Evidence map›Paper›PMID 33834521›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2021

Impact of baricitinib in combination with topical steroids on atopic dermatitis symptoms, quality of life and functioning in adult patients with moderate-to-severe atopic dermatitis from the BREEZE-AD7 Phase 3 randomized trial.

A Wollenberg, T Nakahara, C Maari, K Peris, P Lio, M Augustin, J I Silverberg, M J Rueda, A M DeLozier, E Pierce and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05969730 (Efficacy and Safety of Baricitinib Versus Azathioprine in Combination With Topical Corticosteroids For Patients With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
9.9field-weighted citation impact, top 2% 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.

NCT05969730 nacompletednot on this mapstarted 2023, after this paper: background citation

Efficacy and Safety of Baricitinib Versus Azathioprine in Combination With Topical Corticosteroids For Patients With Moderate-to-Severe Atopic Dermatitis

TypeinterventionalSponsorMazandaran University of Medical SciencesRan2023 to 2025Enrolled40ConditionsAtopic DermatitisArmsBaricitinib 4 MG, Azathioprine 1.5-2.5 mg/kg
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Observational
  5. Article
  6. Review
  7. Review
  8. Eliminating Ambiguous Treatment Effects Using Estimands.American journal of epidemiology · 2023
    Article
  9. Review
  10. Review
  11. Review
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Baricitinib: A Review in Moderate to Severe Atopic Dermatitis.American journal of clinical dermatology · 2022
    Review
  18. Review
  19. JAK inhibitors in the treatment of atopic dermatitis.The Journal of allergy and clinical immunology · 2021
    Review
  20. 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

15 authors at 9 institutions in 6 countries.

A WollenbergDepartment of Dermatology and Allergy, Ludwig Maximillian University, Munich, Germany.ORCID https://orcid.org/0000-0003-0177-8722
T NakaharaDepartment of Dermatology, Kyushu University, Fukuoka, Japan.
C MaariDivision of Dermatology, Innovaderm Research and Montreal University, Montreal, Quebec, Canada.
K PerisDermatology, Università Cattolica del Sacro Cuore and Fondazione Policlinico Agostino Gemelli - IRCCS, Rome, Italy.ORCID https://orcid.org/0000-0003-1957-6600
P LioNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.ORCID https://orcid.org/0000-0001-7600-0152
M AugustinUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.ORCID https://orcid.org/0000-0002-4026-8728
J I SilverbergGeorge Washington University School of Medicine and Health Sciences, Washington, DC, USA.ORCID https://orcid.org/0000-0003-3686-7805
M J RuedaEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
A M DeLozierEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
E PierceEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
F E YangEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
L SunEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
S BallEli Lilly and Company, Lilly Corporate Center, Indianapolis, IN, USA.
M TauberToulouse University and CHU Larrey, Toulouse, France.
C PaulToulouse University and CHU Larrey, Toulouse, France.
Eli Lilly (United States) · USHôpital Larrey · FRGeorge Washington University · USInnovaderm (Canada) · CAKyushu University · JPLudwig-Maximilians-Universität München · DENorthwestern University · USUniversità Cattolica del Sacro Cuore · ITUniversität Hamburg · DE

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

backgroundBaricitinib is an oral, selective, reversible Janus kinase 1/2 inhibitor approved in the European Union and Japan and under investigation in the United States for treatment of atopic dermatitis (AD).

objectivesTo evaluate the impact of baricitinib plus background topical corticosteroids (TCS) on health-related quality of life (HRQoL), how AD symptoms impact work productivity and life functioning, and treatment benefit using patient-reported outcome (PRO) assessments in patients with moderate-to-severe AD previously experiencing inadequate response to TCS.

methodsAdult patients with AD in BREEZE-AD7, a Phase 3, multicentre, double-blind trial, were randomised 1 : 1 : 1 to daily oral placebo (control) or baricitinib 4- or 2-mg plus TCS. PROs reported Week 1 through Week 16: Dermatology Life Quality Index (DLQI), Work Productivity and Activity Impairment-AD (WPAI-AD); Patient-Reported Outcomes Measurement Information System (PROMIS) Itch and Sleep measures, and Patient Benefit Index (PBI). Data were analysed using logistic regression (categorical) and mixed model repeated measures (continuous). PBI scores were analysed using analysis of variance.

resultsA total of 329 patients were randomised. Treatment with baricitinib 4-mg (N = 111) or 2 mg (N = 109) plus TCS led to rapid, statistically significant improvements [vs. TCS plus placebo (N = 109)] in DLQI ≥4-point improvement starting at Week 2 (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05), change from baseline in WPAI-AD presenteeism at Week 1 (4-mg plus TCS, P ≤ 0.01; 2-mg plus TCS P ≤ 0.05) and PROMIS itch interference at Week 2 (4-mg plus TCS P ≤ 0.01). Improvements were sustained through Week 16 for baricitinib 4-mg. Statistically significant improvements were observed at Week 16 for PBI global score (4-mg plus TCS, P ≤ 0.001; 2-mg plus TCS P ≤ 0.05).

conclusionsBaricitinib plus TCS vs. placebo plus TCS showed significant improvements in treatment benefit at Week 16 and rapid significant improvements in HRQoL and impact of AD symptoms on work productivity and functioning through 16 weeks.

Indexed as

Dermatitis, AtopicQuality of LifeAdultAzetidinesDouble-Blind MethodHumansJapanPurinesPyrazolesSeverity of Illness IndexSteroidsSulfonamidesTreatment OutcomeAzetidinesbaricitinibPurinesPyrazolesSteroidsSulfonamides

Identifiers

PMID33834521
PMCPMC8251919
OpenAlexW3149413846

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.