Evidence map›Paper›PMID 31564057›Full record

Trial reportThe British journal of dermatology2020

Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials.

N Katoh, Y Kataoka, H Saeki, M Hide, K Kabashima, T Etoh, A Igarashi, S Imafuku, M Kawashima, M Ohtsuki and 6 more

3 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in The British journal of dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
4.4field-weighted citation impact, top 6% 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.

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
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)
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Review
  7. Review
  8. Article
  9. Review
  10. Special Considerations of Atopic Dermatitis in Skin of Color.Advances in experimental medicine and biology · 2024
    Review
  11. Atopic Dermatitis Across Shades of Skin.American journal of clinical dermatology · 2023
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. A Literature Review of Real-World Effectiveness and Safety of Dupilumab for Atopic Dermatitis.JID innovations : skin science from molecules to population health · 2021
    Review
  18. Article
  19. 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

16 authors at 11 institutions in 2 countries.

N KatohDepartment of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.ORCID 0000-0002-3498-2482
Y KataokaDepartment of Dermatology, Osaka Habikino Medical Center, Osaka, Japan.ORCID 0000-0002-5121-0134
H SaekiDepartment of Dermatology, Nippon Medical School, Tokyo, Japan.ORCID 0000-0002-1095-0355
M HideDepartment of Dermatology, Hiroshima University, Hiroshima, Japan.ORCID 0000-0002-1569-6034
K KabashimaDepartment of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.ORCID 0000-0002-0773-0554
T EtohDepartment of Dermatology, Tokyo Teishin Postal Services Agency Hospital, Tokyo, Japan.
A IgarashiDepartment of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.
S ImafukuDepartment of Dermatology, Fukuoka University, Fukuoka, Japan.
M KawashimaDepartment of Dermatology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.
M OhtsukiDepartment of Dermatology, Jichi Medical University, Tochigi, Japan.
H FujitaSanofi K.K., Tokyo, Japan.
K ArimaSanofi K.K., Tokyo, Japan.ORCID 0000-0002-0607-8787
H TakagiSanofi K.K., Tokyo, Japan.
Z ChenRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
B ShumelRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
M ArdeleanuRegeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.
Regeneron (United States) · USSanofi (Japan) · JPFukuoka University · JPHiroshima University · JPJichi Medical University · JPKyoto Prefectural University of Medicine · JPKyoto University · JPNippon Medical School · JPNTT Medical Center · JPOsaka Prefectural Medical Center · JPTokyo Women's Medical University · JP

Funding

Regeneron PharmaceuticalsSanofi
6 · The paper itself

Abstract

backgroundDupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13. International phase II and III studies have evaluated the efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis (AD), but the effects of dupilumab in Japanese patients have not been reported.

objectivesTo evaluate the efficacy and safety of dupilumab in Japanese patients with moderate-to-severe AD.

methodsWe analysed the efficacy and safety of dupilumab in the Japanese cohorts of a 16-week, phase IIb dose-finding trial (AD-1021; NCT01859988); a 16-week, phase III, placebo-controlled monotherapy trial (LIBERTY AD SOLO 1; NCT02277743) and a 52-week, phase III, placebo-controlled study of dupilumab with topical corticosteroids (LIBERTY AD CHRONOS; NCT02260986).

resultsTwenty-seven, 106 and 117 Japanese patients were enrolled in AD-1021, SOLO 1 and CHRONOS, respectively. Baseline disease severity was numerically higher in the Japanese cohort than in the overall study population. Generally, dupilumab significantly improved signs and symptoms of AD, including pruritus and patient quality of life, compared with placebo in the Japanese cohort, consistent with the overall study population. The combined safety profile of dupilumab in the Japanese cohort was similar to that in the total study populations; dupilumab was associated with an increased incidence of injection-site reactions and conjunctivitis compared with placebo. Dupilumab was associated with rapid reduction in thymus and activation-regulated chemokine and gradual IgE reductions.

conclusionsDupilumab alone or with topical corticosteroids improved signs and symptoms of AD, had an acceptable safety profile, and suppressed biomarkers of type 2 inflammation compared with placebo in Japanese adult patients with moderate-to-severe AD. What's already known about this topic? Differences in atopic dermatitis (AD) pathology have been reported between Asian and Western populations, in which distinct helper T-cell activation profiles have been observed. International clinical studies in adults with moderate-to-severe AD have evaluated the efficacy and safety of dupilumab, which blocks interleukin-4 and interleukin-13, key molecules in type 2 inflammation. The effects of dupilumab in Japanese patients specifically have not yet been reported. What does this study add? Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD and had an acceptable safety profile compared with placebo in Japanese patients with moderate-to-severe AD. The effects were comparable with those observed in the overall study population. Reported immunological differences in AD pathology in Asian patients may be secondary to type 2 immune activation.

Indexed as

Dermatitis, AtopicAdultAntibodies, Monoclonal, HumanizedHumansJapanQuality of LifeSeverity of Illness IndexTreatment OutcomeAntibodies, Monoclonal, Humanizeddupilumab

Identifiers

PMID31564057
PMCPMC7384164
OpenAlexW2976798343

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.