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UCB [BE0003739530 / UCB]

UCB Media Room: EADV Congress Data highlights

INFORMATION REGLEMENTEE


[29/10/2020 | 18:04]
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** UCB Presents Nine Abstracts at EADV 2020, Showcasing Ongoing Commitment =
to Dermatology
------------------------------------------------------------

=C2=B7 First results from the Phase 3 BE SURE study will be presented showi=
ng superior skin clearance with bimekizumab compared to Humira^=C2=AE (adal=
imumab) in patients with moderate-to-severe plaque psoriasis
=C2=B7 Two oral presentations from the Phase 3 BE VIVID study show consiste=
nt levels of skin clearance with bimekizumab irrespective of patient demogr=
aphics, disease characteristics and prior treatment experience, and an acce=
ptable safety profile based on an integrated analysis across Phase 2 and Ph=
ase 3 psoriasis trials
=C2=B7 Two e-posters show complete clearance with bimekizumab in high impac=
t areas: scalp, nails, palms and soles, and that disease control with bimek=
izumab translates to substantial improvements in health-related quality of =
life
=C2=B7 New data also showcase the long-term quality of life improvements th=
at are possible for psoriasis patients through treatment with CIMZIA^=C2=AE=
(certolizumab pegol)=C2=A0

Brussels, Belgium =E2=80=93 October 29, 2020 =E2=80=93 UCB, a global biopha=
rmaceutical company, today announced that new data on the investigational I=
L-17A and IL-17F inhibitor, bimekizumab, and TNF inhibitor, CIMZIA^=C2=AE (=
certolizumab pegol), in the management of moderate-to-severe plaque psorias=
is are being presented at the European Academy of Dermatology and Venereolo=
gy (EADV) Congress, taking place virtually on October 29-31, 2020. =C2=A0

The first presentation of the Phase 3 BE SURE study results demonstrates th=
e superior levels of psoriasis skin clearance observed with bimekizumab tre=
atment, as compared to adalimumab until week 24, the durability of bimekizu=
mab=E2=80=99s response to week 56, and the rapid increase in rates of skin =
clearance in patients switching from adalimumab to bimekizumab.^1=C2=A0

=E2=80=9CWe are excited to share the bimekizumab BE SURE study results, fur=
ther results from the BE VIVID study, plus new pooled safety data. These st=
udies further demonstrate the rationale for inhibiting IL-17F in addition t=
o IL-17A. The data also show that bimekizumab has the potential to raise th=
e treatment bar with respect to speed, depth and durability of response for=
psoriasis patients and dermatologists, if approved by health authorities. =
We are also presenting long-term results from our CIMPASI-1 and CIMPASI-2 c=
linical program for CIMZIA^=C2=AE, and support for our ongoing commitment t=
o addressing the unmet needs of patients living with psoriatic disease. EAD=
V represents an opportunity for UCB to demonstrate its ongoing commitment t=
o delivering innovative solutions to help meet the needs of the dermatology=
community,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President Immun=
ology Solutions and Head of US, UCB.=C2=A0

UCB is sharing data from further analyses of the Phase 3 BE VIVID study inv=
estigating bimekizumab=E2=80=99s effect on high impact areas that can be mo=
st burdensome to psoriasis patients, complete skin clearance across differe=
nt baseline demographics and treatment experience and the impact of bimekiz=
umab treatment on health-related quality of life. The results show:

=C2=B7 Complete clearance of scalp, nail and psoriasis of the palms of hand=
s and feet was observed in a higher proportion of bimekizumab-treated patie=
nts with moderate-to-severe disease versus the study comparator, Stelara^=
=C2=AE (ustekinumab) at weeks 16 and 52.^2=C2=A0
=C2=B7 Bimekizumab provided similar levels of complete skin clearance, as m=
easured by the proportion of patients achieving a 100 percent improvement i=
n the Psoriasis Area and Severity Index (PASI 100), up to one year in patie=
nts with moderate-to-severe disease regardless of weight, baseline disease =
severity or prior treatment exposure.^3
=C2=B7 Lasting skin clearance translates to rapid and sustained improvement=
s in quality of life.^4=C2=A0 Increased disease control seen with bimekizum=
ab treatment, compared with ustekinumab, translated to greater quality of l=
ife as measured by the Dermatology Life Quality Index (DLQI).^4 After one y=
ear of treatment with bimekizumab, almost 70 percent of patients achieved c=
omplete skin clearance and reported no impact of psoriasis on their quality=
of life, versus 40 percent with ustekinumab.^4

Other results being presented at the virtual meeting include a pooled short=
and longer-term safety analysis across Phase 2 and Phase 3 clinical trials=
of bimekizumab in patients with moderate-to-severe plaque psoriasis. The m=
ajority of treatment emergent adverse events (TEAEs) were mild-to-moderate =
in severity and discontinuations were low.^5=C2=A0In general, the exposure-=
adjusted incidence rates (EAIRs) of TEAEs and TEAEs of interest did not inc=
rease with bimekizumab exposure duration. The vast majority of candida infe=
ctions were oral, mild-to-moderate, and did not lead to treatment discontin=
uation.^5

UCB is also sharing long-term psoriasis quality of life data for certolizum=
ab pegol. Pooled data from CIMPASI-1 and CIMPASI-2 Phase 3 trials show that=
rapid improvements in health-related quality of life were seen as early as=
week 8 after treatment with certolizumab pegol. These positive treatment e=
ffects were generally durable to week 144.^6,7=C2=A0=C2=A0

In efforts to better understand the unmet needs of women of childbearing ag=
e living with psoriatic disease, UCB conducted a survey of attitudes toward=
s family planning amongst ~600 (n=3D573) women from 11 European countries. =
Survey results will be presented, showing that those surveyed reported cons=
iderable negative impact on family planning and pregnancy due to psoriasis =
and/or psoriatic arthritis. A large proportion also reported dissatisfactio=
n with their support networks, highlighting an unmet need in this patient p=
opulation.^8

Findings of a new survey into the competencies of dermatologists practicing=
in Germany, UK and the U.S. are also being presented. Results demonstrated=
that interventions which may provide opportunities to enhance care include=
education about optimal risk assessment, treatment and management of women=
of childbearing age with chronic inflammatory diseases and support for sha=
red decision making.^9=C2=A0Findings also showed that overall shared decisi=
on making was uncommon due to a lack of knowledge, skills and attitude.^9

Following is a guide to the UCB data presentations:

Bimekizumab Oral Presentations:

Bimekizumab efficacy and safety versus adalimumab in patients with moderate=
to severe plaque psoriasis: Results from a multicentre, randomised, double=
-blinded active comparator-controlled phase 3 trial (BE SURE), R. Warren, A=
. Blauvelt, J. Bagel, K. Papp, P. Yamauchi, A. Armstrong, R. Langley, V. Va=
nvoorden, L. Peterson, D. de Cuyper, N. Cross, K. Reich

Bimekizumab versus ustekinumab efficacy across subgroups of patients with m=
oderate to severe plaque psoriasis: Results from the multicentre, randomise=
d, double-blinded phase 3 BE VIVID trial, B. Strober, J. Krueger, N. Magnol=
o, R. Vender, D. Toth, D. Tha=C3=A7i, M. Wang, C. Cioffi, C. Madden, R. War=
ren
Bimekizumab safety in patients with moderate to severe psoriasis: Analysis =
of pooled data from phase 2 and 3 clinical trials, K. Reich, A. Blauvelt, M=
. Lebwohl, K. Papp, P. Rich, B. Strober, D. de Cuyper, C. Madden, L. Peters=
on, V. Vanvoorden, R. Warren

Bimekizumab e-Posters:

Bimekizumab for the treatment of moderate to severe plaque psoriasis with s=
calp, nail and palmoplantar involvement through 52 weeks: Post-hoc analysis=
from the BE VIVID phase 3 trial, K. Papp, M. Lebwohl, A. Gottlieb, M. Seba=
stian, R. Langley, Y. Okubo, M. Wang, C. Cioffi, F. Staelens, K. Reich

Bimekizumab versus ustekinumab in plaque psoriasis: Lasting efficacy transl=
ates to rapid and sustained improvements in quality of life in the BE VIVID=
multicentre, randomised, double-blinded phase 3 trial, K. Gordon, P. Foley=
, P. Rich, K. Duffin, A. Pinter, C. Griffiths, M. Wang, V. Vanvoorden, F. S=
taelens, V. Ciaravino, J. Merola

CIMZIA e-Posters:

Long-term improvements in health-related quality of life of patients with m=
oderate to severe plaque psoriasis treated with certolizumab pegol: Results=
from the CIMPASI-1 and CIMPASI-2 phase 3 trials, D. Tha=C3=A7i, A. Blauvel=
t, K. Reich, R. Warren, V. Piguet, F. Brock, F. Fierens, V. Ciaravino, M. L=
ebwohl
Durability of Certolizumab Pegol in Patients with Psoriasis or Rheumatoid A=
rthritis Over Three Years: An Analysis of Pooled Clinical Trial Data, A. Bl=
auvelt, A. Gottlieb, K. Reich, Y. Tanaka, K. Winthrop, C. Popova, N. Tilt, =
V. Bykerk=C2=A0

UCB-Sponsored e-Poster:

Impact of Psoriatic Disease on Family Planning in Women Aged 18=E2=80=9345:=
Results from a Multinational Survey across 11 Countries in Europe, S. McBr=
ide, M. Fargnoli, A. Fougerousse, M. Bustinduy, L. Catton, L. Senturk, C. E=
coffet, J. Koren, A. Titialii=C2=A0

Humira^=C2=AE is a registered trademark of AbbVie, Inc; Stelara=C2=AE is a =
registered trademark of Johnson & Johnson.

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively inhibits both IL-17A and IL-17F, two key cytokines driving infla=
mmatory processes.^10=C2=A0IL-17F has overlapping biology with IL-17A and d=
rives inflammation independently to IL-17A.^11,12,13,14,15=C2=A0Selective i=
nhibition of IL-17F in addition to IL-17A suppresses inflammation to a grea=
ter extent than IL-17A inhibition alone.^14,15 The safety and efficacy of b=
imekizumab are being evaluated across multiple disease states as part of a =
robust clinical program.=C2=A0

About CIMZIA^=C2=AE in the EU/EEA
In the EU, CIMZIA^=C2=AE in combination with methotrexate (MTX) is indicate=
d for the treatment of moderate to severe active RA in adult patients inade=
quately responsive to disease-modifying anti-rheumatic drugs (DMARDs) inclu=
ding MTX.=C2=A0

CIMZIA can be given as monotherapy in case of intolerance to MTX or when co=
ntinued treatment with MTX is inappropriate. CIMZIA in combination with MTX=
is also indicated for the treatment of severe, active and progressive RA i=
n adults not previously treated with MTX or other DMARDs.

CIMZIA 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 combinati=
on with MTX.

CIMZIA, in combination with MTX, is also indicated for the treatment of act=
ive psoriatic arthritis in adults when the response to previous DMARD thera=
py has been inadequate. CIMZIA can be given as monotherapy in case of intol=
erance to MTX or when continued treatment with MTX is inappropriate.

CIMZIA is also indicated in the EU for the treatment of adult patients 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.

CIMZIA is also indicated for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.=C2=A0

Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information=C2=
=A0

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 percent) in clinical trials with Cimzia=C2=AE a=
nd post-marketing were viral infections (includes herpes zoster, papillomav=
irus, influenza), bacterial infections (including abscess), rash, headache =
(including migraine), asthenia, leukopenia (including lymphopenia, neutrope=
nia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormaliti=
es, hypertension, pruritus (any sites), hepatitis (including hepatic enzyme=
increase), injection site reactions, and nausea. Serious adverse reactions=
include sepsis, opportunistic infections, tuberculosis (including miliary,=
disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, soli=
d organ tumours, angioneurotic oedema, cardiomyopathies (includes heart fai=
lure), ischemic coronary artery disorders, pancytopenia, hypercoagulation (=
including thrombophlebitis, pulmonary embolism), cerebrovascular accident, =
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairmen=
t/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4 p=
ercent of patients discontinued taking Cimzia=C2=AE due to adverse events v=
s. 2.7 percent for placebo.

Cimzia^=C2=AE was initially studied in 325 patients with active axial spond=
yloarthritis (including ankylosing spondylitis and non-radiographic axial s=
pondyloarthritis) in the AS001 clinical study for up to 4 years, which incl=
udes a 24-week placebo-controlled phase followed by a 24-week dose-blind pe=
riod and a 156-week open-label treatment period. Cimzia^=C2=AE was subseque=
ntly studied in 317 patients with non-radiographic axial spondyloarthritis =
in a placebo-controlled study for 52 weeks (AS0006). Cimzia^=C2=AE was also=
studied in patients with axial spondyloarthritis (including ankylosing spo=
ndylitis 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=3D7=
36) followed by a 48-week placebo-controlled phase (N=3D313) for patients i=
n sustained remission (C-OPTIMISE). In all 3 studies, the safety profile fo=
r these patients was consistent with the safety profile in rheumatoid arthr=
itis and previous experience with Cimzia^=C2=AE. =C2=A0
=C2=A0
Cimzia^=C2=AE was studied in 409 patients with psoriatic arthritis (PsA) in=
a clinical study for up to 4 years which included a 24-week placebo-contro=
lled phase followed by a 24-week dose-blind period and a 168-week open-labe=
l treatment period.

The safety profile for axSpA and PsA patients treated with Cimzia=C2=AE was=
consistent with the safety profile in RA and previous experience with Cimz=
ia^=C2=AE.

Cimzia^=C2=AE was studied in 1112 patients with psoriasis in controlled and=
open-label studies for up to 3 years. In the Phase III program, the initia=
l and maintenance periods were followed by a 96-week open-label treatment p=
eriod. The long-term safety profile of Cimzia^=C2=AE 400 mg every 2 weeks a=
nd Cimzia^=C2=AE 200 mg every 2 weeks was generally similar and consistent =
with previous experience with Cimzia.

Cimzia^=C2=AE is contraindicated in patients with hypersensitivity to the a=
ctive substance or any of the excipients, active tuberculosis or other seve=
re infections such as sepsis or opportunistic infections, and moderate to s=
evere heart failure.

Serious infections including sepsis, tuberculosis and opportunistic infecti=
ons (e.g. histoplasmosis, nocardia, candidiasis) have been reported in pati=
ents receiving Cimzia^=C2=AE. Some of these events have been fatal. Before =
initiation of therapy with Cimzia^=C2=AE, all patients must be evaluated fo=
r both active and inactive (latent) tuberculosis infection. If active tuber=
culosis is diagnosed prior to or during treatment, Cimzia^=C2=AE therapy mu=
st not be initiated and must be discontinued. If latent tuberculosis is dia=
gnosed, appropriate anti-tuberculosis therapy must be started before initia=
ting treatment with Cimzia^=C2=AE.

Reactivation of hepatitis B has occurred in patients receiving a TNF-antago=
nist including Cimzia^=C2=AE who are chronic carriers of the virus (i.e. su=
rface antigen positive). Some cases have had a fatal outcome. Patients shou=
ld be tested for HBV infection before initiating treatment with Cimzia^=C2=
=AE. Carriers of HBV who require treatment with Cimzia^=C2=AE should be clo=
sely monitored and in the case of HBV reactivation Cimzia^=C2=AE should be =
stopped and effective anti-viral therapy with appropriate supportive treatm=
ent should be initiated.

TNF antagonists including Cimzia^=C2=AE may increase the risk of new onset =
or exacerbation of clinical symptoms and/or radiographic evidence of demyel=
inating disease including multiple sclerosis; of formation of autoantibodie=
s and uncommonly of the development of a lupus-like syndrome; of severe hyp=
ersensitivity reactions. If a patient develops any of these adverse reactio=
ns, Cimzia^=C2=AE 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 Cimzia^=C2=AE.

Adverse reactions of the haematologic system, including medically significa=
nt cytopenia, have been reported with Cimzia^=C2=AE. Advise all patients to=
seek immediate medical attention if they develop signs and symptoms sugges=
tive of blood dyscrasias or infection (e.g., persistent fever, bruising, bl=
eeding, pallor) while on Cimzia^=C2=AE. Consider discontinuation of Cimzia^=
=C2=AE therapy in patients with confirmed significant haematological abnorm=
alities.

The use of Cimzia^=C2=AE in combination with anakinra or abatacept is not r=
ecommended due to a potential increased risk of serious infections. As no d=
ata are available, Cimzia^=C2=AE should not be administered concurrently wi=
th live vaccines. The 14-day half-life of Cimzia^=C2=AE should be taken int=
o consideration if a surgical procedure is planned. A patient who requires =
surgery while on Cimzia^=C2=AE should be closely monitored for infections.

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

European SmPC date of revision July 2020.
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E=
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lFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf=
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ammojnFPCrYiFbIWr9tfn7f8CmNzymV1U0SbsMVbFZsm1u9yBVeDuewB1CbVYppsn-2FvSpBpXv=
KRn-2BQQ85WhXvFFAUTvb4LzYc7fPQKX3oByRYdUSgKHEdTGSWNHLoVWgoQCVgArTwYMObQszZZ=
dw-3D =C2=A0

About CIMZIA^=C2=AE in the US
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.

CIMZIA is indicated for reducing signs and symptoms of Crohn's disease (CD)=
and maintaining clinical response in adult patients with moderately to sev=
erely active disease who have had an inadequate response to conventional th=
erapy.

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.

In addition, CIMZIA is indicated for the treatment of moderate to severe pl=
aque psoriasis (PSO) in adults who are candidates for systemic therapy or p=
hototherapy. See important safety information including risk of serious bac=
terial, viral and fungal infections and tuberculosis below.

IMPORTANT SAFETY INFORMATION about CIMZIA in the U.S.=C2=A0

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.

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.

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. =C2=A0Approximately=
half of the cases were lymphoma, while the rest were other types of malign=
ancies, including rare types associated with immunosuppression and malignan=
cies not 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=E2=80=99s disease or ulcerative colitis, an=
d the majority were in adolescent and young adult males. =C2=A0Almost all o=
f these patients had received treatment with azathioprine or 6-mercaptopuri=
ne concomitantly with a TNF blocker at or prior to diagnosis. Carefully ass=
ess 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://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdKdn=
kD23fns-2FvC-2FH2O-2FRu906jSnkSmAsA6kkfIJiZLZFYPecTEBc0DLeE4Es5opQAqUaLqtEK=
-2BdxgvhbitwZiT9ZL7ZFvn5zIE818WgejABRLOv_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVW=
u7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9=
g1wbHr7ZqSDYYuhR-2BCTR6JItOrEFmnwGfDkLRhiZ8htS9f-2BXgsix-2BoGKR-2BslYsZBLqH=
lPSGOoZ1iUzMq3x7U40XbhfE-2Bk9qN-2BuLRW-2F9TCnzz2oRAmgCbYL5jEDfhHukcLcOwsjWF=
M6Og03-2Fq6D0OCTPtSnNiz0aIAlSGIyWoQ9UR0gc5-2Bvkl8QkxWdAL3-2FAGJizHpImLErlpf=
4UzwOZfq-2BFR81ZDj3euHQQYLi23Dy-2FMEawuc5AnbcPBFpOKp08Cix-2Fo-3D =C2=A0 =C2=
=A0

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

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 more than 7 600 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news.

Forward looking statements UCB
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=
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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=
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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 partnersh=
ips, joint ventures or licensing collaborations may be subject to differenc=
es 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 pa=
rtnership. UCB=E2=80=99 efforts to acquire other products or companies and =
to integrate the operations of such acquired companies may not be as succes=
sful as UCB may have believed at the moment of acquisition. Also, UCB or ot=
hers could discover safety, side effects or manufacturing problems with its=
products and/or devices after they are marketed. The discovery of signific=
ant problems with a product similar to one of UCB=E2=80=99s products that i=
mplicate an entire class of products may have a material adverse effect on =
sales of the entire class of affected products. Moreover, sales may be impa=
cted by international and domestic trends toward managed care and health ca=
re cost containment, including pricing pressure, political and public scrut=
iny, customer and prescriber patterns or practices, and the reimbursement p=
olicies imposed by third-party payers as well as legislation affecting biop=
harmaceutical pricing and reimbursement activities and outcomes. Finally, a=
breakdown, cyberattack or information security breach could compromise the=
confidentiality, integrity and availability of UCB=E2=80=99s data and syst=
ems.=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=A0Additionally, i=
nformation contained in this document shall not constitute an 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 jurisdiction in which =
such offer, solicitation or sale would be unlawful prior to the registratio=
n or qualification under the securities laws of such jurisdiction. =C2=A0=
=C2=A0=C2=A0 =C2=A0

For further information, UCB:=C2=A0

Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
Antje Witte =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
Investor Relations, UCB
T +32.2.559.94.14 antje.witte@ucb.com

Isabelle Ghellynck,
=C2=A0Investor Relations, UCB
T+32.2.559.9588, isabelle.ghellynck@ucb.com=C2=A0

Brand Communications
Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0
=C2=A0
References:

1. Warren R, et al. Bimekizumab efficacy and safety versus adalimumab in pa=
tients with moderate to severe plaque psoriasis: Results from a multicentre=
, randomised, double-blinded active comparator-controlled phase 3 trial (BE=
SURE). Abstract to be presented at EADV 2020, 29-31 October.
2. Papp K, et al. Bimekizumab for the treatment of moderate to severe plaqu=
e psoriasis with scalp, nail and palmoplantar involvement through 52 weeks:=
Post-hoc analysis from the BE VIVID phase 3 trial. Abstract to be presente=
d at EADV 2020, 29-31 October.
3. Strober B, et al. Bimekizumab versus ustekinumab efficacy across subgrou=
ps of patients with moderate to severe plaque psoriasis: Results from the m=
ulticentre, randomised, double-blinded phase 3 BE VIVID trial. Abstract to =
be presented at EADV 2020, 29-31 October.
4. Gordon K, et al. Bimekizumab versus ustekinumab in plaque psoriasis: Las=
ting efficacy translates to rapid and sustained improvements in quality of =
life in the BE VIVID multicentre, randomised, double-blinded phase 3 trial.=
Abstract to be presented at EADV 2020, 29-31 October.
5. Reich K, et al. Bimekizumab safety in patients with moderate to severe p=
soriasis: Analysis of pooled data from phase 2 and 3 clinical trials. Abstr=
act to be presented at EADV 2020, 29-31 October.
6. Tha=C3=A7i D, et al. Long-term improvements in health-related quality of=
life of patients with moderate to severe plaque psoriasis treated with cer=
tolizumab pegol: Results from the CIMPASI-1 and CIMPASI-2 phase 3 trials. A=
bstract to be presented at EADV 2020, 29-31 October.
7. European Medicines Agency (EMA). Certolizumab pegol summary of product c=
haracteristics, July 2020: https://u7061146.ct.sendgrid.net/ls/click?upn=3D=
4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJ=
CI8bbCZVOamVwH9nu7OTyWvLsHdN1-2FyZYmHi9NLhb7vDDKsRPZltwUi15uS1-2FlNNEJGWLOb=
TwwGSlAw-3D-3Dd0oO_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bS=
l0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wbHr7ZqSDYYuhR-2BCTR=
6JItOrEFmnwGfDkLRhiZ8htS9f-2BXgsix-2BoGKR-2BslYsZBLqHlPSGOoZ1iUzMq3x7U40Xbh=
fE-2Bk9qN-2BuLRW-2F9TCnzz2oazCjbe80rdZerUPH2fkzwTQ8CiXIJ0-2BomkMqgpEpdrGeXc=
92NtnJZj5hjY3A7QIPxdHGM5MXPXn2QrpxlkgRDWnVwusrkrJd4yXwrW70cTTrQTqw1Xie7s5Rw=
0kOTLN4A2XXramBff3JUB7tSDGRP8-3D Last accessed: October 2020.
8. McBride S, et al. Impact of Psoriatic Disease on Family Planning in Wome=
n Aged 18=E2=80=9345: Results from a Multinational Survey across 11 Countri=
es in Europe. Abstract to be presented at EADV 2020, 29-31 October.
9. Murray S, et al. Psoriasis, pregnancy, and shared decision making: Chall=
enges experienced by dermatologists. Abstract to be presented at EADV 2020,=
29-31 October.
10. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, 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.
11. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses =
by IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
12. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot f=
old: structure and activity of a novel cytokine, IL-17F, and implications f=
or receptor binding. Embo J. 2001;20(19):5332=E2=80=935341.
13. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous expres=
sion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syn=
ovium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: poss=
ible explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther.=
2014;16(4):426.
14. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-=
17A and IL-17F provides evidence of IL-17F contribution to chronic inflamma=
tion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
15. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisatio=
n by bimekizumab in psoriatic arthritis: evidence from preclinical experime=
nts and a randomised placebo-controlled clinical trial that IL-17F contribu=
tes to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.

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