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** UCB Reinforces Commitment to Advancing Care in Hidradenitis Suppurativa =
with Six Abstracts at SHSA 2023
------------------------------------------------------------
=C2=B7 Results from the Phase 3 studies evaluating impact of bimekizumab on=
pain and health-related quality of life in moderate to severe hidradenitis=
suppurativa will be shared in two oral presentations
=C2=A0
Brussels (Belgium), 13 October 2023 =E2=80=93 18:00 (CEST) =E2=80=93 UCB, a=
global biopharmaceutical company, today announced that it will present six=
abstracts in hidradenitis suppurativa (HS) at the 8th Annual Symposium on =
Hidradenitis Suppurativa Advances (SHSA), October 13=E2=80=9315th in Phoeni=
x, Arizona, U.S. Data and analyses in HS will be presented across two oral =
presentations and four posters.=C2=A0
=E2=80=9CThe data to be presented at SHSA reinforce our commitment to advan=
cing medicines in areas where patients have the greatest need,=E2=80=9D sai=
d Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Hea=
d of U.S., UCB. =E2=80=9CThese new analyses complement and build on the bim=
ekizumab Phase 3 evidence in hidradenitis suppurativa shared to date and fu=
rther highlight the potential of bimekizumab for the treatment of this chro=
nic, painful, inflammatory condition.=E2=80=9D=C2=A0
An oral presentation will showcase 16-Week data from the BE HEARD I and BE =
HEARD II Phase 3 studies evaluating the impact of bimekizumab on pain in mo=
derate to severe HS. In a second oral presentation, 48-Week data evaluating=
the impact of bimekizumab on health-related quality of life will be shared=
. Three poster presentations will include subgroup analyses from the two Ph=
ase 3 studies, including 48 Week data in U.S. patients. A disease-focused p=
oster presentation will share barriers to accessing timely and adequate tre=
atment, care and resources for HS patients in select U.S. states.=C2=A0
The safety and efficacy of bimekizumab in HS have not been established, and=
it is not approved for use in HS by any regulatory authority worldwide.=C2=
=A0
UCB-sponsored data presentations at SHSA 2023
=C2=B7 Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: 48-Week =
HiSQoL data from BE HEARD I & II
Kirby JS, Jemec GB, Thorlacius L, Garg A, Kimball AB, Rolleri R, Muller E, =
Lambert J, Ingram JR
Oral presentation: Saturday, October 14, 16:05=E2=80=9316:15 MST
=C2=B7 Bimekizumab Impact on Pain in Moderate to Severe Hidradenitis Suppur=
ativa: Week 16 Results from BE HEARD I & II
Orenstein LAV, Shi V, Lev-Tov H, Prens E, Podda M, Fujita H, Lambert J, Rol=
leri R, Muller E, Szepietowski JC
Oral presentation: Saturday, October 14, 16:35=E2=80=9316:45 MST
=C2=B7 Bimekizumab in Black/African-American Patients with Moderate to Seve=
re Hidradenitis Suppurativa in BE HEARD I & II
Mayo T, Chovatiya R, Shi V, Naik HB, Benhadou F, Costanzo A, Davis L, Lambe=
rt J, Rolleri R, Zouboulis CC=C2=A0
Poster=C2=A0
=C2=B7 Bimekizumab in Patients with Moderate to Severe Hidradenitis Suppura=
tiva by Subgroup: Week 16 Data from BE HEARD I & II
Naik HB, Hsiao J, Porter M, Reguiai Z, Martorell A, Frew JW, Pansar I, Roll=
eri R, Tilt N, Lambert J, Kirby B
Poster
=C2=B7 Bimekizumab in Moderate to Severe Hidradenitis Suppurativa: 48-Week =
Efficacy in US Patients from BE HEARD I & II
Gottlieb AB, Mayo T, Sayed C, Kirby JS, Garg A, Oh T, Gomez B, Dokhe P, Rol=
leri R, Davis L, Daveluy=C2=A0
Poster=C2=A0
=C2=B7 Barriers to Accessing Timely and Adequate Treatment, Care, and Resou=
rces for Patients with HS in Select US States
Daveluy S, Brooks B, Hazelett B, Hamzavi I, DiSalvo A, Schmidt T, Marchi D,=
McClung L, Beaty S, Espy JI, Goldberg S
Poster
Notes to editors:
About Hidradenitis Suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit=
ating inflammatory skin disease, that is associated with systemic manifesta=
tions.^1,2=C2=A0 The main symptoms are nodules, abscesses, and pus-discharg=
ing fistulas (channels leading out of the skin) which typically occur in th=
e armpits, groin, and buttocks.^1,2 People with HS experience flare-ups of =
the disease as well as severe pain, which can have a major impact on qualit=
y of life.^1,2 HS, most commonly develops in early adulthood and affects ap=
proximately one percent of the population in most studied countries.1,2 App=
roximately one-third of people with HS have a family history of HS, and lif=
estyle factors such as smoking and obesity can also play a crucial role in =
the clinical course of HS.1,2 The symptoms of pain, discharge and scarring =
are not only a physical burden. People with HS also experience stigma: worr=
ying about, or directly experiencing, negative attitudes and reactions from=
society in response to their symptoms.^3=C2=A0These feelings can lead to e=
mbarrassment, social isolation, low self-esteem and sexual life impairment,=
and impact all areas of life, including interpersonal relationships, educa=
tion, and work.^4=C2=A0=C2=A0
About BE HEARD I and BE HEARD II
BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled=
, parallel-group, multicenter, Phase 3 studies designed to evaluate the eff=
icacy and safety of bimekizumab in adults with moderate to severe hidradeni=
tis suppurativa (HS).^5,6=C2=A0The two studies had a combined enrolment of =
1,014 participants with a diagnosis of moderate to severe HS.^5,6 The prima=
ry endpoint in both studies was HiSCR50 at Week 16.^5,6
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. =C2=A0The therapeutic i=
ndications in the European Union are:
=C2=B7 Plaque psoriasis: Bimekizumab is indicated for the treatment of mode=
rate to severe plaque psoriasis in adults who are candidates for systemic t=
herapy.^8
=C2=B7 Psoriatic arthritis: Bimekizumab, alone or in combination with metho=
trexate, is indicated for the treatment of active psoriatic arthritis in ad=
ults who have had an inadequate response or who have been intolerant to one=
or more disease-modifying antirheumatic drugs (DMARDs).^8
=C2=B7 Axial Spondyloarthritis: Bimekizumab is indicated for the treatment =
of adults with active non radiographic axial spondyloarthritis with objecti=
ve signs of inflammation as indicated by elevated C-reactive protein (CRP),=
and/or magnetic resonance imaging (MRI) who have responded inadequately or=
are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs), and for =
the treatment of adults with active ankylosing spondylitis who have respond=
ed inadequately or are intolerant to conventional therapy.^8=C2=A0
The label information may differ in other countries where approved. Please =
check local prescribing information.
In the U.S., the efficacy and safety of bimekizumab have not been establish=
ed for any indication and it is not approved by the U.S. Food and Drug Admi=
nistration.=C2=A0
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA* Important Safety Inform=
ation
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%, 14.6%, 16.3% in plaque psoriasis (PSO)=
, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), respective=
ly) and oral candidiasis (7.3%, 2.3%, 3.7% in PSO, PsA and axSpA, respectiv=
ely). Common adverse reactions (=E2=89=A51/100 to <1/10) were oral candidia=
sis, tinea infections, ear infections, herpes simplex infections, oropharyn=
geal candidiasis, gastroenteritis, folliculitis, headache, rash, dermatitis=
and eczema, acne, injection site reactions, fatigue. Elderly may be more l=
ikely to experience certain adverse reactions such as oral candidiasis, der=
matitis 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).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be initiated in patients with any clinically important active inf=
ection. Patients treated with bimekizumab should be instructed to seek medi=
cal advice if signs or symptoms suggestive of an infection occur. If a pati=
ent develops an infection the patient should be carefully monitored. If the=
infection becomes serious or is not responding to standard therapy, treatm=
ent should be discontinued until the infection resolves. Prior to initiatin=
g treatment with bimekizumab, patients should be evaluated for tuberculosis=
(TB) infection. Bimekizumab should not be given in patients with active TB=
. Patients receiving bimekizumab should be monitored for signs and symptoms=
of active TB.
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 including anaphylactic reactions have be=
en observed with IL-17 inhibitors. If a serious hypersensitivity reaction o=
ccurs, administration of bimekizumab should be discontinued immediately and=
appropriate therapy initiated.
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.
http://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-prod=
uct-information_en.pdf
European SmPC date of revision: June 2023.
Last accessed: October 2023.
*EU/EEA means European Union/European Economic Area
=E2=96=BCThis medicinal product is subject to additional monitoring. This w=
ill allow quick identification of new safety information. Healthcare profes=
sionals are asked to report any suspected adverse reactions.
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). Follo=
w us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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ates=E2=80=9D, =E2=80=9Cmay=E2=80=9D, =E2=80=9Cwill=E2=80=9D, =E2=80=9Ccont=
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Given these uncertainties, you should not place undue reliance on any of su=
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04242446. Last accessed: October 2023.
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04242498. Last accessed: October 2023.
7. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of bi=
mekizumab, a humanized monoclonal antibody and selective dual inhibitor of =
IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017;83(5):991=
=E2=80=931001.
8. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. Avai=
lable at:=C2=A0https://www.ema.europa.eu/en/documents/product-information/b=
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