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** New BIMZELX^=C2=AE=E2=96=BC (bimekizumab) two-year data in moderate to s=
evere plaque psoriasis presented at the 30th European Academy of Dermatolog=
y and Venereology (EADV) Congress
------------------------------------------------------------
=C2=B7 Interim results from the BE BRIGHT open-label extension study showed=
clinical responses observed in bimekizumab-treated patients during the fir=
st 16 weeks of BE SURE were sustained through to two years of treatment wit=
h continuous maintenance dosing*
=C2=B7 Clinical responses observed in patients switching from adalimumab to=
bimekizumab were also sustained through to two years, with response rates =
similar to patients receiving bimekizumab from baseline=C2=A0
=C2=B7 Switching from ustekinumab to bimekizumab in the open-label extensio=
n study showed sustained improvements in PASI 100 up to week 100
=C2=B7 Analysis of pooled safety data from up to two years of treatment in =
Phase 2 and 3 clinical trials showed bimekizumab was generally well tolerat=
ed with no new safety signals identified over two years
Brussels, Belgium =E2=80=93 29th September 2021 =E2=80=93 07:30 CEST =E2=80=
=93 UCB, a global biopharmaceutical company, today announced new interim re=
sults from the BE BRIGHT open-label extension (OLE) study evaluating the lo=
ng-term safety, tolerability and efficacy of BIMZELX^=C2=AE (bimekizumab) t=
hrough to two years in adult patients with moderate to severe plaque psoria=
sis who completed one of the three Phase 3 pivotal studies. These data, tog=
ether with additional findings from the Phase 3/3b clinical program for bim=
ekizumab in psoriasis, were presented today across nine UCB-supported abstr=
acts at the 30th European Academy of Dermatology and Venereology (EADV) Con=
gress.=C2=A0
Bimekizumab is the first selective IL-17A and IL-17F inhibitor to be approv=
ed in the European Union for the treatment of moderate to severe plaque pso=
riasis in adults who are candidates for systemic therapy.^1=C2=A0 =C2=A0
=E2=80=9CFollowing the recent approval of bimekizumab in Europe, we are ple=
ased to share new two-year data at EADV supporting the clinical value of bi=
mekizumab in the treatment of moderate to severe psoriasis. The range of lo=
nger-term efficacy and safety data presented offer important new insights f=
or the dermatology community and reflect our commitment to improving the st=
andard of care for people with psoriasis,=E2=80=9D said Emmanuel Caeymaex, =
Executive Vice President, Immunology Solutions and Head of U.S., UCB.=C2=A0
Interim data from the BE BRIGHT study presented at EADV showed that patient=
s treated with bimekizumab achieved sustained levels of skin clearance (PAS=
I 90 and PASI 100) through to two years with continuous maintenance dosing*=
, and that bimekizumab was generally well tolerated, with no new safety sig=
nals identified.^2,3,4=C2=A0Switching to bimekizumab following 24 weeks of =
adalimumab treatment (BE SURE) resulted in a sustained increase in PASI 90 =
and PASI 100 responder rates up to two years.^2,5 In addition, switching to=
bimekizumab following 52 weeks of ustekinumab treatment (BE VIVID) resulte=
d in a sustained increase in PASI 100 responder rates up to week 100.^3,6 P=
atients switching to bimekizumab after an inadequate response to ustekinuma=
b at week 52 also showed sustained improvements in levels of skin clearance=
(PASI 90 and PASI 100).^3=C2=A0
=E2=80=9CIn clinical practice, patients with moderate to severe plaque psor=
iasis may need to transition between biologics to optimally control their d=
isease. Longer-term results from the BE SURE study and the BE BRIGHT open-l=
abel extension study shared at EADV 2021 demonstrated that switching from a=
dalimumab to bimekizumab helped more patients with moderate to severe psori=
asis to achieve and maintain completely clear skin, as measured by PASI 100=
, through two years of treatment,=E2=80=9D said Professor Diamant Tha=C3=A7=
i, Institute and Comprehensive Center for Inflammation Medicine, University=
Hospital of L=C3=BCbeck, L=C3=BCbeck, Germany.=C2=A0
Longer-term results from BE SURE and BE BRIGHT open-label extension trial=
=C2=A5 =C2=A0
After completing the phase 3 BE SURE trial, patients could enrol in the OLE=
study.^2,5=C2=A0In bimekizumab-randomized patients (320 mg every four week=
s [Q4W] through two years), PASI 90 response rates were 91.2 percent at bot=
h weeks 16 and 104.^2,5 PASI 100 response rates in this group were 61.6 per=
cent at week 16 and 72.3 percent at week 104.^2,5 In bimekizumab-randomized=
patients (320 mg Q4W for 16 weeks, and then every eight weeks [Q8W] throug=
h two years), the percentage of patients reaching PASI 90 was 89.4 percent =
at week 16 and 89.7 percent at week 104.^2,5 Levels of PASI 100 response in=
this group were 62.8 percent at week 16 and 68.1 percent at week 104.^2,5=
=C2=A0
Switching from adalimumab to bimekizumab 320 mg Q4W resulted in sustained r=
esponse rates (PASI 90 and PASI 100) through to two years (week 104), which=
were comparable to the response rates seen in patients receiving continuou=
s bimekizumab treatment.^2 Bimekizumab was well tolerated over two years, w=
ith no new safety signals.^2=C2=A0
Bimekizumab data up to two years in patients switching from ustekinumab^=C2=
=B1=C2=A0
This analysis included adult patients from BE VIVID who were initially rand=
omized to ustekinumab 45 mg / 90 mg (by weight) at weeks 0 / four, then eve=
ry 12 weeks, or bimekizumab 320 mg Q4W through week 52.^3,6=C2=A0 Based on =
the PASI 90 response at week 52, patients entering the OLE were re-randomiz=
ed to bimekizumab 320 mg Q4W or Q8W.^3
At entry to the OLE study, 44.9 percent of ustekinumab-treated patients and=
73.6 percent of bimekizumab-treated patients had achieved PASI 100.^3 For =
all patients who switched from ustekinumab to bimekizumab the PASI 100 resp=
onse increased to 65.4 percent at week 56, 78.7 percent at week 68 and 69.9=
percent at week 100, which was comparable to the response rate seen in pat=
ients receiving continuous bimekizumab treatment at week 68 (75.4 percent) =
through week 100 (68.8 percent).^3 For patients who switched to bimekizumab=
following an inadequate response to ustekinumab at week 52, high levels of=
response were achieved. At week 56, after one dose of bimekizumab, 77.3 pe=
rcent of these patients achieved PASI 90 and 40.9 percent achieved PASI 100=
. These responses were sustained and further improved at week 100, with 84.=
1 percent and 54.5 percent of patients achieving PASI 90 and PASI 100, resp=
ectively. There were no unexpected safety findings in patients who switched=
from ustekinumab to bimekizumab during the OLE.^3
Pooled safety data from up to two years of treatment in Phase 2 and 3 clini=
cal trials
Across Phase 2 and 3 trials, the total bimekizumab exposure was 3109.7 pati=
ent-years (N=3D1789).^4 Treatment emergent adverse events (TEAEs) occurred =
at an exposure-adjusted incidence rate (EAIR) of 202.4 per 100 patient-year=
s, serious TEAEs were seen at an EAIR of 5.9 new cases per 100 patient-year=
s and TEAEs leading to discontinuation at 3.8 new cases per 100 patient-yea=
rs.^4 The most common TEAEs in the Phase 2 and 3 trials with bimekizumab we=
re nasopharyngitis (EAIR: 19.1 new cases per 100 patient-years), oral candi=
diasis (12.6 new cases per 100 patient-years) and upper respiratory tract i=
nfection (8.9 new cases per 100 patient-years).^4 =C2=A0The EAIR for oral c=
andidiasis showed a decrease compared with one year of bimekizumab treatmen=
t (12.6 new cases per 100 patient-years versus 16.4 new cases per 100 patie=
nt-years) and was lower with bimekizumab dosed Q8W (9.6 per 100 patient-yea=
rs) compared with Q4W (16.4 per 100 patient-years).^4 The majority of cases=
(98.5 percent of patients experiencing oral candidiasis) were mild or mode=
rate and rarely led to study discontinuation.^4
*The recommended bimekizumab dose for adult patients with plaque psoriasis =
is 320 mg (given as two subcutaneous injections of 160 mg) at week 0, four,=
eight, 12, 16 and every eight weeks thereafter.1 For some patients with a =
body weight =E2=89=A5 120 kg who did not achieve complete skin clearance at=
week 16, 320 mg every four weeks after week 16 may further improve treatme=
nt response.1 In the studies reported at EADV 2021, patients received maint=
enance dosing of bimekizumab 320 mg Q4W or Q8W.=C2=A0
=C2=A5 Modified non-responder imputation analyses
=C2=B1Non-responder imputation analyses=C2=A0
About BE BRIGHT^7=C2=A0
BE BRIGHT (NCT03598790) is an ongoing, multicentre, open-label extension st=
udy assessing the long-term safety, tolerability and efficacy of bimekizuma=
b in adult patients with moderate to severe plaque psoriasis. Patients who =
completed one of three bimekizumab Phase 3 studies, BE READY, BE VIVID and =
BE SURE, were eligible to enroll in the BE BRIGHT study. More details can b=
e found at ClinicalTrials.gov.=C2=A0
About BIMZELX (bimekizumab) in the EU
Bimekizumab is a humanized IgG1 monoclonal antibody that selectively binds =
with high affinity to IL-17A, IL-17F and IL-17AF cytokines, blocking their =
interaction with the IL-17RA/IL-17RC receptor complex.^1 Elevated concentra=
tions of IL-17A and IL-17F have been implicated in the pathogenesis of seve=
ral immune-mediated inflammatory diseases including plaque psoriasis.^1 Bim=
ekizumab inhibits these proinflammatory cytokines, resulting in the normali=
zation of skin inflammation and as a consequence improvement in clinical sy=
mptoms associated with psoriasis.^1=C2=A0
Bimzelx^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA* Important Safety Informa=
tion
The most frequently reported adverse reactions with bimekizumab were upper =
respiratory tract infections (14.5%) (most frequently nasopharyngitis) and =
oral candidiasis (7.3%). Common adverse reactions (=E2=89=A51/100 to <1/10)=
were oral candidiasis, tinea infections, ear infections, herpes simplex in=
fections, oropharyngeal candidiasis, gastroenteritis, folliculitis, headach=
e, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly =
may be more likely to experience certain adverse reactions such as oral can=
didiasis, dermatitis and eczema when using bimekizumab.
*EU/EEA means European Union/European Economic Area
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).=C2=A0
Bimekizumab may increase the risk of infections. Treatment with bimekizumab=
must not be administered in patients with any clinically important active =
infection. Patients treated with bimekizumab should be instructed to seek m=
edical advice if signs or symptoms suggestive of an infection occur. Prior =
to initiating treatment with bimekizumab, patients should be evaluated for =
tuberculosis (TB) infection. Bimekizumab should not be given in patients wi=
th active TB and patients receiving bimekizumab should be monitored for sig=
ns and symptoms of active TB.=C2=A0
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.=C2=A0
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.=C2=A0
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. https://www.ema.euro=
pa.eu/en/documents/product-information/bimzelx-epar-product-information_en.=
pdf
European summary of product characteristics date of revision August 2021
Last accessed: September 2021.=C2=A0=C2=A0=C2=A0
=E2=96=BC=C2=A0This medicinal product is subject to additional monitoring. =
This will allow quick identification of new safety information. Healthcare =
professionals are asked to report any suspected adverse reactions=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 8,400 peopl=
e in nearly 40 countries, the company generated revenue of =E2=82=AC5.3 bil=
lion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us o=
n Twitter: @UCB_news.
Forward looking statements UCB=C2=A0
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Corporate Communications
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Media Relations, UCB =C2=A0
T+32.2.559.92.64=C2=A0 laurent.schots@ucb.com=C2=A0
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Investor Relations, UCB
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References
1. BIMZELX (bimekizumab) EU Summary of Product Characteristics, August 2021=
. https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-p=
roduct-information_en.pdf. =C2=A0
2. Tha=C3=A7i D, Vender R, de Rie M, et al. Safety and efficacy of bimekizu=
mab through 2 years in patients with moderate to severe plaque psoriasis: L=
onger-term results from the BE SURE randomised controlled trial and the BE =
BRIGHT open-label extension trial. Presented at EADV 2021.
3. Leonardi C, Sator PG, Morita A, et al. Bimekizumab efficacy and safety u=
p to two years in patients with moderate to severe plaque psoriasis switchi=
ng from ustekinumab: Interim results from the BE BRIGHT open-label extensio=
n trial. Presented at EADV 2021.
4. Reich K, St=C3=A5hle M, Okubo Y, et al. Bimekizumab safety in patients w=
ith moderate to severe plaque psoriasis: Analysis of pooled data from up to=
two years of treatment in phase 2 and 3 clinical trials. Presented at EADV=
2021.=C2=A0
5. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in =
Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
6. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for =
the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy a=
nd safety from a 52-week, multicentre, double-blind, active comparator and =
placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
7. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (=
BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/NCT03598790?t=
erm=3DNCT03598790&draw=3D2&rank=3D1. Last accessed September 2021.
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