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** New Long-Term Complete Skin Clearance Data for BIMZELX^=C2=AE=E2=96=BC (=
bimekizumab) in Moderate to Severe Plaque Psoriasis Presented at the 2022 A=
AD Annual Meeting
------------------------------------------------------------
=C2=B7 Eleven abstracts highlight new data on bimekizumab in the treatment =
of adults with moderate to severe plaque psoriasis=C2=A0
=C2=B7 Pooled data from five Phase 3/3b trials showed that more than eight =
out of 10 patients who achieved complete skin clearance with bimekizumab at=
week 16, and entered open-label extension, maintained this response throug=
h two years
=C2=B7 Data from the open-label extension period of the BE RADIANT study sh=
owed that complete skin clearance achieved at week 48 was maintained throug=
h week 96 with continuous bimekizumab treatment and improved for patients w=
ho switched from secukinumab to bimekizumab =C2=A0
Brussels (Belgium), 26th March 2022 =E2=80=93 15:30 CEST =E2=80=93 UCB, a g=
lobal biopharmaceutical company, today announced that it is presenting 11 a=
bstracts on bimekizumab in the treatment of adults with moderate to severe =
plaque psoriasis at the 2022 American Academy of Dermatology (AAD) Annual M=
eeting in Boston, Massachusetts, U.S., on March 25-29, including a late bre=
aking oral platform presentation and 10 posters. The platform presentation =
details new analysis of pooled data from five bimekizumab Phase 3/3b clinic=
al trials, which showed that over 80 percent of patients who achieved compl=
ete skin clearance (PASI100) at week 16 and entered the open-label extensio=
n (OLE) studies maintained this response through two years follow up, and n=
o new safety signals were identified.^1
Among the poster presentations, new data from the OLE period of the Phase 3=
b BE RADIANT study showed that clinical responses (PASI100 and absolute PAS=
I, PASI =E2=89=A42) achieved at week 48 were maintained through week 96 wit=
h continuous treatment with bimekizumab and improved for patients who switc=
hed from secukinumab to bimekizumab on entry to the OLE.^2,3=C2=A0 Patients=
who were PASI90 non-responders with secukinumab at week 48 achieved improv=
ed clinical responses (PASI90 and PASI100) after switching to bimekizumab i=
n the OLE.^3 Among patients who were PASI90 responders with secukinumab at =
week 48, PASI90 response was maintained and PASI100 response increased foll=
owing switch to bimekizumab in the OLE.^3
In the European Union and Great Britain, bimekizumab is the first selective=
IL-17A and IL-17F inhibitor to be approved for the treatment of moderate t=
o severe plaque psoriasis in adults who are candidates for systemic therapy=
.^4,5=C2=A0Bimekizumab is currently under review by the U.S. Food and Drug =
Administration (FDA) for the treatment of moderate to severe plaque psorias=
is in adults.=C2=A0
=E2=80=9CLong term complete skin clearance is an important goal for people =
with psoriasis, and the new 96-week data from the open-label extension peri=
od of the BE RADIANT study offer fresh insights on the sustained response a=
nd clinical potential of bimekizumab in moderate to severe plaque psoriasis=
,=E2=80=9D said Bruce Strober, M.D., Ph.D., Clinical Professor, Department =
of Dermatology, Yale University School of Medicine, New Haven, CT, U.S., an=
d Central Connecticut Dermatology Research, Cromwell, CT, U.S. =E2=80=9CIn =
addition, the improved clinical responses seen in patients who switched to =
bimekizumab after 48 weeks of treatment with secukinumab offer further new =
insights that should help to inform future clinical practice.=E2=80=9D=C2=
=A0
Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head =
of U.S., UCB, said: =E2=80=9CWe are pleased to share our latest long-term d=
ata on bimekizumab with the dermatology community at the 2022 AAD Annual Me=
eting. The wealth of new data, insights and progress being presented underl=
ines our commitment to advances in psoriasis care for people living with th=
is challenging, life-long condition.=E2=80=9D=C2=A0
Phase 3/3b studies: two-year pooled data for bimekizumab in patients with m=
oderate to severe plaque psoriasis1=C2=A5
Data were pooled from the BE VIVID, BE READY, and BE SURE Phase 3 trials, t=
he Phase 3b BE RADIANT trial and OLE (48 weeks), and the first year of the =
BE BRIGHT OLE study. Analysis evaluated PASI100 maintenance through two yea=
rs (OLE 48 weeks) among PASI100 week 16 responders who entered the respecti=
ve OLE studies and received continuous bimekizumab maintenance dosing from =
week 16 (320 mg every four weeks [Q4W/Q4W/Q4W] or Q4W/Q8W/Q8W*). At week 16=
, 62.4 percent of bimekizumab-treated patients (n=3D850) achieved PASI100. =
Of those who entered the OLEs, 85.1 percent (Q4W/Q4W/Q4W; n=3D316) and 83.8=
percent (Q4W/Q8W/Q8W*; n=3D267) maintained PASI100 at year two (OLE week 4=
8). The exposure-adjusted incidence rates (EAIRs) of overall and serious tr=
eatment emergent adverse events (TEAEs) were 192.7 and 5.9. The most common=
TEAEs were nasopharyngitis (EAIR of 18.4), oral candidiasis (13.0) and upp=
er respiratory tract infections (7.8). Almost all cases of oral candidiasis=
(98.1 percent) were mild or moderate.
BE RADIANT open-label extension study in patients with moderate to severe p=
laque psoriasis: efficacy and safety data through 96 weeks^2 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0
Complete skin clearance (PASI100) levels observed with bimekizumab in the B=
E RADIANT study were maintained in the OLE through week 96 (74.8 percent an=
d 70.6 percent at weeks 48 and 96, respectively) and improved for patients =
who switched from secukinumab to bimekizumab on entry to the OLE period (52=
.8 percent and 76.1 percent at weeks 48 and 96, respectively). The absolute=
PASI response (PASI=E2=89=A42) was also maintained through week 96 (94.3 p=
ercent and 93.4 percent at weeks 48 and 96, respectively) and improved for =
patients who switched from secukinumab to bimekizumab on entry to the OLE p=
eriod (83.9 percent and 94.6 percent at weeks 48 and 96, respectively). Dur=
ing the OLE, the most common adverse events with bimekizumab were nasophary=
ngitis (11.8/100 patient-years), oral candidiasis (7.8/100 patient-years), =
and urinary tract infection (4.5/100 patient-years). Adverse events were co=
mparable between patients continuing bimekizumab or switching from secukinu=
mab to bimekizumab. The incidence of serious adverse events was low. These =
analyses included 336 patients treated with bimekizumab, and 318 patients t=
reated with secukinumab who completed the BE RADIANT double-blinded period =
and entered the OLE.=C2=A0
=C2=A0
BE RADIANT open-label extension study in patients with moderate to severe p=
laque psoriasis: responder analysis in patients switching from secukinumab =
to bimekizumab^3=C2=A0
At week 48, 53/318 patients (16.7 percent) treated with secukinumab had not=
achieved PASI90. After switching to bimekizumab in the OLE, responses impr=
oved. At week 96, 79.2 percent of this group achieved PASI90 and 50.9 perce=
nt achieved PASI100. At week 48, 256/318 patients (80.5 percent) treated wi=
th secukinumab had achieved PASI90. After switching to bimekizumab in the O=
LE, 95.2 percent of this group maintained this response at week 96 and the =
PASI100 response increased from 65.2 percent at week 48 to 79.9 percent at =
week 96. No clinically relevant differences in safety outcomes for patients=
who switched from secukinumab to bimekizumab were observed from weeks 48-9=
6.
*In the EU the recommended bimekizumab dose for adult patients with plaque =
psoriasis is 320 mg (given as two subcutaneous injections of 160 mg) at wee=
k 0, four, eight, 12, 16 and every eight weeks thereafter. For some patient=
s with a body weight =E2=89=A5120 kg who did not achieve complete skin clea=
rance at week 16, 320 mg every four weeks after week 16 may further improve=
treatment response.^4=C2=A0
=C2=A5 Modified non-responder imputation analyses
=C2=A0
About the BE READY, BE VIVID and BE SURE studies and the BE BRIGHT open-lab=
el extension study^6,7,8,9
The efficacy and safety of bimekizumab in the treatment of adults with mode=
rate to severe plaque psoriasis were evaluated in three Phase 3 studies, ve=
rsus placebo and ustekinumab (BE VIVID), versus placebo (BE READY) and vers=
us adalimumab (BE SURE). Patients who completed one of these three Phase 3 =
studies were eligible to enroll in the BE BRIGHT open-label extension study=
.
About the BE RADIANT and BE RADIANT open-label extension study^10=C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=
=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =
=C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0 =C2=A0
BE RADIANT was a Phase 3b, randomized, multicenter, double-blind, active co=
mparator-controlled, parallel-group study designed to assess the efficacy a=
nd safety of bimekizumab compared to secukinumab in adults with moderate to=
severe chronic plaque psoriasis. Patients who completed the 48-week double=
-blinded period were able to enroll in the ongoing 96-week open-label exten=
sion, where they all received bimekizumab.
About BIMZELX^=C2=AE (bimekizumab) =C2=A0
Bimekizumab is a humanized monoclonal IgG1 antibody that is designed to sel=
ectively and directly inhibit both interleukin 17A (IL-17A) and interleukin=
17F (IL-17F), two key cytokines driving inflammatory processes.^11
About BIMZELX^=C2=AE=C2=A0=E2=96=BC in the EU/EEA*=C2=A0
In the EU, BIMZELX^=C2=AE is indicated for the treatment of moderate to sev=
ere plaque psoriasis in adults who are candidates for systemic therapy.^4=
=C2=A0
BIMZELX^=C2=AE=E2=96=BC (bimekizumab) EU/EEA* Important Safety Information
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
EU summary of product characteristics date of revision August 2021
Last accessed: March 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
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t limitation, statements containing the words =E2=80=9Cbelieves=E2=80=9D, =
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uch partnership. UCB=E2=80=99s efforts to acquire other products or compani=
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References
1. =C2=A0Gordon KB, Armstrong A, Lebwohl M et al. Bimekizumab efficacy and =
safety through two years in patients with moderate to severe plaque psorias=
is: Analysis of pooled data from five phase 3/3b clinical trials. To be pre=
sented at the 2022 AAD Annual Meeting.
2. Strober B, Paul C, Blauvelt A et al. Bimekizumab efficacy and safety thr=
ough 96 weeks in patients with moderate to severe plaque psoriasis: Results=
from the open-label extension period of the BE RADIANT phase 3b trial. To =
be presented at the 2022 AAD Annual Meeting.=C2=A0
3. Lebwohl M, Ghoreschi K, Strober B et al. Bimekizumab efficacy and safety=
in patients with moderate to severe plaque psoriasis who switched from sec=
ukinumab: Results from the open-label extension period of the BE RADIANT ph=
ase 3b trial To be presented at the 2022 AAD Annual Meeting.=C2=A0
4. BIMZELX (bimekizumab) EU Summary of Product Characteristics. https://www=
.ema.europa.eu/en/documents/product-information/bimzelx-epar-product-inform=
ation_en.pdf Last accessed March 2022.
5. BIMZELX (bimekizumab) GB Summary of Product Characteristics https://www.=
medicines.org.uk/emc/product/12834 (https://us-east-2.protection.sophos.com=
/?d=3Dmedicines.org.uk&u=3DaHR0cHM6Ly93d3cubWVkaWNpbmVzLm9yZy51ay9lbWMvcHJv=
ZHVjdC8xMjgzNA=3D=3D&i=3DNWUxNjEzNjVhNTFkYjMxNjRmMDQzMjRl&t=3DdjFPdEQwalJ3N=
Vk0UHRpOWFLaVVwNzkrZWNLMGQ0QTR1V0ZsVjJJcFFOZz0=3D&h=3Db04c5e77d7584a62938f5=
7b18b621ea4) ;=C2=A0
https://www.medicines.org.uk/emc/product/12833. Last accessed: March 2022.
6. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for =
the treatment of moderate to severe plaque psoriasis =C2=A0 (BE VIVID): eff=
icacy and safety from a 52-week, multicentre, double-blind, active comparat=
or and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.=
=C2=A0
7. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety i=
n moderate to severe plaque psoriasis (BE READY): a=C2=A0multicentre, doubl=
e-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2=
021;397(10273):475-486.
8. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in =
Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.=C2=A0
9. ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Bimek=
izumab in Adult Subjects With Moderate to Severe Chronic =C2=A0 =C2=A0Plaqu=
e Psoriasis (BE BRIGHT). Available at: https://clinicaltrials.gov/ct2/show/=
NCT03598790?term=3DNCT03598790&draw=3D2&rank=3D1. Last accessed : March 202=
2.
10. Reich K, Warren R, Lebwohl M et al. Bimekizumab versus Secukinumab in P=
laque Psoriasis N Engl J Med. 2021;385(2):142-152.
11. Glatt S, Helmer E, Haier B, et al. First-in-human randomized study of b=
imekizumab, 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-=
1001.=C2=A0
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