Synopsis Objective
To compare the efficacy of bimekizumab with ustekinumab and placebo in 
patients with moderate to severe plaque psoriasis with scalp, palmoplantar, 
and nail involvement.

Background
• Psoriasis is the archetypal Th17-driven disease, for which both interleukin 

(IL)-17A and IL-17F have emerged as pivotal drivers of inflammation.2

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

• In the BE VIVID phase 3 trial (NCT03370133) bimekizumab demonstrated 
superior clinical efficacy versus ustekinumab and placebo over 16 weeks of 
treatment (PASI 90: 85.0% versus 49.7% and 4.8%, respectively; p<0.001). 
This rapid initial response was durable over one year.5 

• Here, we report efficacy of bimekizumab for patients with scalp, 
palmoplantar (palms and soles) or nail psoriasis; psoriasis localized in these 
areas can restrict activities of daily living and negatively impact quality of 
life, and continues to pose a challenge for both physicians and patients.6

Methods
• Patients were enrolled in BE VIVID, a randomized, double-blinded, 

placebo- and active comparator (ustekinumab)-controlled study (Figure 1).

• These post-hoc analyses include patient subsets with scalp Investigator’s 
Global Assessment (IGA) ≥3, palmoplantar (pp)-IGA ≥3, or modified Nail 
Psoriasis Severity Index (mNAPSI) >10 at baseline. 

• Proportions of patients achieving complete clearance in each region 
(scalp IGA 0, pp-IGA 0, mNAPSI 0) are reported through Week 52.

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

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

Scalp, Palmoplantar and Nail Outcomes
• Among patients with baseline scalp IGA ≥3 treated with bimekizumab, 

scalp response was rapid, with a higher proportion of patients achieving 
scalp IGA 0 at Week 16, compared with ustekinumab or placebo; 
response rates remained high through Week 52 (Figure 2A). 

• Similar trends were observed in the pp-IGA 0 response rates among 
patients with baseline pp-IGA ≥3 (Figure 2B).

• Among those with baseline mNAPSI >10, a higher proportion of 
bimekizumab- versus ustekinumab-treated patients achieved nail 
clearance by Week 52 (Figure 2C).

Conclusions
Bimekizumab demonstrated high levels of efficacy in high-impact areas in 
patients with moderate to severe plaque psoriasis. 

Complete clearance of scalp, palmoplantar, and nail psoriasis was observed 
in a higher proportion of patients after 16 weeks of treatment with 
bimekizumab, compared with ustekinumab or placebo.

Initial responses were durable through Week 52 for bimekizumab-treated 
patients with scalp and palmoplantar symptoms, and further increased 
for those with nail symptoms, reflecting the longer timescale required for 
nail growth.

K.A. Papp,1 M. Lebwohl,2 A.B. Gottlieb,2 M. Sebastian,3 R. Langley,4 
Y. Okubo,5 M. Wang,6 C. Cioffi,6 F. Staelens,7 K. Reich8

Institutions: 1Probity Medical Research and K Papp Clinical Research, Waterloo, Ontario, Canada; 2Icahn School of Medicine at Mount Sinai, New York, New York, USA; 3Dermatological Practice Dr. med. Michael Sebastian, Mahlow, Germany; 4Dalhousie University, Halifax, Nova Scotia, Canada; 5Tokyo Medical University, Tokyo, Japan; 6UCB Pharma, Raleigh, North 
Carolina, USA; 7UCB Pharma, Braine-l’Alleud, Belgium; 8Center 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 for the Treatment of Moderate to Severe Plaque Psoriasis with 
Scalp, Nail and Palmoplantar Involvement Through 52 Weeks: Post-Hoc 
Analysis from the BE VIVID Phase 3 Trial

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 Oral Presentation; 6Merola JF. Dermatol Ther 2018;e12589. Author Contributions: Substantial contributions to study conception/
design, or acquisition/analysis/interpretation of data: KAP, ML, ABG, MS, RL, YO, MW, CC, FS, KR; drafting of the publication, or revising it critically for important intellectual content: KAP, ML, ABG, MS, RL, YO, MW, CC, FS, KR; final approval of the publication: KAP, ML, ABG, MS, RL, YO, MW, CC, FS, KR. Author Disclosures: 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; 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; ABG: Honoraria as an advisory board member and consultant for Avotres Therapeutics, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis, Sun Pharma, UCB Pharma 
and XBiotech (only stock options which she has not used); research/educational grants (paid to Mount Sinai Medical School) from Boehringer Ingelheim, Incyte, Janssen, Novartis, Sun Pharma, UCB Pharma and XBiotech; MS: Received honoraria as an investigator, or received grants and has been an advisor/consultant for AbbVie, Affibody, Almirall, Boehringer 
Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Dr. August Wolff, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Genentech, GSK, Incythe, Janssen, LEO Pharma, MedImmune, MSD, Mundipharma, Novartis, Pfizer, Regeneron and UCB Pharma; RL: Honoraria from AbbVie, Amgen, Boehringer Ingelheim, Centocor, Eli Lilly, Janssen, LEO Pharma, Pfizer and Valeant/
Bausch Health for serving as an advisory board member, principal investigator and speaker; YO: Research grants from Eisai, Maruho, Shiseido, and Torii Pharmaceutical; current consulting/advisory board agreements and/or speakers bureau and/or clinical trials from AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Eli Lilly, Janssen, 
Jimro, Kyowa Kirin, LEO Pharma, Maruho, Mitsubishi Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, Taiho Pharma, Torii Pharmaceutical and UCB Pharma; MW, FS: Employees of UCB Pharma; CC: Employee and shareholder 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 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; Joe Dixon, PhD, Costello Medical, Cambridge, UK for medical writing and editorial support; 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

Table 1 Baseline characteristics

aUstekinumab dosing was based on weight: patients ≤100 kg at baseline received one ustekinumab 45 mg injection 
and one placebo injection, patients >100 kg at baseline received two ustekinumab 45 mg injections.

Figure 3 Bimekizumab treatment examples over 52 weeks

Scalp IGA and mNAPSI data shown are total scores for that region in the patient shown. Photos are representative of 
part of that region: back of the scalp and left hand fingers.

A) Scalp

B) Nail

Baseline 
mNAPSI = 22

Week 28 
mNAPSI = 5

Week 52 
mNAPSI = 0

Baseline 
Scalp IGA = 3

Week 8 
Scalp IGA = 1

Week 12 
Scalp IGA = 0 

Week 52 
Scalp IGA = 0 

Week 2 
Scalp IGA = 2

Bimekizumab 
320 mg Q4W

(n=321)

Ustekinumab 
45/90 mg Q12W  

(n=163)a

Placebo 
(n=83)

Age (years), mean ± SD 45.2 ± 14.0 46.0 ± 13.6 49.7 ± 13.6

Male, n (%) 229 (71.3) 117 (71.8) 60 (72.3)

Caucasian, n (%) 237 (73.8) 120 (73.6) 63 (75.9)

Weight (kg), mean ± SD 88.7 ± 23.1 87.2 ± 21.1 89.1 ± 26.4

Duration of PSO (years), 
mean ± SD

16.0 ± 11.6 17.8 ± 11.6 19.7 ± 13.8

Scalp IGA ≥3, n (%) 235 (73.2) 114 (69.9) 62 (74.7)

pp-IGA ≥3, n (%) 61 (19.0) 28 (17.2) 14 (16.9)

mNAPSI >10, n (%) 113 (35.2) 62 (38.0) 30 (36.1)

Any prior systemic therapy, 
n (%)

267 (83.2) 132 (81.0) 64 (77.1)

Prior biologic therapy, n (%) 125 (38.9) 63 (38.7) 33 (39.8)

anti-TNF 51 (15.9) 24 (14.7) 16 (19.3)

anti-IL-17 76 (23.7) 38 (23.3) 18 (21.7)

anti-IL-23 16 (5.0) 6 (3.7) 5 (6.0)

IGA: Investigator’s Global Assessment; IL: interleukin; mNAPSI: modified Nail Psoriasis Severity Index; NRI: non-responder imputation; PASI: Psoriasis Area and Severity Index; pp: palmoplantar; PSO: plaque psoriasis; Q4W: every 4 weeks; Q12W: every 12 weeks; SD: standard deviation; TNF: tumor necrosis factor.

Figure 1 Study design

aBimekizumab dosing was 320 mg regardless of weight, while ustekinumab dosing was based on weight: patients  
≤100 kg at baseline received one ustekinumab 45 mg injection and one placebo injection, patients >100 kg at 
baseline received two ustekinumab 45 mg injections; bBE BRIGHT: NCT03598790. Enrolled patients were adults 
with moderate to severe plaque psoriasis (Psoriasis Area Severity Index ≥12, ≥10% body surface area affected and 
IGA score ≥3 on a 5 point scale).

aNominal p<0.001 versus ustekinumab and placebo; bNominal p<0.001 versus ustekinumab; cNominal p=0.087 
versus ustekinumab and p<0.001 versus placebo; dNominal p=0.052 versus ustekinumab; eNominal p=0.261 versus 
ustekinumab and p=0.035 versus placebo; fNominal p=0.001 versus ustekinumab.

Figure 2 Scalp, nail, and palmoplantar clearance through Week 52 (NRI)

A) Scalp IGA 0 in patients with scalp IGA ≥3 at baseline B) pp-IGA 0 in patients with pp-IGA ≥3 at baseline 

C) mNAPSI 0 in patients with mNAPSI >10 at baseline

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8.1%

58.8%

75.7%a

51.8%

71.9%b

Ustekinumab (n=114)Bimekizumab (n=235) Placebo (n=62)

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67.9%

80.3%d

75.0%

86.9%c

28.6%

Placebo (n=14)

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30.6%

54.0%f

11.3%

18.6%e

3.3%

n=321

n=163

n=83

Week 16Baseline Week 52

2–5 
weeks

Bimekizumab 320 mg Q4Wa

Bimekizumab 320 mg Q4WaPlacebo

Ustekinumab 45/90 mg Q12Wa

Screening
Initial treatment 

period

Active comparator period

Maintenance period 

20 weeks 
after last 

dose: safety 
follow-up

Open-label
extension 

study
(BE BRIGHT)b 4:1:2

randomization

N=567

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

• Range of 0 to 4

• Analysis includes patients scoring 3 
(moderate) or 4 (severe) at baseline

• Score of 0 = clear scalp

Scalp IGA

• Range of 0 to 4

• Analysis includes patients scoring 3 
(moderate) or 4 (severe) at baseline

• Score of 0 = clear hands and feet

pp-IGA

• Range of 0 to 130 (0 to 13 per fingernail)

• Analysis includes patients scoring >10 
at baseline

• Score of 0 = clear nails

mNAPSI