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. 2025 Aug 31.
doi: 10.1007/s40257-025-00968-2. Online ahead of print.

Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies

Joseph F Merola  1 , Richard B Warren  2   3 , Diamant Thaçi  4 , Kenneth B Gordon  5 , Emi Nishida  6 , Bruce Strober  7   8 , Curdin Conrad  9 , Sarah Kavanagh  10 , José Manuel López Pinto  11 , Bengt Hoepken  12 , Paolo Gisondi  13
Affiliations

Bimekizumab Complete Clearance of Both Skin and Nail Psoriasis: Comparative Efficacy in Phase III/IIIb Studies

Joseph F Merola et al. Am J Clin Dermatol. .

Abstract

Background: Nail psoriasis can have a substantial negative impact on both the physical and emotional well-being of patients, and is a risk factor for psoriatic arthritis. Achieving complete clearance of nails in addition to skin is therefore an important treatment goal.

Objectives: We aimed to evaluate concurrent complete skin and nail clearance in patients with moderate-to-severe plaque psoriasis treated with bimekizumab or active comparators.

Methods: Data were analyzed from the BE SURE and BE VIVID phase III trials, their open-label extension BE BRIGHT, and the BE RADIANT phase IIIb trial and its open-label extension. Included patients had baseline modified Nail Psoriasis Severity Index (mNAPSI) >0 and entered their respective open-label extension. Proportions of patients achieving complete skin (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) and nail (mNAPSI 0) clearance at the same time are reported for bimekizumab- and active comparator-treated patients during controlled trial periods, and in the long term for continuous bimekizumab-treated patients and those switching from comparators. Data are reported using modified non-responder imputation.

Results: At the end of comparator-controlled periods, 45.8% of bimekizumab (N = 151) versus 18.3% of adalimumab (N = 91) patients (BE SURE week 24), 51.1% of bimekizumab (N = 169) versus 26.5% of ustekinumab (N = 92) patients (BE VIVID week 52), and 63.3% of bimekizumab (N = 182) versus 36.1% of secukinumab (N = 155) patients (BE RADIANT week 48) achieved PASI 100 and mNAPSI 0. Following long-term treatment, 57.7% of adalimumab switchers/49.1% of continuous bimekizumab patients (BE SURE/BE BRIGHT year 4), 52.2% of ustekinumab switchers/48.3% of continuous bimekizumab patients (BE VIVID/BE BRIGHT year 4), and 51.9% of secukinumab switchers/57.4% of continuous bimekizumab patients (BE RADIANT year 3) achieved PASI 100 and mNAPSI 0.

Conclusions: Numerically higher proportions of bimekizumab-treated patients achieved concurrent complete skin and nail clearance versus adalimumab, ustekinumab, and secukinumab. Clearance rates increased following switch to bimekizumab, and were sustained long-term in both switchers to bimekizumab and continuous bimekizumab-treated patients. [Graphical abstract available.] CLINICAL TRIAL REGISTRATION: NCT03412747, NCT03370133, NCT03598790, NCT03536884.

Plain language summary

An investigation of how well bimekizumab works in completely clearing skin and nail psoriasis together.What is psoriasis?Psoriasis is a long-lasting disease that can cause red, scaly patches on the skin, and it can cause symptoms in other parts of the body because it affects more than just one area. These patches can flake, itch, and hurt. The nails are also affected in up to six out of ten people living with psoriasis, causing discomfort and impacting quality of life, even though nails are small. Nail psoriasis takes longer to treat than skin psoriasis. It is associated with the development of psoriatic arthritis, which causes joint pain, swelling, and stiffness, and can cause permanent changes to the joints. Many people with psoriasis therefore want treatments that can clear both skin and nail symptoms.What did we do?In this global study, we looked at how well bimekizumab, a psoriasis medication, works to clear both skin and nail psoriasis at the same time. We analyzed how many patients treated with bimekizumab had achieved completely clear skin and nails after up to 1 year compared with other medications (adalimumab, ustekinumab, and secukinumab). We also looked over the long term in patients receiving bimekizumab throughout or those switching from other medications to bimekizumab.What did we find?More patients treated with bimekizumab achieved completely clear skin and nails compared with other medications. Similar numbers of bimekizumab-treated patients maintained completely clear skin and nails through up to 4 years, including those switching from other medications. These results suggest bimekizumab helps improve different areas of psoriasis that affect patients.

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Conflict of interest statement

Declarations. Funding: This study was sponsored by UCB. This article, and its associated graphical abstract, were based on the original studies BE VIVID (NCT03370133), BE SURE (NCT03412747), BE BRIGHT (NCT03598790), and BE RADIANT (NCT03536884), sponsored by UCB. Support for third-party writing assistance for this article and its associated graphical abstract, provided by Michael Haycox, PhD, Alexa Holland, MSc, and Ria Gill, BSc, Costello Medical, UK, was funded by UCB in accordance with Good Publication Practice (GPP 2022) guidelines ( https://www.ismpp.org/gpp-2022 ). Conflicts of Interest/Competing Interests: Joseph F. Merola: consultant and/or investigator for AbbVie, Amgen, AstraZeneca, Biogen, Bristol Myers Squibb, Boehringer Ingelheim, Dermavant, Eli Lilly and Company, Incyte, Janssen, LEO Pharma, MoonLake Immunotherapeutics, Novartis, Pfizer, Sanofi-Regeneron, Sun Pharma, and UCB. Richard B. Warren: consulting fees from AbbVie, Almirall, Amgen, Arena, Astellas, Avillion, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DICE Therapeutics, Eli Lilly and Company, GSK, Janssen, LEO Pharma, Meiji Pharma, Novartis, Pfizer, RAPT Therapeutics, Sanofi, Sun Pharma, UCB, and Union; research grants to his institution from AbbVie, Almirall, Amgen, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Novartis, Pfizer, and UCB; honoraria from AbbVie, Almirall, Bristol Myers Squibb, Eli Lilly and Company, Galderma, Janssen, and Novartis. Diamant Thaçi: investigator and/or consultant/advisor for AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Galderma, Johnson & Johnson, Kyowa Kirin, LEO Pharma, L’Oreal, New Bridge, Novartis, Pfizer, Regeneron, Samsung, Sanofi, Takeda, Target-RWE, UCB, and Vichy; received grants from AbbVie, LEO Pharma, and Novartis. Kenneth B. Gordon: received consulting fees from AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly and Company, Janssen, Novartis, Pfizer, Sun Pharma, and UCB; research support from AbbVie, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Janssen, Novartis, and UCB. Emi Nishida: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly and Company, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, Taiho, Torii, and UCB. Bruce Strober: consultant (honoraria) for AbbVie, Alumis, Almirall, Amgen, Arcutis, Boehringer Ingelheim, Bristol Myers Squibb, Capital One, CorEvitas, Dermavant, Janssen, LEO Pharma, Eli Lilly and Company, Maruho, Oruka, Meiji Seika Pharma, Protagonist, Takeda, Novartis, Pfizer, UCB, Rapt, Regeneron, Sanofi-Genzyme, and Union Therapeutics; stock options from Connect Biopharma and Mindera Health; speaker for AbbVie, Arcutis, Dermavant, Eli Lilly and Company, Incyte, Janssen, Regeneron, and Sanofi Genzyme; scientific co-director (consulting fee): CorEvitas Psoriasis Registry; investigator for CorEvitas Psoriasis Registry; editor-in-chief (honorarium): Journal of Psoriasis and Psoriatic Arthritis. Curdin Conrad: consultant and/or principal investigator in clinical trials for AbbVie, Actelion, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly and Company, Galderma, Incyte, Johnson & Johnson, LEO Pharma, MSD, Novartis, Pfizer, Samsung, Sanofi, Takeda, and UCB. Sarah Kavanagh: consultant for Aclipse Therapeutics, Aliada Therapeutics, Allay Therapeutics, Autobahn Therapeutics, Cognition Therapeutics, Colorado Prevention Center, Karuna Therapeutics, Kisbee Therapeutics, LB Pharmaceuticals, Nesos, Novartis, Onward Medical, PharPoint Research, Summit Analytical, Tonix Pharmaceuticals, Tornado Therapeutics, UCB, Whitsell Innovations, Worldwide Clinical Trials, and Zosano Pharma. José Manuel López Pinto, Bengt Hoepken: employees and shareholders of UCB. Paolo Gisondi: consultant for AbbVie, Abiogen, Almirall, Celgene, Eli Lilly and Company, Janssen, LEO Pharma, Merck, MSD, Novartis, Otsuka, Pfizer, Pierre Fabre, Sanofi, and UCB. Ethics Approval: Studies were conducted in accordance with the principles of the Declaration of Helsinki and approved by an independent review board and independent ethics committee. Consent to Participate: All participants provided informed written consent documented in accordance with local regulations. Consent for Publication: All the results presented in this article are in aggregate form, and no personally identifiable information was used for this study. Availability of Data and Material: Underlying data from this article may be requested by qualified researchers 6 months after product approval in the USA and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents, which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of these data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password-protected portal. Code Availability: Not applicable. Authors’ Contributions: Substantial contributions to study conception and design: JFM, RBW, DT, KBG, EN, BS, CC, SK, JMLP, BH, PG; substantial contributions to analysis and interpretation of the data: JFM, RBW, DT, KBG, EN, BS, CC, SK, JMLP, BH, PG; drafting the article or revising it critically for important intellectual content: JFM, RBW, DT, KBG, EN, BS, CC, SK, JMLP, BH, PG; final approval of the version of the article to be published: JFM, RBW, DT, KBG, EN, BS, CC, SK, JMLP, BH, PG.

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