Evidence map›Paper›PMID 39104653›Full record

ArticleSkin health and disease2024

Abrocitinib may improve itch and quality of life in patients with itch-dominant atopic dermatitis.

Jonathan I Silverberg, Jacob P Thyssen, Irina Lazariciu, Daniela E Myers, Erman Güler, Raj Chovatiya

5 registry-linked trialsAbstract read
In one paragraph

Article in Skin health and disease, 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 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.

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
NCT03422822 phase3completednot on this map

A phase 3 multi-center, long-term extension study investigating the efficacy and safety of abrocitinib, with or without topical medications, administered to subjects aged 12 years and older with moderate to severe atopic dermatitis

TypeinterventionalSponsorPfizerRan2018 to 2025Enrolled3,166ConditionsDermatitis, AtopicArmsAbrocitinib 100 mg, Abrocitinib 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
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

6 authors.

Jonathan I SilverbergDepartment of Dermatology The George Washington University School of Medicine and Health Sciences Washington District of Columbia USA.
Jacob P ThyssenDepartment of Dermatology Bispebjerg Hospital University of Copenhagen Copenhagen Denmark.
Irina LazariciuDepartment of Biostatistics IQVIA Kirkland Quebec Canada.
Daniela E MyersPfizer Inc. Collegeville Pennsylvania USA.
Erman GülerPfizer Inc. Istanbul Turkey.
Raj ChovatiyaChicago Medical School, Rosalind Franklin University of Medicine and Science North Chicago Illinois USA.ORCID https://orcid.org/0000-0001-6510-399X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Patients with atopic dermatitis (AD) exhibit heterogeneous clinical phenotypes, reflecting different combinations of itch and lesional severity. AD with severe itch but clear-moderate lesions, also known as itch-dominant AD, is a common clinical phenotype. Objectives: To evaluate abrocitinib efficacy in patients with moderate-to-severe AD who have itch-dominant AD. Methods: This post hoc analysis includes pooled data from clinical trials of patients with moderate-to-severe AD receiving abrocitinib (100 or 200 mg) as monotherapy (phase 2b; phase 3 JADE MONO-1 and JADE MONO-2) or in combination with topical therapy (phase 3 JADE COMPARE). Data from the ongoing long-term JADE EXTEND trial (data cutoff April 2020) were also evaluated. Itch-dominant AD was defined as baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score of 7-10 and Investigator's Global Assessment of 0-3 or Eczema Area and Severity Index of 0‒21. Assessments included a ≥4-point improvement in PP-NRS (PP-NRS4), PP-NRS score of 0 (no itch) or 1 (little itch) in patients with PP-NRS score ≥2 at baseline, ≥4-point improvement from baseline in Patient-Oriented Eczema Measure (POEM-4), Patient Global Assessment (PtGA) of clear or almost clear, and Dermatology Life Quality Index (DLQI) score of 0 or 1 (no impact or little impact of AD on quality of life [QoL]). Results: In the pooled monotherapy trials, 37% of patients had itch-dominant AD at baseline. As early as Week 2, more patients with itch-dominant AD achieved PP-NRS4 with abrocitinib 100 mg (35%) and abrocitinib 200 mg (57%) versus placebo (7%); 6% and 22% versus 0%, respectively, achieved PP-NRS 0/1. More patients achieved a PtGA of clear/almost clear at Week 12 with abrocitinib 100 mg (28%) and abrocitinib 200 mg (45%) than placebo (9%). Additionally, abrocitinib led to clinically meaningful improvements in POEM and DLQI. Most patients with itch-dominant AD experienced itch improvement over time with abrocitinib monotherapy or with concomitant topical therapy; 86%-87% and 62%-67% of patients had no itch-moderate itch and clear-moderate lesions by weeks 24 and 48, respectively. Conclusions: Abrocitinib is highly efficacious in patients with itch-dominant AD, demonstrating rapid, deep, and sustained improvements in itch and clinically meaningful improvements in patients' QoL. Trial Registration Numbers: NCT02780167; NCT03349060; NCT03575871; NCT03720470; NCT03422822.

Identifiers

PMID39104653
PMCPMC11297436

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.