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** UCB Shares Breadth of Innovative New Data from Rheumatology Portfolio fo=
r EULAR 2020 E-Congress
------------------------------------------------------------
=C2=B7 C-OPTIMISE results give rheumatologists and patients new considerati=
ons for the maintenance of remission in axial spondyloarthritis (axSpA) wit=
h certolizumab pegol treatment=C2=A0
=C2=B7 Four-year results from the RAPID-axSpA study of CIMZIA^=C2=AE (certo=
lizumab pegol) highlight the importance of early, effective and long-term t=
reatment targeting inflammation
=C2=B7 Robust, patient-reported data on UCB=E2=80=99s investigational IL-17=
A and IL-17F inhibitor, bimekizumab, showcase its potential to make a meani=
ngful difference for people living with ankylosing spondylitis (AS) and pso=
riatic arthritis (PsA)=C2=A0
=C2=B7 Efficacy and safety of EVENITY^=C2=AE=E2=96=BC(romosozumab) evaluate=
d among postmenopausal women with osteoporosis and mild-to-moderate chronic=
kidney disease
=C2=B7 Research unveils barriers to shared decision-making between women wi=
th chronic inflammatory diseases and their specialists=C2=A0
Brussels, Belgium =E2=80=93 4 June 2020 =E2=80=93 UCB, a global biopharmace=
utical company, today announced significant new data on CIMZIA^=C2=AE (cert=
olizumab pegol), EVENITY^=C2=AE (romosozumab) and its investigational IL-17=
A and IL-17F inhibitor, bimekizumab, that are being presented at the Annual=
European Congress of Rheumatology (EULAR) 2020. With a total of 14 accepte=
d abstracts and five accepted as oral presentations across multiple rheumat=
ology solutions, UCB=E2=80=99s research is set to take center stage at this=
year=E2=80=99s virtual congress.=C2=A0
=E2=80=9CWe are thrilled to participate in the EULAR 2020 E-Congress and sh=
are important information for rheumatologists and their patients. The bread=
th of data from our rheumatology portfolio shows that we are continuing to =
connect innovative research to the gaps and barriers in the patient journey=
, making optimal care possible for more patients every day. With our contin=
ued development in axSpA and PsA, and successful launch of EVENITY in osteo=
porosis, UCB has an incredibly exciting future in rheumatology,=E2=80=9D sa=
id Emmanuel Caeymaex, Executive Vice President Immunology Solutions and Hea=
d of US, UCB.
Following are summaries of UCB abstracts accepted as oral presentations.
CERTOLIZUMAB PEGOL C-OPTIMISE STUDY: DOSE REDUCTION FOR MAINTENANCE OF REMI=
SSION IN axSpA
The Phase 3b C-OPTIMISE study of certolizumab pegol is the first-ever rando=
mized, placebo-controlled trial to compare TNF inhibitor full maintenance d=
ose continuation and dose reduction with the effects of treatment withdrawa=
l in patients with axSpA who achieved sustained clinical remission.^1=C2=A0=
The findings presented highlight that certolizumab pegol treatment should b=
e continued beyond the achievement of sustained remission. Furthermore, the=
data confirm that a reduced maintenance dose can be suitable for patients =
with axSpA who achieve sustained remission following 48 weeks of certolizum=
ab pegol treatment, regardless of axSpA subpopulation (radiographic [r]- an=
d non-radiographic [nr]- axSpA), gender or age.^1 Achievement of a state of=
low disease activity or remission is key to optimizing health-related qual=
ity of life in patients with axSpA. The C-OPTIMISE findings can give rheuma=
tologists and patients an alternative strategy to consider for the maintena=
nce of axSpA remission with certolizumab pegol treatment.
The primary C-OPTIMISE outcome was remaining flare-free during the maintena=
nce period, which was achieved by eight out of ten patients, regardless of =
whether they took the full certolizumab pegol dose or a reduced maintenance=
dose.^1 Results showed that 83.7 percent of patients on the full dose (83.=
9 percent r-axSpA and 83.3 percent nr-axSpA) and 79 percent of those on the=
reduced maintenance dose (82.1 percent r-axSpA and 75.5 percent nr-axSpA) =
remained flare-free.^1 Only 20.2 percent of patients randomized to placebo =
remained flare-free (17.9 percent r-axSpA and 22.9 percent nr-axSpA), under=
scoring the need for continued treatment after achieving sustained remissio=
n.^1 Overall, five serious treatment emergent adverse events (TEAEs) were r=
eported, all of which occurred in patients continuing the full certolizumab=
pegol maintenance dose.^1 A full recovery was made for all five events, in=
cluding the two serious TEAEs considered by the study investigator to be tr=
eatment-related (one case of intestinal obstruction and one of latent tuber=
culosis).^1=C2=A0
CIMZIA RAPID-axSpA STUDY: RISK REDUCTION OF SPINAL FAT LESIONS DEVELOPMENT
Four-year results from the RAPID-axSpA study of CIMZIA highlight the import=
ance of early, effective and long-term treatment targeting inflammation. =
=C2=A0Spinal fat lesions are one of the tell-tale signs of disease progress=
ion, considered to be post-inflammatory precursors to new bone formation th=
at cause worsening of patient mobility and function over time.^2 RAPID-axSp=
A results show that reduction of inflammation by week 12 with CIMZIA mitiga=
ted the risk of developing fat lesions over four years, while inflammation =
that prevailed after the start of TNF inhibition treatment was associated w=
ith increased fat lesions prevalence over that time.^2=C2=A0
CIMZIA C-VIEW STUDY: REDUCTION OF ANTERIOR UVEITIS FLARES IN axSpA
In addition to the above CIMZIA oral presentations, 48-week interim results=
from the open-label, Phase 4 C-VIEW study of CIMZIA in axSpA will be selec=
ted as a poster tour.^3 The interim analysis revealed that acute anterior u=
veitis (AAU) flare rate was significantly reduced in axSpA patients with a =
history of recurrent AAU during the first 48 weeks of CIMZIA treatment.^3 P=
atients also experienced substantial improvements in axSpA disease activity=
.^3 AAU is reported in up to 40 percent of patients with axSpA, and is asso=
ciated with significant clinical burden.^3 These C-VIEW results provide imp=
ortant information for axSpA patients and their rheumatologists to consider=
for their treatment plans.
BIMEKIZUMAB BE AGILE STUDY: PATIENT-REPORTED OUTCOMES IN AS
Findings from the Phase 2b BE AGILE study of bimekizumab in ankylosing spon=
dylitis (AS) showed rapid and sustained improvements in patient-reported ou=
tcomes with bimekizumab treatment.^4=C2=A0Results demonstrated greater impr=
ovements at week 12 in spinal pain, fatigue, morning stiffness, sleep, dise=
ase activity and quality of life in bimekizumab-treated patients than those=
receiving placebo.^4 Responses were further improved and maintained to wee=
k 48.^4 Serious TEAEs occurred in 4.3 percent of patients, which included t=
wo major adverse cardiac events considered not related to study drug.^4 Ora=
l candidiasis occurred in 5.3 percent of patients and did not lead to treat=
ment discontinuation.^4
The safety and efficacy of bimekizumab have not been established and it is =
not approved by any regulatory authority worldwide.
BARRIERS TO SHARED DECISION-MAKING WITH WOMEN
New survey findings exploring barriers to shared decision-making between pa=
tients and their specialists highlight some of the complex reasons why wome=
n with chronic inflammatory diseases may be likely to discontinue treatment=
during pregnancy, as indicated by previous research.^5=C2=A0=C2=A0
A total of 173 rheumatologists from Germany (G, n=3D55), the United Kingdom=
(UK, n=3D54) and the United States (US, n=3D64) rated their level of knowl=
edge and skills compared to what is expected in their role.^5 Respondents s=
cored themselves as sub-optimal against the following key areas relating to=
the care of women:^5
=C2=B7 Knowledge of biologic treatments licensed for women of childbearing =
age (G: 25 percent; UK: 33 percent; US: 22 percent);
=C2=B7 Knowledge of methods to achieve shared decision-making between physi=
cians and patients (G: 34 percent; UK: 40 percent; US: 35 percent);=C2=A0
=C2=B7 Skills discussing contraceptive methods with patients (G: 58 percent=
; UK: 79 percent; US: 55 percent);
=C2=B7 Skills monitoring changes in pregnancy status or child-bearing aspir=
ations (G: 65 percent; UK: 65 percent; US: 51 percent);
=C2=B7 Skills approaching women of reproductive age in a way that makes the=
m feel comfortable discussing their health concerns (G: 46 percent; UK: 48 =
percent; US: 44 percent);=C2=A0
=C2=B7 A greater proportion of male rheumatologists reported having sub-o=
ptimal skills in this area, compared to female rheumatologists (52 percent =
vs 30 percent, p=3D0.046).
By highlighting the knowledge and skills gaps that prevent optimal shared d=
ecision-making, medical learning interventions can be developed to help rhe=
umatologists address the needs of women of childbearing age living with chr=
onic inflammatory diseases.
EVENITY (ROMOSOZUMAB) IN PATIENTS WITH MILD-TO-MODERATE IMPAIRED RENAL FUNC=
TION
A post-hoc analysis of the Phase 3 ARCH and FRAME studies evaluated the eff=
icacy and safety of EVENITY in postmenopausal women with osteoporosis and m=
ild-to-moderate renal insufficiency.^6=C2=A0=C2=A0
In ARCH, the incidence of new vertebral fractures with EVENITY versus alend=
ronate at month 12 was =E2=80=93 among patients with normal renal function =
(eGFR=E2=89=A590): 3.3 percent vs 7.3 percent; among patients with mild ren=
al insufficiency (eGFR=E2=89=A560-89): 3.2 percent vs 3.9 percent; and amon=
g patients with moderate renal insufficiency (eGFR=E2=89=A530-59): 3.4 perc=
ent vs 6.2 percent.^6=C2=A0
In FRAME, the incidence of new vertebral fractures with EVENITY versus plac=
ebo at month 12 was =E2=80=93 among patients with normal renal function eGF=
R=E2=89=A590): 0.5 percent vs 3.0 percent; among patients with mild renal i=
nsufficiency (eGFR=E2=89=A560-89): 0.4 percent vs 1.5 percent; and among pa=
tients with moderate renal insufficiency (eGFR=E2=89=A530-59): 0.6 percent =
vs 2.1 percent.^6=C2=A0
In both studies, the incidences of adverse events (AEs) and serious AEs wer=
e similar with EVENITY treatment across different levels of renal function.=
^6=C2=A0
Across three different levels of renal function (normal, mild, moderate) EV=
ENITY treatment resulted in significant bone mineral density gains (from ba=
seline) and a reduction in the risk of new vertebral fractures versus contr=
ol (alendronate or placebo).^6EULAR virtual presentations are available to =
delegates via the congress portal: https://u7061146.ct.sendgrid.net/ls/clic=
k?upn=3D4tNED-2FM8iDZJQyQ53jATUa3m-2BmH5LGf0qo5fbKqUP1LAuuyaj3hCZuWbh-2FdMi=
-2BSGUq3i_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6E=
FaZqddW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wat2CbiF-2FWhLY87OM0k5aozkLTY=
pSq1x0kPblSV-2BEuL63DlA8wqCzkUww-2FO-2Bgv-2FtdagD9j3Ot4siPHDVrGeXERDW0R8wr-=
2FbIpA1bEVG2NuMwfrHPLHhGmP5gLXE-2Fq72F9Ej3JaPJb2GayIXraaKCB27LKKRgfvbSKbTUx=
kQhZoKUUpUxTacVfOzwJBifaxkcL5x9SToYZAjVeQ7MgVvyidZn4oVbMkhsOOl6sfS9QCEo63WS=
unI9iRumVLk43-2FrSmg-3D
CIMZIA oral presentations:
Does gender, age or subpopulation influence the maintenance of clinical rem=
ission in axial spondyloarthritis following certolizumab pegol dose reducti=
on? R. Landew=C3=A9, D. van der Heijde, M. Dougados, X. Baraliakos, F. Van =
den Bosch, K. Gaffney, L. Bauer, B. Hoepken, N. de Peyrecave, K. Thomas, L.=
Gensler
The impact of persistent inflammatory changes on prevalence of fat lesions =
in patients with axial spondyloarthritis treated with certolizumab pegol: 4=
-year MRI results from RAPID-axSpA, X. Baraliakos, S. Kruse, S. Auteri, N. =
de Peyrecave, T. Nurminen, T. Kumke, B. Hoepken, J. Braun
CIMZIA posters:
Reduction of anterior uveitis flares in patients with axial spondyloarthrit=
is following one year of treatment with certolizumab pegol: 48-week interim=
results from a 96-week open-label study, I. Van der Horst-Bruinsma, R. Van=
Bentum, F. Verbraak, T. Rath, J. Rosenbaum, M. Misterska-Skora, B. Hoepken=
, O. Irvin-Sellers, B. Vanlunen, L. Bauer, M. Rudwaleit
Achievement of very low disease activity and remission treatment targets is=
associated with reduced radiographic progression in patients with psoriati=
c arthritis treated with certolizumab pegol, L.C Coates, J.F. Merola, A. Ka=
vanaugh, P.J. Mease, O. Davies, O. Irvin-Sellers, T. Nurminen, D. van der H=
eijde
Durability of certolizumab pegol in patients with rheumatoid arthritis or p=
soriasis over three years: an analysis of pooled clinical trial data, V. By=
kerk, A. Gottlieb, K. Reich, Y. Tanaka, K. Winthrop, C. Popova, N. Tilt, A.=
Blauvelt
Certolizumab pegol in patients with rheumatoid arthritis: pooled efficacy a=
nalysis of phase 3 clinical trials across baseline rheumatoid factor quarti=
les, Y. Tanaka, Z. LI, N. Inanc, R. Xavier, N. Tilt, C. Cara,=C2=A0C. Saado=
un, T. Takeuchi
Bimekizumab oral presentation:
Efficacy and safety of bimekizumab in ankylosing spondylitis: 48-week patie=
nt-reported outcomes from a phase 2b, randomised, double-blind, placebo-con=
trolled, dose-ranging study, D. van der Heijde, L. Gensler, A. Deodhar, X. =
Baraliakos, D. Poddubnyy, A. Kivitz, M.K. Farmer, D. Baeten, N. Goldammer,
J. Coarse, M. Oortgiesen, M. Dougados
Bimekizumab posters and abstracts:
Efficacy and safety of 108 weeks=E2=80=99 bimekizumab treatment in patients=
with psoriatic arthritis: interim results from a phase 2 open-label extens=
ion study, I.B. Mcinnes, J.F. Merola, P.J. Mease, L.C. Coates, P. Joshi, J.=
Coarse, B. Ink, C.T Ritchlin
Association between patient-reported outcomes and disease activity in bimek=
izumab-treated patients with psoriatic arthritis, L. Gossec, P.J. Mease, A.=
Gottlieb, A. Ogdie, D. Assudani, J. Coarse, B. Ink, L.C. Coates
EVENITY oral presentation:
Efficacy and safety of romosozumab among postmenopausal women with osteopor=
osis and mild-to-moderate chronic kidney disease, P. Miller, J. Adachi, B. =
Albergaria, A. Cheung, A. Chines, E. Gielen, B. Langdahl, A. Miyauchi, M. O=
ates, I. Reid, N. Ruiz Santiago, M. Vanderkelen, W. Yang, Z. Yu
Shared decision-making oral presentation:
Barriers to shared decision-making with women of reproductive age affected =
by chronic inflammatory diseases, S. Murray, R. Fischer-Betz, M. Augustynia=
k, J. Murase, C.Nelson-Piercy, I. Vlaev, C. Ecoffet, M. Peniuta, D. Jenkins
Other UCB abstracts:
Awareness about family planning and pregnancy expectation among patients wi=
th chronic inflammatory disease of the skin or joints, K. Schreiber, C. Joh=
ansen, U. Jensen, A. Egeberg, S. Thomsen, A. Hansen, T. Laurberg, L. Skov, =
L. Kristensen
Tumour necrosis factor inhibitor therapy does not reduce the incidence of c=
omorbidities and extra-articular manifestations in ankylosing spondylitis: =
an analysis of three US claims databases, A. Deodhar, K. Winthrop, R. Bohn,=
B. Chan, R. Suruki, J. Stark, H. Yun, S. Siegel, L. Chen, J. Curtis
Annual diagnostic prevalence of ankylosing spondylitis (AS) in the United S=
tates using Medicare and MarketScan data, J. Curtis, K. Winthrop, B. Chan, =
S. Siegel, J. Stark, R. Suruki, R. Bohn, F. Xie, H. Yun, L. Chen, A. Deodhar
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
About CIMZIA^=C2=AE in Fertility, Pregnancy and Lactation in the EU/EEA
=C2=A0
Women of childbearing potential
The use of adequate contraception should be considered for women of childbe=
aring potential. For women planning pregnancy, continued contraception may =
be considered for 5 months after the last CIMZIA^=C2=AE dose due to its eli=
mination rate, but the need for treatment of the woman should also be taken=
into account (see below).
=C2=A0
Pregnancy
Data from more than 500 prospectively collected pregnancies exposed to CIMZ=
IA with known pregnancy outcomes, including more than 400 pregnancies expos=
ed during the first trimester, does not indicate a malformative effect of C=
IMZIA. However, the available clinical experience is too limited to, with a=
reasonable certainty, conclude that there is no increased risk associated =
with CIMZIA administration during pregnancy.
=C2=A0
Animal studies using a rodent anti-rat TNF=CE=B1 did not reveal evidence of=
impaired fertility or harm to the foetus. However, these are insufficient =
with respect to human reproductive toxicity. Due to its inhibition of TNF=
=CE=B1, CIMZIA administered during pregnancy could affect normal immune res=
ponse in the newborn.
=C2=A0
CIMZIA should only be used during pregnancy if clinically needed. Pharmacok=
inetic studies suggest low or negligible level of placental transfer of a h=
omologue Fab-fragment of certolizumab pegol (no Fc region).
=C2=A0
In a clinical study 16 women were treated with certolizumab pegol (200 mg e=
very 2 weeks or 400 mg every 4 weeks) during pregnancy. Certolizumab pegol =
plasma concentrations measured in 14 infants at birth were Below the Limit =
of Quantification (BLQ) in 13 samples; one was 0.042 =C2=B5g/ml with an inf=
ant/mother plasma ratio at birth of 0.09 percent. At Week 4 and Week 8, all=
infant concentrations were BLQ. The clinical significance of low levels ce=
rtolizumab pegol for infants is unknown. It is recommended to wait a minimu=
m of 5 months following the mother's last CIMZIA administration during preg=
nancy before administration of live or live-attenuated vaccines (e.g. BCG v=
accine), unless the benefit of the vaccination clearly outweighs the theore=
tical risk of administration of live or live-attenuated vaccines to the inf=
ants.
=C2=A0
Breastfeeding
In a clinical study in 17 lactating women treated with CIMZIA, minimal tran=
sfer of certolizumab pegol from plasma to breast milk was observed. The per=
centage of the maternal certolizumab pegol dose reaching an infant during a=
24 hour period was estimated to 0.04 percent to 0.30 percent. In addition,=
since certolizumab pegol is a protein that is degraded in the gastrointest=
inal tract after oral administration, the absolute bioavailability is expec=
ted to be very low in a breastfed infant. Consequently, CIMZIA can be used =
during breastfeeding.
=C2=A0
Cimzia^=C2=AE (certolizumab pegol) EU/EEA* Important Safety Information
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 =
and post-marketing were viral infections (includes herpes zoster, papilloma=
virus, influenza), bacterial infections (including abscess), rash, headache=
(including migraine), asthenia, leukopenia (including lymphopenia, neutrop=
enia), eosinophilic disorder, pain (any sites), pyrexia, sensory abnormalit=
ies, hypertension, pruritus (any sites), hepatitis (including hepatic enzym=
e increase), injection site reactions, and nausea. Serious adverse reaction=
s include sepsis, opportunistic infections, tuberculosis (including miliary=
, disseminated and extrapulmonary), herpes zoster, lymphoma, leukaemia, sol=
id organ tumours, angioneurotic oedema, cardiomyopathies (includes heart fa=
ilure), ischemic coronary artery disorders, pancytopenia, hypercoagulation =
(including thrombophlebitis, pulmonary embolism), cerebrovascular accident,=
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal impairme=
nt/nephropathy (includes nephritis). In RA controlled clinical trials, 4.4 =
percent of patients discontinued taking Cimzia=C2=AE due to adverse events =
vs. 2.7 percent for placebo.
Cimzia^=C2=AE was studied in 325 patients with active axial spondyloarthrit=
is (axSpA) in a clinical study for up to 4 years which included a 24-week p=
lacebo-controlled phase followed by a 24-week dose-blind period and a 156-w=
eek open-label treatment period and in 317 patients with non-radiographic a=
xial spondyloarthritis in a placebo-controlled study for 52 weeks (AS0006).
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 GL-P-CZ-axSpA-1900034 Important Safety Information Cimzi=
a Revised April 2020 * EU/EEA means European Union/European Economic Area c=
linical symptoms and/or radiographic evidence of demyelinating disease incl=
uding multiple sclerosis; of formation of autoantibodies and uncommonly of =
the development of a lupuslike syndrome; of severe hypersensitivity reactio=
ns. If a patient develops any of these adverse reactions, Cimzia^=C2=AE sho=
uld 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 into=
consideration if a surgical procedure is planned. A patient who requires s=
urgery 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 April 2020.
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E=
U-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH9nu7OTyWvLsHd=
N1-2FyZYmHjLZqbiXDQS8oPYmUsJ6fM-2BvtFbzqdutL-2Fr2YbsSY7P8w-3D-3DYPKD_xDPID0=
vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB5=
2Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wat2CbiF-2FWhLY87OM0k5aozkLTYpSq1x0kPblSV-2BE=
uL63DlA8wqCzkUww-2FO-2Bgv-2FtdagD9j3Ot4siPHDVrGeXERDW0R8wr-2FbIpA1bEVG2NuMw=
VlBeGapl3DKTDYWIPJuuNqTSdJkJeeFdHcTQm9hvnWrwepMPkhQ1fARxQBEElYODzEZz8Eyv-2B=
msbsYZ1CC45gdObJoFo5OKmobCOUK-2FDXlqPXtTMHNPgmXjDzCp41VfJXt3isiFjNsPj14b3fz=
XMhw-3D =C2=A0
CIMZIA^=C2=AE is a registered trademark of the UCB Group of Companies.
About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively inhibits both IL-17A and IL-17F, two key cytokines that drive in=
flammation and tissue damage across multiple diseases.^7=C2=A0IL-17F has ov=
erlapping biology with IL-17A and can drive inflammation independently to I=
L-17A.^8,9,10,11,12=C2=A0Selective inhibition of IL-17F in addition to IL-1=
7A suppresses inflammation to a greater extent than IL-17A inhibition alone=
.^11,12 The safety and efficacy of bimekizumab are being evaluated across m=
ultiple disease states as part of a robust clinical program. UCB plans to s=
ubmit applications to regulatory authorities for approval of bimekizumab to=
treat adults with moderate-to-severe plaque psoriasis in 2020.
About EVENITY^=C2=AE (romosozumab)=C2=A0
Romosozumab is a bone-forming monoclonal antibody.^13=C2=A0It is designed t=
o work by inhibiting the activity of sclerostin, which simultaneously resul=
ts in increased bone formation and to a lesser extent decreased bone resorp=
tion.^13 The romosozumab development program includes 19 clinical studies t=
hat enrolled approximately 14,000 patients.^14=C2=A0Romosozumab has been st=
udied for its potential to reduce the risk of fractures in an extensive glo=
bal Phase 3 program that included two large fracture trials comparing romos=
ozumab to either placebo or active comparator in over 11,000 postmenopausal=
women with osteoporosis.^15,16=C2=A0Amgen and UCB are co-developing romoso=
zumab.
Important Safety Information about EVENITY^=C2=AE (romosozumab)
In the EU, Romosozumab is indicated for treatment of severe osteoporosis in=
postmenopausal women at high risk of fracture. Contraindications: Romosozu=
mab is contraindicated in patients who are allergic to romosozumab or any o=
f the excipients, who have low levels of calcium in the blood (hypocalcaemi=
a), or who have a history of myocardial infarction (heart attack) or stroke=
. Myocardial infarction or stroke: Heart attack and stroke have been report=
ed in patients receiving Romosozumab in randomised controlled trials (uncom=
mon). Treatment with Romosozumab should not be initiated in patients with a=
history of heart attack or stroke. When determining whether to use Romosoz=
umab for an individual patient, the presence of risk factors for cardiovasc=
ular problems, including established cardiovascular disease, high blood pre=
ssure, high blood fat levels, diabetes, smoking or kidney problems, should =
be evaluated. Romosozumab should only be used if the prescriber and patient=
agree that the benefit outweighs the risk. If a patient experiences a myoc=
ardial infarction or stroke during therapy, treatment with Romosozumab shou=
ld be discontinued. Hypocalcaemia: Transient hypocalcaemia has been observe=
d in patients receiving Romosozumab. Hypocalcaemia should be corrected prio=
r to initiating therapy with Romosozumab and patients should be monitored f=
or signs and symptoms of hypocalcaemia. If any patient presents with suspec=
ted symptoms of hypocalcaemia during treatment, calcium levels should be me=
asured. Patients should be adequately supplemented with calcium and vitamin=
D. Patients with severe renal impairment (estimated glomerular filtration =
rate [eGFR] 15 to 29ml/min/1.73m2) or receiving dialysis are at greater ris=
k of developing hypocalcaemia and the safety data for these patients are li=
mited. Calcium levels should be monitored in these patients. Hypersensitivi=
ty: Clinically significant hypersensitivity reactions, including angioedema=
, erythema multiforme, and urticaria occurred in the Romosozumab group in c=
linical trials. If an anaphylactic or other clinically significant allergic=
reaction occurs, appropriate therapy should be initiated and use of Romoso=
zumab should be discontinued. Osteonecrosis of the Jaw: Osteonecrosis of th=
e jaw (ONJ) has been reported rarely in patients receiving Romosozumab. The=
following risk factors should be considered when evaluating a patient=E2=
=80=99s risk of developing ONJ: (1) potency of the medicinal product that i=
nhibits bone resorption (the risk increases with the antiresorptive potency=
of the compound), and cumulative dose of bone resorption therapy, (2) canc=
er, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking=
, (3) concomitant therapies: corticosteroids, chemotherapy, angiogenesis in=
hibitors, radiotherapy to head and neck, (4) poor oral hygiene, periodontal=
disease, poorly fitting dentures, history of dental disease, invasive dent=
al procedures e.g. tooth extractions. All patients should be encouraged to =
maintain good oral hygiene and receive routine dental check-ups. Dentures s=
hould fit correctly. Patients under dental treatment, or who will undergo d=
ental surgery (e.g. tooth extractions) whilst being treated with Romosozuma=
b should inform their doctor about their dental treatment and inform their =
dentist that they are receiving Romosozumab. Patients should immediately re=
port any oral symptoms such as dental mobility, pain or swelling or non-hea=
ling of sores or pus discharge during treatment with Romosozumab. Patients =
who are suspected of having or who develop ONJ while receiving Romosozumab =
should receive care by a dentist or an oral surgeon with expertise in ONJ. =
Discontinuation of Romosozumab therapy should be considered until the condi=
tion resolves and contributing risk factors are mitigated where possible. A=
typical Femoral Fractures: Atypical low-energy or low trauma fracture of th=
e femoral shaft, which can occur spontaneously, has been reported rarely in=
patients receiving Romosozumab. Any patient who presents with new or unusu=
al thigh, hip, or groin pain should be suspected of having an atypical frac=
ture and should be evaluated to rule out an incomplete femur fracture. Pati=
ent presenting with an atypical femur fracture should also be assessed for =
symptoms and signs of fracture in the contralateral limb. Interruption of R=
omosozumab therapy should be considered, based on an individual benefit-ris=
k assessment. Adverse Reactions: The most common adverse reactions were nas=
opharyngitis (13.6 percent) and arthralgia (12.4 percent). Common adverse r=
eactions included hypersensitivity, sinusitis, rash, dermatitis, headache, =
neck pain, muscle spasms and injection site reactions (most frequent inject=
ion site reactions were pain and erythema). Uncommon adverse reactions were=
urticaria, hypocalcaemia, stroke, myocardial infarction and cataract. Fina=
lly, rare side effects were serious allergic reactions which caused swellin=
g of the face, throat, hands, feet, ankles or lower legs (angioedema) and a=
cute skin eruption (erythema multiforme).
Refer to the attached European Summary of Product Characteristics (https://=
u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZe=
bf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH2R2rXOUms8GNCinFGLD4A=
Jip5b-2BG7gW2-2B2HZVc0ntxjV9rBWhquj4FiUZlsMiNf7Q-3D-3D-g7y_xDPID0vOuylFAU8f=
v4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqddW-2FBZlGB52Zlf-2FOeo=
COG9ekocVj-2F2X9c9g1wat2CbiF-2FWhLY87OM0k5aozkLTYpSq1x0kPblSV-2BEuL63DlA8wq=
CzkUww-2FO-2Bgv-2FtdagD9j3Ot4siPHDVrGeXERDW0R8wr-2FbIpA1bEVG2NuMwVrOsa4PT0d=
vLF7uEIOzif4iw3RAffgdgRvVmk7kMkhsZCyVq-2BehKGBtItE-2FCI2PDxbk6V-2BrFITLug17=
jmn0bb2UwjYZPacTjBNRrIQV2N3-2BB92TBMm-2FHaKCgo6Q5Fe1YsIqzH2bE0dLjQETFYBj7xI=
-3D for other adverse reactions and full prescribing information for EVENIT=
Y^=C2=AE=E2=96=BC.
=E2=96=BC This medicinal product is subject to additional monitoring.
About the Amgen and UCB Collaboration
Since 2004, Amgen and UCB have been working together under a collaboration =
and license agreement to research, develop and market antibody products tar=
geting the protein sclerostin. As part of this agreement, the two companies=
continue to collaborate on the development of romosozumab for the treatmen=
t of osteoporosis. This gene-to-drug project demonstrates how Amgen and UCB=
are joining forces to translate a genetic discovery into a new medicine, t=
urning conceptual science into a reality.
CONTACT: UCB, Brussels
Scott Fleming, Bone Communications, UCB, T +44 7702777378, scott.fleming@uc=
b.com
Laurent Schots, Media Relations, UCB, T+32.2.559.92.64, laurent.schots@ucb.=
com
Antje Witte, Investor Relations, UCB, T +32.2.559.94.14, antje.witte@ucb.com
Isabelle Ghellynck, Investor Relations, UCB, T+32.2.559.9588, isabelle.ghel=
lynck@ucb.com
CONTACT: Amgen, Thousand Oaks
Jessica Akopyan, 805-447-0974 (media)=C2=A0
Trish Hawkins, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)
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=
=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 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=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.
For further information, UCB:
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
1.
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3. Van der Horst-Bruinsma I, Van Bentum R, Verbraak F, et al. Reduction of =
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11. 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=
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vailable at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJ=
QyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH=
2R2rXOUms8GNCinFGLD4AJip5b-2BG7gW2-2B2HZVc0ntxjzGgWC6r3TjUeWGZr1SEA8w-3D-3D=
_ue9_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI3b8sYN46DL86bSl0KxvPs6EFaZqd=
dW-2FBZlGB52Zlf-2FOeoCOG9ekocVj-2F2X9c9g1wat2CbiF-2FWhLY87OM0k5aozkLTYpSq1x=
0kPblSV-2BEuL63DlA8wqCzkUww-2FO-2Bgv-2FtdagD9j3Ot4siPHDVrGeXERDW0R8wr-2FbIp=
A1bEVG2NuMwZBK72LBm5mfGxtoWDd1-2F-2Bw5TTJ0ZUyLs8Ll-2FQEAM1zuPz8nJfx-2FLgqeE=
m2zrRHjkNUWriZCYxE9Q-2Fu9Pr-2ByQQTZ-2BLJmktKzuWKJtwUxqtmIEsgQi8pmlp8IwBmhL5=
EgoWlA-2FDqvaroAAY9Ck7wE5To-3D Last accessed: June 2020.
14. EVENITY Advisory Committee Briefing Book 2019. Available at https://u70=
61146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATURCR3fbVNBzIoxGp=
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-2FOeoCOG9ekocVj-2F2X9c9g1wat2CbiF-2FWhLY87OM0k5aozkLTYpSq1x0kPblSV-2BEuL63=
DlA8wqCzkUww-2FO-2Bgv-2FtdagD9j3Ot4siPHDVrGeXERDW0R8wr-2FbIpA1bEVG2NuMwTT4M=
2b0SvFBjnaehjNThx6txHz7lhzXjWG9uONkWo14qo3xHSU-2F0iuindz55BRiO-2Bs7o8c14zgn=
yHnV8qxfQsDMfqQI2P-2FX4ruFWo487Zcoqf-2F4p-2BKhjbJFTFpvsekN88fIsXwo-2F1Z5gFr=
Re4bV8Xs-3D Last accessed: June 2020.
15. Cosman F, Crittenden DB, Adachi JD, et al. Romosozumab treatment in pos=
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