Evidence map›Paper›PMID 38081155›Full record

Trial reportDermatology (Basel, Switzerland)2024

Abrocitinib Provides Rapid and Sustained Improvement in Skin Pain and Is Associated with Improved Quality of Life Outcomes in Adult and Adolescent Patients with Moderate-to-Severe Atopic Dermatitis.

Jacob P Thyssen, Anthony Bewley, Sonja Ständer, Carla Castro, Laurent Misery, Brian S Kim, Pinaki Biswas, Gary Chan, Daniela E Myers, Melissa Watkins and 3 more

5 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Dermatology (Basel, Switzerland), 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.3field-weighted citation impact, top 12% 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.

NCT02780167 phase2completednot on this map

A phase 2b randomized, double-blind, placebo-controlled, parallel, multicenter, dose-ranging, study to evaluate the efficacy and safety profile of pf-04965842 in subjects with moderate to severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2016 to 2017Enrolled269ConditionsAtopic DermatitisArmsPF-04965842, Placebo
NCT03349060 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2017 to 2019Enrolled387ConditionsDermatitis, AtopicArmsPF-04965842 100 mg, PF-04965842 200 mg, Placebo
NCT03575871 phase3completednot on this map

A phase 3 randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate the efficacy and safety of pf-04965842 monotherapy in subjects aged 12 years and older, with moderate to severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2018 to 2019Enrolled391ConditionsDermatitis, AtopicArmsPF-04965842 100 mg, PF-04965842 200 mg, Placebo
NCT03720470 phase3completednot on this map

A phase 3 randomized, double-blind, double-dummy, placebo-controlled, parallel group, multi-center study investigating the efficacy and safety of pf-04965842 and dupilumab in comparison with placebo in adult subjects on background topical therapy, with moderate to severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2018 to 2020Enrolled838ConditionsDermatitis, Dermatitis, Atopic, Eczema, Skin DiseasesArmsPF-04965842 100 mg, PF-04965842 200 mg, Dupilumab, Oral Placebo, Injectable Placebo
NCT03796676 phase3completednot on this map

A phase 3, randomized, double-blind, placebo-controlled, multi-center study investigating the efficacy and safety of pf-04965842 co-administered with background medicated topical therapy in adolescent participants 12 to <18 years of age with moderate-to-severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2019 to 2020Enrolled287ConditionsAtopic DermatitisArmsPlacebo, PF-04965842, PF04965842
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 8 citations in OpenAlex.

  1. Skin pain in pediatric atopic dermatitis: mechanisms and management.Current opinion in allergy and clinical immunology · 2026
    Review
  2. Article
  3. Observational
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

13 authors at 7 institutions in 5 countries.

Jacob P ThyssenDepartment of Dermatology and Wound Healing, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Anthony BewleyBarts Health NHS Trust, London, UK.
Sonja StänderCenter for Chronic Pruritus, Münster University Hospital, Münster, Germany.
Carla CastroPediatric Dermatology, Hospital Universitario Austral, Pilar, Argentina.
Laurent MiseryUniversity Hospital of Brest, Brest, France.
Brian S KimDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Pinaki BiswasPfizer Inc., New York, New York, USA.
Gary ChanPfizer Inc., Groton, Connecticut, USA.
Daniela E MyersPfizer Inc., Collegeville, Pennsylvania, USA.
Melissa WatkinsPfizer Inc., New York, New York, USA.
Justine AlderferPfizer Inc., Collegeville, Pennsylvania, USA.
Erman GülerPfizer Inc., Istanbul, Turkey.
Jonathan I SilverbergThe George Washington University School of Medicine and Health Sciences, Washington, District of Columbia, USA.
Pfizer (United States) · USBarts Health NHS Trust · GBCentre Hospitalier Régional Universitaire de Brest · FRGeorge Washington University · USHospital Universitario Austral · ARIcahn School of Medicine at Mount Sinai · USUniversity Hospital Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSkin pain in atopic dermatitis (AD) increases with disease severity and is associated with substantial quality of life (QoL) burden.

objectivesThe aim of the study was to evaluate abrocitinib efficacy on skin pain and QoL in adults and adolescents with moderate-to-severe AD.

methodsThis post hoc analysis included data with abrocitinib administered as monotherapy (pooled phase 2b [NCT02780167] and phase 3 JADE MONO-1 [NCT03349060] and JADE MONO-2 [NCT03575871]) or in combination with topical therapy (phase 3 JADE COMPARE [NCT03720470] and JADE TEEN [NCT03796676]). Patients received oral, once-daily abrocitinib 200 mg, abrocitinib 100 mg, or placebo for 12 or 16 weeks (JADE COMPARE). Skin pain was rated using the Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) skin pain Numerical Rating Scale (NRS) item ("How painful was your skin over the past 24 h?") on a scale from 0 (not painful) to 10 (extremely painful). Itch (Peak Pruritus NRS) and QoL (Dermatology Life Quality Index or Children's Dermatology Life Quality Index) were assessed. Least squares mean (LSM) change from baseline was analyzed using mixed-effects repeated measures modeling.

resultsA total of 1,822 patients (monotherapy pool, n = 942; JADE COMPARE, n = 595; and JADE TEEN, n = 285) were analyzed. LSM change from baseline in PSAAD skin pain score was significantly greater with abrocitinib versus placebo from week 2 through week 12 or 16 across all 3 study populations and occurred in a dose-dependent manner. A greater proportion of patients achieved a ≥4-point improvement from baseline in PSAAD skin pain score with abrocitinib (200 mg and 100 mg) versus placebo in the monotherapy pool (56% and 38% vs. 12%; week 12), JADE COMPARE (72% and 52% vs. 26%; week 16), and JADE TEEN (51% and 60% vs. 31%; week 12). Additionally, a greater proportion of patients achieved a stringent threshold of skin pain improvement (PSAAD skin pain score &lt;2) with abrocitinib versus placebo. Adults and adolescents who achieved a ≥4-point improvement in skin pain reported greater QoL improvement than those who did not achieve a ≥4-point improvement. A positive correlation (≥0.3) was observed between skin pain and QoL and separately between skin pain and itch across the 3 study populations.

conclusionAbrocitinib as monotherapy or in combination with topical therapy improved skin pain and was associated with improved QoL in both adults and adolescents with moderate-to-severe AD across all evaluated studies.

Indexed as

Dermatitis, AtopicPyrimidinesSulfonamidesAdolescentAdultHumansPainPruritusQuality of LifeSeverity of Illness IndexTreatment OutcomeabrocitinibPyrimidinesSulfonamidesAbrocitinibAtopic dermatitisJAK1 inhibitorQuality of lifeSkin pain

Identifiers

PMID38081155
PMCPMC10997245
OpenAlexW4389541716

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.