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** The Lancet Publishes Results from Two Bimekizumab Phase 3 Studies in Pso=
riatic Arthritis
------------------------------------------------------------
=C2=B7 Two articles report results from the Phase 3 BE OPTIMAL and BE COMPL=
ETE studies evaluating bimekizumab, a selective inhibitor of IL-17A and IL-=
17F, in patients with psoriatic arthritis
=C2=A0
Brussels (Belgium), 7th December 2022 =E2=80=93 07:00 (CET) =E2=80=93 UCB, =
a global biopharmaceutical company, today announced that The Lancet =C2=A0h=
as published two articles detailing 24-week results from the Phase 3 BE OPT=
IMAL study and 16-week results from the Phase 3 BE COMPLETE study, evaluati=
ng the efficacy and safety of bimekizumab in the treatment of adults with a=
ctive psoriatic arthritis who were biologic-na=C3=AFve and tumour necrosis =
factor inhibitor inadequate responders (TNFi-IR), respectively.^1,2=C2=A0
=E2=80=9CPublication of two articles in tandem in The Lancet, one of the wo=
rld=E2=80=99s most prestigious peer-reviewed journals, highlights the signi=
ficance of these Phase 3 bimekizumab studies to the medical community. We l=
ook forward to continuing to work with regulatory agencies to make bimekizu=
mab available to people living with psoriatic arthritis as soon as possible=
,=E2=80=9D said Emmanuel Caeymaex, Executive Vice President, Immunology Sol=
utions and Head of US, UCB.
Data from BE OPTIMAL and BE COMPLETE show that both studies met their prima=
ry and all ranked secondary endpoints.^1,2 A significantly higher proportio=
n of patients treated with bimekizumab achieved improvements in joint sympt=
oms at week 16 compared with placebo =E2=80=93 as measured by ACR50, the pr=
imary endpoint =E2=80=93 with a consistent clinical response observed in bo=
th biologic-na=C3=AFve and TNFi-IR populations (p<0.0001 for each). In addi=
tion, at week 16, a significantly higher proportion of bimekizumab-treated =
patients compared with placebo achieved high levels of skin clearance =E2=
=80=93 as measured by PASI 90, a secondary endpoint =E2=80=93 with a consis=
tent clinical response in both populations (p<0.0001 for each). The safety =
profile of bimekizumab was consistent with safety data seen in previous stu=
dies with no new observed safety signals.^1,2=C2=A0
In September 2022, UCB announced that the European Medicines Agency had acc=
epted the marketing authorization application for bimekizumab for the treat=
ment of active psoriatic arthritis in adults (https://www.ucb.com/stories-m=
edia/Press-Releases/article/European-Medicine-Agency-Accepts-Marketing-Auth=
orization-Applications-for-Bimekizumab-in-Psoriatic-Arthritis-and-Axial-Spo=
ndyloarthritis) . =C2=A0
The efficacy and safety of bimekizumab in the treatment of psoriatic arthri=
tis have not been established and it is not approved for the treatment of p=
soriatic arthritis by any regulatory authority worldwide.
Notes to editors:
About BE OPTIMAL
BE OPTIMAL was a randomized, multicenter, double-blind, placebo-controlled,=
active reference (adalimumab), parallel-group, Phase 3 study designed to e=
valuate the efficacy and safety of bimekizumab in the treatment of adult pa=
tients with active psoriatic arthritis, who are biologic disease-modifying =
anti-rheumatic drug na=C3=AFve. For additional details on the study, see ar=
ticle in The Lancet.^1=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).^2 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. For additional details on the study, see article in The Lan=
cet.^2=C2=A0
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.^3 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).^4
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.^5,6=C2=A0 In August 202=
1, bimekizumab was approved in the European Union (EU)/European Economic Ar=
ea (EEA) and in Great Britain, for the treatment of moderate to severe plaq=
ue psoriasis in adults who are candidates for systemic therapy.^6,7=C2=A0Th=
e label information may differ in other countries. Please check local presc=
ribing information.
About BIMZELX^=C2=AE=C2=A0=E2=96=BC (bimekizumab) in the EU/EEA
In the EU/ EEA, BIMZELX^=C2=AE is indicated for the treatment of moderate t=
o severe plaque psoriasis in adults who are candidates for systemic therapy=
.^6=C2=A0
BIMZELX^=C2=AE=E2=96=BC=C2=A0(bimekizumab) EU/EEA Important Safety Informat=
ion in Psoriasis^6
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: December 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.
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References
1. McInnes I.B., Asahina A, Coates L.C. et al. Bimekizumab in patients with=
psoriatic arthritis, na=C3=AFve to biologic treatment: a randomised, doubl=
e-blind, placebo-controlled, phase 3 trial (BE OPTIMAL) The Lancet. 2022. P=
ublished online. Available at: =C2=A0https://www.thelancet.com/journals/lan=
cet/article/PIIS0140-6736(22)02302-9/fulltext=C2=A0
2. Merola J.F., Landew=C3=A9 R, McInnes I.B. et al. Bimekizumab in patients=
with active psoriatic arthritis and previous inadequate response or intole=
rance to tumour necrosis factor-=CE=B1 inhibitors: a randomised, double-bli=
nd, placebo-controlled, phase 3 trial (BE COMPLETE) The Lancet. 2022. Publi=
shed online. Available at: https://www.thelancet.com/journals/lancet/articl=
e/PIIS0140-6736(22)02303-0/fulltext
3. Ogdie A, Weiss P. The Epidemiology of Psoriatic Arthritis. Rheum Dis Cli=
n North Am. 2015;41(4):545=E2=80=93568.=C2=A0
4. 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(4):423=E2=80=93441.
5. 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=
=E2=80=931001.
6. 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: December 2022.
7. BIMZELX^=C2=AE (bimekizumab) GB Summary of Product Characteristics. Avai=
lable at: https://www.medicines.org.uk/emc/product/12834; https://www.medic=
ines.org.uk/emc/product/12833. Last accessed: December 2022.
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