https://mb.cision.com/Public/18595/3775463/9d8e27cb55c96e14_800x800ar.png
** UCB Showcases Commitment to Advancing Care in Immune-Mediated Inflammato=
ry Diseases with 23 Abstracts at EULAR 2023
------------------------------------------------------------
=C2=B7 Data to be presented on bimekizumab, CIMZIA^=C2=AE (certolizumab peg=
ol), and dapirolizumab pegol
=C2=B7 First presentation of bimekizumab 52-week data from the open-label e=
xtension of the Phase 3 BE COMPLETE study in psoriatic arthritis=C2=A0
=C2=B7 New 52-week data evaluating the impact of bimekizumab on peripheral =
manifestations of axial spondyloarthritis and inflammatory lesions of the s=
acroiliac joints and spine=C2=A0
Brussels (Belgium), 30th May 2023 (07:00 CET) =E2=80=93 UCB, a global bioph=
armaceutical company, today announced that it will present 23 abstracts acr=
oss multiple immune-mediated inflammatory diseases at the European Congress=
of Rheumatology, EULAR 2023, in Milan, Italy, May 31=E2=80=93June 3. The a=
bstracts including data on bimekizumab, CIMZIA^=C2=AE (certolizumab pegol) =
and dapirolizumab pegol have been accepted as five poster tours, eleven pos=
ter views and seven abstract book presentations. =C2=A0=C2=A0
=E2=80=9CThe breadth of data that we are presenting at EULAR 2023 highlight=
our expanding rheumatology portfolio and enduring effort to advance care f=
or diverse immune-mediated inflammatory conditions,=E2=80=9D said Emmanuel =
Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., =
UCB.=C2=A0
The abstracts highlight UCB=E2=80=99s latest research in axial spondyloarth=
ritis (axSpA), psoriasis, psoriatic arthritis (PsA) and systemic lupus eryt=
hematosus (SLE) with key data to be shared including:
=C2=B7 Results from the phase 3 BE COMPLETE study and its open-label extens=
ion evaluating bimekizumab up to one year in patients with active PsA and p=
rior inadequate response to tumour necrosis factor inhibitors.
=C2=B7 52-week results from the phase 3 BE MOBILE 1 and BE MOBILE 2 studies=
in patients with active axSpA evaluating the impact of bimekizumab on infl=
ammatory lesions of the sacroiliac joints and spine as assessed by magnetic=
resonance imaging (MRI).
=C2=B7 Results from the phase 3 BE MOBILE 1 and BE MOBILE 2 studies evaluat=
ing the impact of bimekizumab on the main peripheral manifestations of axSp=
A, enthesitis and peripheral arthritis, up to week 52.
=C2=B7 Post hoc analysis of phase 2 clinical data evaluating clinical respo=
nse of dapirolizumab pegol in subgroups in patients with SLE.
Bimekizumab is not approved for use in ankylosing spondylitis (AS), PsA or =
non-radiographic axSpA (nr-axSpA) by any regulatory authority worldwide. Th=
e safety and efficacy of bimekizumab in AS, PsA and nr-axSpA have not been =
established.=C2=A0
Dapirolizumab pegol is not approved for use in SLE by any regulatory author=
ity worldwide. The safety and efficacy of dapirolizumab pegol in SLE have n=
ot been established.=C2=A0
The following is a guide to the UCB-sponsored data presentations at
EULAR 2023:
Bimekizumab abstracts: Psoriatic Arthritis=C2=A0
=C2=B7 Sustained efficacy and safety of bimekizumab in patients with active=
psoriatic arthritis and prior inadequate response to tumour necrosis facto=
r inhibitors: Results from the phase 3 BE COMPLETE study and its open-label=
extension up to 1 year
Coates LC, Landew=C3=A9 R, McInnes IB, Mease PJ, Ritchlin CT, Tanaka Y, Asa=
hina A, Behrens F, Gladman DD, Gossec L, Gottlieb AB, Warren RB, Ink B, Baj=
racharya R, Coarse J, Merola JF
# POS0231
Poster tour presentation: Friday, June 2, 12:00=E2=80=9313:30 CEST
=C2=B7 Bimekizumab maintained efficacy responses through 52 weeks in biolog=
ic disease-modifying antirheumatic drug-na=C3=AFve patients with psoriatic =
arthritis who were responders at Week 16: Results from BE OPTIMAL, a phase =
3, active-reference study
Tillett W, Merola JF, Tanaka Y, Favalli EG, McGonagle D, Walsh JA, Tha=C3=
=A7i D, Ink B, Bajracharya R, Taieb V, Ritchlin CT
# POS1534
Poster view presentation: Saturday, June 3, 10:30=E2=80=9311:30 CEST
=C2=B7 Bimekizumab efficacy and safety in biologic DMARD-na=C3=AFve patient=
s with psoriatic arthritis was consistent with or without methotrexate: 52-=
week results from the phase 3 active-reference study BE OPTIMAL
McInnes IB, Mease PJ, Tanaka Y, Behrens F, Gossec L, Husni ME, Kristensen L=
E, Warren RB, Ink B, Bajracharya R, Coarse J, Eells J, Gottlieb AB
# POS1537
Poster view presentation: Saturday, June 3, 10:30=E2=80=9311:30 CEST
=C2=B7 Bimekizumab treatment resulted in clinically meaningful improvements=
in the psoriatic arthritis impact of disease-12 (PsAID-12) scores using po=
oled results from two phase 3 trials in patients with psoriatic arthritis
Gossec L, Coates LC, Orbai A-M, de Wit M, Lambert J, Ink B, Taieb V, Gladma=
n DD
# POS1533
Poster view presentation: Saturday, June 3, 10:30=E2=80=9311:30 CEST
=C2=B7 Identification of responder and disease activity thresholds for the =
Psoriatic Arthritis Impact of Disease-12 (PsAID-12) using pooled data from =
two phase 3 trials of bimekizumab in patients with psoriatic arthritis
Gossec L, Coates LC, Orbai A-M, de Wit M, Pelligra C, Lambert J, Ciaravino =
V, Ink B, Taieb V,=C2=A0
Gladman DD
# POS0590-HPR=C2=A0
Poster view presentation: Wednesday, May 31, 15:30=E2=80=9316:30 CEST
=C2=B7 Achievement of increasingly stringent clinical disease control crite=
ria was associated with greater improvements in physical function, pain and=
fatigue in patients with active psoriatic arthritis: 52-week results from =
BE OPTIMAL, a phase 3 randomised, placebo-controlled study
Kristensen LE, Coates LC, Mease PJ, Merola JF, Gisondi P, Nash P, Orbai A-M=
, Tillett W, Ink B, Bajracharya R, Taieb V, Lambert J, Willems D, Walsh JA
# AB1100
Abstract book
=C2=B7 Sustained efficacy of bimekizumab treatment assessed using composite=
measures of disease activity in patients with psoriatic arthritis and prio=
r inadequate response or intolerance to tumour necrosis factor inhibitors: =
Results from the phase 3 BE COMPLETE study and its open-label extension up =
to 1 year
Coates LC, Landew=C3=A9 R, McInnes IB, Ritchlin CT, Gottlieb AB, Orbai A-M,=
Warren RB, Ink B, Bajracharya R, Coarse J, Merola JF
# AB1099
Abstract book
Bimekizumab abstracts: Axial Spondyloarthritis
=C2=B7 Bimekizumab reduced MRI inflammatory lesions in patients with axial =
spondyloarthritis: Week 52 results from the BE MOBILE 1 and BE MOBILE 2 pha=
se 3 studies
Baraliakos X, Navarro-Compan V, Poddubnyy D, Dubrueil M, Bennett A, Jans L,=
Massow U, Fleurinck C, Vaux T, Ellis AM, de Peyrecave N, Maksymowych WP
# POS0246=C2=A0
Poster tour presentation: Friday, June 2, 12:00=E2=80=9313:30 CEST
=C2=B7 Resolution of enthesitis and peripheral arthritis with bimekizumab i=
n patients with axial spondyloarthritis: Week 52 results from the BE MOBILE=
1 and BE MOBILE 2 phase 3 studies
Ramiro S, Poddubnyy D, Mease PJ, Lopez-Medina C, Fleurinck C, Kim M, Massow=
U, Taieb V, Wenzel Kragstrup T, McGonagle DG
# POS0247
Poster tour presentation: Friday, June 2, 12:00=E2=80=9313:30 CEST
=C2=B7 Bimekizumab maintained improvements in efficacy endpoints and had a =
consistent safety profile through 52 weeks in patients with non-radiographi=
c and radiographic axial spondyloarthritis: Results from two parallel phase=
3 studies=C2=A0
Baraliakos X, Deodhar A, van der Heijde D, Magrey M, Maksymowych WP, Tomita=
T, Xu H, Oortgiesen M, Massow U, Fleurinck C, Ellis AM, Vaux T, Shepherd-S=
mith J, Marten A, Gensler LS
# POS1103
Poster view presentation: Friday, June 2, 09:30=E2=80=9310:30 CEST
=C2=B7 Achievement of low disease activity over 52 weeks in patients with a=
ctive axial spondyloarthritis on bimekizumab treatment: Results from the ph=
ase 3 studies BE MOBILE 1 and BE MOBILE 2
Baraliakos X, Ramiro S, Magrey M, Rudwaleit M, Haroon N, Fleurinck C, Masso=
w U, de Peyrecave N, Vaux T, Marzo-Ortega H, Navarro-Comp=C3=A1n V
# POS1106
Poster view presentation: Friday, June 2, 09:30=E2=80=9310:30 CEST
=C2=B7 Bimekizumab maintained stringent clinical responses through Week 52 =
in patients with axial spondyloarthritis: Results from the phase 3 studies =
BE MOBILE 1 and 2
Proft F, van der Heijde D, Baraliakos X, Ermann J, Fleurinck C, Massow U, d=
e Peyrecave N, Taieb V, van Tubergen A, Navarro-Comp=C3=A1n V
# POS1104
Poster view presentation: Friday, June 2, 09:30=E2=80=9310:30 CEST
=C2=B7 Bimekizumab achieved sustained improvements in efficacy outcomes in =
patients with axial spondyloarthritis, regardless of prior TNF inhibitor tr=
eatment: Week 52 pooled results from two phase 3 studies=C2=A0
Magrey M, van de Sande M, Breban M, Van den Bosch F, Fleurinck C, Massow U,=
de Peyrecave N, Vaux T, Baraliakos X, Marzo-Ortega H
# POS1107=C2=A0
Poster view presentation: Friday, June 2, 09:30=E2=80=9310:30 CEST
=C2=B7 Low uveitis rates in patients with axial spondyloarthritis treated w=
ith bimekizumab: Pooled results from phase 2b/3 trials=C2=A0
Brown M, van Gaalen FA, van der Horst-Bruinsma IE, Rudwaleit M, Haroon N, G=
ensler LS, Deodhar A, Fleurinck C, Marten A, Massow U, Vaux T, White K, de =
Peyrecave N, Rosenbaum J
# POS0668
Poster view presentation: Thursday, June 1, 09:30=E2=80=9310:30 CEST
=C2=B7 Achievement of increasingly stringent clinical response criteria and=
lower levels of disease activity was associated with greater improvements =
in physical function and HRQoL in patients with active axial spondyloarthri=
tis: 52-week results from two phase 3 studies on bimekizumab
Magrey M, Deodhar, A, Mease PJ, Navarro-Compan V, Ramiro S, Rudwaleit M, de=
la Loge C, Fleurinck C, Taieb V, Morup MF, Oortgiesen M, Kay J
# AB1000
Abstract book
=C2=B7 Self-reported hidradenitis suppurativa-like skin symptoms in patient=
s with spondyloarthritis: Results from an online survey
Spoorenberg A, Kim M, Pasnar I, Glassner HL
# AB1044
Abstract book
Bimekizumab abstract: Psoriatic arthritis and Axial Spondyloarthritis
=C2=B7 Safety profile of bimekizumab at Week 16 in patients with axial spon=
dyloarthritis and psoriatic arthritis: Results from four placebo-controlled=
phase 3 studies=C2=A0
Poddubnyy D, Gensler LS, Mease PJ, Orbai A-M, Warren RB, Ink B, Massow U, A=
ssudani D, Fleurinck C, Shende V, Shepherd-Smith J, Peterson L, White K, La=
ndew=C3=A9 R
# AB0938
Abstract book
Bimekizumab abstract: Psoriasis
=C2=B7 Bimekizumab efficacy in high-impact areas for patients with moderate=
to severe plaque psoriasis: Pooled results through two years from the BE S=
URE and BE RADIANT phase 3 trials
Merola J, Gottlieb A, Morita A, Carrascosa JM, Elewski B, Davis L, Wixed K,=
Wiegratz S,=C2=A0
Mrowietz U
# AB1089=C2=A0
Abstract book
Certolizumab pegol abstracts: Axial Spondyloarthritis
=C2=B7 Performance analysis of a deep learning algorithm to detect positive=
SIJ MRI according to the ASAS definition in axSpA patients
Nicolaes J, Tselenti E, Aouad T, Medina CL, Feydy A, Talbot H, Hoepken B, d=
e Peyrecave N, Dougados M
# POS0341
Poster tour presentation: Saturday, June 3, 10:00=E2=80=9311:30 CEST
=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
Rudwaleit M, Van den Bosch F, Marzo-Ortega H, Navarro-Compan V, Tham R, Kum=
ke T, Bauer L, Kim M, Gensler LS
# POS0683
Poster view presentation: Thursday, June 1, 9:30=E2=80=9310:30 CEST
=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
Baraliakos X, Machado PM, Bauer L, Hoepken B, Kim M, Kumke T, Tham R, Rudwa=
leit M
# POS0679
Poster view presentation: Thursday, June 1, 9:30=E2=80=9310:30 CEST
Dapirolizumab Pegol: Systemic Lupus Erythematosus
=C2=B7 Dapirolizumab pegol efficacy by subgroups in patients with systemic =
lupus erythematosus: A post hoc analysis of phase 2 clinical trial data
Askanase AD, Stach C, Brittain C, Stojan G, Furie RA
# POS0115
Poster tour presentation: Thursday, June 1, 12:00=E2=80=9313:30 CEST
Disease: Psoriatic Arthritis=C2=A0
=C2=B7 Real-world usage of biologic disease-modifying antirheumatic drugs i=
n patients with psoriatic arthritis in Sweden
Song J, Ab=C3=A9 C, Banefelt J, Rieem Dun A, Willems D, M=C3=B8rup M, Taieb=
V, Lindberg I, Welby S=C2=A0
# AB1113
Abstract book
Abstracts to be presented at EULAR 2023 Congress are available at: https://=
congress.eular.org =C2=A0 https://congress.eular.org/scientific_programme.c=
fm
Notes to editors:
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.^1,2=C2=A0 In August 202=
1, bimekizumab was first approved in the European Union (EU)/European Econo=
mic Area (EEA) and in Great Britain, for the treatment of moderate to sever=
e plaque psoriasis in adults who are candidates for systemic therapy.^2,3=
=C2=A0The label information may differ in other countries where approved. P=
lease check local prescribing information.
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informa=
tion in 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: May 2023.
=E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. =
This will allow quick identification of new safety information. Healthcare =
professionals are asked to report any suspected adverse reactions.=C2=A0
About Cimzia=C2=AE (certolizumab pegol) in the EU/EEA^4
In the EU, certolizumab pegol in combination with methotrexate (MTX) is ind=
icated for the treatment of moderate to severe active RA in adult patients =
when the response to disease-modifying antirheumatic drugs (DMARDs), includ=
ing MTX, has been inadequate. Certolizumab pegol can be given as monotherap=
y in case of intolerance to MTX or when continued treatment with MTX is ina=
ppropriate. Certolizumab pegol in combination with MTX is also indicated fo=
r the treatment of severe, active and progressive RA in adults not previous=
ly treated with MTX or other DMARDs. Certolizumab pegol has been shown to r=
educe the rate of progression of joint damage as measured by X-ray and to i=
mprove 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. CIMZIA can be given as monotherapy in c=
ase of intolerance to MTX or when continued treatment with MTX is inappropr=
iate.
Certolizumab pegol is also indicated for the treatment of adult patients wi=
th 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.
Cimzia^=C2=AE (certolizumab pegol) EU/EEA Important Safety Information^4
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: March 2023
About dapirolizumab pegol=C2=A0
Dapirolizumab pegol is an investigational humanized polyethylene glycol (PE=
G)-conjugated antigen-binding (Fab=E2=80=99) fragment lacking a functional =
Fc domain. Dapirolizumab pegol inhibits CD40L signaling which has been show=
n to reduce B cell activation and autoantibody production, mitigate type 1 =
interferon (IFN) secretion, and attenuate T cell and antigen-presenting cel=
l (APC) activation.^5 Dapirolizumab pegol is presently in Phase 3 clinical =
development for the treatment of systemic lupus erythematosus (SLE) under a=
collaboration between UCB and Biogen.^6
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). Foll=
ow us on Twitter: @UCB_news.
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t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
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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=
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s in general economic, business and competitive conditions, the inability t=
o obtain necessary regulatory approvals or to obtain them on acceptable ter=
ms or within expected timing, costs associated with research and developmen=
t, changes in the prospects for products in the pipeline or under developme=
nt by UCB, effects of future judicial decisions or governmental investigati=
ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
ch laws, and hiring and retention of its employees. There is no guarantee t=
hat new product candidates will be discovered or identified in the pipeline=
, will progress to product approval or that new indications for existing pr=
oducts will be developed and approved. Movement from concept to commercial =
product is uncertain; preclinical results do not guarantee safety and effic=
acy of product candidates in humans. So far, the complexity of the human bo=
dy cannot be reproduced in computer models, cell culture systems or animal =
models. The length of the timing to complete clinical trials and to get reg=
ulatory approval for product marketing has varied in the past and UCB expec=
ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
ations may be subject to differences disputes between the partners or may p=
rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
or manufacturing problems with its products and/or devices after they are =
marketed. The discovery of significant problems with a product similar to o=
ne of UCB=E2=80=99s products that implicate an entire class of products may=
have a material adverse effect on sales of the entire class of affected pr=
oducts. Moreover, sales may be impacted by international and domestic trend=
s toward managed care and health care cost containment, including pricing p=
ressure, political and public scrutiny, customer and prescriber patterns or=
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well as legislation affecting biopharmaceutical pricing and reimbursement =
activities and outcomes. Finally, a breakdown, cyberattack or information s=
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lity of UCB=E2=80=99s data and systems.=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=
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o update any information contained in this press release, either to confirm=
the actual results or to report or reflect any change in its forward-looki=
ng statements with regard thereto or any change in events, conditions or ci=
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required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
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shall there be any offer, solicitation or sale of securities in any jurisdi=
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References
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6. ClinGov.gov (NCT04294667). A Study to Evaluate the Efficacy and Safety o=
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ay 2023
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