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Introduction <p>Individuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] &gt; 0).</p> Methods <p>We conducted a post hoc analysis of BE&#xa0;OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE&#xa0;COMPLETE/BE&#xa0;VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160&#xa0;mg every 4&#xa0;weeks (Q4W), placebo or reference arm (adalimumab 40&#xa0;mg Q2W; BE&#xa0;OPTIMAL only). At week&#xa0;16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE&#xa0;COMPLETE week&#xa0;16 could enter BE&#xa0;VITAL. Efficacy and safety data are reported by study to week&#xa0;52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).</p> Results <p>Overall, 263 (placebo <i>n</i> = 88; bimekizumab <i>n</i> = 133; reference [adalimumab] <i>n</i> = 42) biologic-naïve and 159 (placebo <i>n</i> = 54; bimekizumab <i>n</i> = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week&#xa0;16 to week&#xa0;52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week&#xa0;16 to week&#xa0;52 after receiving 36&#xa0;weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week&#xa0;52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).</p> Conclusions <p>Bimekizumab treatment resulted in consistent, sustained efficacy to 52&#xa0;weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports.&#xa0;Graphical abstract available for this article.</p> Trial Registration <p>BE&#xa0;OPTIMAL: NCT03895203; BE&#xa0;COMPLETE: NCT03896581; BE&#xa0;VITAL: NCT04009499 (ClinicalTrials.gov).</p> Graphical Abstract <p></p>

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Bimekizumab Efficacy and Safety in Patients with Psoriatic Arthritis with Substantial Skin and Nail Psoriasis to 1 Year

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月12日

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  • Diamant Thaçi,
  • Akihiko Asahina,
  • Wolf-Henning Boehncke,
  • Alice B. Gottlieb,
  • Mark Lebwohl,
  • Richard B. Warren,
  • Heather Edens,
  • Barbara Ink,
  • Rajan Bajracharya,
  • Jason Coarse,
  • Joseph F. Merola

摘要

Introduction

Individuals with psoriatic arthritis (PsA) and plaque-type psoriasis and nail involvement have more severe disease and worse quality of life than those without. Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A. Here, we assess 52-week efficacy and safety of bimekizumab in individuals with PsA who had baseline plaque-type psoriasis (≥ 3% body surface area) and nail involvement (modified Nail Psoriasis Severity Index [mNAPSI] > 0).

Methods

We conducted a post hoc analysis of BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug [biologic]-naïve patients) and BE COMPLETE/BE VITAL open-label extension (NCT03896581/NCT04009499; patients with prior inadequate response/intolerance to tumour necrosis factor inhibitors [TNFi-IR]). Participants were randomised to subcutaneously administered bimekizumab 160 mg every 4 weeks (Q4W), placebo or reference arm (adalimumab 40 mg Q2W; BE OPTIMAL only). At week 16, placebo-randomised participants switched to bimekizumab (PBO/BKZ). Participants who completed BE COMPLETE week 16 could enter BE VITAL. Efficacy and safety data are reported by study to week 52. Efficacy outcomes included American College of Rheumatology ≥ 50% improvement (ACR50), Psoriasis Area and Severity Index 100% improvement (PASI100) and nail psoriasis resolution (mNAPSI = 0).

Results

Overall, 263 (placebo n = 88; bimekizumab n = 133; reference [adalimumab] n = 42) biologic-naïve and 159 (placebo n = 54; bimekizumab n = 105) TNFi-IR participants had baseline plaque-type psoriasis and nail involvement. In bimekizumab-randomised participants with baseline plaque-type psoriasis and nail involvement, improvements in the proportion of participants achieving efficacy responses across disease domains were sustained from week 16 to week 52, including ACR50 (65.4% biologic-naïve; 61.0% TNFi-IR), PASI100 (60.9%; 63.8%), and mNAPSI = 0 (68.4%; 70.5%). PBO/BKZ switchers demonstrated improvements from week 16 to week 52 after receiving 36 weeks of bimekizumab treatment, for ACR50 (63.6% biologic-naïve; 51.9% TNFi-IR), PASI100 (64.8%; 57.4%), and mNAPSI = 0 (73.9%; 63.0%). To week 52, exposure-adjusted incidence rates/100 patient years for ≥ 1 treatment-emergent adverse event in all bimekizumab-treated (≥ 1 dose) participants with baseline plaque-type psoriasis and nail involvement were 181.1 (biologic-naïve) and 99.2 (TNFi-IR).

Conclusions

Bimekizumab treatment resulted in consistent, sustained efficacy to 52 weeks in biologic-naïve and TNFi-IR individuals with PsA and baseline plaque-type psoriasis and nail involvement. Bimekizumab was well tolerated, with a safety profile consistent with previous reports. Graphical abstract available for this article.

Trial Registration

BE OPTIMAL: NCT03895203; BE COMPLETE: NCT03896581; BE VITAL: NCT04009499 (ClinicalTrials.gov).

Graphical Abstract