BIMEKIZUMAB IMPACT ON PAIN AND QUALITY OF LIFE STRATIFIED BY IHS4 LEVELS IN PATIENTS WITH HIDRADENITIS SUPPURATIVA: 3-YEAR RESULTS FROM BE HEARD EXT
Author(s)
Brian Kirby, MD1, Saakshi Khattri, MD2, John R Ingram, MA MSc DM(Oxon) FRCP(Derm) FAcadMEd3, Georgios Kokolakis, MD PhD4, Thrasyvoulos Tzellos, MD PhD5, Ichiro Kurokawa, MD6, Jérémy Lambert, PhD7, Sandeep Kiri, MSc8, Bengt Hoepken, PhD9, Nicola Tilt, MSc8, John Frew, MBBS MMed MSc PhD FACD10.
1St Vincent’s University Hospital, Elm Park and the Charles Institute, University College Dublin, Dublin, Ireland, 2The Mount Sinai Hospital, New York, NY, USA, 3Division of Infection and Immunity, Cardiff University, Cardiff, United Kingdom, 4Department of Dermatology, Venereology, and Allergology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, 5Department of Dermatology, Nordland Hospital Trust, Bodø, Norway, 6Department of Dermatology, Meiwa Hospital, Nishimomiya, Japan, 7UCB, Courbevoie, France, 8UCB, Slough, United Kingdom, 9UCB, Monheim am Rhein, Germany, 10Department of Dermatology, Liverpool Hospital, Sydney, Australia.
1St Vincent’s University Hospital, Elm Park and the Charles Institute, University College Dublin, Dublin, Ireland, 2The Mount Sinai Hospital, New York, NY, USA, 3Division of Infection and Immunity, Cardiff University, Cardiff, United Kingdom, 4Department of Dermatology, Venereology, and Allergology, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany, 5Department of Dermatology, Nordland Hospital Trust, Bodø, Norway, 6Department of Dermatology, Meiwa Hospital, Nishimomiya, Japan, 7UCB, Courbevoie, France, 8UCB, Slough, United Kingdom, 9UCB, Monheim am Rhein, Germany, 10Department of Dermatology, Liverpool Hospital, Sydney, Australia.
OBJECTIVES: Hidradenitis suppurativa (HS), a chronic, progressive, inflammatory skin disease, impacts patients’ health-related quality of life (HRQoL) and is characterised by debilitating pain and lesion burden. Bimekizumab (BKZ), a humanised IgG1 monoclonal antibody, selectively inhibits interleukin (IL)-17A and IL-17F and has demonstrated efficacy in phase 3 clinical trials.
We report the association between Week48 lesion count-based International Hidradenitis Suppurativa Severity Score System (IHS4) levels and improvements in skin pain and HRQoL through Year3 of BKZ treatment.
METHODS: Data were pooled from the phase 3 BE HEARD (BH)I&II (NCT04242446, NCT04242498) and BH EXT trials (BHEXT; NCT04901195), for patients with moderate-to-severe HS. Data are reported for patients randomised to BKZ 320mg in BHI&II and enrolled in BHEXT (BKZ Total).
Associations between mutually-exclusive Week48 IHS4 levels (<IHS4-55 [reduction from baseline of <55%]/IHS4-90-100) and clinically meaningful improvements in patient-reported outcomes: HS symptom questionnaire (HSSQ) skin pain response (≥30% and ≥1-point reduction from baseline), HS Quality of Life (HiSQOL) questionnaire response (total score ≤14 [no/mild impact]) and Dermatology Life Quality Index (DLQI 0/1 [no impact on life]) are reported (observed case) at Year1/3 (Week48/148).
RESULTS: Of 1,014 patients in BHI&II, 868 were randomised to BKZ at baseline; 556 completed Year1 and entered BHEXT.
At Year1, greater HSSQ skin pain response rates were observed with greater Week48 IHS4 reductions (<IHS4-55/90-100: 51.3%/85.5%); these were maintained to Year3 (<IHS4-55/90-100: 68.1%/89.1%).
No/mild impact HiSQOL responses at Year1 were more frequent with greater Week48 IHS4 reductions (<IHS4-55/90-100: 54.4%/84.6%) which maintained to Year3 (<IHS4-55/90-100: 65.1%/82.4%).
At Year1, DLQI 0/1 responses were more frequent with greater Week48 IHS4 reductions (<IHS4-55/90-100: 8.1%/44.9%); DLQI 0/1 response increased to Year3 in <IHS4-55 responders (27.7%) and was maintained in IHS4-90-100 responders (45.1%).
CONCLUSIONS: Greater Week48 IHS4 reductions translated into greater clinically meaningful longer-term improvements in skin pain and HRQoL to Year3.
We report the association between Week48 lesion count-based International Hidradenitis Suppurativa Severity Score System (IHS4) levels and improvements in skin pain and HRQoL through Year3 of BKZ treatment.
METHODS: Data were pooled from the phase 3 BE HEARD (BH)I&II (NCT04242446, NCT04242498) and BH EXT trials (BHEXT; NCT04901195), for patients with moderate-to-severe HS. Data are reported for patients randomised to BKZ 320mg in BHI&II and enrolled in BHEXT (BKZ Total).
Associations between mutually-exclusive Week48 IHS4 levels (<IHS4-55 [reduction from baseline of <55%]/IHS4-90-100) and clinically meaningful improvements in patient-reported outcomes: HS symptom questionnaire (HSSQ) skin pain response (≥30% and ≥1-point reduction from baseline), HS Quality of Life (HiSQOL) questionnaire response (total score ≤14 [no/mild impact]) and Dermatology Life Quality Index (DLQI 0/1 [no impact on life]) are reported (observed case) at Year1/3 (Week48/148).
RESULTS: Of 1,014 patients in BHI&II, 868 were randomised to BKZ at baseline; 556 completed Year1 and entered BHEXT.
At Year1, greater HSSQ skin pain response rates were observed with greater Week48 IHS4 reductions (<IHS4-55/90-100: 51.3%/85.5%); these were maintained to Year3 (<IHS4-55/90-100: 68.1%/89.1%).
No/mild impact HiSQOL responses at Year1 were more frequent with greater Week48 IHS4 reductions (<IHS4-55/90-100: 54.4%/84.6%) which maintained to Year3 (<IHS4-55/90-100: 65.1%/82.4%).
At Year1, DLQI 0/1 responses were more frequent with greater Week48 IHS4 reductions (<IHS4-55/90-100: 8.1%/44.9%); DLQI 0/1 response increased to Year3 in <IHS4-55 responders (27.7%) and was maintained in IHS4-90-100 responders (45.1%).
CONCLUSIONS: Greater Week48 IHS4 reductions translated into greater clinically meaningful longer-term improvements in skin pain and HRQoL to Year3.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR255
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Biologics & Biosimilars, Sensory System Disorders (Ear, Eye, Dental, Skin)