https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUb513=
9PTmAm2ORJ-2Fb7C-2B6ekbnNioRzG-2F1tQvuizBSv8nUwAPU0rnDOeNVeak663X40L-2FY2DT=
vbbjWJOPwfCyqaM-3D3xzt_xDPID0vOuylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr=
-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011X=
KEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92Q71s6SFKCcQZOz7LPMBkxM4KX-2BbePSzOWDXo1MzdvJ=
F-2BdIi58IfnwronFPqSjZLcNYH3RJOxP4AMm9SRYpRbtCxhlq-2FfM53GI7EdTG9qStX5kEo5J=
iVOTZ2uVWLdgB6BXE4qSKhTp-2Fc5uR-2FgqOakhfKfwQyMB0uUnKkMSq1Ss2-2BGav3Nx28OoQ=
WWTGuvudRYRxos-2FUzrHfCIJb8o98iJsh4-3D
** Latest analyses of bimekizumab phase 3 studies in moderate to severe hid=
radenitis suppurativa to be presented at EHSF 2024
------------------------------------------------------------
=C2=B7 At Week 48, ~7 of 10 patients treated with bimekizumab achieved IHS4=
-55, an IHS4 dichotomous outcome, that measures treatment effect and signif=
ies reduction in abscesses, nodules and draining tunnels
=C2=B7 Bimekizumab treatment demonstrated improvements in overall lesion co=
unt and lesion clearance, across abscesses, inflammatory nodules and draini=
ng tunnels over 48 weeks
=C2=B7 Patient-reported data showed that high levels of clinical responses =
observed with bimekizumab treatment translated into benefits in health-rela=
ted quality of life=C2=A0
Brussels (Belgium), 9th February 2024 =E2=80=93 07:00 CET =E2=80=93 UCB, a =
global biopharmaceutical company, today announced results from the latest p=
ost hoc analyses of the Phase 3 studies, BE HEARD I and BE HEARD II, evalua=
ting the efficacy and safety of bimekizumab in the treatment of adults with=
moderate to severe hidradenitis suppurativa (HS).^1,2,3,4=C2=A0 These data=
are being presented at the 13th Conference of the European Hidradenitis Su=
ppurativa Foundation (EHSF) in Lyon, France (7-9 February).=C2=A0
=E2=80=9CThe analyses presented at EHSF 2024 build on the Phase 3 data comm=
unicated to date and reinforce our belief in the potential of bimekizumab t=
o make a meaningful difference to patients,=E2=80=9D said Emmanuel Caeymaex=
, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. =
=E2=80=9CResults presented re-affirm the high levels of sustained clinical =
response achieved with bimekizumab treatment, the positive impact on health=
-related quality of life as reported by patients, and the importance of tim=
ely treatment following diagnosis.=E2=80=9D=C2=A0
=E2=80=9CThe achievement of IHS4-55 shows reduction in inflammatory nodules=
, abscesses and draining tunnels. This is a novel dichotomous version of th=
e International Hidradenitis Suppurativa Severity Score System that allows =
for the inclusion and quantification of draining tunnels in a validated man=
ner and reflects at least 55% improvement in the total score from baseline.=
With bimekizumab, the analyses showed that over 48 weeks, the majority of =
patients, ~7 out of 10, achieved IHS4-55,=E2=80=9D said Professor Tzellos, =
Department of Dermatology, Nordland Hospital Trust, Bod=C3=B8, Norway.=C2=
=A0
The efficacy and safety of bimekizumab in HS have not been established and =
it is not approved for use in HS by any regulatory authority worldwide.=C2=
=A0
The BE HEARD I and II studies included an initial (Weeks 0=E2=80=9316) and =
maintenance treatment period (Weeks 16=E2=80=9348). At baseline, adult pati=
ents (n=3D1,014) were randomized 2:2:2:1 (initial/maintenance) to receive, =
either bimekizumab 320 mg every two weeks (Q2W)/Q2W (n=3D288), bimekizumab =
Q2W/Q4W (n=3D292), bimekizumab Q4W/Q4W (n=3D288) or placebo/bimekizumab Q2W=
(n=3D146). Primary data from these studies have been previously reported.^=
1,2,3
Highlights of the bimekizumab BE HEARD I and BE HEARD II Data Presented at =
EHSF 2024=C2=A0
=C2=B7 Dichotomous IHS4: At Week 16, a greater proportion of patients achie=
ved IHS4-55 with bimekizumab treatment vs placebo (51.1-62.9% vs. 25.7=E2=
=80=9330.8%).1=E2=80=A0 By Week 48, these responses were sustained or incre=
ased (pooled, 71.0=E2=80=9377.4%).^1=E2=80=A0 Patients that switched from p=
lacebo to bimekizumab achieved comparable responses to those receiving cont=
inuous bimekizumab treatment (pooled, 76.2%).^1=E2=80=A0 The higher thresho=
lds of IHS4-75 and IHS4-90 were also achieved by greater proportions of pat=
ients treated with bimekizumab vs placebo at Week 16 (IHS4-75: 30.6=E2=80=
=9344.7% vs 15.7=E2=80=9323.1%; IHS4-90: 16.5=E2=80=9323.0% vs 7.1=E2=80=93=
10.8%).^1=E2=80=A0 By Week 48, these responses were sustained or increased =
(IHS4-75 pooled, 56.0-61.9%; IHS4-90 pooled, 36.2-44.1%).^1=E2=80=A0
=C2=B7 Lesion Count and Clearance Across Lesion Type and Anatomical Area: A=
t Week 16, bimekizumab treatment demonstrated improvements in overall lesio=
n count. Following bimekizumab treatment lesion clearance also increased at=
Week 16.^2 Results were sustained or improved across 48 weeks of treatment=
.^2 Improvements were observed across different anatomical regions and acro=
ss all three lesion types presented (abscesses, inflammatory nodules and dr=
aining tunnels).^2
=C2=B7 Depth of Response and Impact on Quality of Life: The vast majority o=
f patients (69.5=E2=80=9374.8%) who achieved Hidradenitis Suppurativa Clini=
cal Response 50 (HiSCR50) at Week 16 reported a Hidradenitis Suppurativa Qu=
ality of Life (HiSQoL) rating of =E2=80=98None/Mild=E2=80=99 at Week 16.^3 =
A higher proportion of patients reported a HiSQoL rating of =E2=80=98None/M=
ild=E2=80=99 at Week 16 if they achieved HiSCR75 (77.2=E2=80=9384.3%) or Hi=
SCR90 (80.0=E2=80=9389.3%) at Week 16.^3 A similar trend was also observed =
at Week 48.^3
=C2=B7 Clinical Response Across Duration Quartiles: At Week 16, patients tr=
eated with bimekizumab in the lowest (<2.40 years) disease duration quartil=
es achieved HiSCR50/HiSCR75 of 67.5% (n=3D133/197)/48.2% (95/197) vs 43.8% =
(n=3D14/32)/21.9%(n=3D7/32) for placebo.^4 Patients treated with bimekizuma=
b in the highest (=E2=89=A510.87 years) disease duration quartiles achieved=
HiSCR50/HiSCR75 of 53.8% (n=3D99/184)/34.2% (n=3D63/184) vs. 28.9% (n=3D13=
/45)/20.0% (n=3D9/45) =C2=A0for placebo. Results with bimekizumab were sust=
ained across 48 weeks of treatment.^4
=E2=80=A0Observed Case Analysis=C2=A0
Notes to editors:
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).^1,2,3,4 The primary endpoint in both studies was HiSC=
R50 at Week 16.^5=C2=A0 A key secondary endpoint was HiSCR75 at Week 16. Hi=
SCR50 and HiSCR75 are defined as at least either a 50 or 75% reduction from=
baseline in the total abscess and inflammatory nodule count with no increa=
se from baseline in abscess or draining tunnel count.^5
About IHS4-55, IHS4-75 and IHS4-90
Hidradenitis suppurativa (HS) severity can be assessed using the Internatio=
nal Hidradenitis Suppurativa Severity Score System (IHS4) that includes the=
number of inflammatory nodules, abscesses and draining tunnels and classif=
ies disease severity as mild (=E2=89=A43 points), moderate (4=E2=80=9310 po=
ints) or severe (=E2=89=A511 points).^1 In order to discriminate between ac=
tive treatment and placebo, a novel outcome measure built on the IHS4 was d=
eveloped using dichotomous thresholds.1 IHS4-55 is a dichotomous version of=
IHS4 that is based on an improvement of at least 55% in the total score fr=
om baseline.^1 IHS4-55 response is achieved if a patient=E2=80=99s IHS4 sco=
re improves by at least 55% from baseline.^1 Similarly, IHS4-75 and IHS4-90=
responses are achieved if a patient=E2=80=99s IHS4 score improves by 75% o=
r 90%, respectively, from baseline.^1
About hidradenitis suppurativa (HS)
Hidradenitis suppurativa (HS) is a chronic, recurring, painful, and debilit=
ating inflammatory skin disease that is associated with systemic manifestat=
ions.^6,7=C2=A0 The main symptoms are nodules, abscesses, and pus-dischargi=
ng fistulas (channels leading out of the skin) which typically occur in the=
armpits, groin, and buttocks.^6,7 People with HS experience flare-ups of t=
he disease as well as severe pain, which can have a major impact on quality=
of life. HS most commonly develops in early adulthood and affects approxim=
ately one percent of the population in most studied countries.^6,7 Approxim=
ately one-third of people with HS have a family history of HS, and lifestyl=
e factors such as smoking and obesity can also play a crucial role in the c=
linical course of HS. =C2=A0The symptoms of pain, discharge and scarring ar=
e not only a physical burden.^6,7 People with HS also experience stigma: wo=
rrying about, or directly experiencing, negative attitudes and reactions fr=
om society in response to their symptoms.^6,7,9 These feelings can lead to =
embarrassment, social isolation, low self-esteem and sexual life impairment=
, and impact all areas of life, including interpersonal relationships, educ=
ation, and work.^9=C2=A0
About BIMZELX^=C2=AE=E2=96=BC ^10
BIMZELX^=C2=AE (bimekizumab) is a humanized monoclonal IgG1 antibody that i=
s designed to selectively inhibit both interleukin 17A (IL-17A) and interle=
ukin 17F (IL-17F), two key cytokines driving inflammatory processes.^11 The=
therapeutic indications 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.^10
=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).^10
=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.^10
BIMZELX^=C2=AE (bimekizumab) EU/EEA* Important Safety Information^10
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 and fatigue. Elderly individual=
s may be more likely to experience certain adverse reactions such as oral c=
andidiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the act=
ive substance or any of the excipients and in patients with clinically impo=
rtant active infections (e.g. active tuberculosis).
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 includ=
ing anaphylactic reactions have been observed with IL-17 inhibitors. If a s=
erious hypersensitivity reaction occurs, administration of bimekizumab shou=
ld 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:=C2=A0
https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3E=
U-2FWvZebf3RrOmE3Tk7MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH6uJI6dDXHRika=
HhL8HIZVsPc5Q6uIhYECs-2Fl2G-2Bmd0FmcyR4Sx9QdcHWQECFWENWQ-3D-3DUy0H_xDPID0vO=
uylFAU8fv4e60wei4JxqEGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPs=
k4gNr-2BW6M70OIHMB7vQEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92=
Q71s6SFKCcQZOz7LPMBkxM4KX-2BbePSzOWDXo1MzdvJF-2BdIi58IfnwronFPqSjZLcNXYy0zP=
l3HLM91xpnuyQjjvWCMLFomAJq3yLV7mptlEH7VjSeuW-2BTpvEeDWK3c0xVK0j98jcGt9bGuHK=
hwfV7p5HXk3w5UCFeYCgfScSGyIRouN9vLbRDnXufkQs0ue2Dqcyu4ArinbFWuQ1Xsv-2F7Fg-3=
D
European SmPC date of revision: November 2023.=C2=A0
Last accessed: February 2024.
^*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
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=
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ng margins, capital expenditures, cash, other financial information, expect=
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or industry results, to differ materially from those that may be expressed =
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s in general economic, business and competitive conditions, the inability t=
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ons, safety, quality, data integrity or manufacturing issues; potential or =
actual data security and data privacy breaches, or disruptions of our infor=
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rotection for products or product candidates, competition from other produc=
ts including biosimilars, changes in laws or regulations, exchange rate flu=
ctuations, changes or uncertainties in tax laws or the administration of su=
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hat new product candidates will be discovered or identified in the pipeline=
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oducts will be developed and approved. Movement from concept to commercial =
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lity of UCB=E2=80=99s data and systems.=C2=A0
Given these uncertainties, you should not place undue reliance on any of su=
ch forward-looking statements. There can be no guarantee that the investiga=
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References
1. Tzellos T, Alavi A, Kyrgidis A, et al. Bimekizumab Impact on Dichotomous=
IHS4 Response Levels in Patients with Moderate to Severe Hidradenitis Supp=
urativa: Results up to Week 48 from BE HEARD I & II. Abstract presented at =
EHSF 2024.
=C2=A0
2. van der Zee HH, Kirby B, Bechara FG, et al. Bimekizumab Impact on Lesion=
Count by Anatomical Region in Moderate to Severe Hidradenitis Suppurativa:=
Results to Week 48 from BE HEARD I & II. Abstract presented at EHSF 2024.
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ate to Severe Hidradenitis Suppurativa: A Focus on Patient Quality of Life =
and Depth of Responses from BE HEARD I & II to Week 48. Abstract presented =
at EHSF 2024.=C2=A0
4. Kimball A, Shi VY, Porter M, et al. Bimekizumab Efficacy by Disease Dura=
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Results from BE HEARD I & II. Abstract presented at EHSF 2024.
5. Kimball AB, Zouboulis CC, Sayed C, et al. Bimekizumab in patients with m=
oderate-to-severe hidradenitis suppurativa: 48-week efficacy and safety fro=
m BE HEARD I & II, two phase 3, randomized, double-blind, placebo controlle=
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And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Inve=
stig Dermatol. 2019;12:785=E2=80=9390.
10. BIMZELX=C2=AE (bimekizumab) EU SmPC. Available at: https://u7061146.ct.=
sendgrid.net/ls/click?upn=3D4tNED-2FM8iDZJQyQ53jATUdN3EU-2FWvZebf3RrOmE3Tk7=
MlrShjDNSVHpnfL6TfOxZowbuWXJCI8bbCZVOamVwH6uJI6dDXHRikaHhL8HIZVsPc5Q6uIhYEC=
s-2Fl2G-2Bmd0FmcyR4Sx9QdcHWQECFWENWQ-3D-3DSUpX_xDPID0vOuylFAU8fv4e60wei4Jxq=
EGBdVWu7KiDwjI08XD0QNwOr-2FIUHus1SulXMZQic-2FUwvA-2BfPsk4gNr-2BW6M70OIHMB7v=
QEQ19ecNE7nFy8buOLD3011XKEBm5Xlxg2PNYS8j2dt-2FPjf7GBT92Q71s6SFKCcQZOz7LPMBk=
xM4KX-2BbePSzOWDXo1MzdvJF-2BdIi58IfnwronFPqSjZLcNUfTcOpcBUuROzn6-2FfF-2FNzZ=
jEXQBa-2F86uP125lSIfc-2FqCAYQqOgKWWey1j2PHwdVFGXDtDLdZ0wXmvAN2m7uVT-2BNm5wK=
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d: February 2024. =C2=A0
11. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, 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.
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