Evidence map›Paper›PMID 40652434›Full record

ArticleDermatology and therapy2025

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

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 and 3 more

2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04242446 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

TypeinterventionalSponsorUCB Biopharma SRLRan2020 to 2023Enrolled505ConditionsHidradenitis SuppurativaArmsBimekizumab, Placebo
NCT04242498 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

TypeinterventionalSponsorUCB Biopharma SRLRan2020 to 2022Enrolled509ConditionsHidradenitis SuppurativaArmsBimekizumab, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Vivian Y ShiDepartment of Dermatology, University of Washington, Seattle, WA, USA. vivianshi918@gmail.com.ORCID http://orcid.org/0000-0002-7510-9428
John R IngramDepartment of Dermatology and Academic Wound Healing, Division of Infection and Immunity, Cardiff University, Cardiff, UK.ORCID http://orcid.org/0000-0002-5257-1142
Hadar Lev-TovDr. Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL, USA.ORCID http://orcid.org/0000-0001-6223-7001
Sylke Schneider-BurrusCenter for Skin Surgery, Havelklinik, Berlin, Germany.ORCID http://orcid.org/0000-0002-9740-6845
Seth FormanForCare Clinical Research, Tampa, FL, USA.
Martina L PorterDepartment of Dermatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.ORCID http://orcid.org/0000-0002-4738-4385
Koremasa HayamaDivision of Cutaneous Science, Department of Dermatology, Nihon University School of Medicine, Tokyo, Japan.ORCID http://orcid.org/0000-0001-8651-2493
Linnea ThorlaciusDepartment of Dermatology, Zealand University Hospital, Roskilde, Denmark.ORCID http://orcid.org/0000-0002-3734-9607
Jérémy LambertUCB, Colombes, France.ORCID http://orcid.org/0000-0002-7164-1492
Tom VauxUCB, Slough, UK.
Bartosz LukowskiVedim/UCB, Warsaw, Poland.ORCID http://orcid.org/0009-0008-0217-6313
Robert L RolleriUCB, Morrisville, NC, USA.
Jacek C SzepietowskiEuropean Hidradenitis Suppurativa Foundation (EHSF) e.V., Dessau, Germany.ORCID http://orcid.org/0000-0003-0766-6342

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHidradenitis 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.

methodsPatients 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

resultsOf 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.

conclusionBimekizumab 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 registrationNCT04242446; NCT04242498.

Indexed as

BE HEARDBimekizumabDLQIHidradenitis suppurativaHiSQOLHSSDDHSSQIL-17 inhibitorsInflammatory skin diseasePatient-reported outcomes

Identifiers

PMID40652434
PMCPMC12354430

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.