Evidence map›Paper›PMID 41999446›Full record

Trial reportAdvances in therapy2026

Long-Term Dupilumab Treatment Is Not Associated with an Increased Overall Risk of Infections in Adults with Moderate-to-Severe Atopic Dermatitis: Results from an Open-Label 5-Year Extension Study.

Lisa A Beck, Eric L Simpson, Diamant Thaçi, Marjolein de Bruin-Weller, Mette Deleuran, Yoko Kataoka, Andrew Blauvelt, Andreas Wollenberg, Lawrence F Eichenfield, Faisal A Khokhar and 6 more

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 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 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.

NCT01949311 phase3completednot on this map

An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2013 to 2022Enrolled2,733ConditionsAtopic DermatitisArmsDupilumab
NCT02260986 phase3completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Study to Demonstrate the Efficacy and Long-Term Safety of Dupilumab in Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled740ConditionsAtopic DermatitisArmsDupilumab, Placebo (for Dupilumab), Topical Corticosteroid (TCS)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Infection risk in atopic dermatitis patients treated with biologics and JAK inhibitors: BioDay results.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    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

16 authors.

Lisa A BeckDepartment of Dermatology, University of Rochester Medical Center, Rochester, NY, USA. Lisa_Beck@URMC.Rochester.edu.ORCID http://orcid.org/0000-0002-8452-667X
Eric L SimpsonDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA.
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Marjolein de Bruin-WellerNational Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
Mette DeleuranDepartment of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
Yoko KataokaDepartment of Dermatology, Osaka Habikino Medical Center, Osaka, Japan.
Andrew BlauveltBlauvelt Consulting, LLC, Annapolis, MD, USA.
Andreas WollenbergInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.
Lawrence F EichenfieldDepartments of Dermatology and Pediatrics, University of California San Diego School of Medicine, La Jolla, CA, USA.
Faisal A KhokharRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Anna ColemanRegeneron Pharmaceuticals Inc., Dublin, Ireland.
Michael Van SpallSanofi, Cambridge, MA, USA.
Yonghao MaRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Elena AvetisovaRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Annie ZhangSanofi, Cambridge, MA, USA.
Tien V NguyenRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPatients with atopic dermatitis (AD) are at an increased risk for infections. Here, we report a confirmatory follow-up study analyzing the incidence of infections in adults with moderate-to-severe AD treated with dupilumab for up to 5 years.

methodsInfections in adults with moderate-to-severe AD treated with dupilumab 300 mg weekly (qw) or every 2 weeks (q2w; approved regimen) were assessed for up to 5 years in the open-label extension study, LIBERTY AD OLE. Topical corticosteroids (TCS) and calcineurin inhibitors (TCI) were permitted. Exposure-adjusted incidence rates [number of patients with at least one event per 100 patient-years (nP/100 PY)] are reported. Since the OLE had no control arm, safety results from the placebo + TCS arm of the 1-year LIBERTY AD CHRONOS study are included for comparisons.

resultsOf the 2677 patients included, 2207 (82.4%) completed up to week 52, 557 (20.8%) up to week 148, and 334 (12.5%) up to week 260; 226 patients (8.4%) switched from qw to q2w during the trial due to a protocol amendment. Overall infections (70.69 nP/100 PY), serious infections (0.87 nP/100 PY), severe infections (0.92 nP/100 PY), and infections leading to treatment discontinuation (0.34 nP/100 PY) were consistent with previous 4-year open-label extension (OLE) analyses and were low compared with 1-year results from the CHRONOS placebo + TCS arm. The cumulative number of patients with treatment-emergent serious or severe infections, non-herpetic or herpetic infections, and total skin infections decreased throughout the OLE study period. Limitations of this study include the absence of a placebo arm in the OLE, decreasing sample size at later time points, inclusion of qw dosing analyses (different from approved q2w dosing), and possible confounding effects of TCS/TCI use that may impact infection rates.

conclusionsLong-term dupilumab treatment for up to 5 years in adults with moderate-to-severe AD is not associated with an increased overall risk of infections. Graphical abstract available for this article.

trial registrationClinicalTrials.gov Identifier: NCT01949311, NCT02260986.

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatitis, AtopicDermatologic AgentsInfectionsAdultDrug Administration ScheduleFemaleFollow-Up StudiesHumansIncidenceMaleMiddle AgedSeverity of Illness IndexAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsdupilumabAtopic dermatitisDupilumabInfections

Identifiers

PMID41999446
PMCPMC13291011

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.