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Introduction <p>Hidradenitis suppurativa (HS) symptoms (pain, itch, odour and drainage) impair quality of life (QoL). Bimekizumab, a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F. The impact of bimekizumab on patient-reported outcomes (PROs) was assessed using pooled 48-week data from BE&#xa0;HEARD&#xa0;I&amp;II (BHI&amp;II) studies in moderate to severe HS.</p> Methods <p>Patients received (initial/maintenance) bimekizumab 320&#xa0;mg every 2&#xa0;weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W or placebo/bimekizumab Q2W. HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) captured HS-specific patient-reported symptoms; HS Quality of Life questionnaire (HiSQOL<sup>©</sup>) and Dermatology Life Quality Index (DLQI) captured health-related QoL (HRQoL). Change from baseline (CfB) and proportions of patients achieving clinically meaningful improvement thresholds or low disease impact are reported to Week&#xa0;48 (observed case).</p> Results <p>Of 1014 randomised patients, 868 received bimekizumab and 146 placebo. Greater numerical reductions at Week&#xa0;16 were observed across HSSDD/HSSQ scores with bimekizumab vs placebo. From Week&#xa0;16 to 48, HSSQ scores further numerically reduced with continuous bimekizumab and substantially reduced for placebo/bimekizumab switchers. At Week&#xa0;16, bimekizumab showed numerically greater improvement in HRQoL vs placebo (HiSQOL total score mean CfB: − 11.7 to − 10.3 vs − 5.5). HiSQOL response rate (21-point total score reduction) was numerically higher by Week&#xa0;4 in bimekizumab-treated patients (17.2–21.4%) vs placebo (9.2%); rates increased to Week&#xa0;48 with continuous bimekizumab (42.0–47.4%) and in switchers (55.0%). Patients with very severe disease impact (HiSQOL total score ≥ 24) decreased over time with bimekizumab. At Week&#xa0;16, DLQI minimal clinically important difference (4-point decrease) achievement was numerically greater with bimekizumab vs placebo (54.9–64.6% vs 49.1%). Achievement increased to Week&#xa0;48 and switchers attained similar proportions (63.5–74.5% vs 76.5%). Comparable trends were observed for DLQI score of 0/1 (no HRQoL impact) achievement rates.</p> Conclusion <p>Bimekizumab demonstrated clinically meaningful improvements by Week&#xa0;4 in HRQoL, which were maintained over 1&#xa0;year across PROs in patients with moderate to severe HS.</p> <p>Graphical Abstract available for this article.</p> Trial Registration <p>NCT04242446; NCT04242498.</p>

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Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月13日

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  • Vivian Y. Shi,
  • John R. Ingram,
  • Hadar Lev-Tov,
  • Sylke Schneider-Burrus,
  • Seth Forman,
  • Martina L. Porter,
  • Koremasa Hayama,
  • Linnea Thorlacius,
  • Jérémy Lambert,
  • Tom Vaux,
  • Bartosz Lukowski,
  • Robert L. Rolleri,
  • Jacek C. Szepietowski

摘要

Introduction

Hidradenitis suppurativa (HS) symptoms (pain, itch, odour and drainage) impair quality of life (QoL). Bimekizumab, a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F. The impact of bimekizumab on patient-reported outcomes (PROs) was assessed using pooled 48-week data from BE HEARD I&II (BHI&II) studies in moderate to severe HS.

Methods

Patients received (initial/maintenance) bimekizumab 320 mg every 2 weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W or placebo/bimekizumab Q2W. HS Symptom Daily Diary (HSSDD) and HS Symptom Questionnaire (HSSQ) captured HS-specific patient-reported symptoms; HS Quality of Life questionnaire (HiSQOL©) and Dermatology Life Quality Index (DLQI) captured health-related QoL (HRQoL). Change from baseline (CfB) and proportions of patients achieving clinically meaningful improvement thresholds or low disease impact are reported to Week 48 (observed case).

Results

Of 1014 randomised patients, 868 received bimekizumab and 146 placebo. Greater numerical reductions at Week 16 were observed across HSSDD/HSSQ scores with bimekizumab vs placebo. From Week 16 to 48, HSSQ scores further numerically reduced with continuous bimekizumab and substantially reduced for placebo/bimekizumab switchers. At Week 16, bimekizumab showed numerically greater improvement in HRQoL vs placebo (HiSQOL total score mean CfB: − 11.7 to − 10.3 vs − 5.5). HiSQOL response rate (21-point total score reduction) was numerically higher by Week 4 in bimekizumab-treated patients (17.2–21.4%) vs placebo (9.2%); rates increased to Week 48 with continuous bimekizumab (42.0–47.4%) and in switchers (55.0%). Patients with very severe disease impact (HiSQOL total score ≥ 24) decreased over time with bimekizumab. At Week 16, DLQI minimal clinically important difference (4-point decrease) achievement was numerically greater with bimekizumab vs placebo (54.9–64.6% vs 49.1%). Achievement increased to Week 48 and switchers attained similar proportions (63.5–74.5% vs 76.5%). Comparable trends were observed for DLQI score of 0/1 (no HRQoL impact) achievement rates.

Conclusion

Bimekizumab demonstrated clinically meaningful improvements by Week 4 in HRQoL, which were maintained over 1 year across PROs in patients with moderate to severe HS.

Graphical Abstract available for this article.

Trial Registration

NCT04242446; NCT04242498.