ad=
ults who have had an inadequate response or who have been intolerant to one=
or more disease-modifying antirheumatic drugs (DMARDs).^3
=C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment =
of adults with active non radiographic axial spondyloarthritis with objecti=
ve 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-steroidal anti-inflammatory drugs (NSAIDs), and for =
the treatment of adults with active ankylosing spondylitis who have respond=
ed inadequately or are intolerant to conventional therapy.^3=C2=A0
The label information may differ in other countries where approved. Please =
check local prescribing information.=C2=A0
BIMZELX U.S. IMPORTANT SAFETY INFORMATION^2
Suicidal Ideation and Behavior
BIMZELX^=C2=AE (bimekizumab-bkzx) may increase the risk of suicidal ideatio=
n and behavior (SI/B). =C2=A0A causal association between treatment with BI=
MZELX and increased risk of SI/B has not been established. =C2=A0Prescriber=
s should weigh the potential risks and benefits before using BIMZELX in pat=
ients with a history of severe depression or SI/B. Advise monitoring for th=
e emergence or worsening of depression, suicidal ideation, or other mood ch=
anges. If such changes occur, advise to promptly seek medical attention, re=
fer to a mental health professional as appropriate, and re-evaluate the ris=
ks and benefits of continuing treatment.=C2=A0
Infections
BIMZELX may increase the risk of infections. Do not initiate treatment with=
BIMZELX in patients with any clinically important active infection until t=
he infection resolves or is adequately treated. =C2=A0In patients with a ch=
ronic infection or a history of recurrent infection, consider the risks and=
benefits prior to prescribing BIMZELX. =C2=A0Instruct patients to seek med=
ical advice if signs or symptoms suggestive of clinically important infecti=
on occur. If a patient develops such an infection or is not responding to s=
tandard therapy, monitor the patient closely and do not administer BIMZELX =
until the infection resolves.
Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treat=
ment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infe=
ction. Initiate treatment of latent TB prior to administering BIMZELX. Cons=
ider anti-TB therapy prior to initiation of BIMZELX in patients with a past=
history of latent or active TB in whom an adequate course of treatment can=
not be confirmed. Closely monitor patients for signs and symptoms of active=
TB during and after treatment.
Liver Biochemical Abnormalities
Elevated serum transaminases were reported in clinical trials with BIMZELX.=
Test liver enzymes, alkaline phosphatase and bilirubin at baseline, period=
ically during treatment with BIMZELX and according to routine patient manag=
ement. =C2=A0If treatment-related increases in liver enzymes occur and drug=
-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of =
liver injury is excluded. =C2=A0Permanently discontinue use of BIMZELX in p=
atients with causally associated combined elevations of transaminases and b=
ilirubin. =C2=A0Avoid use of BIMZELX in patients with acute liver disease o=
r cirrhosis.
Inflammatory Bowel Disease
Cases of inflammatory bowel disease (IBD) have been reported in patients tr=
eated with IL-17 inhibitors, including BIMZELX. =C2=A0Avoid use of BIMZELX =
in patients with active IBD. =C2=A0During BIMZELX treatment, monitor patien=
ts for signs and symptoms of IBD and discontinue treatment if new onset or =
worsening of signs and symptoms occurs.
Immunizations
Prior to initiating therapy with BIMZELX, complete all age-appropriate vacc=
inations according to current immunization guidelines. Avoid the use of liv=
e vaccines in patients treated with BIMZELX. =C2=A0
Most Common Adverse Reactions
Most common adverse reactions (=E2=89=A5 1%) are upper respiratory infectio=
ns, oral candidiasis, headache, injection site reactions, tinea infections,=
gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Cand=
ida infections, and fatigue.
BIMZELX^=C2=AE =E2=96=BC=C2=A0 (bimekizumab) EU/EEA* Important Safety Infor=
mation^3=C2=A0
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO)=
, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respective=
ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv=
ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia=
sis, tinea infections, ear infections, herpes simplex infections, oropharyn=
geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis=
and eczema, acne, injection site reactions, fatigue. Elderly may be more l=
ikely to experience certain adverse reactions such as oral candidiasis, der=
matitis 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).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be initiated in patients with any clinically important active inf=
ection. Patients treated with bimekizumab should be instructed to seek medi=
cal advice if signs or symptoms suggestive of an infection occur. If a pati=
ent develops an infection the patient should be carefully monitored. If the=
infection becomes serious or is not responding to standard therapy, treatm=
ent should be discontinued until the infection resolves. Prior to initiatin=
g treatment with bimekizumab, patients should be evaluated for tuberculosis=
(TB) infection. Bimekizumab should not be given in patients with active TB=
. Patients receiving bimekizumab should be monitored for signs and symptoms=
of active TB.
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 including anaphylactic reactions have be=
en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o=
ccurs, 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.
European SmPC date of revision: June 2023.
https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-pro=
duct-information_en.pdf
Last accessed: November 2023.
*EU/EEA means European Union/European Economic Area
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 8,700 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.5 billion in 2022 UCB is listed on Euronext Brussels (symbol: UCB). Follo=
w us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
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Given these uncertainties, you should not place undue reliance on any of su=
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UCB is providing this information, including forward-looking statements, on=
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References
1. Deodhar A, Navarro-Comp=C3=A1n V, Poddubnyy D, et al. Long-Term Safety a=
nd Efficacy of Bimekizumab in Patients with Active Ankylosing Spondylitis: =
5-Year Results from a Phase 2b Study and its Open-Label Extension. Abstract=
presented at ACR Convergence 2023, San Diego, U.S.
2. BIMZELX (bimekizumab) U.S. Prescribing Information https://www.ucb-usa.c=
om/Innovation/Products/BIMZELX. Last accessed: November 2023.
3. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. Avai=
lable at:=C2=A0https://www.ema.europa.eu/en/documents/product-information/b=
imzelx-epar-product-information_en.pdf. Last accessed: November 2023.
4. Deodhar A. Understanding Axial Spondyloarthritis: A Primer for Managed C=
are. Am J Manag Care. 2019;25:S319=E2=80=9330.
5. 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=9310.
6. 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;16:392.=C2=A0
7. 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.
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