Evidence map›Paper›PMID 39578348›Full record

ArticleDermatology and therapy2024

Bimekizumab Efficacy in High-Impact Areas: Pooled 2-Year Analysis in Scalp, Nail, and Palmoplantar Psoriasis from Phase 3/3b Randomized Controlled Trials.

Joseph F Merola, Alice B Gottlieb, Andreas Pinter, Boni Elewski, Melinda Gooderham, Richard B Warren, Stefano Piaserico, Krista Wixted, Nancy Cross, Nicola Tilt and 2 more

5 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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.

NCT03370133 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active Comparator-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma SRLRan2017 to 2019Enrolled567ConditionsChronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic ArthritisArmsBimekizumab, Ustekinumab, Placebo
NCT03410992 phase3completednot on this map

A Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study With an Initial Treatment Period Followed by a Randomized-Withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma SRLRan2018 to 2020Enrolled435ConditionsChronic Plaque Psoriasis, Moderate to Severe Chronic Plaque Psoriasis, Psoriatic ArthritisArmsBimekizumab, Placebo
NCT03412747 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind Study With an Active-Controlled Initial Treatment Period Followed by a Dose-Blind Maintenance Treatment Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma SRLRan2018 to 2020Enrolled478ConditionsChronic Plaque Psoriasis, Moderate to Severe Plaque PsoriasisArmsBimekizumab, Adalimumab, Placebo
NCT03536884 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Secukinumab-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma SRLRan2018 to 2023Enrolled743ConditionsChronic Plaque Psoriasis, Moderate to Severe Chronic Plaque PsoriasisArmsBimekizumab, Secukinumab, Placebo
NCT03598790 phase3completednot on this map

A Multicenter, Open-Label Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

TypeinterventionalSponsorUCB Biopharma SRLRan2018 to 2023Enrolled1,353ConditionsChronic Plaque Psoriasis, Moderate to Severe Chronic Plaque PsoriasisArmsBimekizumab
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

12 authors.

Joseph F MerolaDepartment of Dermatology and Department of Medicine, Division of Rheumatology, UT Southwestern Medical Center, 5323 Harry Hines Blvd, Dallas, TX, 75390, USA. Joseph.Merola@UTSouthwestern.edu.ORCID http://orcid.org/0000-0001-6514-4353
Alice B GottliebDepartment of Dermatology, The Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Andreas PinterUniversity Hospital Frankfurt, Frankfurt Am Main, Germany.ORCID http://orcid.org/0000-0002-1330-1502
Boni ElewskiDepartment of Dermatology, University Hospitals of Cleveland, Case Western Reserve University, Cleveland, OH, USA.ORCID http://orcid.org/0000-0002-1475-2874
Melinda GooderhamSKiN Centre for Dermatology, Probity Medical Research, Peterborough, ON, Canada.ORCID http://orcid.org/0000-0001-8926-0113
Richard B WarrenDermatology Centre, Northern Care Alliance NHS Foundation Trust, Manchester, UK.
Stefano PiasericoDermatology Unit, Department of Medicine, Università Di Padova, Padova, Italy.ORCID http://orcid.org/0000-0002-1091-4733
Krista WixtedUCB, Morrisville, NC, USA.
Nancy CrossUCB, Morrisville, NC, USA.
Nicola TiltUCB, Slough, UK.
Susanne WiegratzUCB, Monheim Am Rhein, Germany.
Ulrich MrowietzPsoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Germany.ORCID http://orcid.org/0000-0002-9539-0712

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPsoriasis in high-impact areas, including the scalp, nails, palms, and soles, can disproportionately impair patient quality of life. Here, we evaluate the 2-year efficacy of bimekizumab treatment in patients with moderate to severe plaque psoriasis in post hoc analyses of five phase 3/3b trials.

methodsHigh-impact area efficacy data were pooled through 2 years across five phase 3/3b trials: BE VIVID, BE READY, BE SURE, their ongoing open-label extension (OLE) BE BRIGHT, and BE RADIANT (including its double-blinded treatment period and the first year of its OLE). Complete clearance of psoriasis in high-impact areas is reported over 2 years using the scalp Investigator's Global Assessment (IGA), palmoplantar IGA, and modified Nail Psoriasis Severity Index (mNAPSI). Patients included in these analyses had baseline moderate to severe scalp or palmoplantar involvement (scalp or palmoplantar IGA score ≥ 3) or mNAPSI score > 10.

resultsA total of 1107 patients were randomized to bimekizumab and entered the OLEs. Subsets of 821 patients had scalp IGA ≥ 3 at baseline, 377 had mNAPSI > 10, and 193 had palmoplantar IGA ≥ 3. Complete scalp clearance in patients with baseline scalp IGA ≥ 3 randomized to bimekizumab was achieved rapidly, with high responses sustained from first (86.4%) to second year (85.9%). Nail clearance responses in patients with baseline mNAPSI > 10 increased from 63.4% to 68.5% from first to second year. Palmoplantar clearance in patients with baseline palmoplantar IGA ≥ 3 was sustained from first (88.3%) to second year (89.8%). Similar trends were seen in the 374 patients who received bimekizumab 320 mg every 4 weeks (Q4W)/every 8 weeks (Q8W) initial/maintenance dosing.

conclusionIn these analyses pooled across 2 years, bimekizumab showed sustained efficacy in psoriasis in high-impact areas. CLINICALTRIALS: GOV TRIAL REGISTRATION NUMBERS: NCT03370133, NCT03410992, NCT03412747, NCT03598790, NCT03536884.

Indexed as

BimekizumabClinical trialEfficacyHigh-impact areasNailPalmoplantarPalmsPsoriasisScalpSoles

Identifiers

PMID39578348
PMCPMC11604908

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.