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** New Long-Term Data on Bimekizumab in Psoriatic Arthritis and Axial Spond=
yloarthritis Presented at EULAR 2023
------------------------------------------------------------
=C2=B7 In patients with psoriatic arthritis with prior inadequate response =
to tumour necrosis factor inhibitors, bimekizumab demonstrated sustained jo=
int and skin clearance responses to week 52=C2=A0
=C2=B7 Across the spectrum of axial spondyloarthritis, bimekizumab demonstr=
ated sustained reduction of inflammatory lesions of the sacroiliac joints a=
nd spine, as well as sustained improvements in the main peripheral manifest=
ations of disease, to week 52=C2=A0
Brussels (Belgium), 31st May 2023 =E2=80=93 07:00 (CET) =C2=A0=E2=80=93 UCB=
, a global biopharmaceutical company, today announced new long-term 52-week=
data from three Phase 3 studies =E2=80=93 BE COMPLETE with its long-term e=
xtension study, BE MOBILE 1 and BE MOBILE 2 =E2=80=93 evaluating the effica=
cy and safety profile of bimekizumab, an inhibitor of IL-17F in addition to=
IL-17A, in adults with active psoriatic arthritis (PsA), active non-radiog=
raphic axial spondyloarthritis (nr-axSpA) and active ankylosing spondylitis=
(AS), also known as radiographic axSpA (r-axSpA), respectively.^1,2,3=C2=
=A0These results from the bimekizumab phase 3 program in PsA and axSpA are =
being presented at the European Congress of Rheumatology, EULAR 2023, in Mi=
lan, Italy, May 31=E2=80=93June 3. The safety and efficacy of bimekizumab i=
n PsA, nr-axSpA and r-axSpA have not been established, and it is not approv=
ed for use in PsA, nr-axSpA or AS by any regulatory authority worldwide.
=E2=80=9CPsoriatic arthritis and axial spondyloarthritis are chronic and pr=
ogressive inflammatory diseases requiring long-term management. The new lon=
g-term bimekizumab data presented at EULAR 2023 showed sustained clinical r=
esponses across multiple disease manifestations and patient populations up =
to one year. These results reinforce our belief in bimekizumab as a potenti=
al new future treatment for patients living with psoriatic arthritis and ax=
ial spondyloarthritis,=E2=80=9D said Emmanuel Caeymaex, Executive Vice Pres=
ident, Immunology and U.S. Solutions, UCB.
Bimekizumab 52-week PsA data: patients with prior inadequate response to tu=
mour necrosis factor inhibitors (TNFi-IR)
Key 52-week results from the BE COMPLETE open-label extension study (BE VIT=
AL) are shared below and build on the previously announced 16-week results =
(https://www.ucb.com/stories-media/Press-Releases/article/UCB-Announces-Fir=
st-Detailed-Data-from-Two-Phase-3-Bimekizumab-Studies-in-Psoriatic-Arthriti=
s-to-be-Presented-at-EULAR-2022) from the BE COMPLETE study and 52-week res=
ults (https://www.ucb.com/stories-media/Press-Releases/article/Bimekizumab-=
Demonstrated-Sustained-Clinical-Responses-to-Week-52-in-Phase-3-Studies-in-=
Psoriatic-Arthritis-Non-Radiographic-Axial-Spondyloarthritis-and-Ankylosing=
-Spondylitis) from the BE OPTIMAL study.^1
=E2=80=9CThe long-term data from BE COMPLETE showed that over six out of 10=
patients continuously treated with bimekizumab achieved complete skin clea=
rance and almost one in two had minimal disease activity at week 52. These =
results complement the previously reported 52-week results from the BE OPTI=
MAL study and highlight the consistent and sustained response seen with bim=
ekizumab in both biologic-na=C3=AFve and TNF inhibitor-experienced patients=
with psoriatic arthritis,=E2=80=9D said Professor Iain McInnes, University=
of Glasgow, College of Medicinal Veterinary and Life Sciences, Glasgow, Sc=
otland.=C2=A0
=C2=B7 American College of Rheumatology (ACR) 50: At week 52, 51.7 percent =
of psoriatic arthritis patients (TNFi-IR) continuously treated with bimekiz=
umab (160 mg every four weeks [Q4W]; n=3D267), and 40.6 percent of patients=
who switched from placebo to bimekizumab at week 16 (n=3D133) achieved ACR=
50.^1=C2=B1
=C2=B7 Complete Skin Clearance (PASI100): At week 52, in patients with base=
line psoriasis =E2=89=A53 percent body surface area, 65.9 percent of patien=
ts continuously treated with bimekizumab (n=3D176) and 60.2 percent of pati=
ents who switched from placebo to bimekizumab at week 16 (n=3D88) achieved =
complete skin clearance (PASI100).^1=C2=B1=C2=A0
=C2=B7 Minimal Disease Activity (MDA): At week 52, 47.2 percent (n=3D126/26=
7) of patients continuously treated with bimekizumab and 33.1 percent (n=3D=
44/133) of patients who switched from placebo to bimekizumab achieved MDA.^=
1=C2=B1
Over 52 weeks, 62.6 percent (n=3D243/388) of patients treated with bimekizu=
mab had =E2=89=A51 treatment emergent adverse event (TEAE) and 5.9 percent =
(n=3D23/388) reported a serious TEAE.^1 Candida infections were reported by=
6.4 percent (n=3D25/388) of patients receiving bimekizumab with all cases =
reported as mild or moderate and none reported as systemic.^1=C2=A0
Bimekizumab 52-week axSpA data: inflammation of the sacroiliac joints and s=
pine and peripheral manifestations
Key 52-week results from the phase 3 BE MOBILE 1 and BE MOBILE 2 studies ev=
aluating the effect of bimekizumab on inflammatory lesions of the sacroilia=
c joints (SIJ) and spine as measured objectively by magnetic resonance imag=
ing (MRI), and on the main peripheral manifestations of axSpA are shared be=
low and build on previously announced 16-week (https://www.ucb.com/stories-=
media/Press-Releases/article/First-Presentations-of-Phase-3-Data-for-Bimeki=
zumab-Across-the-Full-Spectrum-of-Axial-Spondyloarthritis-to-be-Shared-at-E=
ULAR-2022) and 52-week results (https://www.ucb.com/stories-media/Press-Rel=
eases/article/Bimekizumab-Demonstrated-Sustained-Clinical-Responses-to-Week=
-52-in-Phase-3-Studies-in-Psoriatic-Arthritis-Non-Radiographic-Axial-Spondy=
loarthritis-and-Ankylosing-Spondylitis) from BE MOBILE 1 and BE MOBILE 2.^2=
,3=C2=A0
=E2=80=9CTreatment with bimekizumab versus placebo reduced inflammation of =
the spine and sacroiliac joints as detected by magnetic resonance imaging. =
In the two studies, approximately one in two patients with MRI inflammation=
at baseline achieved MRI remission at week 16, which was sustained out to =
week 52,=E2=80=9D said Xenofon Baraliakos, Professor of Internal Medicine a=
nd Rheumatology, Ruhr-University Bochum, Bochum, Germany.
=C2=B7 Inflammation SIJ: At week 52, in the BE MOBILE 1 imaging sub-study, =
80.0 percent (n=3D32/40) of patients with inflammation at baseline receivin=
g continuous bimekizumab and 57.1 percent (n=3D20/35) who switched from pla=
cebo to bimekizumab at week 16 achieved remission in inflammatory lesions o=
f the SIJs (Spondyloarthritis Research Consortium of Canada [SPARCC SIJ<2])=
; in BE MOBILE 2, 75.7 percent (n=3D28/37) receiving bimekizumab and 66.7 p=
ercent (n=3D12/18) who switched from placebo to bimekizumab at week 16 achi=
eved remission in inflammatory lesions of the SIJ.^2=C2=A5=C2=A0
=C2=B7 Inflammation Spine: At week 52, in the BE MOBILE 1 imaging sub-study=
, 40.0 percent (n=3D6/15) of patients with inflammation at baseline receivi=
ng continuous bimekizumab and 27.3 percent (n=3D3/11) who switched from pla=
cebo to bimekizumab at week 16 achieved remission (Berlin Spine=E2=89=A42);=
in BE MOBILE 2, 76.7 percent (n=3D23/30) receiving continuous bimekizumab =
and 62.5 percent (n=3D10/16) who switched from placebo to bimekizumab at we=
ek 16 achieved remission.^2=C2=A5
=C2=B7 Enthesitis: At week 52, in BE MOBILE 1, 54.3 percent of patients rec=
eiving continuous bimekizumab (n=3D94) and 44.6 percent who switched from p=
lacebo to bimekizumab (n=3D92) at week 16 achieved resolution of enthesitis=
(Maastricht Ankylosing Spondylitis Enthesitis=3D0); in BE MOBILE 2, 50.8 p=
ercent receiving continuous bimekizumab (n=3D132) and 46.3 percent who swit=
ched from placebo to bimekizumab at week 16 (n=3D67) achieved resolution of=
enthesitis.^3=C2=B1=C2=A0
=C2=B7 Peripheral arthritis: At week 52, in BE MOBILE 1, 62.2 percent of pa=
tients receiving continuous bimekizumab (n=3D45) and 65.1 percent who switc=
hed from placebo to bimekizumab at week 16 (n=3D43) achieved resolution (Sw=
ollen Joint Count=3D0); in BE MOBILE 2, 72.7 percent receiving continuous b=
imekizumab (n=3D44) and 81.8 percent who switched from placebo to bimekizum=
ab at week 16 (n=3D22) achieved resolution (Swollen Joint Count=3D0).^3=C2=
=B1
In addition, in the largest pool of bimekizumab phase 2b and phase 3 data a=
vailable, the exposure-adjusted incidence rate of uveitis in patients with =
axSpA treated with bimekizumab (160 mg Q4W) remains low at 1.2/100 patient-=
years. In this pooled data, the total bimekizumab exposure was 2,034.4 pati=
ent years (N=3D848) and 15.3 percent of patients (n=3D130) had a history of=
uveitis. All uveitis TEAEs reported were mild to moderate and one event le=
d to discontinuation.^4
Notes to editors:
=C2=B1=E2=80=93Non-responder imputation
=C2=A5 =E2=80=93 Observed Case
About BE COMPLETE
BE COMPLETE was a 16-week randomized, double-blind, placebo-controlled stud=
y in which patients with active psoriatic arthritis and prior inadequate re=
sponse to tumor necrosis factor inhibitors (TNFi-IR) were randomized (2:1) =
to bimekizumab (160 mg every four weeks [Q4W]; N=3D267) or placebo (N=3D133=
).^1 Week 16 completers were eligible to enter the open-label extension up =
to one year.^1 Patients initially randomized to placebo were switched to bi=
mekizumab at week 16 and received 36 weeks=E2=80=99 bimekizumab treatment u=
p to week 52.^1 A total of 86.8 percent (n=3D347) of randomized patients co=
mpleted week 52.^1 The primary endpoint in the BE COMPLETE study was ACR50 =
at week 16 with ranked secondary endpoints including PASI90 at week 16 and =
minimal disease activity (MDA) at week 16, with other endpoints including c=
omplete skin clearance (PASI100) at week 16.^5
About BE MOBILE 1 and BE MOBILE 2 ^2,3=C2=A0
The phase 3 studies BE MOBILE 1 and BE MOBILE 2 comprised a 16-week double-=
blind treatment period followed by a 36-week maintenance period. In BE MOBI=
LE 1 and BE MOBILE 2, patients were randomized to bimekizumab (160 mg Q4W; =
N=3D128 for BE MOBILE 1 and N=3D221 for BE MOBILE 2) or to placebo (N=3D126=
for BE MOBILE 1 and N=3D111 for BE MOBILE 2). Patients initially randomize=
d to placebo were switched to bimekizumab (160 mg Q4W) at week 16. The prim=
ary endpoint in the BE MOBILE 1 and BE MOBILE 2 studies was ASAS40 at week =
16.^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.^7,8=C2=A0 In August 202=
1, bimekizumab was first approved in the European Union (EU)/European Econo=
mic Area (EEA) and in Great Britain, for the treatment of moderate to sever=
e plaque psoriasis in adults who are candidates for systemic therapy.^8,9 T=
he label information may differ in other countries. Please check local pres=
cribing information where approved.=C2=A0
BIMZELX^=C2=AE =E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informa=
tion in Psoriasis^8
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 and fatigue. Elder=
ly may be more likely to experience certain adverse reactions such as oral =
candidiasis, 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: May 2022.
Last accessed: May 2023.
=C2=A0=C2=A0 =C2=A0
=C2=A0=E2=96=BC =C2=A0This medicinal product is subject to additional monit=
oring. This will allow quick identification of new safety information. Heal=
thcare 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 8,700 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
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=
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actual data security and data privacy breaches, or disruptions of our infor=
mation technology systems, product liability claims, challenges to patent p=
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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models. The length of the timing to complete clinical trials and to get reg=
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ts similar unpredictability going forward. Products or potential products, =
which are the subject of partnerships, joint ventures or licensing collabor=
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rove to be not as safe, effective or commercially successful as UCB may hav=
e believed at the start of such partnership. UCB=E2=80=99s efforts to acqui=
re other products or companies and to integrate the operations of such acqu=
ired companies may not be as successful as UCB may have believed at the mom=
ent of acquisition. Also, UCB or others could discover safety, side effects=
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s toward managed care and health care cost containment, including pricing p=
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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=
tional or approved products described in this press release will be submitt=
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UCB is providing this information, including forward-looking statements, on=
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Additionally, information contained in this document shall not constitute a=
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References=C2=A0
1. Coates LC, Landew=C3=A9 R, McInnes IB, et al. Sustained efficacy and saf=
ety of bimekizumab in patients with active psoriatic arthritis and prior in=
adequate response to tumour necrosis factor inhibitors: Results from the ph=
ase 3 BE COMPLETE study and its open-label extension up to 1 year. Abstract=
#POS0231 presented at EULAR 2023, Milan, Italy.
2. Baraliakos X, Navarro-Compan V, Poddubnyy D, et al. Bimekizumab reduced =
MRI inflammatory lesions in patients with axial spondyloarthritis: Week 52 =
results from the BE MOBILE 1 and BE MOBILE 2 phase 3 studies. Abstract #POS=
0246 presented at EULAR 2023, Milan, Italy.
3. Ramiro S, Poddubnyy D, Mease PJ, et al. Resolution of enthesitis and per=
ipheral arthritis with bimekizumab in patients with axial spondyloarthritis=
: Week 52 results from the BE MOBILE 1 and BE MOBILE 2 phase 3 studies. Abs=
tract #POS0247 presented at EULAR 2023, Milan, Italy.
4. Brown M, van Gaalen FA, van der Horst-Bruinsma IE, et al. Low uveitis ra=
tes in patients with axial spondyloarthritis treated with bimekizumab: Pool=
ed results from phase 2b/3 trials. Abstract #POS0668 presented at EULAR 202=
3, Milan, Italy.
5. Merola JF, Landew=C3=A9 R, McInnes IB, et al. Bimekizumab in patients wi=
th active psoriatic arthritis and previous inadequate response or intoleran=
ce to tumour necrosis factor-=CE=B1 inhibitors: a randomised, double-blind,=
placebo-controlled, phase 3 trial (BE COMPLETE). Lancet. 2023;401(10370):3=
8=E2=80=9348.
6. van der Heijde D, Deodhar A, Baraliakos X, et al. Efficacy and safety of=
bimekizumab in axial spondyloarthritis: results of two parallel phase 3 ra=
ndomized controlled trials. Ann Rheum Dis. Published Online First: January =
2023. doi:10.1136/ard-2022-223595 (https://ard.bmj.com/content/early/2023/0=
1/16/ard-2022-223595) . Last accessed: May 2023.
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.
8. BIMZELX^=C2=AE (bimekizumab) EU SmPC. =C2=A0https://www.ema.europa.eu/en=
/documents/product-information/bimzelx-epar-product-information_en.pdf. Acc=
essed on May 2023.
9. BIMZELX^=C2=AE (bimekizumab) GB SmPC. https://www.medicines.org.uk/emc/p=
roduct/12834. https://www.medicines.org.uk/emc/product/12833 Accessed on Ma=
y 2023.
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