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UCB Media Room: UCB Reinforces Commitment to Rheumatology with 15 Abstracts including New Late-Breaking Data at ACR Convergence 2022

INFORMATION REGLEMENTEE


[08/11/2022 | 18:01]
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** UCB Reinforces Commitment to Rheumatology with 15 Abstracts including Ne=
w Late-Breaking Data at ACR Convergence 2022
------------------------------------------------------------

=C2=B7 Late-breaking 52-week data on investigational bimekizumab in the tre=
atment of adults with active psoriatic arthritis and active axial spondyloa=
rthritis to be presented
=C2=B7 New data on CIMZIA^=C2=AE (certolizumab pegol) and bimekizumab under=
score UCB=E2=80=99s commitment to innovative research in rheumatology

Brussels (Belgium), 8th November 2022 (18:00 CET) =E2=80=93 UCB, a global b=
iopharmaceutical company, today announced that it will present 15 abstracts=
across its rheumatology portfolio at ACR Convergence 2022 to be held in Ph=
iladelphia, November 10=E2=80=9314, 2022. The abstracts, including two with=
late-breaking data, have been accepted as four oral presentations, eight e=
-posters, and three =E2=80=98Ignite Talks=E2=80=99 which are five-minute in=
-person presentations focused on the highest ranked posters at the meeting.=
=C2=A0

=E2=80=9CThe breadth of new data we are presenting at ACR Convergence 2022,=
including the first presentation of bimekizumab 52-week data in psoriatic =
arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthri=
tis, underscore our commitment to address unmet patient needs and to raise =
standards of care,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Presiden=
t, Immunology Solutions and Head of U.S., UCB.=C2=A0

UCB is investigating bimekizumab in psoriatic arthritis (PsA), non-radiogra=
phic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) als=
o known as radiographic axSpA. The efficacy and safety of bimekizumab in Ps=
A, nr-axSpA and AS have not been established, and it is not approved for us=
e in these indications by any regulatory authority worldwide.

Bimekizumab data highlights

Data evaluating bimekizumab in the treatment of PsA and across the spectrum=
of axSpA will be shared across three oral presentations, three =E2=80=98Ig=
nite Talks=E2=80=99 and six e-posters.

One oral presentation and one =E2=80=98Ignite Talk=E2=80=99 will detail lat=
e-breaking 52-week data from the bimekizumab studies. The oral presentation=
will present results from the Phase 3 BE OPTIMAL study evaluating bimekizu=
mab in patients with active PsA who were biologic na=C3=AFve. The =E2=80=98=
Ignite Talk=E2=80=99 will share data from the Phase 3 BE MOBILE 1 and BE MO=
BILE 2 studies evaluating bimekizumab in the treatment of nr-axSpA and AS, =
respectively.=C2=A0

A second oral presentation will share data from the Phase 3 BE COMPLETE stu=
dy, evaluating bimekizumab in the treatment of active PsA in patients with =
a previous inadequate response or intolerance to Tumor Necrosis Factor Inhi=
bitors (TNFi-IR). A third oral presentation will share 24-week data from th=
e Phase 3 BE MOBILE 1 study evaluating bimekizumab in nr-axSpA. =C2=A0

In addition, 24-week data from the BE MOBILE 2 study evaluating bimekizumab=
in the treatment of AS and key patient reported outcomes from the Phase 3 =
BE MOBILE 1 and BE MOBILE 2 studies will be presented in two =E2=80=98Ignit=
e Talks=E2=80=99.=C2=A0

CIMZIA^=C2=AE (certolizumab pegol) data highlights

Data evaluating certolizumab pegol in the treatment of active axSpA will al=
so be shared across one oral presentation and two e-posters. The oral prese=
ntation will detail an exploratory analysis which aims to evaluate the rela=
tionship between objective signs of inflammation and clinical outcomes foll=
owing 12 weeks of certolizumab pegol treatment in patients with active axSp=
A.

=C2=A0 The following is a guide to the UCB-sponsored data presentations at
ACR Convergence 2022:

Bimekizumab abstracts: Psoriatic Arthritis=C2=A0

=C2=B7 Bimekizumab Treatment in Biologic DMARD-Na=C3=AFve Patients with Act=
ive Psoriatic Arthritis: 52-Week Efficacy and Safety Results from a Phase 3=
, Randomized, Placebo-Controlled, Active Reference Study

C. Ritchlin, L. C. Coates, I. McInnes, P. J. Mease, J. Merola, Y. Tanaka, A=
. Asahina, L. Gossec, A. Gottlieb, D. Tha=C3=A7i, B. Ink, D. Assudani, R. B=
ajracharya, V. Shende, J. Coarse, R. Landew=C3=A9

#L02
Oral presentation: Monday, November 14, 9:15am =E2=80=93 9:25am (ET)

=C2=B7 Bimekizumab Treatment in Patients with Active Psoriatic Arthritis an=
d Inadequate Response to Tumor Necrosis Factor Inhibitors: 16-week Efficacy=
and Safety from a Phase 3, Randomized, Double-Blind, Placebo-Controlled St=
udy

J. Merola, R. Landew=C3=A9, I.B. McInnes, P.J. Mease, C. Ritchlin, Y. Tanak=
a, A. Asahina, F. Behrens, D. Gladman, L. Gossec, R. Warren, B. Ink, D. Ass=
udani, R. Bajracharya, J. Coarse, L. Coates
#1599
Oral presentation: Sunday, November 13, 3:30pm =E2=80=93 3:40pm (ET)

=C2=B7 Bimekizumab Treatment Improves Health-Related Quality of Life in Bio=
logic DMARD-Na=C3=AFve and TNFi-IR Patients with Active PsA: Pooled 16-Week=
Results From two Phase 3 Randomized, Placebo-Controlled Studies

D. Gladman, L.E. Kristensen, D. Tha=C3=A7i, P. Gisondi, L. Gossec, M.E. Hus=
ni, A. Gottlieb, H. Dobashi, B. Ink, D. Assudani, R. Bajracharya, J. Coarse=
, J. Lambert, W. Tillett=C2=A0
#2122
e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET)

=C2=B7 Bimekizumab Improvements in Efficacy on Disease Activity Assessed vi=
a Composite Endpoints in Biologic DMARD-na=C3=AFve and TNFi-IR Patients wit=
h Active PsA: Pooled 16-Week Results from Phase 3 Randomized, Placebo-Contr=
olled Studies

P.J. Mease, L. Coates, R. Landew=C3=A9, I.B. McInnes, C. Ritchlin, T. Atsum=
i, F. Behrens, D. Gladman, L. Gossec, P. Nash, B. Ink, D. Assudani, R. Bajr=
acharya, J. Coarse, A.R. Prickett, A.B. Gottlieb
# 2117
e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET)

=C2=B7 Bimekizumab Treatment Results in Improvements in Fatigue and Pain in=
Biologic DMARD-Na=C3=AFve or TNFi-IR Patients with Active Psoriatic Arthri=
tis: Pooled 16- Week Results from Two Phase 3 Randomized, Placebo-Controlle=
d Studies

M.E. Husni, P.J. Mease, J. Merola, F. Behrens, E.G. Favalli, D. McGonagle, =
W. Tillett, S. Tsuji, B. Ink, D. Assudani, R. Bajracharya, J. Coarse, J. La=
mbert, L. Gossec=C2=A0
#2119
e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET)

=C2=B7 Achieving Increasingly Stringent Clinical Disease Control Criteria i=
s Associated with Greater Improvements in Patient-Centric Measures of Physi=
cal Function and Pain in Patients with Active PsA: 16-Week Results from Two=
Phase 3 Randomized, Placebo-Controlled Studies

J. Walsh, L. Coates, P.J. Mease, J. Merola, P. Nash, A. Ogdie, W. Tillett, =
P. Gisondi, B. Ink, D. Assudani, R. Bajracharya, J. Lambert, V. Taieb, D. W=
illems, L.E. Kristensen=C2=A0
#2118
e-Poster: Monday, November 14, 1:00pm =E2=80=93 3:00pm (ET)

Bimekizumab abstracts: Axial Spondyloarthritis

=C2=B7 Bimekizumab Maintains Improvements in Efficacy Endpoints and has a C=
onsistent Safety Profile Through 52 Weeks in Patients with Non-Radiographic=
Axial Spondyloarthritis and Ankylosing Spondylitis: Results from Two Paral=
lel Phase 3 Studies=C2=A0

X. Baraliakos, A. Deodhar, D. van der Heijde, M. Magrey, W. Maksymowych, T.=
Tomita, H. Xu, M. Oortgiesen, U. Massow, C. Fleurinck, A. M. Ellis, T. Vau=
x, J. Shepherd-Smith, A. Marten, L. S. Gensler
#L14
Ignite Talk: Monday, November 14, 2:35pm =E2=80=93 2:40pm (ET)

=C2=B7 Bimekizumab Improves Signs and Symptoms, Including Inflammation, in =
Patients with Active Non-Radiographic Axial Spondyloarthritis: 24-Week Effi=
cacy & Safety from a Phase 3, Multicenter, Randomized, Placebo-Controlled S=
tudy

A. Deodhar, D. van der Heijde, L. Gensler, H. Xu, K. Gaffney, H. Dobashi, W=
.P. Maksymowych, M. Rudwaleit, M. Magrey, D. Elewaut, M. Oortgiesen, C. Fle=
urinck, N. de Peyrecave, A. Ellis, T. Vaux, J. Shepherd-Smith, X. Baraliako=
s=C2=A0
#0544
Oral presentation: Saturday, November 12, 5:00pm =E2=80=93 5.10pm (ET)

=C2=B7 Bimekizumab Improves Signs and Symptoms, Including Inflammation, in =
Patients with Active Ankylosing Spondylitis: 24-Week Efficacy & Safety From=
a Phase 3, Multicenter, Randomized, Placebo Controlled Study

D. van der Heijde, X. Baraliakos, M. Dougados, M. Brown, D. Poddubnyy, F. v=
an den Bosch, N. Haroon, H. Xu, T. Tomita, L. Gensler, M. Oortgiesen, C. Fl=
eurinck, N. de Peyrecave, T. Vaux, A Marten, A. Deodhar=C2=A0
#0411
Ignite Talk: Sunday, November 13, 9:10am =E2=80=93 9.15am (ET)

=C2=B7 Bimekizumab Improves Key Patient Reported Symptoms of Axial Spondylo=
arthritis Including Spinal Pain and Fatigue: Results from Two Phase 3 Studi=
es

P.J. Mease, A. Deodhar, M. Dougados, M. Dubreuil, M. Magrey, H. Marzo-Orteg=
a, M. Rudwaleit, C. de la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. T=
aieb, L. Gensler
#0409
Ignite Talk: Sunday, November 13, 9:00am =E2=80=93 9:05am (ET)

=C2=B7 Bimekizumab Improves Physical Function and Health-Related Quality of=
Life in Patients with Axial Spondyloarthritis: Results From Two Phase 3 St=
udies

M. Dubreuil, K. Gaffney, L. Gensler, J. Kay, V. Navarro-Comp=C3=A1n, C. de =
la Loge, A. Ellis, C. Fleurinck, M. Oortgiesen, V. Taieb, A. Deodhar=C2=A0
#0412
e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET)

=C2=B7 Achieving Increasingly Stringent Clinical Response Criteria & Lower =
Levels Of Disease Activity is Associated With Greater Improvements In Physi=
cal Function And HRQoL in Patients With Active Axial Spondyloarthritis: 16-=
Week Results From Two Phase 3 Randomized, Placebo-Controlled Studies

M. Magrey, A. Deodhar, P.J. Mease, V. Navarro-Comp=C3=A1n, S. Ramiro, M. Ru=
dwaleit, C. de la Loge, C. Fleurinck, V. Taieb, M.F. M=C3=B8rup, M. Oortgie=
sen, J. Kay
#0410
e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET)

CIMZIA^=C2=AE (certolizumab pegol) abstracts: Axial Spondyloarthritis

=C2=B7 An Exploratory Analysis of the Potential Disconnect Between Objectiv=
e Inflammatory Response and Clinical Response following Certolizumab Pegol =
Treatment in Patients with Active Axial Spondyloarthritis

M. Rudwaleit, F. van den Bosch, H. Marzo-Ortega, V. Navarro-Comp=C3=A1n, R.=
Tham, T. Kumke, L. Bauer, M. Kim, L. Gensler=C2=A0
#0543
Oral presentation: Saturday, November 12, 4:45pm =E2=80=93 4:55pm (ET)

=C2=B7 Long-Term Clinical Outcomes of Certolizumab Pegol Treatment in Patie=
nts with Active Non=E2=80=91Radiographic Axial Spondyloarthritis Stratified=
by Baseline MRI and C-Reactive Protein Status

P.C. Robinson, W.P. Maksymowych, L. Gensler, M. Rudwaleit, B. Hoepken, L. B=
auer, T. Kumke, M. Kim, A. Deodhar=C2=A0
#0408
e-Poster: Saturday, November 12, 1:00pm =E2=80=93 3:00pm (ET)

=C2=B7 Comparison of Established and New, Preliminarily Proposed ASAS Cut-O=
ffs for Inflammatory MRI Lesions in the Sacroiliac Joints of Axial Spondylo=
arthritis Patients and Implications for Recruitment in Clinical Studies

X. Baraliakos, P. Machado, L. Bauer, B. Hoepken, M. Kim, T. Kumke, R. Tham,=
M. Rudwaleit=C2=A0
#1010
e-Poster: Sunday, November 13, 9:00am =E2=80=93 10:30am (ET)

Abstracts to be presented at ACR Convergence 2022 are available at ACR Conv=
ergence 2022 Archives - ACR Meeting Abstracts (acrabstrats.org)=C2=A0 (http=
s://acrabstracts.org/meetings/acr-convergence-2022/)

Notes to editors:

About BE OPTIMAL

BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled,=
active reference (adalimumab), parallel-group, Phase 3 study designed to e=
valuate the efficacy and safety of bimekizumab in the treatment of adult pa=
tients with active psoriatic arthritis, who are biologic disease-modifying =
anti-rheumatic drug na=C3=AFve. For additional details on the study, visit =
BE OPTIMAL (https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=3DBE+O=
PTIMAL&draw=3D2&rank=3D1) on clinicaltrials.gov.^1

About BE COMPLETE

BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled=
, parallel-group, Phase 3 study designed to evaluate the efficacy and safet=
y of bimekizumab in adults with active psoriatic arthritis and an inadequat=
e response to tumor necrosis factor-alpha inhibitors (TNF=CE=B1i). All enro=
lled study participants had a history of inadequate response (lack of effic=
acy after at least three months of therapy at an approved dose) or intolera=
nce to treatment with one or two TNF=CE=B1i for either psoriatic arthritis =
or psoriasis. For additional details on the study, visit BE COMPLETE (https=
://www.clinicaltrials.gov/ct2/show/NCT03896581) on clinicaltrials.gov.^2

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 safet=
y of bimekizumab in the treatment of adult patients with active nr-axSpA. F=
or additional details on the study, visit BE MOBILE 1 (https://clinicaltria=
ls.gov/ct2/show/NCT03928704) on clinicaltrials.gov.^3

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. For add=
itional details on the study, visit BE MOBILE 2 (https://www.clinicaltrials=
.gov/ct2/show/NCT03928743) on clinicaltrials.gov.^4

About CIMZIA^=C2=AE in the U.S.^5

CIMZIA^=C2=AE is the only Fc-free, PEGylated anti-TNF (Tumor Necrosis Facto=
r). CIMZIA has a high affinity for human TNF-alpha, selectively neutralizin=
g the pathophysiological effects of TNF-alpha.=C2=A0

CIMZIA is also indicated for the treatment of adults with moderately to sev=
erely active rheumatoid arthritis (RA), adults with active psoriatic arthri=
tis (PsA), adults with active ankylosing spondylitis (AS), and adults with =
active non-radiographic axial spondyloarthritis (nr-axSpA) with objective s=
igns of inflammation.

CIMZIA is indicated for the treatment of moderate to severe plaque psoriasi=
s (PSO) in adults who are candidates for systemic therapy or phototherapy.=
=C2=A0

In addition, CIMZIA is indicated for reducing signs and symptoms of Crohn's=
disease (CD) and maintaining clinical response in adult patients with mode=
rately to severely active disease who have had an inadequate response to co=
nventional therapy. See important safety information including risk of seri=
ous bacterial, viral and fungal infections and tuberculosis below.

IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S.

CONTRAINDICATIONS

CIMZIA is contraindicated in patients with a history of hypersensitivity re=
action to certolizumab pegol or to any of the excipients. Reactions have in=
cluded angioedema, anaphylaxis, serum sickness, and urticaria.

SERIOUS INFECTIONS

Patients treated with CIMZIA are at increased risk for developing serious i=
nfections that may lead to hospitalization or death. Most patients who deve=
loped these infections were taking concomitant immunosuppressants such as m=
ethotrexate or corticosteroids.=C2=A0

Discontinue CIMZIA if a patient develops a serious infection or sepsis.

Reported infections include:

=C2=B7 Active tuberculosis (TB), including reactivation of latent TB. Patie=
nts with TB have frequently presented with disseminated or extrapulmonary d=
isease. Test patients for latent TB before CIMZIA use and during therapy. I=
nitiate treatment for latent TB prior to CIMZIA use.
=C2=B7 Invasive fungal infections, including histoplasmosis, coccidioidomyc=
osis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patien=
ts with histoplasmosis or other invasive fungal infections may present with=
disseminated, rather than localized, disease. Antigen and antibody testing=
for histoplasmosis may be negative in some patients with active infection.=
Consider empiric anti-fungal therapy in patients at risk for invasive fung=
al infections who develop severe systemic illness.
=C2=B7 Bacterial, viral, and other infections due to opportunistic pathogen=
s, including Legionella and Listeria.=C2=A0

Carefully consider the risks and benefits of treatment with CIMZIA prior to=
initiating therapy in the following patients: with chronic or recurrent in=
fection; who have been exposed to TB; =C2=A0with a history of opportunistic=
infection; who resided in or traveled in regions where mycoses are endemic=
; with underlying conditions that may predispose them to infection. Monitor=
patients closely for the development of signs and symptoms of infection du=
ring and after treatment with CIMZIA, including the possible development of=
TB in patients who tested negative for latent TB infection prior to initia=
ting therapy.

=C2=B7 Do not start CIMZIA during an active infection, including localized =
infections.
=C2=B7 Patients older than 65 years, patients with co-morbid conditions, an=
d/or patients taking concomitant immunosuppressants may be at greater risk =
of infection.
=C2=B7 If an infection develops, monitor carefully and initiate appropriate=
therapy.

MALIGNANCY

Lymphoma and other malignancies, some fatal, have been reported in children=
and adolescent patients treated with TNF blockers, of which CIMZIA is a me=
mber. CIMZIA is not indicated for use in pediatric patients.

=C2=B7 Consider the risks and benefits of CIMZIA treatment prior to initiat=
ing or continuing therapy in a patient with known malignancy.
=C2=B7 In clinical trials, more cases of malignancies were observed among C=
IMZIA-treated patients compared to control patients.
=C2=B7 In CIMZIA clinical trials, there was an approximately 2-fold higher =
rate of lymphoma than expected in the general U.S. population. Patients wit=
h rheumatoid arthritis, particularly those with highly active disease, are =
at a higher risk of lymphoma than the general population.
=C2=B7 Malignancies, some fatal, have been reported among children, adolesc=
ents, and young adults being treated with TNF blockers. Approximately half =
of the cases were lymphoma, while the rest were other types of malignancies=
, including rare types associated with immunosuppression and malignancies n=
ot usually seen in this patient population.
=C2=B7 Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare=
type of T-cell lymphoma, have been reported in patients treated with TNF b=
lockers, including CIMZIA. These cases have had a very aggressive disease c=
ourse and have been fatal. The majority of reported TNF blocker cases have =
occurred in patients with Crohn's disease or ulcerative colitis, and the ma=
jority were in adolescent and young adult males. Almost all of these patien=
ts had received treatment with azathioprine or 6-mercaptopurine concomitant=
ly with a TNF blocker at or prior to diagnosis. Carefully assess the risks =
and benefits of treating with CIMZIA in these patient types.
=C2=B7 Cases of acute and chronic leukemia were reported with TNF blocker u=
se.

HEART FAILURE

=C2=B7 Worsening and new onset congestive heart failure (CHF) has been repo=
rted with TNF blockers. Exercise caution and monitor carefully.

HYPERSENSITIVITY

=C2=B7 Angioedema, anaphylaxis, dyspnea, hypotension, rash, serum sickness,=
and urticaria have been reported following CIMZIA administration. If a ser=
ious allergic reaction occurs, stop CIMZIA and institute appropriate therap=
y. The needle shield inside the removable cap of the CIMZIA prefilled syrin=
ge contains a plastic derivative of natural rubber latex which may cause an=
allergic reaction in individuals sensitive to latex.

HEPATITIS B VIRUS REACTIVATION

=C2=B7 Use of TNF blockers, including CIMZIA, may increase the risk of reac=
tivation of hepatitis B virus (HBV) in patients who are chronic carriers. S=
ome cases have been fatal.
=C2=B7 Test patients for HBV infection before initiating treatment with CIM=
ZIA.
=C2=B7 Exercise caution in patients who are carriers of HBV and monitor the=
m before and during CIMZIA treatment.
=C2=B7 Discontinue CIMZIA and begin antiviral therapy in patients who devel=
op HBV reactivation. Exercise caution when resuming CIMZIA after HBV treatm=
ent.

NEUROLOGIC REACTIONS

=C2=B7 TNF blockers, including CIMZIA, have been associated with rare cases=
of new onset or exacerbation of central nervous system and peripheral demy=
elinating diseases, including multiple sclerosis, seizure disorder, optic n=
euritis, peripheral neuropathy, and Guillain-Barr=C3=A9 syndrome.

HEMATOLOGIC REACTIONS

=C2=B7 Rare reports of pancytopenia, including aplastic anemia, have been r=
eported with TNF blockers. Medically significant cytopenia has been infrequ=
ently reported with CIMZIA.
=C2=B7 Consider stopping CIMZIA if significant hematologic abnormalities oc=
cur.

DRUG INTERACTIONS

=C2=B7 Do not use CIMZIA in combination with other biological DMARDS.

AUTOIMMUNITY

=C2=B7 Treatment with CIMZIA may result in the formation of autoantibodies =
and, rarely, in development of a lupus-like syndrome. Discontinue treatment=
if symptoms of a lupus-like syndrome develop.

IMMUNIZATIONS

=C2=B7 Patients on CIMZIA should not receive live or live-attenuated vaccin=
es.

ADVERSE REACTIONS

=C2=B7 The most common adverse reactions in CIMZIA clinical trials (=E2=89=
=A58%) were: upper respiratory infections (18%), rash (9%), and urinary tra=
ct infections (8%).

For full prescribing information, please visit
https://www.ucb.com/_up/ucb_com_products/documents/Cimzia_09_11_2019_en.pdf=
=C2=A0

CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.=C2=
=A0

About certolizumab pegol in the EU/EEA^6

In the EU, CIMZIA^=C2=AE (certolizumab pegol) in combination with methotrex=
ate (MTX) is indicated for the treatment of moderate to severe active RA in=
adult patients when the response to disease-modifying antirheumatic drugs =
(DMARDs) including MTX, has been inadequate. Certolizumab pegol can be give=
n as monotherapy in case of intolerance to MTX or when continued treatment =
with MTX is inappropriate. Certolizumab pegol in combination with MTX is al=
so indicated for the treatment of severe, active and progressive RA in adul=
ts not previously treated with MTX or other DMARDs. Certolizumab pegol has =
been shown to reduce the rate of progression of joint damage as measured by=
X-ray and to improve physical function, when given in combination with MTX=
.

Certolizumab pegol, in combination with MTX, is also indicated for the trea=
tment of active psoriatic arthritis in adults when the response to previous=
DMARD therapy has been inadequate. Certolizumab pegol can be given as mono=
therapy in case of intolerance to MTX or when continued treatment with MTX =
is inappropriate.

Certolizumab pegol is also indicated in the EU for the treatment of adult p=
atients with severe active axial spondyloarthritis (axSpA), comprising:=C2=
=A0

=C2=B7 Ankylosing spondylitis (AS) =E2=80=93 adults with severe active AS w=
ho have had an inadequate response to, or are intolerant to non-steroidal a=
nti-inflammatory drugs (NSAIDs).=C2=A0
=C2=B7 Axial spondyloarthritis (axSpA) without radiographic evidence of AS =
=E2=80=93 adults with severe active axSpA without radiographic evidence of =
AS but with objective signs of inflammation by elevated C-reactive protein =
(CRP) and/or Magnetic Resonance Imaging (MRI) who have had an inadequate re=
sponse to, or are intolerant to NSAIDs.

Certolizumab pegol is also indicated for the treatment of moderate to sever=
e plaque psoriasis in adults who are candidates for systemic therapy.=C2=A0

Cimzia^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^6

Cimzia^=C2=AE was studied in 4,049 patients with rheumatoid arthritis (RA) =
in controlled and open label trials for up to 92 months. The commonly repor=
ted adverse reactions (1-10%) in clinical trials with certolizumab pegol an=
d post-marketing were viral infections (includes herpes =C2=A0zoster, papil=
lomavirus, influenza), bacterial infections (including abscess), rash, head=
ache =C2=A0(including migraine), asthenia, leukopenia (including lymphopeni=
a, neutropenia), eosinophilic disorder, pain (any sites), pyrexia, sensory =
abnormalities, hypertension, =C2=A0pruritus (any sites), hepatitis (includi=
ng hepatic enzyme increase), injection site reactions, and nausea. Serious =
adverse reactions include sepsis, opportunistic infections, tuberculosis (i=
ncluding miliary, disseminated and extrapulmonary), herpes zoster, lymphoma=
, leukaemia, solid organ tumours, angioneurotic oedema, cardiomyopathies (i=
ncludes heart failure), ischemic coronary artery disorders, pancytopenia, h=
ypercoagulation (including thrombophlebitis, pulmonary embolism), cerebrova=
scular accident, vasculitis, hepatitis/hepatopathy (includes cirrhosis), an=
d renal impairment/nephropathy (includes nephritis). In RA controlled clini=
cal trials, 4.4% of patients discontinued taking certolizumab pegol due to =
adverse events vs. 2.7% for placebo.

Certolizumab pegol was initially studied in 325 patients with active axial =
spondyloarthritis (including ankylosing spondylitis and non-radiographic ax=
ial spondyloarthritis) in the AS001 clinical study for up to 4 years, which=
includes a 24-week placebo-controlled phase followed by a 24-week dose-bli=
nd period and a 156-week open-label treatment period. Certolizumab pegol wa=
s subsequently studied in 317 patients with non-radiographic axial spondylo=
arthritis in a placebo-controlled study for 52 weeks (AS0006). Certolizumab=
pegol was also studied in patients with axial spondyloarthritis (including=
ankylosing spondylitis and non-radiographic axial spondyloarthritis) in a =
clinical study for up to 96 weeks, which included a 48-week open-label run-=
in phase (N=3D736) followed by a 48-week placebo-controlled phase (N=3D313)=
for patients in sustained remission (C-OPTIMISE). Certolizumab pegol was a=
lso studied in a 96-week open-label study in 89 axSpA patients with a histo=
ry of documented anterior uveitis flares. In all 4 studies, the safety prof=
ile for these patients was consistent with the safety profile in rheumatoid=
arthritis and previous experience with certolizumab pegol.

Certolizumab pegol was studied in 409 patients with psoriatic arthritis (Ps=
A) in a clinical study for up to 4 years which included a 24-week placebo-c=
ontrolled phase followed by a 24-week dose-blind period and a 168-week open=
-label treatment period.=C2=A0

The safety profile for axSpA and PsA patients treated with certolizumab peg=
ol was consistent with the safety profile in RA and previous experience wit=
h certolizumab pegol.

Certolizumab pegol was studied in 1112 patients with psoriasis in controlle=
d and open-label studies for up to 3 years. In the Phase III program, the i=
nitial and maintenance periods were followed by a 96-week open-label treatm=
ent period. The long-term safety profile of certolizumab pegol 400 mg every=
2 weeks and certolizumab pegol 200 mg every 2 weeks was generally similar =
and consistent with previous experience with certolizumab pegol.

Certolizumab pegol is contraindicated in patients with hypersensitivity to =
the active substance or any of the excipients, active tuberculosis or other=
severe infections such as sepsis or opportunistic infections, and moderate=
to severe heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati=
ents receiving certolizumab pegol. Some of these events have been fatal. Be=
fore initiation of therapy with certolizumab pegol, all patients must be ev=
aluated for both active and inactive (latent) tuberculosis infection. If ac=
tive tuberculosis is diagnosed prior to or during treatment, certolizumab p=
egol therapy must not be initiated and must be discontinued. If latent tube=
rculosis is diagnosed, appropriate anti- tuberculosis therapy must be start=
ed before initiating treatment with certolizumab pegol.=C2=A0

Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including certolizumab pegol who are chronic carriers of the virus (i.=
e. surface antigen positive). Some cases have had a fatal outcome. Patients=
should be tested for HBV infection before initiating treatment with certol=
izumab pegol. Carriers of HBV who require treatment with certolizumab pegol=
should be closely monitored and in the case of HBV reactivation Certolizum=
ab pegol should be stopped and effective anti-viral therapy with appropriat=
e supportive treatment should be initiated.

TNF antagonists including certolizumab pegol may increase the risk of new o=
nset or exacerbation of clinical symptoms and/or radiographic evidence of d=
emyelinating disease including multiple sclerosis; of formation of autoanti=
bodies and uncommonly of the development of a lupus-like syndrome; of sever=
e hypersensitivity reactions. If a patient develops any of these adverse re=
actions, certolizumab pegol should be discontinued and appropriate therapy =
instituted.

With the current knowledge, a possible risk for the development of lymphoma=
s, leukaemia or other malignancies in patients treated with a TNF antagonis=
t cannot be excluded. Rare cases of neurological disorders, including seizu=
re disorder, neuritis and peripheral neuropathy, have been reported in pati=
ents treated with certolizumab pegol.

Adverse reactions of the haematologic system, including medically significa=
nt cytopenia, have been reported with certolizumab pegol. Advise all patien=
ts to seek immediate medical attention if they develop signs and symptoms s=
uggestive of blood dyscrasias or infection (e.g., persistent fever, bruisin=
g, bleeding, pallor) while on certolizumab pegol. Consider discontinuation =
of certolizumab pegol therapy in patients with confirmed significant haemat=
ological abnormalities.

The use of certolizumab pegol in combination with anakinra or abatacept is =
not recommended due to a potential increased risk of serious infections. As=
no data are available, certolizumab pegol should not be administered concu=
rrently with live vaccines. The 14-day half-life of certolizumab pegol shou=
ld be taken into consideration if a surgical procedure is planned. A patien=
t who requires surgery while on certolizumab pegol should be closely monito=
red for infections.

Please consult the full prescribing information in relation to other side e=
ffects, full safety and prescribing information.=C2=A0

European SmPC date of revision June 2022. https://www.ema.europa.eu/en/docu=
ments/product-information/cimzia-epar-product-information_en.pdf Last Acces=
sed November 2022

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.^7,8=C2=A0 In August 202=
1, bimekizumab was approved in the European Union (EU)/European Economic Ar=
ea (EEA) and in Great Britain, for the treatment of moderate to severe plaq=
ue psoriasis in adults who are candidates for systemic therapy.^8,9=C2=A0Th=
e label information may differ in other countries. Please check local presc=
ribing information. In the U.S., the efficacy and safety of bimekizumab hav=
e not been established for any indication and it is not approved by the U.S=
. Food and Drug Administration (FDA).

BIMZELX^=C2=AE =E2=96=BC(bimekizumab) EU/EEA Important Safety Information i=
n Psoriasis

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 May 2022.

Last accessed: November 2022.

=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
This press release may contain forward-looking statements including, withou=
t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
=E2=80=9Canticipates=E2=80=9D, =E2=80=9Cexpects=E2=80=9D, =E2=80=9Cintends=
=E2=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestim=
ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
inue=E2=80=9D and similar expressions. These forward-looking statements are=
based on current plans, estimates and beliefs of management. All statement=
s, other than statements of historical facts, are statements that could be =
deemed forward-looking statements, including estimates of revenues, operati=
ng margins, capital expenditures, cash, other financial information, expect=
ed legal, arbitration, political, regulatory or clinical results or practic=
es and other such estimates and results. By their nature, such forward-look=
ing statements are not guarantees of future performance and are subject to =
known and unknown risks, uncertainties and assumptions which might cause th=
e actual results, financial condition, performance or achievements of UCB, =
or industry results, to differ materially from those that may be expressed =
or implied by such forward-looking statements contained in this press relea=
se. Important factors that could result in such differences include: the gl=
obal spread and impact of COVID-19, changes in general economic, business a=
nd competitive conditions, the inability to obtain necessary regulatory app=
rovals or to obtain them on acceptable terms or within expected timing, cos=
ts associated with research and development, changes in the prospects for p=
roducts in the pipeline or under development by UCB, effects of future judi=
cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
candidates, competition from other products including biosimilars, changes=
in laws or regulations, exchange rate fluctuations, changes or uncertainti=
es in tax laws or the administration of such laws, and hiring and retention=
of its employees. There is no guarantee that new product candidates will b=
e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
results do not guarantee safety and efficacy of product candidates in huma=
ns. So far, the complexity of the human body cannot be reproduced in comput=
er models, cell culture systems or animal models. The length of the timing =
to complete clinical trials and to get regulatory approval for product mark=
eting has varied in the past and UCB expects similar unpredictability going=
forward. Products or potential products, which are the subject of partners=
hips, joint ventures or licensing collaborations may be subject to differen=
ces disputes between the partners or may prove to be not as safe, effective=
or commercially successful as UCB may have believed at the start of such p=
artnership. UCB=E2=80=99s efforts to acquire other products or companies an=
d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
ts products and/or devices after they are marketed. The discovery of signif=
icant problems with a product similar to one of UCB=E2=80=99s products that=
implicate an entire class of products may have a material adverse effect o=
n sales of the entire class of affected products. Moreover, sales may be im=
pacted by international and domestic trends toward managed care and health =
care cost containment, including pricing pressure, political and public scr=
utiny, customer and prescriber patterns or practices, and the reimbursement=
policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
he confidentiality, integrity and availability of UCB=E2=80=99s data and sy=
stems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
ly as of the date of this press release and it does not reflect any potenti=
al impact from the evolving COVID-19 pandemic, unless indicated otherwise. =
UCB is following the worldwide developments diligently to assess the financ=
ial significance of this pandemic to UCB. UCB expressly disclaims any duty =
to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
ing statements with regard thereto or any change in events, conditions or c=
ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
n offer to sell or the solicitation of an offer to buy any securities, nor =
shall there be any offer, solicitation or sale of securities in any jurisdi=
ction in which such offer, solicitation or sale would be unlawful prior to =
the registration or qualification under the securities laws of such jurisdi=
ction.=C2=A0

References

1. A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment =
of Subjects with Active Psoriatic Arthritis (BE OPTIMAL). ClinicalTrials.go=
v. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=
=3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: November 2022.
2. A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatm=
ent of Subjects with Active Psoriatic Arthritis (BE COMPLETE). ClinicalTria=
ls.gov. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03896581=
Last accessed: November 2022.
3. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects w=
ith Active Non-radiographic Axial Spondyloarthritis (BE MOBILE 1). Clinical=
Trials.gov. Available from: https://clinicaltrials.gov/ct2/show/NCT03928704=
Last accessed: November 2022.
4. A Study to Evaluate the Efficacy and Safety of Bimekizumab in Subjects w=
ith Active Ankylosing Spondylitis (BE MOBILE 2). ClinicalTrials.gov. Availa=
ble from: https://www.clinicaltrials.gov/ct2/show/NCT03928743 Last accessed=
: November 2022.
5. CIMZIA (certolizumab pegol) US Prescribing Information. Available at: Ci=
mzia_09_11_2019_en.pdf (ucb.com) (https://www.ucb.com/_up/ucb_com_products/=
documents/Cimzia_09_11_2019_en.pdf) Last accessed: November 2022.
6. CIMZIA^=C2=AE (certolizumab pegol) EU Summary of Product Characteristics=
. June 2022. https://www.ema.europa.eu/en/documents/product-information/cim=
zia-epar-product-information_en.pdf. Last accessed November 2022.
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):991-1=
001.
8. BIMZELX=C2=AE (bimekizumab) EU Summary of Product Characteristics, March=
2022. Available at:=C2=A0https://www.ema.europa.eu/en/documents/product-in=
formation/bimzelx-epar-product-information_en.pdf. Last accessed: November =
2022.
9. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834/smpc#gref. Last ac=
cessed: November 2022.

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595/3663475/802f6268d130f454.pdf)

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