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UCB Media Room: bimekizumab BE SURE detailed results


[31/10/2020 | 07:04]

** Bimekizumab Phase 3 Data Shows Superior Skin Clearance Over Humira^=C2=
=AE in Moderate-to-Severe Psoriasis Patients

=C2=B7 Data from the Phase 3 BE SURE study demonstrated that patients treat=
ed with investigational IL-17A and IL-17F inhibitor bimekizumab achieved si=
gnificantly higher PASI 90 and PASI 100 skin clearance rates, compared to H=
umira^=C2=AE (adalimumab), at week 16, which were maintained up to one year=
with both four and eight week dosing
=C2=B7 Skin clearance rates rapidly increased in patients who switched from=
adalimumab to bimekizumab at week 24, with response rates at week 56 compa=
rable to patients treated with bimekizumab throughout the study

Brussels, Belgium =E2=80=93 October 31, 2020 =E2=80=93 UCB, a global biopha=
rmaceutical company, today announced the detailed results of the head-to-he=
ad Phase 3 BE SURE study, which demonstrated that patients treated with inv=
estigational IL-17A and IL-17F inhibitor bimekizumab achieved superior skin=
clearance, as compared to adalimumab, in adults with moderate-to-severe pl=
aque psoriasis.^1=C2=A0These findings were presented for the first time as =
an oral presentation at the European Academy of Dermatology and Venereology=
Congress, taking place virtually between October 29-31, 2020.

BE SURE met all primary and secondary ranked endpoints.^1 The co-primary en=
dpoints were at least a 90 percent improvement in the Psoriasis Area and Se=
verity Index (PASI 90) and Investigator Global Assessment (IGA) of clear or=
almost clear (IGA 0/1) versus adalimumab at week 16. Secondary endpoints i=
ncluded PASI 90 and IGA 0/1 at weeks 24 and 56, and PASI 100 at weeks 16 an=
d 24.=C2=A0

In BE SURE, patients treated with bimekizumab achieved significantly higher=
PASI 90, IGA 0/1 and PASI 100 skin clearance rates compared to patients tr=
eated with adalimumab at week 16.^1 In patients that started bimekizumab at=
baseline, response rates were maintained up to a year. Rapid increases in =
skin clearance rates were seen in patients who switched from adalimumab to =
bimekizumab at week 24.^1 The safety and efficacy of bimekizumab have not b=
een established, and it is not approved by any regulatory authority worldwi=

=E2=80=9CIn BE SURE, we saw significantly higher skin clearance rates with =
bimekizumab compared with one of the most commonly used biologic treatments=
in psoriasis. The study results also demonstrated the potential benefits o=
f switching patients who are being treated with adalimumab to bimekizumab,=
=E2=80=9D said study investigator, Professor Richard Warren, Salford Royal =
NHS Foundation Trust and The University of Manchester, United Kingdom.

=E2=80=9CThese findings from BE SURE, the third positive study in the psori=
asis clinical development program, are further evidence of bimekizumab=E2=
=80=99s superior depth of response. The results also add to the mounting ev=
idence supporting the potential value of selective inhibition of IL-17F, in=
addition to IL-17A, for rapid, complete and durable skin clearance, if app=
roved by health authorities. UCB is proud to be developing innovative solut=
ions for psoriasis patients,=E2=80=9D said Emmanuel Caeymaex, Executive Vic=
e President Immunology Solutions and Head of US, UCB.

In BE SURE, 86.2 percent of patients treated with bimekizumab achieved almo=
st clear skin (PASI 90), compared with 47.2 percent of patients treated wit=
h adalimumab at week 16 (p<0.001).^1 Additionally, 85.3 percent of patients=
treated with bimekizumab achieved IGA 0/1, versus 57.2 percent of patients=
treated with adalimumab at week 16 (p<0.001).1 Significantly more patients=
treated with bimekizumab achieved complete skin clearance (PASI 100) than =
those treated with adalimumab: 60.8 percent versus 23.9 percent at week 16,=
and 66.8 percent versus 29.6 percent at week 24 (p<0.001 for each comparis=

In the two bimekizumab study arms, PASI 90, PASI 100 and IGA 0/1 response r=
ates were maintained through to week 56.^1 These results were observed acro=
ss both dosing regimens: bimekizumab every four weeks (Q4W dosing) until we=
ek 56, or Q4W dosing for 16 weeks, followed by bimekizumab every eight week=
s (Q8W dosing) from week 16 to week 56.^1 In patients treated with adalimum=
ab, response rates for PASI 90, PASI 100 and IGA 0/1 rapidly increased afte=
r patients were switched to bimekizumab Q4W dosing at week 24, through to w=
eek 56.^1 At week 56, response rates in switched patients were comparable t=
o those who had been treated with bimekizumab throughout the study.^1=C2=A0

Through weeks 0=E2=80=9324, the active comparator period, treatment emergen=
t adverse events (TEAEs) and serious TEAEs were comparable for patients rec=
eiving bimekizumab (71.5 percent and 1.6 percent, respectively) and adalimu=
mab (69.8 percent and 3.1 percent).^1 Through weeks 0=E2=80=9356, 81.4 perc=
ent and 5.1 percent of patients receiving bimekizumab (including those who =
switched from adalimumab) experienced TEAEs and serious TEAEs, respectively=
.^1 The most common TEAEs that were observed for bimekizumab through weeks =
0=E2=80=9356 were nasopharyngitis (20.9 percent), oral candidiasis (16.2 pe=
rcent) and upper respiratory tract infection (9.0 percent).^1=C2=A0Through =
week 56, there were no suicidal ideation/behavior, inflammatory bowel disea=
se, or major adverse cardiac events reported in patients treated with bimek=

About BE SURE=C2=A0=C2=A0 =C2=A0
BE SURE is a Phase 3, randomized, double-blind study comparing the efficacy=
and safety of bimekizumab to adalimumab in adult patients with moderate-to=
-severe chronic plaque psoriasis. The active-controlled initial treatment p=
eriod of 24 weeks is followed by a dose-blind maintenance treatment period =
until week 56. BE SURE enrolled 478 participants with chronic plaque psoria=
sis for at least six months prior to screening and with an affected body su=
rface area of at least 10 percent, PASI of at least 12 and IGA score equal =
to or greater than three on a five-point scale.^2=C2=A0=C2=A0

The co-primary endpoints of the study were PASI 90 response (defined as a p=
atient who achieves a 90 percent improvement in PASI) and IGA response (def=
ined as clear or almost clear with at least a two-category improvement rela=
tive to baseline) at week 16. For additional details on the study, visit BE=
SURE on clinicaltrials.gov (https://u7061146.ct.sendgrid.net/ls/click?upn=
34ooUexJO8g6Z3rCFShsVdT70QWTTDWHIkQJTZwAppmik-3D .^2 UCB announced topline =
findings from BE SURE in December 2019. For additional details, visit: BE S=
URE on UCB.com (https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tNED-2FM8i=
ZJH4LWACbXbuKbLcrlhH5Lj-2FeQCgo2JEEigDjfAuQhw-2B5r0lg8-3D .=C2=A0

Humira^=C2=AE is a registered trademark of AbbVie, Inc.

About Bimekizumab
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that s=
electively inhibits both IL-17A and IL-17F, two key cytokines driving infla=
mmatory processes.^3=C2=A0IL-17F has overlapping biology with IL-17A and dr=
ives inflammation independently to IL-17A.^4,5,6,7,8=C2=A0Selective inhibit=
ion of IL-17F in addition to IL-17A suppresses inflammation to a greater ex=
tent than IL-17A inhibition alone.^7,8 The safety and efficacy of bimekizum=
ab are being evaluated across multiple disease states as part of a robust c=
linical program.=C2=A0

About Psoriasis
Psoriasis is a common, chronic inflammatory disease with primary involvemen=
t of the skin. This skin condition affects men and women of all ages and et=
hnicities.^9=C2=A0Psoriasis signs and symptoms can vary but may include red=
patches of skin covered with silvery scales; dry, cracked skin that may bl=
eed; and thickened, pitted or ridged nails.^10

Psoriasis affects nearly three percent of the population, or about 125 mill=
ion people worldwide.^6 Unmet needs remain in the treatment of psoriasis. A=
population-based survey identified that approximately 30 percent of psoria=
sis patients reported that their primary goals of therapy, including keepin=
g symptoms under control, reducing itching and decreasing flaking, were not=
met with their current treatment.^11=C2=A0Psoriasis has a considerable psy=
chological and quality of life impact, potentially affecting work, recreati=
on, relationships, sexual functioning, family and social life.^12=C2=A0

About UCB
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 more than 7,600 people in=
approximately 40 countries, the company generated revenue of =E2=82=AC 4.9=
billion in 2019. UCB is listed on Euronext Brussels (symbol: UCB). Follow =
us on Twitter: @UCB_news.

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For further information, UCB:=C2=A0
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Corporate Communications
Laurent Schots=C2=A0
Media Relations, UCB =C2=A0
T+32.2.559.92.64 =C2=A0Laurent.schots@ucb.com=C2=A0

Investor Relations
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=C2=A0Investor Relations, UCB
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1. Warren R, Blauvelt A, Bagel J, et al. Bimekizumab efficacy and safety ve=
rsus adalimumab in patients with moderate to severe plaque psoriasis: Resul=
ts from a multicentre, randomised, double-blinded active comparator-control=
led phase 3 trial (BE SURE). Abstract ID 1958. Presented at the virtual 29t=
h European Academy of Dermatology and Venereology Congress, October 29-31, =
2. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (=
BE SURE). Available at: https://u7061146.ct.sendgrid.net/ls/click?upn=3D4tN=
O9kpLQRoMiaiIHzO6nculVr4vEcck-3D Last accessed: October 2020.
3. 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):991-1=
4. Yang XO, Chang SH, Park H, et al. Regulation of inflammatory responses b=
y IL-17F. J Exp Med. 2008;205(5):1063=E2=80=931075.
5. Hymowitz SG, Filvaroff EH, Yin JP, et al. IL-17s adopt a cystine knot fo=
ld: structure and activity of a novel cytokine, IL-17F, and implications fo=
r receptor binding. Embo J. 2001;20(19):5332=E2=80=935341.
6. van Baarsen LG, Lebre MC, van der Coelen D, et al. Heterogeneous express=
ion pattern of interleukin 17A (IL-17A), IL-17F and their receptors in syno=
vium of rheumatoid arthritis, psoriatic arthritis and osteoarthritis: possi=
ble explanation for nonresponse to anti-IL-17 therapy? Arthritis Res Ther. =
7. Maroof A, Okoye R, Smallie T, et al. Bimekizumab dual inhibition of IL-1=
7A and IL-17F provides evidence of IL-17F contribution to chronic inflammat=
ion in disease-relevant cells. Ann Rheum Dis. 2017;76(2):213.
8. Glatt S, Baeten D, Baker T, et al. Dual IL-17A and IL-17F neutralisation=
by bimekizumab in psoriatic arthritis: evidence from preclinical experimen=
ts and a randomised placebo-controlled clinical trial that IL-17F contribut=
es to human chronic tissue inflammation. Ann Rheum Dis. 2018;77(4):523-532.
9. National Psoriasis Foundation. Statistics. Available at: https://u706114=
AzV3xkhWORIbhpI8aWMlSc86gRIzpwhB5KEVe43vSlifDJSVW16aiTMfYqsRvzHsUYqQ4-3D La=
st accessed: October 2020.
10. International Federation of Psoriasis Associations. Available at: https=
4IakWrAJizEoFRzWRJWDpRyV-2Bc2nnTFUH1HKMT3l9HA-3D Last accessed: October 202=
11. Lebwohl MG, Kavanaugh A, Armstrong AW et al. US Perspectives in the Man=
agement of Psoriasis and Psoriatic Arthritis: Patient and Physician Results=
from the Population-Based Multinational Assessment of Psoriasis and Psoria=
tic Arthritis (MAPP) Survey. Am J Clin Dermatol. 2016; 17(1):87-97.
12. Moon HS, Mizara A, McBride SR. Psoriasis and psycho-dermatology. Dermat=
ol Ther (Heidelb). 2013;3:117-130.

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