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Record W3120199534 · doi:10.25251/skin.5.supp.18

Bimekizumab for the Treatment of Moderate to Severe Plaque Psoriasis with Scalp, Nail and Palmoplantar Involvement Through 52 Weeks: Post-Hoc Analysis from the BE VIVID Phase 3 Trial

2021· article· en· W3120199534 on OpenAlexaff
KA Papp, Mark Lebwohl, A.B. Gottlieb, Michael Sebastian, Richard G. Langley, Yukari Okubo, M Wang, Christopher L. Cioffi, Fabienne Staelens, Kristian Reich

Bibliographic record

VenueSKIN The Journal of Cutaneous Medicine · 2021
Typearticle
Languageen
FieldImmunology and Microbiology
TopicPsoriasis: Treatment and Pathogenesis
Canadian institutionsDalhousie UniversityProbity Medical Research
FundersUCB PharmaEuropean Academy of Dermatology and Venereology
KeywordsPost-hoc analysisScalpMedicineDermatologyNail (fastener)PsoriasisPost hocDentistryInternal medicineStructural engineeringEngineering

Abstract

fetched live from OpenAlex

ObjectiveTo compare the efficacy of bimekizumab with ustekinumab and placebo in patients with moderate to severe plaque psoriasis with scalp, palmoplantar, and nail involvement. Background• Psoriasis is the archetypal Th17-driven disease, for which both interleukin (IL)-17A and IL-17F have emerged as pivotal drivers of inflammation.2• Bimekizumab is a monoclonal IgG1 antibody that selectively inhibits IL-17F in addition to IL-17A.3,4 • In the BE VIVID phase 3 trial (NCT03370133) bimekizumab demonstrated superior clinical efficacy versus ustekinumab and placebo over 16 weeks of treatment (PASI 90: 85.0% versus 49.7% and 4.8%, respectively; p<0.001).This rapid initial response was durable over one year.5• Here, we report efficacy of bimekizumab for patients with scalp, palmoplantar (palms and soles) or nail psoriasis; psoriasis localized in these areas can restrict activities of daily living and negatively impact quality of life, and continues to pose a challenge for both physicians and patients.6 Methods • Patients were enrolled in BE VIVID, a randomized, double-blinded, placebo-and active comparator (ustekinumab)-controlled study (Figure 1).• These post-hoc analyses include patient subsets with scalp Investigator's Global Assessment (IGA) ≥3, palmoplantar (pp)-IGA ≥3, or modified Nail Psoriasis Severity Index (mNAPSI) >10 at baseline.• Proportions of patients achieving complete clearance in each region (scalp IGA 0, pp-IGA 0, mNAPSI 0) are reported through Week 52.• Missing data were imputed using non-responder imputation (NRI). Results Patient Population• Baseline characteristics for all randomized patients are shown in Table 1.Scalp, Palmoplantar and Nail Outcomes• Among patients with baseline scalp IGA ≥3 treated with bimekizumab, scalp response was rapid, with a higher proportion of patients achieving scalp IGA 0 at Week 16, compared with ustekinumab or placebo; response rates remained high through Week 52 (Figure 2A).• Similar trends were observed in the pp-IGA 0 response rates among patients with baseline pp-IGA ≥3 (Figure 2B).• Among those with baseline mNAPSI >10, a higher proportion of bimekizumab-versus ustekinumab-treated patients achieved nail clearance by Week 52 (Figure 2C). ConclusionsBimekizumab demonstrated high levels of efficacy in high-impact areas in patients with moderate to severe plaque psoriasis.Complete clearance of scalp, palmoplantar, and nail psoriasis was observed in a higher proportion of patients after 16 weeks of treatment with bimekizumab, compared with ustekinumab or placebo.Initial responses were durable through Week 52 for bimekizumab-treated patients with scalp and palmoplantar symptoms, and further increased for those with nail symptoms, reflecting the longer timescale required for nail growth.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.003
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.018

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0030.002
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0030.003
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0010.003
Insufficient payload (model declined to judge)0.0050.001

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.024
GPT teacher head0.275
Teacher spread0.251 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations7
Published2021
Admission routes1
Has abstractyes

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