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** EULAR 2021: New Data from UCB=E2=80=99s Rheumatology Portfolio Demonstra=
tes Real World Value for Patients with axSpA, PsA, and Women of Childbearin=
g Age
------------------------------------------------------------
=C2=B7 Patients with axial spondyloarthritis (axSpA), who achieve sustained=
remission, benefit from continued CIMZIA^=C2=AE (certolizumab pegol) treat=
ment either at the full or reduced maintenance dose, a post-hoc analysis of=
the C-OPTIMISE study confirms=C2=A0
=C2=B7 Further information for healthcare providers considering certolizuma=
b pegol treatment, if clinically needed, for their patients who are women o=
f childbearing age, is being presented from one of the largest cohorts of p=
rospective pregnancies with known outcomes in patients with axSpA, Crohn=E2=
=80=99s disease (CD), psoriatic arthritis (PsA), psoriasis (PSO) and rheuma=
toid arthritis (RA)=C2=A0
=C2=B7 Long-term safety, efficacy and patient-reported outcomes and quality=
of life data on UCB=E2=80=99s investigational IL-17A and IL-17F inhibitor,=
bimekizumab, show its potential to make a meaningful difference for people=
living with ankylosing spondylitis (AS) and PsA
Brussels, Belgium =E2=80=93 June 1, 2021, 7:00 CET =E2=80=93 UCB, a global =
biopharmaceutical company, today announced that it will present new data fo=
r its Fc-free anti-TNF, CIMZIA^=C2=AE (certolizumab pegol), and its investi=
gational IL-17A and IL-17F inhibitor, bimekizumab, at the European Congress=
of Rheumatology (EULAR) 2021 on June 2-5, 2021. A total of seven abstracts=
were accepted for this year=E2=80=99s E-Congress, all of which highlight U=
CB=E2=80=99s dedication to innovation in rheumatology and ongoing commitmen=
t to address unmet patient needs. Three of the seven abstracts will be pres=
ented as posters with guided narrations and live Q&As.
=E2=80=9CThe information we are presenting at EULAR captures our innovative=
research in rheumatology and sets us up for a promising future. This impor=
tant meeting gives us the opportunity to connect our science and innovation=
to the gaps and barriers that exist in the rheumatology patient journeys,=
=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solu=
tions and Head of U.S., UCB.
CIMZIA (certolizumab pegol) Data Highlights
Certolizumab pegol data include a post-hoc analysis of the Phase 3b C-OPTIM=
ISE study in axSpA. The analysis evaluated disease activity and clinical ma=
rkers of inflammation in patients who did not experience a disease flare fo=
llowing randomization to certolizumab pegol full maintenance dose (200 mg e=
very two weeks [Q2W]), certolizumab pegol reduced maintenance dose (200 mg =
every four weeks [Q4W]) or placebo during weeks 48=E2=80=9396 of C-OPTIMISE=
.^1=C2=A0The analysis identified consistently higher disease activity and i=
ncreases in serologic and inflammatory biomarkers in placebo-randomized pat=
ients who did not experience a flare during weeks 48-96 of C-OPTIMISE, comp=
ared to those who remained on certolizumab pegol.^1 The findings confirm th=
at patients with axSpA who achieve sustained remission benefit from continu=
ed certolizumab pegol treatment, either with the full or reduced maintenanc=
e dose - over treatment withdrawal.^1
Additional certolizumab pegol data include two-year results from the Phase =
4, open-label C-VIEW study investigating the impact of certolizumab pegol t=
reatment on acute anterior uveitis (AAU) flares in patients with axSpA and =
a recent history of AAU flares^2, and a post-hoc analysis from an intervent=
ional 52-week placebo-controlled study in nr-axSpA (C-axSpAnd) to identify =
positive magnetic resonance imaging (MRI) or sacroiliac joints and human le=
ukocyte antigen-B27 (HLA-B27) positive carrier at baseline as predictive fa=
ctors of 52 weeks of clinical response to certolizumab pegol treatment.^3
UCB will share an analysis that includes more than 1,000 prospective pregna=
ncies with certolizumab pegol exposure in at least the first trimester, rep=
resenting one of the largest cohorts of pregnancies with known outcomes in =
patients living with axSpA, CD, PsA, PSO and RA who were exposed to a biolo=
gic.^4=C2=A0No increase in adverse pregnancy outcomes or specific congenita=
l malformations was observed in certolizumab pegol-exposed pregnancies comp=
ared to the general population.^5,6=C2=A0 Our data further confirmed the in=
fluence of confounding factors, such as specific chronic inflammatory disea=
ses (CIDs), concomitant drugs or comorbidities, on pregnancy outcomes. Take=
n together, these data offer further information for healthcare providers c=
onsidering certolizumab pegol treatment, if clinically needed, for their pa=
tients who are women of childbearing age.
Bimekizumab Data Highlights
New Phase 2b data from the BE AGILE and BE ACTIVE open-label extension (OLE=
) studies investigating the long-term safety and efficacy of bimekizumab tr=
eatment (160mg Q4W) in patients with AS and PsA, respectively, show that th=
e safety profile of bimekizumab was in line with previous observations.^7,8=
=C2=A0There were no new signals, and exposure-adjusted incidence rate decre=
ased with longer exposure.^7,9=C2=A0 In both studies, clinical efficacy out=
comes observed at week 48 were sustained through up to three years of treat=
ment.^7,8
Additional data from the BE AGILE OLE study in patients with active AS trea=
ted with bimekizumab over three years demonstrate sustained and consistent =
efficacy in patient-reported outcomes, in disease activity, physical functi=
on, spinal pain, fatigue, morning stiffness and health-related quality of l=
ife (ASQoL).^10=C2=A0Across all reported outcome measures, efficacy was mai=
ntained from week 48 to week 144 or 156.^10=C2=A0
The safety and efficacy of bimekizumab have not been established, and it is=
not approved by any regulatory authority worldwide.
UCB data presentations at EULAR 2021:
CIMZIA e-Posters with Guided Poster Tour:
=C2=B7 Disease Activity and Inflammation Following Withdrawal of Certolizum=
ab Pegol Treatment in Axial Spondyloarthritis Patients Who Did Not Experien=
ce Flares during the C-OPTIMISE Study, L. Gensler, X. Baraliakos, L. Bauer,=
B. Hoepken, T. Kumke, M. Kim, R. Landew=C3=A9 (abstract #POS0229)
=C2=B7 Pharmacovigilance Pregnancy Data in a Large Population of Patients w=
ith Chronic Inflammatory Disease Exposed to Certolizumab Pegol: Pregnancy O=
utcomes and Confounders, M. Clowse, R. Fischer-Betz, C. Nelson-Piercy, A. S=
cheuerle, T. Kumke, B. Lauwerys, R. Kasliwal, F. F=C3=B6rger, Landew=C3=A9 =
(abstract #POS0022)
CIMZIA e-Posters:
=C2=B7 Reduction of Anterior Uveitis Flares in Patients with Axial Spondylo=
arthritis During Certolizumab Pegol Treatment: 96-Week Results from the C-V=
IEW Study, I. Van der Horst-Bruinsma, R. Van Bentum, F. Verbraak, T. Rath, =
B. Hoepken, O. Irvin-Sellers, T. Kumke, L. Bauer, M. Rudwaleit (abstract #P=
OS0897)
=C2=B7 Predictors of Response in Patients with Non-Radiographic Axial Spond=
yloarthritis Receiving Certolizumab Pegol in the C-axSpAnd Study, W. Maksym=
owych, T. Kumke, S. Auteri, B. Hoepken, L. Bauer, M. Rudwaleit (abstract #P=
OS0896)
Bimekizumab e-Poster with Guided Poster Tour:
=C2=B7 Bimekizumab Long-Term Safety and Efficacy in Patients with Ankylosin=
g Spondylitis: 3-Year Results from a Phase 2b Study, D. van der Heijde, A. =
Deodhar, L. S. Gensler, D. Poddubnyy, A. Kivitz, M. Dougados, N. de Peyreca=
ve, M.Oortgiesen, T. Vaux, C.Fleurinck, X.Baraliakos (abstract #POS0226)
Bimekizumab e-Posters:
=C2=B7 Bimekizumab Shows Sustained Long-Term Improvements in Patient-Report=
ed Outcomes and Quality of Life in Ankylosing Spondylitis: 3-Year Results f=
rom a Phase 2b Study, X. Baraliakos, M. Dougados, K. Gaffney, R. Sengupta, =
M. Magrey, N. de Peyrecave, M. Oortgiesen, T. Vaux, C. Fleurinck, V. Ciarav=
ino, A. Deodhar (abstract #POS0919)
=C2=B7 Bimekizumab Safety and Efficacy in Patients with Psoriatic Arthritis=
: 3-Year Results from a Phase 2b Open-Label Extension Study, L. Coates, R. =
Warren, C. Ritchlin, L. Gossec, J. Merola, D. Assudani, J. Coarse, J. Eells=
, B. Ink, I. Mcinnes (abstract #POS1022)
About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively and directly inhibits both IL-17A and IL-17F, two key cytokines =
driving inflammatory processes.^11=C2=A0IL-17F has overlapping biology with=
IL-17A and drives inflammation independently of IL-17A.^12,13,13,14,15,16=
=C2=A0Selective inhibition of IL-17F in addition to IL-17A suppresses infla=
mmation to a greater extent than IL-17A inhibition alone.^15,16 The safety =
and efficacy of bimekizumab are being evaluated across multiple disease sta=
tes 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
Date of revision March 2021
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 Cimzia^=C2=AE and pos=
t-marketing were viral infections (includes herpes zoster, papillomavirus, =
influenza), bacterial infections (including abscess), rash, headache (inclu=
ding migraine), asthenia, leukopenia (including lymphopenia, neutropenia), =
eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalities, hy=
pertension, pruritus (any sites), hepatitis (including hepatic enzyme incre=
ase), injection site reactions, and nausea. Serious adverse reactions inclu=
de sepsis, opportunistic infections, tuberculosis (including miliary, disse=
minated and extrapulmonary), herpes zoster, lymphoma, leukaemia, solid orga=
n tumours, angioneurotic oedema, cardiomyopathies (includes heart failure),=
ischemic coronary artery disorders, pancytopenia, hypercoagulation (includ=
ing thrombophlebitis, pulmonary embolism), cerebrovascular accident, vascul=
itis, hepatitis/hepatopathy (includes cirrhosis), and renal impairment/neph=
ropathy (includes nephritis). In RA controlled clinical trials, 4.4% of pat=
ients discontinued taking Cimzia=C2=AE due to adverse events vs. 2.7% for p=
lacebo.=C2=A0
Cimzia was initially studied in 325 patients with active axial spondyloarth=
ritis (including ankylosing spondylitis and non-radiographic axial spondylo=
arthritis) in the AS001 clinical study for up to 4 years, which includes a =
24-week placebo-controlled phase followed by a 24-week dose-blind period an=
d a 156-week open-label treatment period. Cimzia was subsequently studied i=
n 317 patients with non-radiographic axial spondyloarthritis in a placebo-c=
ontrolled study for 52 weeks (AS0006). Cimzia was also studied in patients =
with axial spondyloarthritis (including ankylosing spondylitis and non-radi=
ographic axial spondyloarthritis) in a clinical study for up to 96 weeks, w=
hich 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). In all 3 studies, the safety profile for these patients was =
consistent with the safety profile in rheumatoid arthritis and previous exp=
erience with Cimzia.=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.=C2=A0
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.=C2=A0
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.=C2=A0
*EU/EEA means European Union/European Economic Area
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.=C2=A0
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 initi=
ating treatment with Cimzia^=C2=AE.=C2=A0
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.=C2=A0
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=
.=C2=A0
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.=C2=A0
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.=C2=A0
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.=
=C2=A0
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 March 2021.=C2=A0
https://www.ema.europa.eu/en/documents/product-information/cimzia-epar-prod=
uct-information_en.pdf
Last accessed: May 2021.
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 5.3=
billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news.
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=80=9D, =E2=80=9Cplans=E2=80=9D, =E2=80=9Cseeks=E2=80=9D, =E2=80=9Cestimate=
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For further information, contact UCB:=C2=A0
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Andrea Levin Christopher,
Immunology Communications, UCB
T +1.404.483.7329, andrea.christopher@ucb.com=C2=A0
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Media Relations, UCB =C2=A0
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References:
1. Gensler L, Baraliakos X, Bauer L, et al. Disease Activity and Inflammati=
on Following Withdrawal of Certolizumab Pegol Treatment in Axial =C2=A0 Spo=
ndyloarthritis Patients Who Did Not Experience Flares during the C-OPTIMISE=
Study. Abstract to be presented at EULAR 2021, June 2-5.
2. Van der Horst-Bruinsma I, Van Bentum R, Verbraak F, et al. Reduction of =
Anterior Uveitis Flares in Patients with Axial Spondyloarthritis During Cer=
tolizumab Pegol Treatment: 96-Week Results from the C-VIEW Study. Abstract =
to be presented at EULAR 2021, June 2-5.
3. Maksymowych W, Kumke T, Auteri S, et al. Predictors of Response in Patie=
nts with Non-Radiographic Axial Spondyloarthritis Receiving Certolizumab Pe=
gol in the C-axSpAnd Study. Abstract to be presented at EULAR 2021, June 2-=
5.
4. Clowse M, Fischer-Betz R, Nelson-Piercy C, et al. Pharmacovigilance Preg=
nancy Data in a Large Population of Patients with Chronic Inflammatory Dise=
ase Exposed to Certolizumab Pegol: Pregnancy Outcomes and Confounders. Abst=
ract to be presented at EULAR 2021, June 2-5.
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Safety and Efficacy in Patients with Ankylosing Spondylitis: 3-Year Results=
from a Phase 2b Study. Abstract to be presented at EULAR 2021, June 2-5.
8. Coates L, Warren R, Ritchlin C, et al. Bimekizumab Safety and Efficacy i=
n Patients with Psoriatic Arthritis: 3-Year Results from a Phase 2b Open-La=
bel Extension Study. Abstract to be presented at EULAR 2021, June 2-5.
9. Mcinnes I, Merola JF, Mease PJ, et al. SAT0403 EFFICACY AND SAFETY OF 10=
8 WEEKS=E2=80=99 BIMEKIZUMAB TREATMENT IN PATIENTS WITH PSORIATIC ARTHRITIS=
: INTERIM RESULTS FROM A PHASE 2 OPEN-LABEL EXTENSION STUDY. Annals of the =
Rheumatic Diseases. 2020;79:1153-1154.
10. Baraliakos X, Dougados M, Gaffney K, et al. Bimekizumab Shows Sustained=
Long-Term Improvements in Patient-Reported Outcomes and Quality of Life in=
Ankylosing Spondylitis: 3-Year Results from a Phase 2b Study. Abstract to =
be presented at EULAR 2021, June 2-5.
11. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, a humanized monoclonal antibody and selective dual=C2=A0inhibit=
or of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5)=
:991-1001.
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