Evidence map›Paper›PMID 40900410›Full record

Trial reportAmerican journal of clinical dermatology2025

Efficacy and Safety of Upadacitinib in Patients With Moderate-to-Severe Atopic Dermatitis: Phase 3 Randomized Clinical Trial Results Through 140 Weeks.

Alan D Irvine, Vimal H Prajapati, Emma Guttman-Yassky, Eric L Simpson, Kim A Papp, Andrew Blauvelt, Chia-Yu Chu, H Chih-Ho Hong, Linda F Stein Gold, Marjolein de Bruin-Weller and 12 more

3 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in American journal of clinical dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

NCT03568318 phase3active not recruitingnot on this map

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorAbbVieRan2018 to 2030Enrolled1,533ConditionsAtopic DermatitisArmsPlacebo, Upadacitinib, Topical corticosteroids (TCS)
NCT03569293 phase3completednot on this map

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorAbbVieRan2018 to 2025Enrolled912ConditionsAtopic DermatitisArmsPlacebo for Upadacitinib, Upadacitinib
NCT03607422 phase3completednot on this map

A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Upadacitinib in Adolescent and Adult Subjects With Moderate to Severe Atopic Dermatitis

TypeinterventionalSponsorAbbVieRan2018 to 2025Enrolled912ConditionsAtopic DermatitisArmsPlacebo for Upadacitinib, Upadacitinib
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
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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

22 authors.

Alan D IrvineClinical Medicine, Trinity College Dublin, Dermatology, Children's Health Ireland at Crumlin, Dublin 12, Ireland. irvinea@tcd.ie.ORCID http://orcid.org/0000-0002-9048-2044
Vimal H PrajapatiDivision of Dermatology, Department of Medicine, University of Calgary, Calgary, AB, Canada.
Emma Guttman-YasskyThe Kimberly and Eric J. Waldman Department of Dermatology Director, Center of Excellence in Eczema Director, Laboratory of Inflammatory Skin Diseases, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Eric L SimpsonDepartment of Dermatology, Oregon Health and Science University, Portland, OR, USA.
Kim A PappProbity Medical Research and Alliance Clinical Trials, Waterloo, ON, Canada.
Andrew BlauveltBlauvelt Consulting, LLC, Annapolis, MD, USA.
Chia-Yu ChuDepartment of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
H Chih-Ho HongDepartment of Dermatology and Skin Science, University of British Columbia, Vancouver, BC, Canada.
Linda F Stein GoldDermatology Clinical Research, Henry Ford Health System, Detroit, MI, USA.
Marjolein de Bruin-WellerNational Expertise Center of Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands.
Thomas BieberChristine Kühne-Center for Allergy Research and Education, Medicine Campus, Davos, Switzerland.
Kenji KabashimaDepartment of Dermatology, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
David RosmarinDepartment of Dermatology, Indiana University School of Medicine, Indianapolis, IN, USA.
Cristina SanchoAbbVie Inc., North Chicago, IL, USA.
Brian M CalimlimAbbVie Inc., North Chicago, IL, USA.
Ayman GradaAbbVie Inc., North Chicago, IL, USA.
Yang YangAbbVie Inc., North Chicago, IL, USA.
Xiaoqiang WuAbbVie Inc., North Chicago, IL, USA.
Gweneth LevyAbbVie Inc., North Chicago, IL, USA.
Eliza M RaymundoAbbVie Inc., North Chicago, IL, USA.
Henrique D TeixeiraAbbVie Inc., North Chicago, IL, USA.
Jonathan I SilverbergDepartment of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUpadacitinib is an oral selective Janus kinase inhibitor approved to treat moderate-to-severe atopic dermatitis (AD) in adults and adolescents; long-term efficacy and safety data beyond 1 year are needed.

objectiveThe aim was to evaluate the long-term efficacy and safety of upadacitinib treatment through 140 weeks in patients with moderate-to-severe AD.

methodsMeasure Up 1 (MeUp1; NCT03569293), Measure Up 2 (MeUp2; NCT03607422), and AD Up (NCT03568318) are ongoing, phase 3, randomized clinical trials evaluating upadacitinib 15 mg (UPA15) and 30 mg (UPA30) in adults and adolescents with moderate-to-severe AD. This interim analysis evaluated efficacy and safety through week 140. At baseline, patients were randomized 1:1:1 to receive once-daily UPA15, UPA30, or placebo alone (MeUp1/2) or with concomitant topical corticosteroids (AD Up). At week 16, patients initially randomized to placebo were rerandomized 1:1 to UPA15 or UPA30. Skin and itch efficacy assessments included achievement of ≥ 75%/≥ 90%/100% improvement from baseline in Eczema Area and Severity Index (EASI 75/90/100), validated Investigator Global Assessment for AD score of clear/almost clear (vIGA-AD 0/1), and ≥ 4-point improvement from baseline in Worst Pruritus Numerical Rating Scale (∆WP-NRS≥4). Safety assessments included incidence of treatment-emergent adverse events.

resultsA total of 2782 patients were randomized in MeUp1/2 or AD Up. Efficacy response rates, including optimal outcomes such as EASI 90 and WP-NRS score of 0/1, were sustained through week 140 in all three studies. At week 140, EASI 75 was achieved by 85.5%/90.5% (UPA15/UPA30; integrated MeUp1/2) and 81.5%/90.0% (UPA15/UPA30; AD Up) of patients, and vIGA-AD 0/1 was achieved by 56.6%/64.4% (UPA15/UPA30; integrated MeUp1/2) and 52.0%/56.8% (UPA15/UPA30; AD Up) of patients. Over 60% of patients across all three studies achieved ∆WP-NRS≥4 at week 140. Pooled safety data across all three studies demonstrated safety profiles consistent with 16-week and 52-week analyses.

conclusionsUPA15 and UPA30 with and without topical corticosteroids demonstrated robust, durable efficacy and a favorable safety profile through 140 weeks in adults and adolescents with moderate-to-severe AD.

trial registrationMeasure Up 1 (NCT03569293; https://clinicaltrials.gov/study/NCT03569293 ), Measure Up 2 (NCT03607422; https://clinicaltrials.gov/study/NCT03607422 ), and AD Up (NCT03568318; https://clinicaltrials.gov/study/NCT03568318 ).

Indexed as

Dermatitis, AtopicHeterocyclic Compounds, 3-RingJanus Kinase InhibitorsAdministration, OralAdolescentAdrenal Cortex HormonesAdultDouble-Blind MethodDrug Therapy, CombinationFemaleHumansMaleMiddle AgedSeverity of Illness IndexTreatment OutcomeYoung AdultAdrenal Cortex HormonesHeterocyclic Compounds, 3-RingJanus Kinase Inhibitorsupadacitinib

Identifiers

PMID40900410
PMCPMC12615543

What Socratic 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 Socratic graph.