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Introduction <p>While bimekizumab has demonstrated rapid, superior clinical efficacy versus adalimumab and ustekinumab, with sustained responses through 4&#xa0;years, its comparative and long-term impact on patient-reported outcomes (PROs) remains underexplored. Here, we report PROs with bimekizumab versus adalimumab/ustekinumab/placebo in phase&#xa0;3 controlled trials, and over 4&#xa0;years with bimekizumab.</p> Methods <p>Data were analyzed from BE&#xa0;SURE, BE&#xa0;VIVID, BE&#xa0;READY (52/56&#xa0;weeks), and their open-label extension (OLE), BE&#xa0;BRIGHT (144&#xa0;weeks; 4&#xa0;years’ total treatment). Patients were randomized to bimekizumab/adalimumab/ustekinumab/placebo during comparator-controlled periods; all received bimekizumab during BE&#xa0;BRIGHT. Proportions of patients reporting Psoriasis Symptoms and Impacts Measure (P‑SIM) = 0 and Dermatology Life Quality Index (DLQI) = 0 (both at item-level) were assessed during comparator‑controlled periods using non-responder imputation (NRI). Over 4&#xa0;years, PROs were analyzed using modified NRI in patients who received continuous bimekizumab from baseline into the OLE.</p> Results <p>BE&#xa0;SURE included 478 patients (bimekizumab, 319; adalimumab, 159); BE&#xa0;VIVID included 567 (bimekizumab, 321; ustekinumab, 163; placebo, 83); BE&#xa0;READY included 435 (bimekizumab, 349; placebo, 86). In total, 771 patients received continuous bimekizumab into the OLE. A larger proportion of bimekizumab-treated patients achieved P-SIM = 0 across key items versus adalimumab (week&#xa0;24; itching, 30.7% vs. 18.9%; skin pain, 43.9% vs. 30.2%; scaling, 39.2% vs. 19.5%), ustekinumab (week&#xa0;16; itching, 31.2% vs. 17.8%; skin pain, 51.7% vs. 27.6%; scaling, 43.6% vs. 17.2%), and placebo. Similar trends were seen for other P-SIM items and in proportions of bimekizumab-treated patients reporting DLQI = 0 across items versus comparators. The patient-reported benefits of bimekizumab were demonstrated throughout the OLE, with 65.5–94.8% of patients reporting DLQI = 0 across items at 4&#xa0;years.</p> Conclusions <p>Bimekizumab provided greater improvements in PROs versus comparators, with durable effects over 4&#xa0;years. These findings reinforce bimekizumab’s role in effective psoriasis management, linking clinical efficacy with sustained patient-reported benefits.</p> Trial Registration <p>NCT03412747, NCT03370133, NCT03410992, NCT03598790.</p> <p>A Graphical Abstract is available for this article.</p> Graphical Abstract <p></p>

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Bimekizumab Impact on Patient-Reported Outcomes in Plaque Psoriasis: 4-Year Results from BE SURE, BE VIVID, BE READY, and BE BRIGHT

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月8日

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  • April Armstrong,
  • Kim A. Papp,
  • Mark Lebwohl,
  • Laura J. Savage,
  • Keiichi Yamanaka,
  • Diana Elena Vlase,
  • Rhys Warham,
  • Jérémy Lambert,
  • José M. López Pinto,
  • Krista Wixted,
  • Diamant Thaçi

摘要

Introduction

While bimekizumab has demonstrated rapid, superior clinical efficacy versus adalimumab and ustekinumab, with sustained responses through 4 years, its comparative and long-term impact on patient-reported outcomes (PROs) remains underexplored. Here, we report PROs with bimekizumab versus adalimumab/ustekinumab/placebo in phase 3 controlled trials, and over 4 years with bimekizumab.

Methods

Data were analyzed from BE SURE, BE VIVID, BE READY (52/56 weeks), and their open-label extension (OLE), BE BRIGHT (144 weeks; 4 years’ total treatment). Patients were randomized to bimekizumab/adalimumab/ustekinumab/placebo during comparator-controlled periods; all received bimekizumab during BE BRIGHT. Proportions of patients reporting Psoriasis Symptoms and Impacts Measure (P‑SIM) = 0 and Dermatology Life Quality Index (DLQI) = 0 (both at item-level) were assessed during comparator‑controlled periods using non-responder imputation (NRI). Over 4 years, PROs were analyzed using modified NRI in patients who received continuous bimekizumab from baseline into the OLE.

Results

BE SURE included 478 patients (bimekizumab, 319; adalimumab, 159); BE VIVID included 567 (bimekizumab, 321; ustekinumab, 163; placebo, 83); BE READY included 435 (bimekizumab, 349; placebo, 86). In total, 771 patients received continuous bimekizumab into the OLE. A larger proportion of bimekizumab-treated patients achieved P-SIM = 0 across key items versus adalimumab (week 24; itching, 30.7% vs. 18.9%; skin pain, 43.9% vs. 30.2%; scaling, 39.2% vs. 19.5%), ustekinumab (week 16; itching, 31.2% vs. 17.8%; skin pain, 51.7% vs. 27.6%; scaling, 43.6% vs. 17.2%), and placebo. Similar trends were seen for other P-SIM items and in proportions of bimekizumab-treated patients reporting DLQI = 0 across items versus comparators. The patient-reported benefits of bimekizumab were demonstrated throughout the OLE, with 65.5–94.8% of patients reporting DLQI = 0 across items at 4 years.

Conclusions

Bimekizumab provided greater improvements in PROs versus comparators, with durable effects over 4 years. These findings reinforce bimekizumab’s role in effective psoriasis management, linking clinical efficacy with sustained patient-reported benefits.

Trial Registration

NCT03412747, NCT03370133, NCT03410992, NCT03598790.

A Graphical Abstract is available for this article.

Graphical Abstract