Evidence map›Paper›PMID 35986699›Full record

Trial reportThe British journal of dermatology2022

Efficacy and safety of topical brepocitinib for the treatment of mild-to-moderate atopic dermatitis: a phase IIb, randomized, double-blind, vehicle-controlled, dose-ranging and parallel-group study.

Megan N Landis, Mark Arya, Stacy Smith, Zoe Draelos, Lisa Usdan, Sanela Tarabar, Vivek Pradhan, Sudeepta Aggarwal, Christopher Banfield, Elena Peeva and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
12.3field-weighted citation impact, top 1% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
    Pooled it
  2. Pooled it
  3. Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  4. Review
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  11. Article
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  14. Review
  15. [Janus kinase inhibitors for skin disorders].Dermatologie (Heidelberg, Germany) · 2024
    Article
  16. Review
  17. Review
  18. Article
  19. Novel Topical Treatments for Itch.Dermatology and therapy · 2024
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 5 institutions in 1 country.

Megan N LandisDepartment of Medicine (Dermatology), University of Louisville School of Medicine, Louisville, KY, USA.
Mark AryaAustralian Clinical Research Network, Maroubra, New South Wales, Australia.
Stacy SmithCalifornia Dermatology & Clinical Research Institute, Encinitas, CA, USA.
Zoe DraelosDermatology Consulting Services, PLLC, High Point, NC, USA.ORCID 0000-0001-9803-7415
Lisa UsdanCNS Healthcare, Memphis, TN, USA.
Sanela TarabarPfizer Inc, Cambridge, MA, USA.
Vivek PradhanPfizer Inc, Cambridge, MA, USA.
Sudeepta AggarwalPfizer Inc, Cambridge, MA, USA.
Christopher BanfieldPfizer Inc, Cambridge, MA, USA.
Elena PeevaPfizer Inc, Cambridge, MA, USA.
Michael S VincentPfizer Inc, Cambridge, MA, USA.
Vanja SikiricaPfizer Inc, Collegeville, PA, USA.
Jason XenakisPfizer Inc, New York, NY, USA.
Jean S BeebePfizer Inc, Cambridge, MA, USA.
Pfizer (United States) · USClinical Research Institute · USCNS Healthcare · USDermatology Consulting Services · USUniversity of Louisville · US

Funding

Pfizer Inc
6 · The paper itself

Abstract

backgroundAtopic dermatitis (AD) is a prevalent inflammatory, pruritic skin disease. The Janus kinase (JAK) pathway is a treatment target.

objectivesTo assess the efficacy, safety and pharmacokinetics of topical cream brepocitinib, a small-molecule tyrosine kinase 2 (TYK2)/JAK1 inhibitor, in participants with mild-to-moderate AD.

methodsIn this phase IIb, double-blind, dose-ranging study, participants were randomized to receive one of eight treatments for 6 weeks: brepocitinib 0·1% once daily (QD), 0·3% QD or twice daily (BID), 1·0% QD or BID, 3·0% QD, or vehicle QD or BID. The primary endpoint was the percentage change from baseline in the Eczema Area and Severity Index (EASI) total score at week 6. Adverse events (AEs) were monitored.

resultsOverall, 292 participants were enrolled and randomized. The brepocitinib 1% QD and 1% BID groups achieved statistically significantly greater (with multiplicity-adjusted P < 0·05 due to Hochberg's step-up method) percentage reductions from baseline in EASI total score at week 6 [least squares mean (90% confidence interval, CI): QD: -70·1 (-82·1 to -58·0); BID: -75·0 (-83·8 to -66·2)] compared with respective vehicle [QD: -44·4 (-57·3 to -31·6); BID: -47·6 (-57·5 to -37·7)]. There was not a dose-dependent trend in AE frequency, and there were no serious AEs or deaths.

conclusionsTopical brepocitinib is effective and well tolerated in participants with mild-to-moderate AD. What is already known about this topic? Janus kinase (JAK) inhibitors are in development for treatment of atopic dermatitis (AD). The tyrosine kinase 2 and JAK 1 inhibition by brepocitinib may bring a new profile for topical JAK inhibitors for treatment of mild-to-moderate AD. What does this study add? Topical brepocitinib can provide rapid, effective symptom reduction, and could offer a novel alternative to current topical treatments for mild-to-moderate AD.

Indexed as

Dermatitis, AtopicJanus Kinase InhibitorsDouble-Blind MethodHumansJanus KinasesSeverity of Illness IndexTreatment OutcomeTYK2 KinaseJanus Kinase InhibitorsJanus KinasesTYK2 Kinase

Identifiers

PMID35986699
PMCPMC10092158
OpenAlexW4292474822

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.