New UCB Data Presented at the Annual European Congress of Rheumatology (EULAR 2018) Serves Key Patient Populations Including Ankylosing Spondylitis, Psoriatic Arthritis, and Women with Chronic Inflamm

Brussels (ots/PRNewswire) -

- Late-breaking oral presentation on bimekizumab shows significant
potential for treating ankylosing spondylitis (AS)
- Oral presentation on CIMZIA® (certolizumab pegol) pregnancy
outcomes shows no increased risk of major congenital malformations
compared to the general population nor an increased risk of fetal
death
- Multiple presentations reveal perceptions, challenges and practices
relative to women of childbearing age with chronic inflammatory
diseases and the physicians who treat them
- Four-year RAPID-PsA data confirm sustained remission and minimal
disease activity in patients with psoriatic arthritis (PsA) treated
with CIMZIA

UCB, a global biopharmaceutical company focusing on immunology,
neurology and bone treatment and research, will be presenting new
data on CIMZIA® (certolizumab pegol) and key pipeline molecules
bimekizumab and romosozumab at the Annual European Congress of
Rheumatology (EULAR 2018), taking place in Amsterdam, June 13-16,
2018.

(Logo: https://mma.prnewswire.com/media/683106/UCB_Logo.jpg )

As a part of a late-breaking oral presentation, week 12 findings
from the BE AGILE study will be presented for the first time,
revealing the promising treatment effect of bimekizumab in patients
living with ankylosing spondylitis (AS) and suggesting the potential
breakthrough value of neutralizing IL-17F in addition to IL-17A. A
separate presentation of long-term findings from RAPID-PsA on CIMZIA
in psoriatic arthritis (PsA) will focus on the sustained achievement
of stringent clinical outcomes, with a substantial proportion of
patients achieving complete remission or very low disease activity.

An additional oral presentation will offer insight into the
positive effect in building bone with one year of romosozumab.

"We are proud to present impressive findings on our pipeline
molecules as well as the sustained value of CIMZIA in populations
with specific treatment needs, such as women of childbearing age and
patients with PsA and AS. The data that will be presented this week
exemplify our mission to understand the needs of underserved patient
populations, and connect them with scientific advancements that can
provide real and immediate impact," said Emmanuel Caeymaex, Head of
Immunology and Executive Vice President, Immunology Patient Value
Unit, UCB. "We are committed to serving as partners in care by
understanding and supporting patients and rheumatologists, who are
engaging especially challenging treatment situations, so we can bring
the broadest possible value to patients in need."

Additional presentations include survey findings from both
patients and healthcare professionals (HCP) on specific challenges
involved in the treatment of chronic inflammatory diseases in women
of childbearing age. Findings from the patient survey, "Fears and
Misconceptions of Women with Chronic Rheumatic Disease on Their
Journey to Motherhood," suggest that many women's decisions to delay
pregnancy or interrupt their treatment may be linked to the need for
greater awareness of disease management options and earlier
consultation with their HCPs. Also to be presented are findings from
a SERMO survey of practicing HCPs, exploring the physician
perspective on the challenges specific to treating women with chronic
inflammatory diseases during family planning. Results from the
largest published cohort of pregnant women exposed to an anti-TNF
during pregnancy that will be presented at EULAR 2018 confirm that
patients treated with certolizumab pegol did not experience increased
risk of major congenital malformations compared to the general
population nor an increased risk of fetal death.

Real world experiences of patients living with rheumatoid
arthritis (RA) are explored in a poster presentation featuring
analysis of data from the ArthritisPower Registry. Data suggest that
rheumatologists tended to forego treatment changes, even when disease
control goals were not met, with patients usually deferring to their
HCPs. Other CIMZIA data featured at EULAR 2018 include data on ava,
the auto-injection e-device, and the impact of the Coach@Home patient
support program.

In addition to 11 data presentations, UCB will be sponsoring two
satellite symposia highlighting research and innovations in the
treatment landscapes of osteoporosis and axial spondyloarthritis
(axSpA). The data presented by UCB at EULAR 2018 showcase the
company's commitment to connecting scientific innovation and insights
into real-world patient goals and unmet needs to make a lasting
difference in the lives of patients.

Following is a guide to the UCB-sponsored data presentations:

UCB Sponsored Symposia

The Reality of Risk - How Are we Responding to Fragility Fracture
in Rheumatology, S. Papapoulos, I. Bruce, I. Vlauv

- Date/Time: June 13, 2018: 18:15 - 19:30 CEST

Axial Spondyloarthritis in 2018: New Data, Less Compromise?, M.
Rudwaleit, L. Gensler, M. Dougados, D. Poddubnyy

- Date/Time: June 15, 2018: 08:15 - 9:45 CEST

Presentations on UCB's Investigational Pipeline:

Dual Neutralization of IL-17A and IL-17F with Bimekizumab in
Patients With Active Ankylosing Spondylitis: 12-Week Results From a
Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Dose-Ranging
Study, D. van der Heijde, L. Gensler, A. Deodhar, X. Baraliakos, D.
Poddubnyy, M. K. Farmer, D. Baeten, T. Kumke, M. Oortgiesen, M.
Dougados

- Date/Time: June 13, 2018: 16:15 - 17:45 CEST

FRAME Study: The Foundation Effect of Rebuilding Bone With One
Year of Romosozumab Leads to Continued Lower Fracture Risk After
Transition to Denosumab, F. Cosman, D. B. Crittenden, S. Ferrari, A.
Khan, N. E. Lane, K. Lippuner, T. Matsumoto, C. E. Milmont, C.
Libanati, A. Grauer

- Date/Time: June 15, 2018: 15:30 - 17:00 CEST

CIMZIA® Presentations:

Certolizumab Pegol Provides Sustained Remission and Minimal
Disease Activity in Patients With Psoriatic Arthritis Over 4 Years'
Treatment, D. van der Heijde, A. Deodhar, O. FitzGerald, R.
Fleischmann, D. Gladman, A. B. Gottlieb, L. C. Coates, B. Hoepken, L.
Bauer, L. Peterson, M. Khraishi, P. J. Mease

- Date/Time: June 16, 2018: 10:30 - 12:00 CEST

Characteristics and Outcomes of Prospectively Reported Pregnancies
Exposed to Certolizumab Pegol From a Safety Database, M. E. B.
Clowse, A. E. Scheuerle, C. Chambers, A. Afzali, A. Kimball, J. J.
Cush, M. Cooney, L. Shaughnessy, M. Vanderkelen, F. Förger

- Date/Time: June 14, 2018: 13:30 - 15:00 CEST

Comparison of the Bioavailability of a Single Dose of Certolizumab
Pegol Injected by Pre-Filled Syringe or by Electro-Mechanical
Auto-Injection e-Device: a Phase 1, Open-Label, Randomized, Parallel
Group, Single-Centre Bioequivalence Study, R. Oliver, B. VanLunen, I.
Mountian, E. Brown, D. Tatla

- Date/Time: June 16, 2018: 10:30 - 12:00 CEST

UCB-sponsored Data on Women of Childbearing Age:

Fears and Misconceptions of Women with Chronic Rheumatic Diseases
on Their Journey to Motherhood, A. Tincani, P. Taylor, R.
Fischer-Betz, C. Ecoffet, E. Chakravarty

- Date/Time: June 15, 2018: 11:45 - 13:30 CEST

Anti-TNF Treatments for Women With Chronic Inflammatory Diseases:
Comparing Attitudes and Perceptions of Physicians in Europe and the
US, A. Tincani, P. Taylor, R. Fischer-Betz, C. Ecoffet, E.
Chakravarty

- Date/Time: June 15, 2018: 11:45 - 13:30 CEST

Pregnancy Outcomes and Disease Activity in Women with Axial
Spondyloarthritis: A Systematic Literature Review A. Moltó, L.
Gensler, M. Clowse, H. Marzo-Ortega, A. Artignan, D. Goff-Leggett, S.
Leonard, H. Resemann, E. Thurtle, N. de Peyrecave, C. Ecoffet, F.
Förger

- Date/Time: June 14, 2018: 11:45 - 13:30 CEST

UCB-sponsored Rheumatology Data:

Baseline Characteristics and Patient Satisfaction Data from
Coach@Home: The German Support Program for Patients with Rheumatic
Diseases Treated with Certolizumab Pegol, N. Böhme, A.-D. Holst, F.
Dybowski, C. Volberg, H.-G. Pott, U. Lendl

- Date/Time: ePoster only

Barriers to Rheumatoid Arthritis Treatment Optimisation:
Real-World Data from the ArthritisPower Registry, J. L. Stark, M.
Yassine, W. B. Nowell, K. Gavigan, S. Ginsberg, M. S. Serna, J. R.
Curtis

- Date/Time: June 14, 2018: 11:45 - 13:30 CEST

Do TNF Inhibitors Impact the Comorbidities and Extra-Articular
Manifestations, and Thereby Alter the Natural History of Ankylosing
Spondylitis? A. Deodhar, K. L. Winthrop, R. L. Bohn, B. K. Chan, R.
Y. Suruki, J. L. Stark, H. Yun, S. A. R. Siegel, L. Chen, M. Yassine,
J. R. Curtis

- Date/Time: June 16, 2018: 10:30 CEST

About Bimekizumab

Bimekizumab is a novel humanized monoclonal IgG1 antibody that
potently and selectively neutralizes both IL-17A and IL-17F, two key
cytokines driving inflammatory processes. IL-17A and IL-17F have
overlapping pro-inflammatory functions and independently cooperate
with other inflammatory mediators to drive chronic inflammation and
damage across multiple tissues.

Previous early Phase clinical studies in psoriasis and psoriatic
arthritis have suggested that neutralizing IL-17F in addition to
IL-17A with bimekizumabmay provide a new targeted approach for the
treatment of immune-mediated inflammatory diseases. Preclinical
results in disease-relevant cells have shown that dual neutralization
of both IL-17A and IL-17F reduces skin and joint inflammation, as
well as pathological bone formation to an extent greater than
inhibition of IL-17A or IL-17F alone.[i],[ii],[iii]

UCB is studying bimekizumab in psoriasis, psoriatic arthritis and
ankylosing spondylitis. Bimekizumab is not approved by any regulatory
authority worldwide.

About Romosozumab

Romosozumab is an investigational bone-forming monoclonal antibody
and is not approved by any regulatory authority for the treatment of
osteoporosis. It is designed to work by inhibiting the activity of
sclerostin, which enables romosozumab to increase bone formation and
reduce bone resorption simultaneously. Romosozumab is being studied
for its potential to reduce the risk of fractures in an extensive
global Phase 3 program. This program includes two large fracture
trials comparing romosozumab to either placebo or active comparator
in more than 11,000 postmenopausal women with osteoporosis. Amgen and
UCB are co-developing romosozumab.

About CIMZIA® in the EU/EEA

In the EU, CIMZIA® in combination with methotrexate (MTX) is
indicated for the treatment of moderate to severe active RA in adult
patients inadequately responsive to disease-modifying anti-rheumatic
drugs (DMARDs) including MTX.

CIMZIA can be given as monotherapy in case of intolerance to MTX
or when continued treatment with MTX is inappropriate. CIMZIA in
combination with MTX is also indicated for the treatment of severe,
active and progressive RA in 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 combination with MTX.

CIMZIA, in combination with MTX, is also indicated for the
treatment of active psoriatic arthritis in adults when the response
to previous DMARD therapy has been inadequate. CIMZIA can be given as
monotherapy in case of intolerance 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:

- Ankylosing spondylitis (AS) - adults with severe active AS who have
had an inadequate response to, or are intolerant to non-steroidal
anti-inflammatory drugs (NSAIDs).
- Axial spondyloarthritis (axSpA) without radiographic evidence of AS
- 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 response to, or are intolerant to NSAIDs.

Important Safety Information about CIMZIA® in the EU/EEA

CIMZIA® was studied in 4,049 patients with rheumatoid arthritis
(RA) in controlled and open label trials for up to 92 months. The
commonly reported adverse reactions (1-10%) in clinical trials with
CIMZIA® and post-marketing were viral infections (includes herpes,
papillomavirus, influenza), bacterial infections (including abscess),
rash, headache (including migraine), asthaenia, leukopaenia
(including lymphopaenia, neutropaenia), eosinophilic disorder, pain
(any sites), pyrexia, sensory abnormalities, hypertension, pruritus
(any sites), hepatitis (including hepatic enzyme increase), injection
site reactions, and nausea. Serious adverse reactions include sepsis,
opportunistic infections, tuberculosis, herpes zoster, lymphoma,
leukaemia, solid organ tumours, angioneurotic oedema,
cardiomyopathies (includes heart failure), ischemic coronary artery
disorders, pancytopaenia, hypercoagulation (including
thrombophlebitis, pulmonary embolism), cerebrovascular accident,
vasculitis, hepatitis/hepatopathy (includes cirrhosis), and renal
impairment/nephropathy (includes nephritis). In RA controlled
clinical trials, 4.4% of patients discontinued taking CIMZIA® due to
adverse events vs. 2.7% for placebo.

CIMZIA® 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 or
moderate-to-severe heart failure.

Serious infections including sepsis, tuberculosis and
opportunistic infections have been reported in patients receiving
CIMZIA®. Some of these events have been fatal. Monitor patients
closely for signs and symptoms of infections including tuberculosis
before, during, and after treatment with CIMZIA®. Treatment with
CIMZIA® must not be initiated in patients with a clinically important
active infection. If an infection develops, monitor carefully and
stop CIMZIA® if infection becomes serious. Before initiation of
therapy with CIMZIA®, all patients must be evaluated for both active
and inactive (latent) tuberculosis infection. If active tuberculosis
is diagnosed prior to or during treatment, CIMZIA® therapy must not
be initiated and must be discontinued. If latent tuberculosis is
diagnosed, appropriate anti-tuberculosis therapy must be started
before initiating treatment with CIMZIA®. Patients should be
instructed to seek medical advice if signs/symptoms (e.g. persistent
cough, wasting/weight loss, low grade fever, listlessness) suggestive
of tuberculosis occur during or after therapy with CIMZIA®.

Reactivation of hepatitis B has occurred in patients receiving a
TNF-antagonist including CIMZIA® 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 CIMZIA®. Carriers of HBV who require
treatment with CIMZIA® should be closely monitored and in the case of
HBV reactivation CIMZIA® should be stopped and effective anti-viral
therapy with appropriate supportive treatment should be initiated.

TNF-antagonists including CIMZIA® may increase the risk of new
onset or exacerbation of clinical symptoms and/or radiographic
evidence of demyelinating disease; of formation of autoantibodies and
uncommonly of the development of a lupus-like syndrome; of severe
hypersensitivity reactions. If a patient develops any of these
adverse reactions, CIMZIA® should be discontinued and appropriate
therapy instituted.

With the current knowledge, a possible risk for the development of
lymphomas, leukaemia or other malignancies in patients treated with a
TNF-antagonist cannot be excluded. Rare cases of neurological
disorders, including seizure disorder, neuritis and peripheral
neuropathy, have been reported in patients treated with CIMZIA®.

Adverse reactions of the haematologic system, including medically
significant cytopaenia, have been infrequently reported with CIMZIA®.
Advise all patients to seek immediate medical attention if they
develop signs and symptoms suggestive of blood dyscrasias or
infection (e.g., persistent fever, bruising, bleeding, pallor) while
on CIMZIA®. Consider discontinuation of CIMZIA® therapy in patients
with confirmed significant haematological abnormalities.

The use of CIMZIA® in combination with anakinra or abatacept is
not recommended due to a potential increased risk of serious
infections. As no data are available, CIMZIA® should not be
administered concurrently with live vaccines. The 14-day half-life of
CIMZIA® should be taken into consideration if a surgical procedure is
planned. A patient who requires surgery while on CIMZIA® should be
closely monitored for infections.

CIMZIA® was studied in 325 patients with active axial
spondyloarthritis (axSpA) in a placebo-controlled clinical trial for
up to 30 months and in 409 patients with psoriatic arthritis (PsA) in
a placebo-controlled clinical trial for up to 30 months. The safety
profile for axSpA and PsA patients treated with CIMZIA® was
consistent with the safety profile in RA and previous experience with
CIMZIA®.

Please consult the full prescribing information in relation to
other side effects, full safety and prescribing information. European
SmPC date of revision January 2018.

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Produc
t_Information/human/001037/WC500069763.pdf

CIMZIA® is a registered trademark of the UCB Group of Companies.

Corporate
Communications Investor Relations Brand
Communications

France Nivelle, Antje Witte, Andrea
Levin Christopher,
Global Communications, UCB Investor Relations, UCB
Immunology Communications, UCB
T +32-2-559-9178, T +32-2-559-94-14, T
+1-404-483-7329
france.nivelle@ucb.com antje.witte@ucb.com
andrea.christopher@ucb.com

Laurent Schots,
Media Relations, UCB
T +32-2-559-92-64,
laurent.schots@ucb.com

ots Originaltext: UCB Pharma
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About UCB
UCB, Brussels, Belgium (http://www.ucb.com) is a global
biopharmaceutical company focused on the discovery and development of
innovative medicines and solutions to transform the lives of people
living with severe diseases in immunology or neurology. With more than
7,500 people in approximately 40 countries, the company generated
revenue of EUR 4.5 billion in 2017. UCB is listed on Euronext Brussels
(symbol: UCB). Follow us on Twitter: @UCB_news
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[i]. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F
neutralisation by bimekizumab in psoriatic arthritis: evidence from
preclinical experiments and a randomized placebo-controlled clinical
trial that IL-17F contributes to human chronic tissue inflammation.
Ann Rheum Dis. In Press.
[ii]. Shah M, Maroof A, Al-Hosni R, Gikas P, Gozzard N, Shaw S,
Roberts S. Bimekizumab Blocks T Cell-Mediated Osteogenic
Differentiation of Periosteal Stem Cells: Coupling Pathological Bone
Formation to IL-17A and IL-17F Signaling [abstract]. Arthritis
Rheumatol. 2017; 69 (suppl 10).
[iii]. 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 inflammation in disease-relevant cells. Ann
Rheum Dis. 201706;76 (suppl.2):213-213.
HQ/0518/MPR/00007 June 2018

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