Evidence map›Paper›PMID 31066001›Full record

ArticleAmerican journal of clinical dermatology2019

Infections in Dupilumab Clinical Trials in Atopic Dermatitis: A Comprehensive Pooled Analysis.

Lawrence F Eichenfield, Thomas Bieber, Lisa A Beck, Eric L Simpson, Diamant Thaçi, Marjolein de Bruin-Weller, Mette Deleuran, Jonathan I Silverberg, Carlos Ferrandiz, Regina Fölster-Holst and 6 more

7 registry-linked trialsOpen access · hybridAbstract read
In one paragraph

Article in American journal of clinical dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 77 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed, 2 pooled it
21.5field-weighted citation impact, top 1% of its field
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.

NCT01548404 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Repeat-Dose Study of the Efficacy, Safety, Tolerability, and Pharmacodynamics of Subcutaneously-Administered REGN668 in Adult Patients With Extrinsic Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2012 to 2013Enrolled109ConditionsAtopic DermatitisArmsPlacebo, Dupilumab
NCT01859988 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of Dupilumab (REGN668) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2013 to 2014Enrolled380ConditionsAtopic DermatitisArmsDupilumab, Placebo
NCT02210780 phase2completednot on this map

A Randomized, Double-Blind, Placebo-Controlled, Study Investigating Vaccine Responses in Adults With Moderate to Severe Atopic Dermatitis Treated With Dupilumab

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2015Enrolled194ConditionsAtopic DermatitisArmsDupilumab, Placebo
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)
NCT02277743 phase3completednot on this map

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled671ConditionsDermatitis, AtopicArmsDupilumab, Placebo (for Dupilumab)
NCT02277769 phase3completednot on this map

A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2014 to 2016Enrolled708ConditionsDermatitis, AtopicArmsDupilumab, Placebo (for Dupilumab)
NCT02755649 phase3completednot on this map

A Phase 3 Study Investigating the Efficacy, Safety, and Tolerability of Dupilumab Administered to Adult Patients With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Are Intolerant to Oral Cyclosporine A, or When This Treatment is Not Medically Advisable

TypeinterventionalSponsorRegeneron PharmaceuticalsRan2016 to 2017Enrolled325ConditionsAtopic DermatitisArmsDupilumab, Matching Placebo
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 2 syntheses or guidelines pooled it, 174 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Review
  12. Article
  13. Addressing potential bias when assessing safety of biologics and JAK inhibitors in atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. From Pathways to Patients in Atopic Dermatitis: Advanced Systemic Therapies.International journal of molecular sciences · 2025
    Review
  20. Article

17 more citing papers are in PubMed but not listed here.

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 at 11 institutions in 5 countries.

Lawrence F EichenfieldDepartments of Dermatology and Pediatrics, University of California, San Diego, San Diego, CA, 92123, USA. Leichenfield@rchsd.org.ORCID https://orcid.org/0000-0002-2760-0474
Thomas BieberDepartment of Dermatology and Allergy, Christine Kühne-Center for Allergy Research and Education, University of Bonn, Bonn, Germany.ORCID https://orcid.org/0000-0002-8800-3817
Lisa A BeckDepartment of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.ORCID https://orcid.org/0000-0002-8452-667X
Eric L SimpsonDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA.ORCID https://orcid.org/0000-0002-8793-7087
Diamant ThaçiComprehensive Center for Inflammation Medicine, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
Marjolein de Bruin-WellerUniversity Medical Center Utrecht, Utrecht, The Netherlands.ORCID https://orcid.org/0000-0002-1249-6993
Mette DeleuranDepartment of Dermatology, Aarhus University Hospital, Aarhus, Denmark.ORCID https://orcid.org/0000-0003-0593-9925
Jonathan I SilverbergNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.ORCID https://orcid.org/0000-0003-3686-7805
Carlos FerrandizServicio de Dermatología, Hospital Universitario Germans Trias i Pujol, Badalona Universidad Autónoma de Barcelona, Barcelona, Spain.
Regina Fölster-HolstUniversity Hospital Schleswig-Holstein, Dermatology, Campus Kiel, Kiel, Germany.
Zhen ChenRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Neil M H GrahamRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Gianluca PirozziSanofi, Bridgewater, NJ, USA.
Bolanle AkinladeRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID https://orcid.org/0000-0003-2334-5717
George D YancopoulosRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Marius ArdeleanuRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.ORCID https://orcid.org/0000-0002-7712-6862
Regeneron (United States) · USUniversity Hospital Schleswig-Holstein · DEAarhus University Hospital · DKNorthwestern University · USOregon Health & Science University · USSanofi (United States) · USUniversitat Autònoma de Barcelona · ESUniversity Medical Center Utrecht · NLUniversity of Bonn · DEUniversity of California San Diego · USUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with moderate-to-severe atopic dermatitis (AD) have increased infection risk, including skin infections and systemic infections. Immunomodulators (e.g., anti-tumor necrosis factors, anti-interleukin [anti-IL]-23, anti-IL-17, Janus kinase inhibitors) increase risk of infections. Dupilumab (a monoclonal antibody blocking the shared receptor component for IL-4 and IL-13) is approved for inadequately controlled moderate-to-severe AD and for moderate-to-severe eosinophilic or oral corticosteroid-dependent asthma.

objectiveThe aim was to determine the impact of dupilumab on infection rates in patients with moderate-to-severe AD.

methodsThis analysis pooled data from seven randomized, placebo-controlled dupilumab trials in adults with moderate-to-severe AD. Exposure-adjusted analyses assessed infection rates.

resultsOf 2932 patients, 1091 received placebo, 1095 dupilumab 300 mg weekly, and 746 dupilumab 300 mg every 2 weeks. Treatment groups had similar infection rates overall per 100 patient-years (placebo, 155; dupilumab weekly, 150; dupilumab every 2 weeks, 156; dupilumab combined, 152), and similar non-skin infection rates. Serious/severe infections were reduced with dupilumab (risk ratio 0.43; p < 0.05), as were bacterial and other non-herpetic skin infections (risk ratio 0.44; p < 0.001). Although herpesviral infection rates overall were slightly higher with dupilumab than placebo, clinically important herpesviral infections (eczema herpeticum, herpes zoster) were less common with dupilumab (risk ratio 0.31; p < 0.01). Systemic anti-infective medication use was lower with dupilumab.

conclusionsDupilumab is associated with reduced risk of serious/severe infections and non-herpetic skin infections and does not increase overall infection rates versus placebo in patients with moderate-to-severe AD. CLINICALTRIALS. GOV IDENTIFIERS: NCT01548404, NCT02210780, NCT01859988, NCT02277743, NCT02277769, NCT02260986, and NCT02755649.

Indexed as

AdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDermatitis, AtopicDouble-Blind MethodHumansIncidenceInjections, SubcutaneousPlacebosRandomized Controlled Trials as TopicSeverity of Illness IndexSkin Diseases, InfectiousTreatment OutcomeAntibodies, MonoclonalAntibodies, Monoclonal, HumanizeddupilumabPlacebos

Identifiers

PMID31066001
PMCPMC6533236
OpenAlexW2944522746

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

and 1 more above

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.