Dermatology and therapy · 2025
Bimekizumab Impact on Patient-Reported Outcomes in Patients with Moderate to Severe Hidradenitis Suppurativa: Pooled 48-Week Results from BE HEARD I&II.
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Shi Vivian Y, Ingram John R, Lev-Tov Hadar, Schneider-Burrus Sylke, Forman Seth, Porter Martina L, Hayama Koremasa, Thorlacius Linnea, Lambert Jérémy, Vaux Tom, Lukowski Bartosz, Rolleri Robert L, Szepietowski Jacek C
Аннотация
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.
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.