Synopsis

Conclusions
Bimekizumab was well-tolerated across the plaque psoriasis clinical program; most TEAEs were mild to moderate and 
discontinuations were low.

All candida infections were mucocutaneous in origin, with oral candidiasis being most frequent; oral candidiasis TEAEs were 
predominantly mild to moderate and the vast majority did not lead to discontinuation.

Objective
To report short- and longer-term safety data in bimekizumab-treated patients with 
moderate to severe plaque psoriasis pooled from eight phase 2/3 trials. 

Background
• Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin 

(IL)-17F in addition to IL-17A.1,2

• Given that psoriasis is a chronic disease requiring long-term management,  
it is important to understand the long-term safety profiles of therapies such  
as bimekizumab.

• We report short- and longer-term safety data in bimekizumab-treated patients 
with moderate to severe plaque psoriasis, and short-term data from adalimumab, 
ustekinumab, and placebo phase 3 comparator arms.

Methods
• Patients were included from four phase 3 trials – BE SURE, BE VIVID, BE READY, 

and the BE BRIGHT open-label extension (interim cut: November 1, 2019) – 
and four phase 2 studies – BE ABLE 1, BE ABLE 2, PS0016, and PS0018. Patients 
received bimekizumab 320 mg every 4 or 8 weeks (Q4W/Q8W; additional doses 
used in phase 2), adalimumab, ustekinumab, or placebo.

• Short-term safety from the initial treatment periods (Weeks 0–16) of three of the 
phase 3 trials (BE SURE, BE VIVID, and BE READY) was evaluated for patients who 
received ≥1 dose of bimekizumab, adalimumab, ustekinumab, or placebo.

• Longer-term safety was also evaluated for patients who received ≥1 dose 
of bimekizumab in BE SURE, BE VIVID, BE READY, BE BRIGHT, and the four 
phase 2 trials.

• We report treatment emergent adverse events (TEAEs; n [%]) for the initial 
treatment period for patients receiving bimekizumab 320 mg Q4W, adalimumab, 
ustekinumab, and placebo, as well as longer-term TEAEs for patients receiving 
bimekizumab 320 mg Q4W and all other doses of bimekizumab.

 – Exposure-adjusted incidence rates (EAIRs) are the incidence of new cases per  
100 patient-years (PY) in patients receiving bimekizumab 320 mg Q4W  
(short-term) and all patients receiving any dose of bimekizumab (longer-term).

 – TEAEs were coded using MedDRA v19.0.

Results
Patient Population
• Over 16 weeks, 989 patients with psoriasis received ≥1 bimekizumab dose,  

159 patients received adalimumab, 163 patients received ustekinumab, and  
169 patients received placebo.

• Patient demographics and baseline disease characteristics are reported in Table 1.

Short-Term Safety Outcomes
• 593 (60.0%) bimekizumab-treated patients experienced ≥1 TEAE, versus 96 

(60.4%) adalimumab-treated patients, 83 (50.9%) ustekinumab-treated patients, 
and 74 (43.8%) placebo-treated patients (Table 2).

• Serious TEAEs occurred in <4% of patients in each treatment group, ranging from 
1.5% for bimekizumab to 3.1% for ustekinumab.

• Discontinuations due to TEAEs occurred in <5% of patients in each group, ranging 
from 1.7% for bimekizumab to 4.1% for placebo (Table 2).

Longer-Term Safety Outcomes
• Over the longer term, TEAEs in bimekizumab-treated patients occurred at a rate 

of 238.0/100 PY, serious TEAEs at 6.6/100 PY, and discontinuations due to TEAEs 
at 4.9/100 PY (Table 2).

• Serious infections occurred at a rate of 1.4/100 PY in bimekizumab-treated 
patients; rates of malignancies and adjudicated major adverse cardiac events were 
lower, occurring at 0.8/100 PY and 0.7/100 PY, respectively (Table 3).

• There was one active suicidal ideation in a bimekizumab-treated patient with  
pre-existing psychological conditions and one case of inflammatory bowel 
disease in a bimekizumab-treated patient (Table 3).

• 17.0% of bimekizumab-treated patients experienced mucocutaneous candida 
infection TEAEs, out of which 15.1% were oral candidiasis (Table 4).

 – 1 serious case (<0.1%) and 6 candidiasis-related discontinuations 
(0.3%) occurred.

K. Reich,1 A. Blauvelt,2 M. Lebwohl,3 K.A. Papp,4 P. Rich,5  
B. Strober,6,7 D. De Cuyper,8 C. Madden,9 L. Peterson,9  
V. Vanvoorden,8 R.B. Warren10

ADA: adalimumab; BKZ: bimekizumab; BSA: body surface area; CI: confidence interval; DLQI: Dermatology Life Quality Index; EAIR: exposure-adjusted incidence rate; IGA: Investigator’s Global Assessment; IL: interleukin; MACE: major adverse cardiovascular event; NMSC: non-melanoma skin cancers; PASI: Psoriasis Area and Severity Index; PBO: placebo;  
PY: patient-years; Q2/4/8/12W: every 2/4/8/12 weeks; SD: standard deviation; SIB: suicidal ideation and behavior; TEAE: treatment emergent adverse event; TNF: tumor necrosis factor; UST: ustekinumab.

Longer-term all BKZ (n=1789)

EAIR per 100 PY (95% CI) n (%) Serious | n (%) Severe | n (%)

Candida infections 18.7 (16.7, 21.0) 304 (17.0) 1 (<0.1) 4 (0.2)

Oral candidiasis 16.4 (14.5, 18.5) 271 (15.1) 0 3 (0.2)

Oropharyngeal candidiasis 1.2 (0.7, 1.8) 21 (1.2) 0 0

Skin candidiasis 0.6 (0.3, 1.1) 11 (0.6) 0 0

Vulvovaginal candidiasis 0.8 (0.5, 1.4) 15 (0.8) 0 0

Esophageal candidiasis 0.3 (0.1, 0.6) 5 (0.3) 1 (<0.1) 1 (<0.1)

Leading to discontinuation 0.3 (0.1, 0.7) 6 (0.3) 1 (<0.1) 1 (<0.1)

Institutions: 1Center for Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf and Skinflammation® Center, Hamburg, Germany; 2Oregon Medical Research Center, Portland, Oregon, USA; 3Icahn School of Medicine at Mount Sinai, New York, New 
York, USA; 4Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada; 5Oregon Dermatology and Research Center, Portland, Oregon, USA; 6Yale University, New Haven, Connecticut, USA; 7Central Connecticut Dermatology Research, Cromwell, Connecticut, USA; 8UCB Pharma, Brussels, Belgium; 9UCB Pharma, Raleigh, North Carolina, 
USA; 10Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK

Bimekizumab Safety in Patients with Moderate to Severe Psoriasis: 
Analysis of Pooled Data from Phase 2 and 3 Clinical Trials

Presented at Winter Clinical 2021 Virtual Congress  |  January 16–24

References: 1Glatt S. Br J Clin Pharmacol 2017;83:991–1001; 2Papp KA. J Am Acad Dermatol 2018;79:277–86 e10. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: KR, AB,ML, KAP, PR, BS, DDC, CM, LP, VV, RBW; drafting of the publication, or revising it critically for important intellectual 
content: KR, AB,ML, KAP, PR, BS, DDC, CM, LP, VV, RBW; final approval of the publication: KR, AB,ML, KAP, PR, BS, DDC, CM, LP, VV, RBW. Author Disclosures: KR: Served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Affibody, Almirall, Amgen, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, 
Centocor, Covagen, Dermira, Eli Lilly, Forward Pharma, Fresenius Medical Care, Galapagos, GSK, Janssen, Kyowa Kirin, LEO Pharma, Medac, MSD, Miltenyi Biotec, Novartis, Ocean Pharma, Pfizer, Regeneron, Samsung Bioepis, Sanofi, Sun Pharma, Takeda, UCB Pharma, Valeant/Bausch Health, and Xenoport; AB: Served as a scientific adviser and/or clinical study 
investigator for AbbVie, Allergan, Almirall, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly, Forte, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Rapt, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma; paid speaker for AbbVie; ML: Employee of Mount Sinai which receives research funds from AbbVie, Amgen, Arcutis, 
Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen, LEO Pharma, Ortho Dermatologics, Pfizer, and UCB Pharma; consultant for Aditum Bio, Allergan, Almirall, Arcutis, Avotres, BirchBioMed, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant, Evelo, Facilitate International Dermatologic 
Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi Pharma, Neuroderm, Pfizer, Promius/Dr. Reddy’s Laboratories, Serono, Theravance, and Verrica; KAP: Honoraria and/or grants from AbbVie, Akros, Amgen, Arcutis, Astellas, Baxalta, Boehringer Ingelheim, Bristol Myers Squibb, 
Canfite, Celgene, Coherus, Dermira, Dow Pharma, Eli Lilly, Forward Pharma, Galderma, Genentech, Gilead, GSK, Janssen, Kyowa Kirin, LEO Pharma, MedImmune, Merck (MSD), Merck-Serono, Mitsubishi Pharma, Moberg Pharma, Novartis, Pfizer, PRCL Research, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, UCB Pharma, and Valeant/Bausch Health; 
consultant (no compensation) for AstraZeneca and Meiji Seika Pharma; PR: Research grants due to being principal investigator from AbbVie, Arcutis, Bristol Myers Squibb, Centocor, Dermavant, Eli Lilly, Kadmon, Merck, Novartis, Pfizer, Sun Pharma, and UCB Pharma; BS: Consultant (honoraria) from AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Boehringer 
Ingelheim, Bristol Myers Squibb, Celgene, Dermavant, Dermira, Eli Lilly, Equillium, GSK, Janssen, LEO Pharma, Meiji Seika Pharma, Mindera, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB Pharma; speaker for AbbVie, Amgen, Eli Lilly, Janssen, and Ortho Dermatologics; Scientific Director (consulting fee) for Corrona 
Psoriasis Registry; investigator for AbbVie, Cara Therapeutics, Corrona Psoriasis Registry, Dermavant, Dermira, and Novartis; Editor-in-Chief (honorarium) for Journal of Psoriasis and Psoriatic Arthritis; DDC, LP, VV: employees of UCB Pharma; CM: employee and shareholder of UCB Pharma; RBW: Consulting fees from AbbVie, Almirall, Amgen, Arena, Avillion, 
Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB Pharma; research grants from AbbVie, Almirall, Amgen, Celgene, Eli Lilly, Janssen, LEO Pharma, Novartis, Pfizer, and UCB Pharma. Acknowledgements: This study was funded by UCB Pharma. We thank the patients and their caregivers in addition 
to the investigators and their teams who contributed to this study. The authors acknowledge Mylene Serna, PharmD, UCB Pharma, Smyrna, GA, USA and Susanne Wiegratz, MSc, UCB Pharma, Monheim am Rhein, Germany for publication coordination; Eva Cullen, PhD, UCB Pharma, Brussels, Belgium for critical review; Daniel Smith, BA, Costello Medical, 
Cambridge, UK for medical writing and editorial assistance; and the Costello Medical Design Team for design support. All costs associated with development of this poster were funded by UCB Pharma.

Previously presented at EADV 2020 Virtual Congress  |  October 29–31

aBKZ initial treatment period (Weeks 0–16) data are included from three pivotal phase 3 studies, BE SURE (NCT03412747), BE VIVID (NCT03370133), and BE READY 
(NCT03410992); bADA initial treatment period data are from one pivotal phase 3 study, BE SURE; cUST initial treatment period data are from one pivotal phase 3 study, BE VIVID; 
dPBO initial treatment period data are from two pivotal phase 3 studies, BE VIVID and BE READY; eBKZ longer-term data are pooled from four phase 3 trials (BE SURE, BE VIVID, 
BE READY, BE BRIGHT [NCT03598790]) and four phase 2 trials (BE ABLE 1, BE ABLE 2, PS0016, and PS0018). fIn the BKZ, UST, and PBO short-term groups, one patient with mild 
IGA score was mistakenly enrolled.

Table 2 Occurrence of short- and longer-term TEAEs

Short-term safety was evaluated for patients receiving bimekizumab  
320 mg Q4W compared with adalimumab, ustekinumab, and placebo in 
three phase 3 trials. Longer-term safety was evaluated for patients receiving 
any dose of bimekizumab across eight phase 2/3 trials.

Initial treatment period (Week 0–16) Short-term Longer-term

n (%) EAIR/100 PY (95% CI)

BKZ  
320 mg Q4W  

(n=989)

ADA  
(n=159)

UST  
(n=163)

PBO 
(n=169)

BKZ  
320 mg Q4W  

(n=989)

All BKZ 
(n=1789)

Any TEAE 593 (60.0) 96 (60.4) 83 (50.9) 74 (43.8) 315.7 (290.8, 342.1) 238.0 (226.0, 250.5)

Serious TEAEs 15 (1.5) 3 (1.9) 5 (3.1) 4 (2.4) 4.9 (2.8, 8.1) 6.6 (5.5, 7.9)

Discontinuation due to TEAEs 17 (1.7) 4 (2.5) 3 (1.8) 7 (4.1) 5.6 (3.3, 8.9) 4.9 (4.0, 6.1)

Drug-related TEAEs 212 (21.4) 32 (20.1) 19 (11.7) 15 (8.9) 79.5 (69.2, 90.9) 47.3 (43.7, 51.1)

Severe TEAEs 12 (1.2) 4 (2.5) 3 (1.8) 4 (2.4) 3.9 (2.0, 6.9) 6.4 (5.2, 7.6)

Deaths 1 (0.1) 1 (0.6) 1 (0.6) 1 (0.6) 0.3 (0.0, 1.8) 0.3 (0.1, 0.6)

aIncludes one event adjudicated by the external Neuropsychiatric Committee (active suicidal ideation with some intent to act) in a patient with pre-existing psychiatric conditions; 
bIncludes one fatal event of circulatory failure (adjudicated MACE), one event of atopic dermatitis-like disseminated eczema, and one case of anaphylactic shock due to insect 
sting, all considered unrelated to study treatment.

Table 1 Patient demographics and baseline disease characteristics

Initial treatment period (Week 0–16) Longer-term

BKZ  
320 mg Q4Wa  

(n=989)

ADAb  
(n=159)

USTc  
(n=163)

PBOd 
(n=169)

All BKZe 
(n=1789)

Age (years), mean ± SD 44.8 ± 13.4 45.5 ± 14.3 46.0 ± 13.6 46.6 ± 13.7 45.2 ± 13.5

Male, n (%) 698 (70.6) 114 (71.7) 117 (71.8) 118 (69.8) 1252 (70.0)

Caucasian, n (%) 841 (85.0) 141 (88.7) 120 (73.6) 142 (84.0) 1468 (82.1)

Weight (kg), mean ± SD 89.6 ± 22.2 90.5 ± 22.1 87.2 ± 21.1 90.4 ± 24.3 89.0 ± 22.0

Duration of plaque psoriasis 
(years), mean ± SD

18.2 ± 12.5 16.2 ± 11.9 17.8 ± 11.6 19.4 ± 13.2 17.7 ± 12.3

PASI, mean ± SD 20.9 ± 7.6 19.1 ± 5.9 21.3 ± 8.3 20.1 ± 7.2 20.6 ± 7.8

BSA (%), mean ± SD 26.4 ± 15.6 25.0 ± 14.4 27.3 ± 16.7 25.7 ± 16.2 26.7 ± 16.3

IGA, n (%)f

3: moderate 656 (66.3) 114 (71.7) 96 (58.9) 116 (68.6) 1217 (68.0)

4: severe 332 (33.6) 45 (28.3) 66 (40.5) 52 (30.8) 567 (31.7)

DLQI total, mean ± SD 10.4 ± 6.3 10.5 ± 7.4 11.0 ± 6.9 10.7 ± 6.8 10.3 ± 6.6

Prior biologic therapy, n (%) 380 (38.4) 53 (33.3) 63 (38.7) 70 (41.4) 636 (35.6)

anti-TNF 132 (13.3) 14 (8.8) 24 (14.7) 26 (15.4) 234 (13.1)

anti-IL-17 231 (23.4) 35 (22.0) 38 (23.3) 36 (21.3) 341 (19.1)

Initial treatment period (Week 0–16) Short-term Longer-term

n (%) EAIR/100 PY (95% CI)

BKZ  
320 mg Q4W  

(n=989)

ADA  
(n=159)

UST  
(n=163)

PBO 
(n=169)

BKZ  
320 mg Q4W  

(n=989)

All BKZ 
(n=1789)

Serious infections 3 (0.3) 0 2 (1.2) 0 1.0 (0.2, 2.9) 1.4 (0.9, 2.0)

Inflammatory bowel disease 1 (0.1) 0 0 0 0.3 (0.0, 1.8) 0.1 (0.0, 0.3)

Candida infections 90 (9.1) 0 0 0 30.6 (24.6, 37.6) 18.7 (16.7, 21.0)

Oral candidiasis 75 (7.6) 0 0 0 25.3 (19.9, 31.8) 16.4 (14.5, 18.5)

Adjudicated MACE 1 (0.1) 0 0 0 0.3 (0.0, 1.8) 0.7 (0.3, 1.1)

Malignancies (inc. NMSC) 4 (0.4) 1 (0.6) 0 1 (0.6) 1.3 (0.4, 3.4) 0.8 (0.5, 1.4)

Adjudicated SIB 0 0 0 0 0 0.1 (0.0, 0.3)a

Serious hypersensitivity 
reactions

0 0 0 0 0 0.2 (0.0, 0.5)b

Injection site reactions 27 (2.7) 3 (1.9) 2 (1.2) 2 (1.2) 9.0 (5.9, 13.1) 3.1 (2.4, 4.1)

Hepatic events 19 (1.9) 9 (5.7) 0 2 (1.2) 6.3 (3.8, 9.8) 5.6 (4.6, 6.8)

Liver function analyses 18 (1.8) 9 (5.7) 0 2 (1.2) 5.9 (3.5, 9.4) 4.8 (3.8, 5.9)

Table 3 Occurrence of short- and longer-term TEAEs of interest

Table 4 Longer-term candida infections in BKZ-treated patients

Bimekizumab was well-tolerated; the majority of TEAEs were mild to 
moderate in severity and discontinuations were low. Oral candidiasis was the 
most frequent candida infection; the vast majority of oral candidiasis TEAEs 
were mild to moderate and did not lead to discontinuation.

Population 
exposure

Dosing
Trials  

administered

Short-term (BE SURE, BE VIVID, and BE READY)  
Week 0–16

BKZ
n=989

306.4 PY
320 mg Q4W 3  

double-blinded trials

ADA
n=159

48.8 PY

80 mg loading dose, 
followed by 40 mg Q2W 

from Week 1

1  
double-blinded trial

UST
n=163
50.1 PY

45/90 mg (by weight) 
Q12W, after Q4W to 

Week 4

1  
double-blinded trial

PBO
n=169
51.6 PY

Placebo 2  
double-blinded trials

Longer term (phase 2/3) 
Data cut-off: November 1, 2019

BKZ all doses

n=1789
1830.4 PY  
(Range:  

1–670 days)

320 mg Q4W, 
320 mg Q8W, 

64 mg Q4W (phase 2), 
160 mg Q4W (phase 2),  
480 mg Q4W (phase 2)

6  
double-blinded trials

2  
open-label extension 

studies

Short-Term Safety Outcomes

5.0%

TEAE-related 
discontinuations

Serious 
TEAEs

5.0% 5.0% 5.0%

Short-term Longer-term

Serious infections

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Short- and Longer-Term Safety for Bimekizumab