Evidence map›Paper›PMID 36066323›Full record

Trial reportJournal of the European Academy of Dermatology and Venereology : JEADV2023

Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis.

Andrew Blauvelt, Leon Kircik, Kim A Papp, Eric L Simpson, Jonathan I Silverberg, Brian S Kim, Shawn G Kwatra, Michael E Kuligowski, May E Venturanza, Shaoceng Wei and 1 more

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the European Academy of Dermatology and Venereology : JEADV, 2023. 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 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Rapid pruritus reduction with ruxolitinib cream treatment in patients with atopic dermatitis.Journal of the European Academy of Dermatology and Venereology : JEADV · 2023
    Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Ruxolitinib Cream 1.5%: A Review in Mild to Moderate Atopic Dermatitis.American journal of clinical dermatology · 2023
    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

11 authors.

Andrew BlauveltOregon Medical Research Center, Portland, Oregon, USA.ORCID https://orcid.org/0000-0002-2633-985X
Leon KircikIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Kim A PappK. Papp Clinical Research and Probity Medical Research, Waterloo, Ontario, Canada.ORCID https://orcid.org/0000-0001-9557-3642
Eric L SimpsonOregon Health & Science University, Portland, Oregon, USA.
Jonathan I SilverbergGeorge Washington University, Washington, District of Columbia, USA.ORCID https://orcid.org/0000-0003-3686-7805
Brian S KimIcahn School of Medicine at Mount Sinai, New York, New York, USA.
Shawn G KwatraJohns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID https://orcid.org/0000-0003-3736-1515
Michael E KuligowskiIncyte Corporation, Wilmington, Delaware, USA.
May E VenturanzaIncyte Corporation, Wilmington, Delaware, USA.
Shaoceng WeiIncyte Corporation, Wilmington, Delaware, USA.
Jacek C SzepietowskiDepartment of Dermatology, Venereology, and Allergology, Wroclaw Medical University, Wroclaw, Poland.ORCID https://orcid.org/0000-0003-0766-6342

Funding

Incyte Corporation
6 · The paper itself

Abstract

backgroundRuxolitinib cream is a topical formulation of ruxolitinib, a Janus kinase (JAK) 1/JAK2 inhibitor.

objectivesTo report timing and magnitude of effect of ruxolitinib cream on itch in patients with atopic dermatitis (AD), a highly pruritic inflammatory skin disease.

methodsTwo phase 3 trials (TRuE-AD1 [NCT03745638]/TRuE-AD2 [NCT03745651]) enrolled patients aged ≥12 years with AD for ≥2 years, Investigator's Global Assessment score of 2 or 3, and 3%-20% affected body surface area. Patients (total N = 1249; median age, 32 years) were randomised (2:2:1) to twice daily 0.75% ruxolitinib cream, 1.5% ruxolitinib cream or vehicle cream for 8 weeks of double-blinded treatment. Worst itch was measured using the numerical rating scale (NRS).

resultsSignificantly more patients who applied ruxolitinib cream (either strength) achieved a ≥2-point itch reduction (NRS2) within approximately 12 h versus vehicle (0.75%/1.5% ruxolitinib cream, 16.3%/13.1%; vehicle, 6.9%; both P < 0.05), with further improvements through Week 8 (58.3%/65.1% vs 29.4%; both P < 0.0001). A ≥4-point itch reduction (NRS4) was achieved by significantly more patients who applied 0.75%/1.5% ruxolitinib cream versus vehicle by Day 2 (8.9%/11.2% vs 2.1%; P < 0.005); higher rates were observed at Week 8 (41.5%/51.5% vs 15.8%; P < 0.0001). Median time for the 0.75%/1.5% ruxolitinib cream groups to achieve NRS4 from baseline was 15.0/13.0 days; this endpoint was not reached by the vehicle group.

conclusionsRuxolitinib cream demonstrated rapid improvement in itch in patients with mild to moderate AD that was sustained for 8 weeks. Significantly more patients applying ruxolitinib cream achieved itch NRS2 within approximately 12 h and itch NRS4 by Day 2 versus vehicle.

Indexed as

Dermatitis, AtopicJanus Kinase InhibitorsAdultDouble-Blind MethodEmollientsHumansNitrilesPruritusPyrazolesPyrimidinesSeverity of Illness IndexTreatment OutcomeEmollientsJanus Kinase InhibitorsNitrilesPyrazolesPyrimidinesruxolitinib

Identifiers

PMID36066323
PMCPMC10087253

What OpenQuestion holds

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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.