Evidence map›Paper›PMID 36808602›Full record

ArticleAmerican journal of clinical dermatology2023

Efficacy and Safety of Dupilumab Maintained in Adults ≥ 60 Years of Age with Moderate-to-Severe Atopic Dermatitis: Analysis of Pooled Data from Four Randomized Clinical Trials.

Jonathan I Silverberg, Charles W Lynde, Katrina Abuabara, Cataldo Patruno, Anna de Benedetto, Haixin Zhang, Ryan B Thomas, Gaëlle Bégo-Le-Bagousse, Faisal A Khokhar, Jignesh Vakil and 2 more

Erratum issued 4 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in American journal of clinical dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
–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.

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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Atopic Dermatitis in the Elderly Population.Acta dermato-venereologica · 2023
    Article
  17. Article
  18. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Jonathan I SilverbergDepartment of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID http://orcid.org/0000-0003-3686-7805
Charles W LyndeUniversity of Toronto, Markham, ON, Canada.
Katrina AbuabaraDepartment of Dermatology, University of California San Francisco, San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-7736-6946
Cataldo PatrunoDepartment of Health Sciences, Magna Graecia University, Catanzaro, Italy.ORCID http://orcid.org/0000-0001-8661-2822
Anna de BenedettoDepartment of Dermatology, University of Rochester Medical Center, Rochester, NY, USA.ORCID http://orcid.org/0000-0001-6293-435X
Haixin ZhangRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Ryan B ThomasRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Gaëlle Bégo-Le-BagousseSanofi, Chilly-Mazarin, France.
Faisal A KhokharRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA.
Jignesh VakilSanofi, Bridgewater, NJ, USA.
Ainara Rodríguez MarcoSanofi, Madrid, Spain.
Noah A LevitRegeneron Pharmaceuticals Inc., Tarrytown, NY, USA. noah.levit@regeneron.com.ORCID http://orcid.org/0000-0002-0797-5121

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAdults aged ≥ 60 years are often underrepresented in atopic dermatitis (AD) clinical trials; age-related comorbidities may impact treatment efficacy and safety.

objectiveThe aim was to report dupilumab efficacy and safety in patients aged ≥ 60 years with moderate-to-severe AD.

methodsData were pooled from four randomized, placebo-controlled dupilumab trials of patients with moderate-to-severe AD (LIBERTY AD SOLO 1 and 2, LIBERTY AD CAFÉ, and LIBERTY AD CHRONOS) and stratified by age (< 60 [N = 2261] and ≥ 60 [N = 183] years). Patients received dupilumab 300 mg every week (qw) or every 2 weeks (q2w), or placebo with/without topical corticosteroids. Post hoc efficacy at week 16 was examined using broad categorical and continuous assessments of skin lesions, symptoms, biomarkers, and quality of life. Safety was also assessed.

resultsIn the ≥ 60-year-old group at week 16, a greater proportion of dupilumab-treated patients achieved an Investigator's Global Assessment score of 0/1 (q2w: 44.4%; qw: 39.7%) and 75% improvement in Eczema Area and Severity Index (63.0%; 61.6%) versus placebo (7.1% and 14.3%, respectively; P < 0.0001). Type 2 inflammation biomarkers (immunoglobulin E and thymus and activation-regulated chemokine) were also significantly reduced in dupilumab- versus placebo-treated patients (P < 0.01). Results were similar in the < 60-year-old group. The exposure-adjusted incidences of adverse events in dupilumab-treated patients were generally similar to those receiving placebo, with numerically fewer treatment-emergent adverse events in the dupilumab-treated ≥ 60-year-old group versus placebo. LIMITATIONS: There were fewer patients in the ≥ 60-year-old group; post hoc analyses.

conclusionDupilumab improved AD signs and symptoms in patients aged ≥ 60 years; results were comparable to those in patients aged < 60 years. Safety was consistent with the known dupilumab safety profile.

trial registrationClinicalTrials.gov: NCT02277743, NCT02277769, NCT02755649, NCT02260986. Does dupilumab benefit adults aged 60 years and older with moderate-to-severe atopic dermatitis?(MP4 20,787 KB).

Indexed as

Dermatitis, AtopicAdultAgedAntibodies, Monoclonal, HumanizedDouble-Blind MethodHumansInjections, SubcutaneousMiddle AgedQuality of LifeRandomized Controlled Trials as TopicSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID36808602
PMCPMC10195762

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.