Evidence map›Paper›PMID 41081535›Full record

ArticleJournal of the European Academy of Dermatology and Venereology : JEADV2026

Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study.

Matthias Augustin, Marie Tauber, Robert Sidbury, Jonathan I Silverberg, Kim A Papp, Diamant Thaçi, Marjolein S De Bruin-Weller, Adam Reich, Ketty Peris, Kirk Barber and 15 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of the European Academy of Dermatology and Venereology : JEADV, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03989206 (A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT03989206 phase3active not recruitingnot on this map

A Prospective, Multicenter, Long-Term Study to Assess the Safety and Efficacy of Nemolizumab (CD14152) in Subjects With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorGalderma R&DRan2019 to 2026Enrolled1,700ConditionsModerate-to-Severe Atopic DermatitisArmsNemolizumab
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Safety and efficacy of nemolizumab for atopic dermatitis up to 2 years in open-label extension study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  4. 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

25 authors.

Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg, Hamburg, Germany.ORCID https://orcid.org/0000-0002-4026-8728
Marie TauberDepartment of Allergy and Clinical Immunology, Lyon Sud Hospital, Hospices Civils de Lyon, Inserm U1111 Centre International de Recherche en Infectiology, Lyon, France.ORCID https://orcid.org/0000-0001-6245-7442
Robert SidburySeattle Children's Hospital, Seattle, Washington, USA.
Jonathan I SilverbergGeorge Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID https://orcid.org/0000-0003-3686-7805
Kim A PappAlliance Clinical Trials and Probity Medical Research, Waterloo, Ontario, Canada.ORCID https://orcid.org/0000-0001-9557-3642
Diamant ThaçiInstitute for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Marjolein S De Bruin-WellerDepartment of Dermatology and Allergology, Utrecht University/UMC Utrecht, Utrecht, Netherlands.
Adam ReichDepartment of Dermatology, University of Rzeszów, Rzeszów, Poland.
Ketty PerisDepartment of Dermatology, Catholic University of the Sacred Heart, Milan, Italy.
Kirk BarberProf., Kirk Barber Research, Calgary, Alberta, Canada.
Ryszard GalusSynexus Polska Sp. z o.o. Oddzial w, Warszawa, Poland.
Andrzej Kaszuba"DERMED" Centrum Medyczne, Sp. z o.o., Lodz, Poland.
Matthew ZirwasDOCS Dermatology, Columbus, Ohio, USA.
Walter K NahmUniversity of California, San Diego School of Medicine, San Diego, California, USA.
Gretel TrullenqueFloridian Research Institute, LLC, Miami, Florida, USA.
Laura MaintzDepartment of Dermatology and Allergy, University Hospital Bonn, Germany.
Sady AlpizarClinical Research Trials of Florida, Inc., Tampa, Florida, USA.
Sang Wook SonKorea University Ansan Hospital, Ansan-si, Gyeonggi-do, Korea.
Vivian LaquerFirst OC Dermatology Research, Fountain Valley, California, USA.
Linda Stein GoldHenry Ford Medical Center, New Center One, Dermatology Research, Detroit, Michigan, USA.ORCID https://orcid.org/0000-0002-2758-1605
Soo Yeon CheongGalderma R&D, Dallas, Texas, USA.
Anna RyzhkovaGalderma R&D, Zug, Switzerland.
Agnes DrahosGalderma R&D, Lausanne, Switzerland.
Liliana UlianovGalderma R&D, Lausanne, Switzerland.
Christophe PikettyGalderma R&D, Zug, Switzerland.ORCID https://orcid.org/0000-0002-9969-2478

Funding

Galderma
6 · The paper itself

Abstract

backgroundAtopic dermatitis (AD) is a common, chronic, relapsing, pruritic, neuroimmune skin disease, requiring long-term symptom control.

objectivesThe ARCADIA long-term extension (LTE) study evaluates nemolizumab safety and efficacy in ≥12-year-old patients with moderate-to-severe AD up to 200 weeks.

methodsPatients from previous nemolizumab AD trials (Phase 2/3) or newly recruited adolescents with moderate-to-severe AD were enrolled. A background regimen of topical corticosteroids with/without topical calcineurin inhibitors was permitted based on disease control. Long-term safety was the primary endpoint. Efficacy assessments were secondary endpoints, including the proportion of patients achieving Investigator's Global Assessment (IGA) 0/1 (clear/almost clear), Eczema Area and Severity Index (EASI)-75 (75% improvement from lead-in baseline in EASI), Visual Analogue Scale (VAS) Pruritus and VAS sleep loss ≥4-point improvement from lead-in baseline and quality of life. Observed data up to Week (W) 104 are presented for patients with previous nemolizumab experience (PNE) and no previous nemolizumab experience (NNE) at LTE baseline.

resultsAt interim analysis data cut-off (21 July 2024), 1062 of 1901 patients completed W104. Exposure to nemolizumab in this study was equal across cohorts. The majority (92.6%) of treatment-emergent adverse events (TEAEs) were mild/moderate in severity; only 22.1% were considered related to nemolizumab. The most common (≥5.0%) TEAEs were COVID-19 (19.6%), nasopharyngitis (19.5%), atopic dermatitis (18.1%), upper respiratory tract infection (12.7%), headache (6.5%) and asthma (5.5%). At LTE baseline, the proportion of PNE and NNE patients was IGA 0/1: 27.1% and 17.1%; EASI-75: 38.8% and 25.8%; VAS Pruritus ≥4-point improvement: 58.7% and 31.6%; and VAS sleep loss ≥4-point improvement: 52.9% and 31.6%, respectively. At W104, this proportion was IGA 0/1: 62.6% and 58.2%; EASI-75: 88.2% and 85.4%; VAS Pruritus ≥4-point improvement: 87.2% and 82.0%; and VAS sleep loss ≥4-point improvement: 70.8% and 68.9%, respectively.

conclusionsContinuous nemolizumab treatment was well-tolerated through W104 with clinically meaningful improvements in AD signs and symptoms and patient-reported outcomes.

trial registrationNCT03989206: https://clinicaltrials.gov/search?term=NCT03989206; EUDRACT number: 2019-001889-15. Data available upon request: clinical.studies@galderma.com.

Indexed as

Antibodies, Monoclonal, HumanizedDermatitis, AtopicAdolescentAdultChildFemaleHumansMalePruritusQuality of LifeSeverity of Illness IndexTreatment OutcomeYoung AdultAntibodies, Monoclonal, Humanizednemolizumabadolescentadultatopic dermatitisIL‐31nemolizumabPruritus

Identifiers

PMID41081535
PMCPMC13109752

What OpenQuestion holds

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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 OpenQuestion graph.