Synopsis

90

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Weeks
32282420161280 564 52484440

90

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Weeks
32282420161280 564 52484440

Bimekizumab Q4W → Q8W (n=161)
Bimekizumab Q4W (n=158)

Adalimumab (n=159)

Adalimumab → Bimekizumab Q4W (n=159)

79.9%

73.6%

84.8%

81.8%

82.6%

88.0%
84.5%

88.0%
86.3%

86.1%*
85.1%*

51.6%

29.6%

72.2%

66.7%

70.2%
70.3%
66.5%

70.3%
69.6%

67.7%*
65.8%*

57.2%

49.7%

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7
5

 (
%

) 100

Bimekizumab
320 mg Q4W 

(n=319)a

Adalimumab
(n=159)

75

50

25

0

76.5%

31.4%

p<0.001

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9

0
 (

%
) 100

Bimekizumab
320 mg Q4W 

(n=319)a

Adalimumab
(n=159)

75

50

25

0

86.2%

47.2%

p<0.001

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G
A

 0
/1

 (
%

) 100

Bimekizumab
320 mg Q4W 

(n=319)a

Adalimumab
(n=159)

75

50

25

0

85.3%

57.2%

p<0.001

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10

0
 (

%
) 100

Bimekizumab
320 mg Q4W 

(n=319)a

Adalimumab
(n=159)

75

50

25

0

60.8%

23.9%

p<0.001

Conclusions
Results demonstrated that bimekizumab was superior to adalimumab over 16 weeks of 
treatment in terms of the speed, depth and durability of skin clearance in patients with 
moderate to severe plaque psoriasis.

Switching from adalimumab to bimekizumab resulted in rapid increases in response rates, 
comparable to rates in bimekizumab-randomized patients at Week 56. 

No unexpected safety findings were reported in patients who switched from adalimumab 
to bimekizumab compared with patients who received continuous bimekizumab.

Bimekizumab 320 mg Q8W maintenance dose efficacy was comparable to 
bimekizumab Q4W.

The most common TEAEs were nasopharyngitis, oral candidiasis and upper respiratory tract 
infections. Cases of oral candidiasis were mostly mild or moderate and localized; none led 
to discontinuation.

Objectives
To compare the efficacy and safety of bimekizumab versus adalimumab in patients with 
moderate to severe plaque psoriasis. 

To assess the maintenance of efficacy of bimekizumab dosed every four weeks versus 
every eight weeks. 

Background
• Psoriasis is the archetypal Th17-driven disease for which both interleukin (IL)-17A and  

IL-17F have emerged as pivotal drivers of inflammation.1,2 

• Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition  
to IL-17A.3,4 

• Bimekizumab led to substantial clinical improvements in patients with moderate 
to severe plaque psoriasis in the phase 3 studies BE VIVID and BE READY with no 
unexpected safety findings.5,6

• Here, efficacy and safety of bimekizumab were evaluated versus adalimumab in patients 
with moderate to severe plaque psoriasis.

Methods
• Patients in BE SURE (NCT03412747) were randomized 1:1:1 to bimekizumab 320 mg 

every four weeks (Q4W), bimekizumab 320 mg Q4W through Week 16 followed by 
bimekizumab 320 mg every eight weeks (Q8W), or adalimumab (dosed 80 mg at  
Week 0 and 40 mg at Week 1, then 40 mg Q2W until Week 23) followed by  
bimekizumab 320 mg Q4W from Week 24–56 (Figure 1).

• Co-primary endpoints were 90% improvement from baseline in Psoriasis Area and 
Severity Index (PASI 90) and an Investigator’s Global Assessment score of 0 or 1 (IGA 0/1) 
versus adalimumab at Week 16. 

• Secondary endpoints included PASI 75 at Week 4, PASI 90 at Weeks 24 and 56, and 
complete skin clearance (PASI 100) at Weeks 16 and 24.

• Treatment-emergent adverse events (TEAEs) were assessed and coded according to 
MedDRA v19.0.

• Missing data were imputed using non-response imputation (NRI).

Results
Patient Population
• 478 patients were randomized to bimekizumab 320 mg Q4W (n=158), bimekizumab 320 mg 

Q4W/Q8W (n=161), and adalimumab 40 mg Q2W/bimekizumab 320 mg Q4W (n=159).

• Baseline characteristics for all randomized patients are shown in Table 1.

Response Rates at Weeks 4 and 16
• At Week 4, a larger proportion of patients treated with bimekizumab reached PASI 75 

than those receiving adalimumab (p<0.001; Figure 2A).

• Both co-primary endpoints were achieved at Week 16: 

 – Significantly more bimekizumab-treated patients achieved PASI 90 and IGA 0/1 than 
those who received adalimumab (p<0.001; Figure 2B–C).

• PASI 100 was achieved by significantly more patients receiving bimekizumab versus 
adalimumab at Week 16 (p<0.001; Figure 2D).

Response Rates Through Week 56
• At Week 24, PASI 90 and PASI 100 response rates remained greater in bimekizumab-

treated patients compared with those receiving adalimumab, regardless of bimekizumab 
dosing regimen (all comparisons: p<0.001; Figure 3).

• After switching from adalimumab to bimekizumab at Week 24, response rates rapidly 
increased. By Week 56, response rates for those who switched were similar to patients 
initially treated with bimekizumab (Figure 3).

Safety
• Proportions of TEAEs, severe TEAEs, and discontinuations due to TEAEs were similar 

between treatment groups (Table 2).

• There were no unexpected safety findings in patients who switched from adalimumab 
to bimekizumab in comparison with patients who received continuous bimekizumab 
treatment (Table 2).

• In patients receiving bimekizumab, the most common TEAEs through both Weeks 0–24 
and Weeks 24–56 were nasopharyngitis, oral candidiasis, and upper respiratory tract 
infection (Table 2).

 – The vast majority of oral candidiasis cases were localized, mild or moderate, 
superficial infections. There were no discontinuations due to candidiasis infection.

• One death occurred during adalimumab treatment (Table 2).

R.B. Warren,1 A. Blauvelt,2 J. Bagel,3 K.A. Papp,4 P. Yamauchi,5,6  
A. Armstrong,7 R. Langley,8 V. Vanvoorden,9 D. De Cuyper,9 L. Peterson,10 
N. Cross,10 K. Reich11

BSA: body surface area; DLQI: Dermatology Life Quality Index; IGA: score of 0 (clear) or 1 (almost clear) with ≥2-category improvement relative to baseline Investigator’s Global Assessment; IL: interleukin; IMP: investigational medicinal product; ITT: intent-to-treat; MACE: major adverse cardiovascular event; NMSC: non-melanoma skin cancer; NRI: non-responder 
imputation; PASI 75/90/100: ≥75/90/100% improvement from baseline Psoriasis Area and Severity Index; Q2W: every 2 weeks; Q4W: every 4 weeks; Q8W: every 8 weeks; SD: standard deviation; SIB: suicidal ideation and behavior; TEAE: treatment-emergent adverse event; TNF: tumor necrosis factor.

Figure 1 Study design

Bimekizumab  
320 mg Q4W 

n=158

Bimekizumab  
320 mg Q4W/Q8W 

n=161

Adalimumab/Bimekizumab 
320 mg Q4W  

n=159

Age (years), mean ± SD 45.3 ± 13.2 44.0 ± 13.5 45.5 ± 14.3

Male, n (%) 102 (64.6) 112 (69.6) 114 (71.7)

Caucasian, n (%) 140 (88.6) 140 (87.0) 141 (88.7)

Weight (kg), mean ± SD 89.6 ± 21.4 93.2 ± 24.4 90.5 ± 22.1

Duration of psoriasis 
(years), mean ± SD

20.4 ± 13.2 17.3 ± 10.9 16.2 ± 11.9

PASI, mean ± SD 20.5 ± 6.9 19.9 ± 6.1 19.1 ± 5.9

BSA (%), mean ± SD 26.5 ± 15.9 25.2 ± 12.4 25.0 ± 14.4

IGA, n (%)

3: moderate 102 (64.6) 111 (68.9) 114 (71.7)

4: severe 56 (35.4) 50 (31.1) 45 (28.3)

DLQI total, mean ± SD 11.1 ± 6.5 10.8 ± 6.2 10.5 ± 7.4

Any prior systemic 
therapy, n (%)

112 (70.9) 116 (72.0) 110 (69.2)

Prior biologic therapy,  
n (%)a

50 (31.6) 50 (31.1) 53 (33.3)

anti-TNF 14 (8.9) 10 (6.2) 14 (8.8)

anti-IL-17 33 (20.9) 37 (23.0) 35 (22.0)

anti-IL-12/23 11 (7.0) 9 (5.6) 15 (9.4)

anti-IL-23 3 (1.9) 2 (1.2) 2 (1.3)

Institutions: 1Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, The University of Manchester, Manchester, UK; 2Oregon Medical Research Center, Portland, OR, USA; 3Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, USA; 4Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada; 5Dermatology Institute and Skin Care Center, Santa Monica, CA, USA; 6Division of Dermatology, David Geffen 
School of Medicine at University of California, Los Angeles, CA, USA; 7Keck School of Medicine of USC, Dermatology, Los Angeles, CA, USA; 8Dalhousie University, Halifax, Nova Scotia, Canada; 9UCB Pharma, Brussels, Belgium; 10UCB Pharma, Raleigh, NC, USA; 11Center 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

Bimekizumab Efficacy and Safety versus Adalimumab in Patients with  
Moderate to Severe Plaque Psoriasis: Results from a Multicenter, Randomized,  
Double-Blinded Active Comparator-Controlled Phase 3 Trial (BE SURE)

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

References: 1Durham L. Curr Rheumatol Reports 2015;17:55; 2Fujishima S. Arch Dermatol Res 2010;302:499–505; 3Glatt S. Br J Clin Pharmacol 2017;83:991–1001; 4Papp KA. J Am Acad Dermatol 2018;79:277–86.e10; 5Reich K. AAD 2020, NCT03370133; 6Gordon K. AAD 2020, NCT03410992. Author Contributions: Substantial contributions to study conception/design, or acquisition/analysis/interpretation of data: RBW, AB, JB, KAP, PY, AA, RL, VV, DDC, LP, NC, KR; drafting of the 
publication, or revising it critically for important intellectual content: RBW, AB, JB, KAP, PY, AA, RL, VV, DDC, LP, NC, KR; final approval of the publication: RBW, AB, JB, KAP, PY, AA, RL, VV, DDC, LP, NC, KR. Author Disclosures: RBW: Research grants and/or 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; AB: 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; JB: Speaker, investigator and/or consultant for AbbVie, Celgene, Eli Lilly, Leo Pharma, Novartis and Ortho Dermatologics; 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; PY: 
Speaker, investigator, consultant for AbbVie, Amgen, Eli Lilly, Janssen, Novartis, Ortho Dermatologics, Sun Pharma and UCB Pharma; AA: Research investigator and/or consultant for AbbVie, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Janssen, LEO Pharma, Kyowa Kirin, Modernizing Medicine, Novartis, Ortho Dermatologics, Regeneron, Sanofi, Sun Pharma and UCB Pharma; RL: Honoraria from AbbVie, Amgen, Boeringer Ingelheim, Centocor, Eli Lilly, Janssen, LEO Pharma, Pfizer 
and Valeant/Bausch Health; VV, LP, DDC, NC: Employees of UCB Pharma; 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. Acknowledgements: This study was funded by UCB Pharma. We would like to thank the patients and their caregivers in addition to all 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; Ruth Moulson, MPH, 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 presentation were funded by UCB Pharma.

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

aAdalimumab was dosed 80 mg at Week 0 and 40 mg at Week 1, then 40 mg every 2 weeks until Week 23. The first 
dose of bimekizumab in this group was administered at Week 24.

Table 1 Baseline characteristics

aPatients with multiple prior biologics use included in n (%).

Figure 2 Response rates at Weeks 4 and 16 (ITT, NRI)

A) PASI 75 at Week 4 B) PASI 90 at Week 16

C) IGA 0/1 at Week 16 D) PASI 100 at Week 16

aData were pooled from both bimekizumab arms as all patients received the same dose regimen through Week 16 
(pre-specified). p values for the comparison of treatment groups are based on the Cochran-Mantel-Haenszel test 
from the general association.

Figure 3 Response rates through Week 56 (ITT, NRI)

A) PASI 90

B) PASI 100

p values for the comparison of treatment groups are based on the Cochran-Mantel-Haenszel test from the general 
association. Data shown include all randomized patients.

aData for Weeks 0–24 are from the full safety set; bData for Weeks 24–56 include only bimekizumab-treated patients; cIncludes all patients who received bimekizumab from Weeks 0–24, regardless of dosing regimen; d50 year-old male 
diagnosed with squamous cell carcinoma of the tongue 6 weeks after the start of adalimumab treatment, which led to a fatal outcome 5 months later; eOccurred in >5% of patients in any treatment group through Weeks 0–24 or 24–56; 
fThe majority of liver function test elevations were transient and resolved by end of study; gAll fungal infections not classified as Candida or Tinea were classified as fungal infections NEC (not elsewhere classified).

Table 2 TEAEs and safety topics of interest

aAdalimumab was dosed 80 mg at Week 0 and 40 mg at Week 1, then 40 mg every 2 weeks until 
Week 23. The first dose of bimekizumab in this group was administered at Week 24.

Bimekizumab was superior to adalimumab at Week 16 with a similar safety 
profile to previous studies.

Weeks 0–24a Weeks 24–56b

Bimekizumab Total 
(n=319) 
n (%)c

Adalimumab 
(n=159) 

n (%)

Bimekizumab 
320 mg Q4W  

(n=152) 
n (%)

Bimekizumab  
320 mg Q8W  

(n=149) 
n (%)

Adalimumab/Bimekizumab  
320 mg Q4W  

(n=149) 
n (%)

Incidence of TEAEs
Any TEAE 228 (71.5) 111 (69.8) 101 (66.4) 104 (69.8) 111 (74.5)
Serious TEAEs 5 (1.6) 5 (3.1) 2 (1.3) 8 (5.4) 9 (6.0)
Discontinuation due to TEAEs 9 (2.8) 5 (3.1) 3 (2.0) 2 (1.3) 5 (3.4)
Drug-related TEAEs 87 (27.3) 38 (23.9) 40 (26.3) 35 (23.5) 45 (30.2)
Severe TEAEs 5 (1.6) 5 (3.1) 5 (3.3) 8 (5.4) 7 (4.7)
Deaths 0 (0.0) 1 (0.6)d 0 (0.0) 0 (0.0) 0 (0.0)

Common TEAEs (>5% patientse)
Nasopharyngitis 59 (18.5) 38 (23.9) 18 (11.8) 15 (10.1) 20 (13.4)
Oral candidiasis 34 (10.7) 0 (0.0) 20 (13.2) 13 (8.7) 26 (17.4)
Upper respiratory tract infection 19 (6.0) 15 (9.4) 8 (5.3) 11 (7.4) 9 (6.0)
Hypertension 15 (4.7) 13 (8.2) 2 (1.3) 3 (2.0) 3 (2.0)
Diarrhea 13 (4.1) 4 (2.5) 2 (1.3) 3 (2.0) 2 (1.3)
Pharyngitis 9 (2.8) 1 (0.6) 3 (2.0) 8 (5.4) 3 (2.0)

Safety topics of interest
Inflammatory bowel disease 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Adjudicated SIB 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Serious hypersensitivity reaction 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Adjudicated MACE 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
All malignancies (inc. NMSC) 4 (1.3) 1 (0.6) 0 (0.0) 2 (1.3) 1 (0.7)
Neutropenia 2 (0.6) 4 (2.5) 0 (0.0) 0 (0.0) 0 (0.0)
Hepatic events 7 (2.2) 11 (6.9) 1 (0.7) 3 (2.0) 6 (4.0)

Liver function analysesf 7 (2.2) 11 (6.9) 1 (0.7) 2 (1.3) 6 (4.0)
Fungal infectionsg 50 (15.7) 1 (0.6) 30 (19.7) 22 (14.8) 35 (23.5)

Candida infections 38 (11.9) 0 (0.0) 22 (14.5) 14 (9.4) 27 (18.1)
Tinea infections 11 (3.4) 1 (0.6) 2 (1.3) 6 (4.0) 1 (0.7)

Serious infections 1 (0.3) 1 (0.6) 1 (0.7) 2 (1.3) 4 (2.7)

Screening
Initial treatment 

period
Maintenance periodScreening

Patient 
inclusion 
criteria

≥18 years of age

Plaque psoriasis with ≥6 months’ symptom duration

Moderate to severe disease: PASI ≥12, BSA a�ected by psoriasis ≥10% 




N=478
1:1:1

Randomization

Open-label 
extension study: 

BE BRIGHT 
(NCT03598790) 

20 weeks after 
last dose of IMP: 
safety follow-up

Week 16 Week 24Baseline

2–5 weeks

Co-primary endpoints: PASI 90 and IGA 0/1 

Bimekizumab 320 mg Q4W

Bimekizumab 
320 mg Q4W

Adalimumab 
40 mg Q2Wa

Bimekizumab 320 mg Q4W

Bimekizumab 320 mg Q8W

Week 56
Dosing 
visits

n=158

n=161

n=159



Bimekizumab 
320 mg Q4W 

(n=319)

Adalimumab 
40 mg Q2Wa 

(n=159)

Bimekizumab 
320 mg Q4W 

(n=319)

Adalimumab 
40 mg Q2Wa 

(n=159)

PASI 90 at Week 16 IGA 0/1 at Week 16
Primary Endpoints

86.2%

47.2%

85.3%

57.2%

n=158

n=161

n=159

Bimekizumab 320 mg Q4W

Bimekizumab  
320 mg Q4W

Bimekizumab  
320 mg Q4W

Bimekizumab  
320 mg Q8W

Adalimumab  
40 mg Q2Wa

Wk 16

Wk 24

Treatment Groups

*p value versus adalimumab <0.001

*p value versus adalimumab <0.001