Evidence map›Paper›PMID 41219577›Full record

Trial reportAmerican journal of clinical dermatology2026

Efficacy and Safety of Dupilumab in Adults with Prurigo Nodularis with or Without Atopic Comorbidities: A Subgroup Analysis from Two Randomized Phase III Clinical Trials.

Brian S Kim, Margarida Gonçalo, Tsukasa Ugajin, Xing-Hua Gao, Amy H Praestgaard, Melanie Makhija, Joseph Zahn, Ashish Bansal, Simmi Wiggins

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2026. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04183335 phase3completednot on this map

A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

TypeinterventionalSponsorSanofiRan2019 to 2022Enrolled151ConditionsNeurodermatitisArmsDupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
NCT04202679 phase3completednot on this map

A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Prurigo Nodularis Who Are Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable

TypeinterventionalSponsorSanofiRan2020 to 2021Enrolled160ConditionsNeurodermatitisArmsDupilumab SAR231893, Placebo, Moisturizers, Low to medium potent topical corticosteroids, Topical calcineurin inhibitors
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Immunopathogenesis of itch: an integrative framework for chronic pruritus.JID innovations : skin science from molecules to population health · 2026
    Review
  2. Review
  3. Article
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

9 authors.

Brian S KimKimberly and Eric J. Waldman Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Margarida GonçaloDepartment of Dermatology, Hospital da Universidade, Unidade Local de Saúde de Coimbra, Coimbra, Portugal.
Tsukasa UgajinDepartment of Dermatology, Institute of Science Tokyo, Tokyo, Japan.
Xing-Hua GaoThe First Hospital of China Medical University, Shenyang, China.
Amy H PraestgaardSanofi, Cambridge, MA, USA.
Melanie MakhijaSanofi, Cambridge, MA, USA.
Joseph ZahnRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Ashish BansalRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Simmi WigginsSanofi, 410 Thames Valley Park Drive, Reading, RG6 1PT, UK. Simmi.Wiggins@sanofi.com.ORCID http://orcid.org/0009-0006-2880-1995

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrurigo nodularis (PN) is a chronic inflammatory skin condition characterized by intensely pruritic papulonodular lesions. Patients with PN frequently experience comorbid atopic conditions. Dupilumab is the first approved therapy for PN, but the efficacy of dupilumab in patients with PN with or without atopic comorbidities has not been investigated.

objectiveWe aimed to assess the efficacy and safety of dupilumab in patients with PN with or without a history of atopic comorbidities.

methodsRandomized, double-blind, parallel-group, placebo-controlled, 24-week, phase III trials LIBERTY-PN PRIME and PRIME2 were conducted independently in 16 countries in North and South America, Europe, and Asia. Patients were randomized 1:1 to dupilumab 300 mg every 2 weeks or matched placebo. In this pre-specified subgroup analysis of pooled data, adults with moderate-to-severe PN, inadequately controlled by topical prescription therapies, were stratified according to the presence or absence of atopic comorbidity history. Investigators assessed itch (Worst Itch Numeric Rating Scale), skin lesions (Investigator's Global Assessment for PN Stage), and patient-reported quality of life (evaluated using the Dermatology Life Quality Index, Skin Pain Numeric Rating Scale, Hospital Anxiety and Depression Scale, and a Sleep Numeric Rating Scale).

resultsThree hundred and eleven patients were randomized to dupilumab (N = 153; atopic/non-atopic n = 67/86) or placebo (N = 158; atopic/non-atopic n = 68/90). At week 24 in both the atopic and non-atopic subgroups, significantly more patients achieved clinically meaningful improvements with dupilumab treatment compared with placebo in itch (atopic: 58.2% vs 20.6%; P < 0.0001; non-atopic: 59.3% vs 17.8%; P < 0.0001), clear/almost clear skin (atopic: 52.2% vs 16.2%; P < 0.0001; non-atopic: 41.9% vs 17.8%; P = 0.0005), and concomitant itch and skin lesion improvements (atopic: 37.3% vs 7.4%; P = 0.0057; non-atopic 33.7% vs 10.0%; P = 0.007). Patients showed significant improvements in skin pain, Dermatology Life Quality Index, Hospital Anxiety and Depression Scale, and sleep, with dupilumab treatment compared with placebo, regardless of atopic history. Safety was generally consistent with the known dupilumab safety profile.

conclusionsDupilumab significantly improved disease signs, symptoms, and health-related quality of life with similar onset time and response magnitude compared with placebo in adult patients with PN, irrespective of the presence or absence of atopic comorbidities. CLINICAL

trial registrationClinicalTrials.gov Identifiers: NCT04183335 and NCT04202679.

Indexed as

Antibodies, Monoclonal, HumanizedDermatitis, AtopicPrurigoAdultAgedComorbidityDouble-Blind MethodFemaleHumansMaleMiddle AgedPatient Reported Outcome MeasuresPruritusQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID41219577
PMCPMC12860806

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.