Evidence map›Paper›PMID 39546129›Full record

Trial reportAmerican journal of clinical dermatology2025

Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.

Eric L Simpson, Matthias Augustin, Diamant Thaçi, Laurent Misery, April W Armstrong, Andrew Blauvelt, Kim A Papp, Jacek C Szepietowski, Mark Boguniewicz, Shawn G Kwatra and 4 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of clinical dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing 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.

NCT03745638 phase3completednot on this map

A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

TypeinterventionalSponsorIncyte CorporationRan2018 to 2020Enrolled631ConditionsAtopic DermatitisArmsRuxolitinib Cream, Vehicle Cream
NCT03745651 phase3completednot on this map

Topical Ruxolitinib Evaluation in Atopic Dermatitis Study 2 (TRuE AD2) - A Phase 3, Double-Blind, Randomized, 8-Week, Vehicle-Controlled Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Adolescents and Adults With Atopic Dermatitis

TypeinterventionalSponsorIncyte CorporationRan2018 to 2020Enrolled618ConditionsAtopic DermatitisArmsRuxolitinib cream, Vehicle cream
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Therapeutic targeting of the cGAS-STING pathway in human disease.The Journal of clinical investigation · 2026
    Review
  6. Review
  7. Review
  8. Review
  9. Review
  10. Review
  11. Skin Care Supports Overall Well-Being.Clinical, cosmetic and investigational dermatology · 2025
    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

14 authors.

Eric L SimpsonOregon Health and Science University, 3303 S. Bond Ave, Portland, OR, 97239, USA. simpsone@ohsu.edu.ORCID http://orcid.org/0000-0003-0853-0252
Matthias AugustinInstitute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Centre Hamburg-Eppendorf (UKE), Hamburg, Germany.ORCID http://orcid.org/0000-0002-4026-8728
Diamant ThaçiInstitute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany.ORCID http://orcid.org/0000-0001-8513-550X
Laurent MiseryUniversity Hospital of Brest, Brest, France.ORCID http://orcid.org/0000-0001-8088-7059
April W ArmstrongUniversity of California Los Angeles, Los Angeles, CA, USA.
Andrew BlauveltOregon Medical Research Center, Portland, OR, USA.ORCID http://orcid.org/0000-0002-2633-985X
Kim A PappAlliance Clinical Trials and Probity Medical Research, Waterloo, ON, Canada.ORCID http://orcid.org/0000-0001-9557-3642
Jacek C SzepietowskiFaculty of Medicine, Wroclaw University of Science and Technology, Wroclaw, Poland.
Mark BoguniewiczNational Jewish Health, Denver, CO, USA.ORCID http://orcid.org/0000-0002-1015-4439
Shawn G KwatraDepartment of Dermatology, University of Maryland School of Medicine, Baltimore, MD, USA.
Howard KallenderIncyte Corporation, Wilmington, DE, USA.
Daniel SturmIncyte Corporation, Wilmington, DE, USA.
Haobo RenIncyte Corporation, Wilmington, DE, USA.
Leon KircikIcahn School of Medicine at Mount Sinai, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream.

objectiveThe aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2.

methodsIn the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8 weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]).

resultsA total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12 h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p < 0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p < 0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p < 0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52).

conclusionsConsistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available).

trial registrationClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).

Indexed as

Dermatitis, AtopicJanus Kinase InhibitorsPyrazolesQuality of LifeAdministration, CutaneousAdolescentAdultChildFemaleHumansMaleMiddle AgedNitrilesPatient Reported Outcome MeasuresPruritusPyrimidinesJanus Kinase InhibitorsNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID39546129
PMCPMC11742460

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.