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Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study.
Dermatol Ther (Heidelb). 2023 Mar; 13(3):751-768.DT

Abstract

INTRODUCTION

Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation.

METHODS

Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted.

RESULTS

There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population.

CONCLUSION

Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients.

TRIAL REGISTRATION

NCT03370133.

Authors+Show Affiliations

Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.Department of Dermatology, Tokyo Medical University, Tokyo, Japan.Department of Geriatric and Environmental Dermatology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.Division of Clinical Dermatology and Cutaneous Science, Department of Medicine, Dalhousie University, Halifax, NS, Canada.UCB Pharma, Braine L'alleud, Belgium.UCB Pharma, UCB Japan Co., Ltd, 8-17-1 Nishi-Shinjuku, Shinjuku-Ku, Tokyo, 160-0023, Japan. Mizuho.Matano@ucb.com.UCB Pharma, Braine L'alleud, Belgium.UCB Pharma, Raleigh, NC, USA.Department of Dermatology, Jichi Medical University, Tochigi, Japan.Department of Dermatology, The Jikei University School of Medicine, Tokyo, Japan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

36648594

Citation

Asahina, Akihiko, et al. "Bimekizumab Efficacy and Safety in Japanese Patients With Plaque Psoriasis in BE VIVID: a Phase 3, Ustekinumab and Placebo-Controlled Study." Dermatology and Therapy, vol. 13, no. 3, 2023, pp. 751-768.
Asahina A, Okubo Y, Morita A, et al. Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023;13(3):751-768.
Asahina, A., Okubo, Y., Morita, A., Tada, Y., Igarashi, A., Langley, R. G., Deherder, D., Matano, M., Vanvoorden, V., Wang, M., Ohtsuki, M., & Nakagawa, H. (2023). Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatology and Therapy, 13(3), 751-768. https://doi.org/10.1007/s13555-022-00883-y
Asahina A, et al. Bimekizumab Efficacy and Safety in Japanese Patients With Plaque Psoriasis in BE VIVID: a Phase 3, Ustekinumab and Placebo-Controlled Study. Dermatol Ther (Heidelb). 2023;13(3):751-768. PubMed PMID: 36648594.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bimekizumab Efficacy and Safety in Japanese Patients with Plaque Psoriasis in BE VIVID: A Phase 3, Ustekinumab and Placebo-Controlled Study. AU - Asahina,Akihiko, AU - Okubo,Yukari, AU - Morita,Akimichi, AU - Tada,Yayoi, AU - Igarashi,Atsuyuki, AU - Langley,Richard G, AU - Deherder,Delphine, AU - Matano,Mizuho, AU - Vanvoorden,Veerle, AU - Wang,Maggie, AU - Ohtsuki,Mamitaro, AU - Nakagawa,Hidemi, Y1 - 2023/01/17/ PY - 2022/09/29/received PY - 2022/12/21/accepted PY - 2023/1/18/pubmed PY - 2023/1/18/medline PY - 2023/1/17/entrez KW - Absolute PASI KW - Active control KW - Bimekizumab KW - Japan subpopulation KW - Plaque psoriasis KW - Randomized controlled trial KW - Ustekinumab SP - 751 EP - 768 JF - Dermatology and therapy JO - Dermatol Ther (Heidelb) VL - 13 IS - 3 N2 - INTRODUCTION: Bimekizumab treatment resulted in improved clinical outcomes in patients with moderate-to-severe plaque psoriasis in BE VIVID, a 52-week, phase 3, randomized, ustekinumab and placebo-controlled study. We present data from the BE VIVID Japan patient subpopulation. METHODS: Globally, patients were randomized to receive bimekizumab 320 mg every 4 weeks (Q4W), ustekinumab (45/90 mg weight-based at baseline and week 4, then every 12 weeks), or placebo (Q4W through week 16, then bimekizumab 320 mg Q4W). Efficacy endpoints included week 16 Psoriasis Area and Severity Index (PASI) 90 and Investigator's Global Assessment (IGA) 0/1, and other outcomes [PASI 100, PASI 75, IGA 0, Dermatology Life Quality Index (DLQI) 0/1, absolute PASI, scalp IGA, Psoriasis Symptoms and Impacts Measure (P-SIM) responses]. Safety analyses were conducted. RESULTS: There were 108 Japanese randomized patients (bimekizumab: 62; ustekinumab: 29; placebo: 17). At week 16, bimekizumab-treated patients had a higher clinical response versus ustekinumab and placebo (PASI 90: 85.5% versus 51.7% and 5.9%; IGA 0/1: 82.3% versus 48.3% and 0.0%). Over 52 weeks, improved clinical response was maintained with bimekizumab, including patients switching from placebo at week 16. Overall, the safety profile in Japanese patients was consistent with that observed in the global population. CONCLUSION: Bimekizumab resulted in improved clinical response versus ustekinumab and placebo, and was well-tolerated in Japanese patients. TRIAL REGISTRATION: NCT03370133. SN - 2193-8210 UR - https://www.unboundmedicine.com/medline/citation/36648594/Bimekizumab_Efficacy_and_Safety_in_Japanese_Patients_with_Plaque_Psoriasis_in_BE_VIVID:_A_Phase_3_Ustekinumab_and_Placebo_Controlled_Study_ DB - PRIME DP - Unbound Medicine ER -