Evidence map›Paper›PMID 40654284›Full record

Trial reportAllergy2025

Multiomics Analysis of the Response to Ritlecitinib in Alopecia Areata Subtypes and Correlation With Efficacy.

Li Xi, Elena Peeva, Yuji Yamaguchi, Zhan Ye, Alexandre Lejeune, Craig Hyde, Emma Guttman-Yassky

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Allergy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02974868 (A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–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.

NCT02974868 phase2completednot on this map

A phase 2a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety profile of pf-06651600 and pf-06700841 in subjects with moderate to severe alopecia areata with a single-blind extension period and a cross-over open label extension period

TypeinterventionalSponsorPfizerRan2016 to 2019Enrolled142ConditionsAlopecia AreataArmsPF-06651600, PF-06700841, Placebo
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. 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

7 authors.

Li XiPfizer Inc, Cambridge, Massachusetts, USA.
Elena PeevaPfizer Inc, Cambridge, Massachusetts, USA.
Yuji YamaguchiPfizer Inc, Collegeville, Pennsylvania, USA.
Zhan YePfizer Inc, Cambridge, Massachusetts, USA.
Alexandre LejeunePfizer Inc, Paris, France.
Craig HydePfizer Inc, Cambridge, Massachusetts, USA.
Emma Guttman-YasskyDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.ORCID https://orcid.org/0000-0002-9363-324X

Funding

Pfizer
6 · The paper itself

Abstract

backgroundAlopecia areata (AA) is an autoimmune disease characterized by hair loss. This study examined changes in molecular signatures in lesional scalp of patients with AA subtypes (patchy-type AA [AAP] or alopecia totalis/alopecia universalis [AT/AU]) in response to treatment with JAK3/TEC family kinase inhibitor ritlecitinib and evaluated correlations between potential biomarker levels/changes and scalp hair regrowth.

methodsThis was a post hoc analysis of a biopsy substudy from a phase 2a trial of ritlecitinib in patients with AA and ≥ 50% scalp hair loss. Transcriptomic expression profiles from scalp samples of patients with AAP or AT/AU were analyzed using microarray. Changes from baseline in transcriptional and serum protein expression were evaluated, as were correlations between both these changes and the baseline profile with clinical response (scalp hair regrowth).

resultsFollowing 12 and 24 weeks of treatment, ritlecitinib downregulated key Type I (CCL5, CD8A, and GZMB) and Type II immunity-related genes (CCL13, CCL18, and IL13RA1), downregulated genes related to ritlecitinib's mechanism of action (ITK, JAK3, and BTK), and upregulated hair keratin genes in AAP and AT/AU lesions, with a lesser extent in AT/AU than AAP lesions. Baseline expression levels and changes from baseline to Weeks 12 and/or 24 in levels of genes and serum proteins related to Type I and II immunity, hair structure/function, and ritlecitinib's mechanism of action significantly correlated with clinical response at Weeks 12 and/or 24.

conclusionThese results provide support that treatment with ritlecitinib improves the gene expression profile in AA lesional scalp and is correlated with subsequent hair regrowth response.

trial registrationNCT02974868.

Indexed as

Alopecia AreataProtein Kinase InhibitorsAdultBiomarkersFemaleGene Expression ProfilingHumansMaleMiddle AgedMultiomicsTranscriptomeTreatment OutcomeBiomarkersProtein Kinase Inhibitorsalopecia areatabiomarkersmicroarrayritlecitinib

Identifiers

PMID40654284
PMCPMC12368755

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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.