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** UCB Announces First Detailed Data from Two Phase 3 Bimekizumab Studies i=
n Psoriatic Arthritis to be Presented at EULAR 2022
------------------------------------------------------------
=C2=B7 First presentations from the BE OPTIMAL and BE COMPLETE studies eval=
uating bimekizumab in the treatment of adults with active psoriatic arthrit=
is who were biologic-na=C3=AFve and TNF-inadequate responders, respectively
=C2=B7 A higher proportion of patients treated with bimekizumab vs. placebo=
achieved improvements in joint symptoms at week 16 as measured by ACR50, w=
ith a consistent clinical response across biologic-na=C3=AFve (43.9 percent=
vs. 10.0 percent; p<0.001) and TNF-inadequate responder populations (43.4 =
percent vs. 6.8 percent; p<0.001)
=C2=B7 At week 16, a greater proportion of bimekizumab-treated patients ach=
ieved high levels of skin clearance, PASI90, vs. placebo, with a consistent=
clinical response across populations (61.3 percent vs. 2.9 percent for bio=
logic na=C3=AFve and 68.8 percent vs. 6.8 percent for TNF-inadequate respon=
ders; p<0.001 for each)
=C2=B7 At week 16, over 40 percent of bimekizumab-treated patients vs. plac=
ebo achieved minimal disease activity in both studies (p<0.001)
Brussels (Belgium), 23 May 2022 =E2=80=93=C2=A08:30 am (CEST)=C2=A0=E2=80=
=93 UCB, a global pharmaceutical company, today announced detailed results =
from two Phase 3 studies which evaluated the efficacy and safety of bimekiz=
umab versus placebo in the treatment of adults with active psoriatic arthri=
tis who were biologic disease-modifying anti-rheumatic drug na=C3=AFve (BE =
OPTIMAL) and in adults who had an inadequate response or intolerance to tum=
our necrosis factor inhibitors (BE COMPLETE).^1,2 The safety and efficacy o=
f bimekizumab in psoriatic arthritis have not been established, and it is n=
ot approved for use in psoriatic arthritis by any regulatory authority worl=
dwide.
Both studies met their primary endpoint of ACR50 at week 16 and all ranked =
secondary endpoints compared with placebo with statistical significance.^1,=
2 At week 16, patients treated with bimekizumab achieved clinically relevan=
t improvements over placebo in both joint and skin symptoms with efficacy o=
utcomes consistent across both biologic-na=C3=AFve and TNF-inadequate respo=
nder populations.^1,2 In addition, at week 16, over 40 percent of patients =
in both studies achieved a minimal disease activity response compared with =
placebo.^1,2 The safety profile of bimekizumab was consistent with safety d=
ata seen in previous studies with no new observed safety signals.^1,2 The r=
esults will be presented at the European Congress of Rheumatology, EULAR 20=
22, in Copenhagen, Denmark, June 1-4.^1,2
=E2=80=9COur Phase 3 clinical studies with bimekizumab used ACR50 at week 1=
6 as the primary endpoint reflecting our goal to raise the treatment bar fo=
r people with psoriatic arthritis. Results show that bimekizumab addressed =
the debilitating joint symptoms of active psoriatic arthritis, while also p=
roviding high levels of skin clearance compared to placebo,=E2=80=9D said E=
mmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head o=
f U.S., UCB. =E2=80=9CImportantly, the consistent findings seen across popu=
lations suggest that bimekizumab can provide a similar clinical response in=
patients that have an inadequate response or intolerance to TNF inhibitors=
, and in patients that are new to biologics.=E2=80=9D
=E2=80=9CToday=E2=80=99s findings from the BE OPTIMAL and BE COMPLETE studi=
es provide clear evidence supporting the potential of bimekizumab, a dual I=
L-17A and IL-17F inhibitor, in the treatment of active psoriatic arthritis.=
This painful, chronic condition can greatly impact patients=E2=80=99 lives=
. Achieving minimal disease activity is an important goal of treatment, tha=
t can ultimately lead to improved quality of life for people with psoriatic=
arthritis,=E2=80=9D said =C2=A0Dr Joseph F. Merola, MD, MMSc, Associate Pr=
ofessor, Harvard Medical School and Brigham and Women=E2=80=99s Hospital, B=
oston, MA, U.S.
Data from BE COMPLETE (16-week analysis) and BE OPTIMAL (24-week interim an=
alysis)
Joint Symptoms: In both studies, patients treated with bimekizumab (160 mg =
every four weeks [Q4W]) achieved statistically significant improvements in =
the primary endpoint of at least 50 percent or greater improvement from bas=
eline in the American College of Rheumatology response criteria (ACR50) at =
week 16, compared with placebo.^1,2=C2=A0
=C2=B7 In BE OPTIMAL, at week 16, 43.9 percent (n=3D189/431) of biologic na=
=C3=AFve patients treated with bimekizumab achieved ACR50 versus 10.0 perce=
nt (n=3D28/281) of patients on placebo; p<0.001.^1=C2=A0
=C2=B7 In BE COMPLETE, at week 16, 43.4 percent (n=3D116/267) of TNF-inadeq=
uate responder patients treated with bimekizumab achieved ACR50 versus 6.8 =
percent (n=3D9/133) of patients on placebo; p<0.001.^2=C2=A0
Skin Symptoms: In both studies, patients treated with bimekizumab achieved =
statistically significant improvements in levels of skin clearance, as meas=
ured by the ranked secondary endpoint of at least a 90 percent improvement =
in the Psoriasis Area and Severity Index (PASI90) at week 16, compared with=
placebo.^1.2
=C2=B7 In BE OPTIMAL, at week 16, 61.3 percent (n=3D133/217) of biologic na=
=C3=AFve patients treated with bimekizumab achieved PASI90 versus 2.9 perce=
nt (n=3D4/140) on placebo; p<0.001.^1
=C2=B7 In BE COMPLETE, at week 16, 68.8 percent (n=3D121/176) of TNF-inadeq=
uate responder patients treated with bimekizumab achieved PASI90 versus 6.8=
percent (n=3D6/88) on placebo; p<0.001.^2
Minimal Disease Activity: In both studies, a significantly higher proportio=
n of patients treated with bimekizumab achieved the ranked secondary endpoi=
nt of Minimal Disease Activity (MDA) response, compared with placebo at wee=
k 16.^1,2
=C2=B7 In BE OPTIMAL, at week 16, 45.0 percent (n=3D194/431) of biologic-na=
=C3=AFve patients treated with bimekizumab achieved MDA versus 13.2 (n=3D37=
/281) percent on placebo; p<0.001.^1
=C2=B7 In BE COMPLETE, at week 16, 44.2 percent (n=3D118/267) of TNF-inadeq=
uate responder patients treated with bimekizumab achieved MDA versus 6.0 pe=
rcent (n=3D8/133) on placebo; p<0.001.^2
=E2=80=9CIn the BE OPTIMAL and BE COMPLETE studies, bimekizumab demonstrate=
d clinically relevant improvements in musculoskeletal and skin outcomes for=
people with psoriatic arthritis compared with placebo. In addition, result=
s from the BE OPTIMAL study show that treatment with bimekizumab was associ=
ated with inhibition of structural joint damage progression by week 16,=E2=
=80=9D said Professor Iain McInnes, Vice Principal and Head of College, Uni=
versity of Glasgow, Scotland.
Additional Outcomes=C2=A0
=C2=B7 In BE OPTIMAL, treatment with bimekizumab compared with placebo was =
associated with a statistically significant inhibition of progression of st=
ructural joint damage at week 16, as measured by mean change from baseline =
in the van der Heijde modified Total Sharp Score (vdHmTSS), a ranked second=
ary endpoint.^1
=C2=B7 The clinical response in both studies was rapid, with separation fro=
m placebo observed from week two in BE OPTIMAL (ACR20; p<0.001, nominal, no=
t controlled for multiplicity) and week four in BE COMPLETE (ACR50; p<0.001=
, nominal, not controlled for multiplicity).^1,2
=C2=B7 In BE OPTIMAL, response rates continued to improve to week 24: 45.5 =
percent (n=3D196/431) of patients treated with bimekizumab achieved ACR50 a=
nd 35.9 percent (n=3D101/281) of patients switching from placebo to bimekiz=
umab at week 16, i.e following an eight week treatment duration; 72.8 perce=
nt (n=3D158/217) of bimekizumab-treated patients achieved PASI90 and 61.4 p=
ercent (n=3D86/140) of patients switching from placebo to bimekizumab at we=
ek 16; 48.5 percent (n=3D209/431) of patients treated with bimekizumab achi=
eved MDA and 37.7 percent (n=3D106/281) switching from placebo to bimekizum=
ab at week 16.^1
=C2=B7 An active reference arm, of adalimumab, was included in the BE OPTIM=
AL study. The study was not powered for statistical comparisons with the bi=
mekizumab treatment group or placebo. At week 16, 45.7 percent (n=3D64/140)=
, 41.2 percent (n=3D28/68) and 45.0 percent (n=3D63/140) of patients treate=
d with adalimumab achieved ACR50, PASI90 and MDA, respectively.^1=C2=A0
In BE OPTIMAL, over 16 weeks, 59.9 percent of patients treated with bimekiz=
umab had =E2=89=A5 one treatment emergent adverse event (TEAE) versus 49.5 =
percent of patients on placebo and 59.3 percent on adalimumab.^1 The three =
most frequent TEAEs (=E2=89=A55 percent in any treatment arm) were nasophar=
yngitis (9.3 percent for bimekizumab; 4.6 percent for placebo and 5.0 perce=
nt for adalimumab), upper respiratory tract infection (4.9 percent for bime=
kizumab; 6.4 percent for placebo and 2.1 percent for adalimumab) and increa=
sed alanine aminotransferase (0.7 percent for bimekizumab; 0.7 percent for =
placebo and 5.0 percent for adalimumab).^1 Candida infections were reported=
in 2.6 per-cent of bimekizumab-treated patients, 0.7 percent on placebo an=
d 0 percent on adalimumab.^1 The incidence of serious adverse events (SAEs)=
was low: 1.6 percent of patients treated with bimekizumab versus 1.1 perce=
nt on placebo and 1.4 percent on adalimumab.^1 No cases of systemic candidi=
asis, inflammatory bowel disease (IBD), major adverse cardiovascular events=
(MACE) or uveitis were reported.^1=C2=A0
In BE COMPLETE, over 16 weeks, 40.1 percent of patients treated with bimeki=
zumab had =E2=89=A5 one TEAE versus 33.3 percent of patients on placebo.^2 =
The three most frequent TEAEs for patients treated with bimekizumab were na=
sopharyngitis (3.7 percent; 0.8 percent for placebo), oral candidiasis (2.6=
percent; 0 percent for placebo) and upper respiratory tract infection (2.2=
percent; 1.5 percent for placebo).^2 Two patients on bimekizumab discontin=
ued treatment due to a TEAE (0.7 percent). The incidence of SAEs was low: 1=
.9 percent of patients treated with bimekizumab versus 0 percent on placebo=
, and none led to discontinuation.^2 No cases of systemic candidiasis, IBD,=
MACE, venous thromboembolism (VTE) or uveitis were reported.^2
Notes to editors :
About BE OPTIMAL
BE OPTIMAL is a randomized, multicenter, double-blind, placebo-controlled, =
active reference (adalimumab), parallel-group, Phase 3 study designed to ev=
aluate the efficacy and safety of bimekizumab in the treatment of adult pat=
ients with active psoriatic arthritis, who are biologic disease-modifying a=
nti-rheumatic drug na=C3=AFve.^3=C2=A0The study is ongoing with 24-week int=
erim analysis presented above. For additional details on the study, visit B=
E OPTIMAL (https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=3DBE+OP=
TIMAL&draw=3D2&rank=3D1) on clinicaltrials.gov.^3=C2=A0
About BE COMPLETE
BE COMPLETE was a randomized, multicenter, double-blind, placebo-controlled=
, parallel-group, Phase 3 study designed to evaluate the efficacy and safet=
y of bimekizumab in adults with active psoriatic arthritis and an inadequat=
e response to tumor necrosis factor-alpha inhibitors (TNF=CE=B1i).^4 All en=
rolled study participants had a history of inadequate response (lack of eff=
icacy after at least three months of therapy at an approved dose) or intole=
rance to treatment with one or two TNF=CE=B1i for either psoriatic arthriti=
s or psoriasis.^4 For additional details on the study, visit BE COMPLETE (h=
ttps://www.clinicaltrials.gov/ct2/show/NCT03896581) on clinicaltrials.gov.^=
4
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a serious, highly heterogeneous, chronic, syst=
emic inflammatory condition affecting both the joints and skin, with a prev=
alence of 0.02 percent to 0.25 percent of the population, and 6 percent to =
41 percent of patients with psoriasis.^5 Symptoms include joint pain and st=
iffness, skin plaques, swollen toes and fingers (dactylitis), and inflammat=
ion of the sites where tendons or ligaments insert into the bone (enthesiti=
s).^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.^7,10 Bimekizumab is in =
Phase 3 clinical development for the treatment of active psoriatic arthriti=
s with 24-week interim analysis from the BE OPTIMAL study and 16-week analy=
sis from the BE COMPLETE study to be presented at EULAR 2022.^1,2 In additi=
on, bimekizumab is in development for the treatment of active axial spondyl=
oarthritis with 24-week interim analysis results from BE MOBILE 1 (non-radi=
ographic axial spondyloarthritis) and BE MOBILE 2 (ankylosing spondylitis) =
studies to be presented at EULAR 2022.^8,9
About BIMZELX=C2=AE=E2=96=BC=C2=A0(bimekizumab) in the European Union/Europ=
ean Economic Area=C2=A0
In the European Union (EU)/European Economic Area (EEA), BIMZELX^=C2=AE is =
indicated for the treatment of moderate to severe plaque psoriasis in adult=
s who are candidates for systemic therapy.^10
BIMZELX^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat=
ion in Psoriasis
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.
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. Serious hypersensitivity reactions inclu=
ding anaphylactic reactions have been observed with IL-17 inhibitors. If a =
serious hypersensitivity reaction occurs, administration of bimekizumab sho=
uld 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
EU summary of product characteristics date of revision March 2022
Last accessed: May 2022.
=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
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 8,600 peopl=
e in approximately 40 countries, the company generated revenue of =E2=82=AC=
5.8 billion in 2021. UCB is listed on Euronext Brussels (symbol: UCB). Foll=
ow 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 =
or implied by such forward-looking statements contained in this press relea=
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cial decisions or governmental investigations, safety, quality, data integr=
ity or manufacturing issues; potential or actual data security and data pri=
vacy breaches, or disruptions of our information technology systems, produc=
t liability claims, challenges to patent protection for products or product=
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e discovered or identified in the pipeline, will progress to product approv=
al or that new indications for existing products will be developed and appr=
oved. Movement from concept to commercial product is uncertain; preclinical=
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or commercially successful as UCB may have believed at the start of such p=
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d to integrate the operations of such acquired companies may not be as succ=
essful as UCB may have believed at the moment of acquisition. Also, UCB or =
others could discover safety, side effects or manufacturing problems with i=
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policies imposed by third-party payers as well as legislation affecting bi=
opharmaceutical pricing and reimbursement activities and outcomes. Finally,=
a breakdown, cyberattack or information security breach could compromise t=
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stems.=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=
tional or approved products described in this press release will be submitt=
ed or approved for sale or for any additional indications or labelling in a=
ny market, or at any particular time, nor can there be any guarantee that s=
uch products will be or will continue to be commercially successful in the =
future.
UCB is providing this information, including forward-looking statements, on=
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UCB is following the worldwide developments diligently to assess the financ=
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to update any information contained in this press release, either to confir=
m the actual results or to report or reflect any change in its forward-look=
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ircumstances on which any such statement is based, unless such statement is=
required pursuant to applicable laws and regulations.=C2=A0
Additionally, information contained in this document shall not constitute a=
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References
1. McInnes I, Coates L, Landew=C3=A9 R.B.M. et al. Bimekizumab in bDMARD-Na=
=C3=AFve Patients with Psoriatic Arthritis: 24-Week Efficacy & Safety from =
BE OPTIMAL, a Phase 3, Multicentre, Randomised, Placebo-Controlled, Active =
Reference Study. Abstract presented at EULAR 2022.
2. Merola JF, Mcinnes I, Ritchlin CT et al. Bimekizumab in Patients with Ac=
tive Psoriatic Arthritis and an Inadequate Response to Tumour Necrosis Fact=
or Inhibitors: 16-Week Efficacy & Safety from BE COMPLETE, a Phase 3, Multi=
centre, Randomised Placebo-Controlled Study. Abstract presented at EULAR 20=
22.
3. ClinicalTrials.gov. A Study to Test the Efficacy and Safety of Bimekizum=
ab in the Treatment of Subjects with Active Psoriatic Arthritis (BE OPTIMAL=
). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03895203?term=
=3DBE+OPTIMAL&draw=3D2&rank=3D1 Last accessed: May 2022.
4. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in the Treatment of Subjects with Active Psoriatic Arthritis (BE COM=
PLETE). Available at: https://www.clinicaltrials.gov/ct2/show/NCT03896581 L=
ast accessed: May 2022.
5. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Cli=
n North Am. 2015; 41(4): 545=E2=80=93568.
6. Mease PJ, Armstrong AW. Managing patients with psoriatic disease: the di=
agnosis and pharmacologic treatment of psoriatic arthritis in patients with=
psoriasis. Drugs. 2014; 74:423-441.
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):991-1=
001.=C2=A0
8. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Subjects With Active Nonradiographic Axial Spondyloarthritis (BE =
MOBILE 1). Available at: https://clinicaltrials.gov/ct2/show/NCT03928704 (h=
ttps://www.clinicaltrials.gov/ct2/show/NCT03896581) . =C2=A0Last accessed: =
May 2022.
9. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Subjects With Active Ankylosing Spondylitis (BE MOBILE 2). Availa=
ble at: https://www.clinicaltrials.gov/ct2/show/NCT03928743. Last accessed:=
May 2022
10. BIMZELX^=C2=AE (bimekizumab) EU Summary of Product Characteristics=C2=
=A0https://www.ema.europa.eu/en/documents/product-information/bimzelx-epar-=
product-information_en.pdf. Last accessed: May 2022.
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