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** Phase 3 Data Analysis Presented at EADV 2023 Showed Bimekizumab Achieved=
High Thresholds of Clinical Response in Hidradenitis Suppurativa
------------------------------------------------------------
=C2=B7 Bimekizumab treatment resulted in clinically meaningful improvements=
in HiSCR50 and the more stringent endpoints HiSCR75, HiSCR90 and HiSCR100 =
vs. placebo at Week 16, with improvements increasing for patients remaining=
in the study through Week 48
=C2=B7 Over 8 in 10 patients treated with bimekizumab who achieved a HiSCR5=
0 response after 16 weeks, maintained response to Week 48=C2=A0
Brussels (Belgium), October 12 2023 =E2=80=93 18:00 (CEST) =E2=80=93 UCB, a=
global biopharmaceutical company, today announced the first analyses of po=
oled data from the two Phase 3 bimekizumab studies (BE HEARD I and BE HEARD=
II) in moderate to severe hidradenitis suppurativa (HS).^1,2,3,4=C2=A0Thes=
e analyses are among bimekizumab data in HS presented this week across thre=
e oral presentations and several posters at the 2023 European Academy of De=
rmatology and Venereology (EADV) Congress in Berlin, Germany, October 11=E2=
=80=9314.=C2=A0
=E2=80=9CPatients with hidradenitis suppurativa live with one of the most b=
urdensome chronic systemic skin diseases. There is a compelling need for ne=
w treatment options that can offer high and durable clinical response,=E2=
=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Solutio=
ns and Head of U.S., UCB. =E2=80=9CData presented at EADV showed that over =
48 weeks many patients treated with bimekizumab achieved high thresholds of=
response. These findings suggest that inhibition of IL-17F in addition to =
IL-17A represents a promising treatment approach in moderate to severe hidr=
adenitis suppurativa.=E2=80=9D
=E2=80=9CThe bimekizumab Phase 3 clinical trial program in hidradenitis sup=
purativa included the more stringent clinical outcomes of HiSCR75, HiSCR90 =
and HiSCR100 in addition to the standard HiSCR50. In these studies, bimekiz=
umab demonstrated clinical meaningful improvements for these outcomes over =
placebo at Week 16, with improvements increasing for patients remaining in =
the studies through Week 48. In addition, improvements in disease severity =
were seen over time, with the majority of patients with severe hidradenitis=
suppurativa at baseline shifting to mild to moderate disease according to =
the IHS4 dynamic classification system,=E2=80=9D said Professor Christos C.=
Zouboulis, President of the European Hidradenitis Suppurativa Foundation, =
Director of the Departments of Dermatology, Venereology, Allergology and Im=
munology, St=C3=A4dtisches Klinikum Dessau, and Founding Professor of Derma=
tology and Venereology at the Brandenburg Medical School, Germany. =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
Data were pooled from the BE HEARD I and II studies, which included an init=
ial (Weeks 0=E2=80=9316) and maintenance treatment period (Weeks 16=E2=80=
=9348).^1,2,3,4 Adult patients (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/every four weeks (Q4W); n=3D292; bimekizumab=
Q4W/Q4W (n=3D288) or placebo/bimekizumab Q2W (n=3D146).^1,2,3,4
Highlights from the pooled data analysis (BE HEARD I and BE HEARD II)=C2=A0
=C2=B7 Bimekizumab-treated patients showed higher response rates in the pri=
mary endpoint (HiSCR50) at Week 16 vs. placebo (58 percent Q2W/Q2W, 55.9 pe=
rcent Q2W/Q4W, 56.1 percent Q4W/Q4W vs. 33.4 percent for placebo).^=E2=80=
=A01 Improvements increased for patients through Week 48 with almost 8 in 1=
0 achieving HiSCR50.^=E2=80=A11 At Week 48, the response in patients who sw=
itched from placebo to bimekizumab at Week 16 approached that reached by pa=
tients on bimekizumab from baseline (70.5 percent [n=3D74/105]).^=E2=80=A11=
=C2=A0
=C2=B7 A similar trend was seen in the more stringent HiSCR75 and HiSCR90 e=
ndpoints through Week 48.^=E2=80=A11,5,6 Bimekizumab-treated patients had i=
mproved responses at Week 48 with approximately 6 in 10 patients achieving =
HiSCR75.^=E2=80=A11 Analysis of the most stringent endpoint, HiSCR100, show=
ed numerically higher responses in bimekizumab patients vs. placebo at Week=
16, and improved responses at Week 48 with approximately 3 out of 10 patie=
nts achieving HiSCR100. Patients who switched from placebo to bimekizumab a=
t Week 16 demonstrated a similar trend in HiSCR100 rates at Week 48.^=E2=80=
=A11=C2=A0
=C2=B7 Across all bimekizumab treatment groups, over 8 out of 10 patients w=
ho achieved HiSCR50 at Week 16 (n=3D160 Q2W/Q2W; n=3D155 Q2W/Q4W; n=3D152 Q=
4W/Q4W), maintained the response through Week 48.^=E2=80=A12 In addition, a=
cross all bimekizumab treatment groups, more than 8 out of 10 patients who =
achieved an abscess and inflammatory nodule (AN) count of 0,1 or 2 at Week =
16 (n=3D104 Q2W/Q2W, n=3D99 Q2W/Q4W; n=3D87 Q4W/Q4W) maintained this respon=
se to Week 48.^=E2=80=A12
=C2=B7 According to the International Hidradenitis Suppurativa Severity Sco=
re System (IHS4), at baseline, 83.7=E2=80=9388.4 percent of the enrolled pa=
tients across bimekizumab dosing regimens had severe HS.^3 A post hoc analy=
sis showed that at Week 16 higher proportions of bimekizumab-treated patien=
ts had mild HS vs. placebo (24.6=C2=AC=E2=80=9327.2 percent vs. 15.3 percen=
t).^3 Similar trends were observed for patients with moderate HS (25.8=E2=
=80=9328.0 percent vs. 17.1 percent).^3 Improvements in IHS4 categories wer=
e sustained over time across bimekizumab groups. At Week 48, 37.3=E2=80=934=
0.1 percent had mild HS and 23.8=E2=80=9325.3 percent had moderate HS.^3
=C2=B7 Analyses showed that regardless of weight and body mass index catego=
ry, a higher proportion of patients treated with bimekizumab vs. placebo ac=
hieved clinical response at Week 16 (HiSCR50, HiSCR75 and HiSCR90) with inc=
reasing levels of response between Week 16 and Week 48.^4
=C2=B7 The safety profile of bimekizumab across BE HEARD I and BE HEARD II =
was consistent with previous studies with no new safety signals observed.^1=
The most frequently reported TEAEs in 995 patients receiving =E2=89=A51 do=
se of bimekizumab were hidradenitis (18.7 percent), oral candidiasis (11.2 =
percent), and coronavirus infection (10.8 percent).^1 Serious treatment eme=
rgent adverse events were reported in 7.0 percent Q4W/Q4W, 4.5 percent Q2W/=
Q4W and 8.1 percent Q2W/Q2W patients.^1
Notes to editors:
=E2=80=A0Modified non-responder imputation
=E2=80=A1Observed Case
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.^7,8=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.^7,8 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.^7.8 HS most commonly develops in early adulthood and affects app=
roximately one percent of the population in most studied countries.^7,8 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.^7,8 The symptoms of pain, discharge and scarring=
are not only a physical burden. People with HS also experience stigma: wor=
rying about, or directly experiencing, negative attitudes and reactions fro=
m society in response to their symptoms.^9=C2=A0These 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.^10
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 The two studies had a combined enrolment of 1,014=
participants with a diagnosis of moderate to severe HS.^5,6 The primary en=
dpoint in both studies was HiSCR50 at Week 16.^5,6 A key secondary endpoint=
was HiSCR75 at Week 16.^5,6 HiSCR50 and HiSCR75 are defined as at least ei=
ther a 50 or 75 percent reduction from baseline in the total abscess and in=
flammatory nodule count, with no increase from baseline in abscess or drain=
ing tunnel count.^5,6=C2=A0
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.^11=C2=A0The 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.^12
=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).^12=C2=A0
=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.^12=C2=A0
BIMZELX^=C2=AE=C2=A0=E2=96=BC (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=BC This medicinal product is subject to additional monitoring. This =
will allow quick identification of new safety information. Healthcare profe=
ssionals 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). Foll=
ow us on Twitter: @UCB_news.
Forward looking statements=C2=A0
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Given these uncertainties, you should not place undue reliance on any of su=
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References
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pooled data from BE HEARD I and II phase 3, randomised, double-blind, plac=
ebo-controlled, multicentre studies. Oral presentation at EADV 2023, Berlin=
, Germany.
2. Ingram JR, Porter M, Chovatiya R, et al. Bimekizumab response maintenanc=
e to 48 weeks in patients with moderate to severe hidradenitis suppurativa:=
Pooled responder analysis from the phase 3, double-blind, placebo-controll=
ed, randomised clinical trials BE HEARD I and II. Poster presentation at EA=
DV 2023, Berlin, Germany.
3. Zouboulis C, Kirby JS, Tzellos T, et al. IHS4 outcomes with bimekizumab =
in patients with moderate to severe hidradenitis suppurativa: Pooled result=
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, Berlin, Germany.
4. Garg A, Lev-Tov H, Naik HB, et al. Bimekizumab efficacy across weight an=
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urativa: 48 week pooled results from the randomised, double-blind, placebo =
controlled, multicentre BE HEARD I and II phase 3 trials. Oral presentation=
at EADV 2023, Berlin, Germany.
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/NCT04242498. Last accessed: October 2023.
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Dis Primers. 2020;6(1):18
9. Koumaki D, Efthymiou O, Bozi E, et al. Perspectives On Perceived Stigma =
And Self-Stigma In Patients With Hidradenitis Suppurativa. Clin Cosmet Inve=
stig Dermatol. 2019;12:785=E2=80=9390.
10. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hi=
dradenitis Suppurativa and Its Effect on Patients and =C2=A0 =C2=A0Healthca=
re System. Dermatology. 2020;236(5):421=E2=80=9330.
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.
12. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics. Ava=
ilable at:=C2=A0https://www.ema.europa.eu/en/documents/product-information/=
bimzelx-epar-product-information_en.pdf. Last accessed: October 2023.
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