Evidence map›Paper›PMID 33954933›Full record

Trial reportAmerican journal of clinical dermatology2021

Impact of Oral Abrocitinib Monotherapy on Patient-Reported Symptoms and Quality of Life in Adolescents and Adults with Moderate-to-Severe Atopic Dermatitis: A Pooled Analysis of Patient-Reported Outcomes.

Jonathan I Silverberg, Jacob P Thyssen, Eric L Simpson, Gil Yosipovitch, Sonja Ständer, Hernan Valdez, Ricardo Rojo, Pinaki Biswas, Daniela E Myers, Claire Feeney and 1 more

Erratum issued 3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of clinical dermatology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 3 registered trials, which are not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
7.0field-weighted citation impact, top 3% 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
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 44 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. The Psychology of Atopic Dermatitis.Journal of clinical medicine · 2024
    Review
  8. Article
  9. Review
  10. Review
  11. Prevalence and associations of fatigue in childhood atopic dermatitis: A cross-sectional study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2023
    Observational
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. JAK-STAT pathway inhibitors in dermatology.Anais brasileiros de dermatologia
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 4 countries.

Jonathan I SilverbergThe George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
Jacob P ThyssenBispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
Eric L SimpsonOregon Health and Science University, Portland, OR, USA.
Gil YosipovitchMiami Itch Center, Miller School of Medicine, University of Miami, Miami, FL, USA.
Sonja StänderCenter for Chronic Pruritus, University of Münster, Münster, Germany.
Hernan ValdezPfizer Inc., New York, NY, USA.
Ricardo RojoPfizer Inc., Groton, CT, USA.
Pinaki BiswasPfizer Inc., New York, NY, USA.
Daniela E MyersPfizer Inc., Collegeville, PA, USA.
Claire FeeneyPfizer Ltd., Surrey, UK.
Marco DiBonaventuraPfizer Inc., New York, NY, USA. marco.dibonaventura@pfizer.com.ORCID http://orcid.org/0000-0002-8333-4676
Pfizer (United States) · USGeorge Washington University · USOregon Health & Science University · USPfizer (United Kingdom) · GBUniversity of Copenhagen · DKUniversity of Miami · USUniversity of Münster · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtopic dermatitis imparts a substantial patient burden, including itch, sleep disturbance, and decreased health-related quality of life.

objectiveThis analysis evaluated changes in patient-reported outcomes of disease-specific signs/symptoms and health-related quality of life in adult and adolescent patients with moderate-to-severe atopic dermatitis treated with once-daily oral abrocitinib 200-mg or 100-mg monotherapy.

methodsPooled data from one phase IIb (NCT02780167) and two phase III (NCT03349060, JADE MONO-1; NCT03575871, JADE MONO-2) monotherapy trials in adult and adolescent patients with moderate-to-severe atopic dermatitis were analyzed. Patient-reported outcome assessments included: global severity, itch, and multi-item measures that assess other signs and symptoms of atopic dermatitis. Additional patient-reported outcome assessments measured depression, anxiety, fatigue, disease-specific and general health-related quality of life, and work and general productivity among employed patients.

resultsOverall, 942 patients were included in this analysis. Improvements were observed from the first post-baseline assessment to week 12 across all patient-reported outcomes, including Patient Global Assessment (PtGA) score of 0/1 (35.5%, 19.8%, and 5.9% for 200 mg, 100 mg, and placebo, respectively), ≥ 4-point improvement in Night Time Itch Scale (NTIS; 57.0%, 42.7%, and 12.7%), change from baseline in Patient-Oriented Eczema Measure (POEM) score (- 11.4, - 8.2, and - 3.4), 1-point improvement in Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD; 75.2%, 65.1%, and 33.5%), Hospital Anxiety and Depression Scales (HADS) anxiety (- 2.0, - 1.7, and - 1.0) and depression (- 1.7, - 1.3, and - 0.1).

conclusionsAbrocitinib monotherapy improved disease-specific signs/symptoms and health-related quality of life across multiple domains as reported by adult and adolescent patients with moderate-to-severe atopic dermatitis, complementing clinician-reported efficacy and safety outcomes. CLINICAL

trial registrationNCT02780167 (registered 23 May, 2016), NCT03349060 (registered 21 November, 2017), NCT03575871 (registered 3 July, 2018).

Indexed as

Dermatitis, AtopicJanus Kinase InhibitorsPruritusQuality of LifeSulfonamidesAdministration, OralAdolescentAdultAgedAnxietyDepressionEfficiencyFatigueFemaleHumansMaleabrocitinibJanus Kinase InhibitorsPyrimidinesSulfonamides

Identifiers

PMID33954933
PMCPMC8200343
OpenAlexW3157192724

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.