Evidence map›Paper›PMID 32557382›Full record

Trial reportAmerican journal of clinical dermatology2020

Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis.

Lisa A Beck, Diamant Thaçi, Mette Deleuran, Andrew Blauvelt, Robert Bissonnette, Marjolein de Bruin-Weller, Michihiro Hide, Lawrence Sher, Iftikhar Hussain, Zhen Chen and 7 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01949311 (An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Participated in Previous Dupilumab Clinical Trials), which is not on this map. Cited by 55 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 3 pooled it
12.0field-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.

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
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 3 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
  2. European Guideline (EuroGuiDerm) on atopic eczema: Living update.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
    Guideline
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. 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
  14. Article
  15. Review
  16. From Pathways to Patients in Atopic Dermatitis: Advanced Systemic Therapies.International journal of molecular sciences · 2025
    Review
  17. Emerging concepts in atopic dermatitis and atopic keratoconjunctivitis.Current opinion in allergy and clinical immunology · 2025
    Review
  18. Review
  19. Review
  20. 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

17 authors at 11 institutions in 6 countries.

Lisa A BeckDepartment of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.
Diamant ThaçiUniversity of Lübeck, Lübeck, Germany.
Mette DeleuranDepartment of Dermatology, Aarhus University Hospital, Aarhus, Denmark.
Andrew BlauveltOregon Medical Research, Portland, OR, USA.
Robert BissonnetteInnovaderm Research, Montreal, QC, Canada.
Marjolein de Bruin-WellerNational Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
Michihiro HideDepartment of Dermatology, Hiroshima University, Hiroshima, Japan.
Lawrence SherPeninsula Research Associates, Rolling Hills Estates, CA, USA.
Iftikhar HussainVital Prospects Clinical Research Institute, PC, Tulsa, OK, USA.
Zhen ChenRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Faisal A KhokharRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Bethany BeazleyRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Marcella RuddyRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Naimish PatelSanofi, Bridgewater, NJ, USA.
Neil M H GrahamRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Marius ArdeleanuRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA.
Brad ShumelRegeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY, 10591, USA. brad.shumel@regeneron.com.
Regeneron (United States) · USAarhus University Hospital · DKClinical Research Institute · USHiroshima University · JPInnovaderm (Canada) · CAOregon Medical Research Center · USPeninsula Research · USSanofi (United States) · USUniversity Medical Center Utrecht · NLUniversity of Lübeck · DEUniversity of Rochester Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundManagement of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment.

objectiveThe aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD.

methodsThis ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety.

resultsOf 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, - 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, - 65.4%) at week 148. LIMITATIONS: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose.

conclusionThese safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD.

trial registrationClinicalTrials.gov: NCT01949311. Dupilumab provides favorable safety and sustained efficacy for up to 3 years in an open-label study of adults with moderate-to-severe atopic dermatitis (MP4  139831 kb).

Indexed as

AdultAntibodies, Monoclonal, HumanizedConjunctivitisDermatitis, AtopicDrug MonitoringFemaleHeadacheHumansInjection Site ReactionInjections, SubcutaneousMaleMiddle AgedNasopharyngitisRespiratory Tract InfectionsSelf ReportSeverity of Illness IndexAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID32557382
PMCPMC7371647
OpenAlexW3036352764

What OpenQuestion holds

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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 OpenQuestion graph.