Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis.


Journal

The journal of allergy and clinical immunology. In practice
ISSN: 2213-2201
Titre abrégé: J Allergy Clin Immunol Pract
Pays: United States
ID NLM: 101597220

Informations de publication

Date de publication:
Dec 2022
Historique:
received: 27 10 2021
revised: 17 08 2022
accepted: 18 08 2022
pubmed: 16 9 2022
medline: 15 12 2022
entrez: 15 9 2022
Statut: ppublish

Résumé

Emerging treatments for moderate-to-severe atopic dermatitis (AD) may provide greater and faster improvement in AD signs and symptoms than current therapies. To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points. Adults with moderate-to-severe AD were randomly assigned 2:2:2:1 to receive oral abrocitinib 200 or 100 mg once daily, subcutaneous dupilumab 300 mg every 2 weeks (600-mg loading dose), or placebo, with medicated topical therapy for 16 weeks. Stringent response thresholds were applied for Eczema Area and Severity Index (EASI), Investigator's Global Assessment, Dermatology Life Quality Index, Peak Pruritus Numerical Rating Scale, and Night Time Itch Scale severity. At week 16, 48.9%, 38.0%, and 38.8% of the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, achieved greater than or equal to 90% improvement from baseline in EASI versus 11.3% placebo; 14.9%, 12.6%, and 6.5% achieved Investigator's Global Assessment 0 (clear) versus 4.8% placebo; 29.7%, 21.6%, and 24.0% achieved Dermatology Life Quality Index 0/1 (no/minimal impact on quality of life) versus 10.6% placebo; and 57.1%, 44.5%, and 46.1% achieved Night Time Itch Scale severity 0/1 (no/minimal night-time itch) versus 31.9% placebo. Kaplan-Meier median time to greater than or equal to 90% improvement from baseline in EASI was 59, 113, and 114 days in the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, and was not evaluable for placebo; median time to Peak Pruritus Numerical Rating Scale 0/1 (no/very minimal itch) was 86 and 116 days for abrocitinib 200-mg and dupilumab groups, respectively, and was not evaluable for abrocitinib 100-mg and placebo groups. A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms.

Sections du résumé

BACKGROUND BACKGROUND
Emerging treatments for moderate-to-severe atopic dermatitis (AD) may provide greater and faster improvement in AD signs and symptoms than current therapies.
OBJECTIVE OBJECTIVE
To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points.
METHODS METHODS
Adults with moderate-to-severe AD were randomly assigned 2:2:2:1 to receive oral abrocitinib 200 or 100 mg once daily, subcutaneous dupilumab 300 mg every 2 weeks (600-mg loading dose), or placebo, with medicated topical therapy for 16 weeks. Stringent response thresholds were applied for Eczema Area and Severity Index (EASI), Investigator's Global Assessment, Dermatology Life Quality Index, Peak Pruritus Numerical Rating Scale, and Night Time Itch Scale severity.
RESULTS RESULTS
At week 16, 48.9%, 38.0%, and 38.8% of the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, achieved greater than or equal to 90% improvement from baseline in EASI versus 11.3% placebo; 14.9%, 12.6%, and 6.5% achieved Investigator's Global Assessment 0 (clear) versus 4.8% placebo; 29.7%, 21.6%, and 24.0% achieved Dermatology Life Quality Index 0/1 (no/minimal impact on quality of life) versus 10.6% placebo; and 57.1%, 44.5%, and 46.1% achieved Night Time Itch Scale severity 0/1 (no/minimal night-time itch) versus 31.9% placebo. Kaplan-Meier median time to greater than or equal to 90% improvement from baseline in EASI was 59, 113, and 114 days in the abrocitinib 200-mg, 100-mg, and dupilumab groups, respectively, and was not evaluable for placebo; median time to Peak Pruritus Numerical Rating Scale 0/1 (no/very minimal itch) was 86 and 116 days for abrocitinib 200-mg and dupilumab groups, respectively, and was not evaluable for abrocitinib 100-mg and placebo groups.
CONCLUSIONS CONCLUSIONS
A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms.

Identifiants

pubmed: 36108923
pii: S2213-2198(22)00926-6
doi: 10.1016/j.jaip.2022.08.042
pii:
doi:

Substances chimiques

abrocitinib 73SM5SF3OR

Banques de données

ClinicalTrials.gov
['NCT03720470']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

3228-3237.e2

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Auteurs

Kristian Reich (K)

University Medical Center Hamburg-Eppendorf, Hamburg, Germany.

Peter A Lio (PA)

Northwestern University Feinberg School of Medicine, Chicago, Ill.

Robert Bissonnette (R)

Innovaderm Research, Inc, Montreal, QC, Canada.

Andrew F Alexis (AF)

Weill Cornell Medicine, New York, NY.

Mark G Lebwohl (MG)

Icahn School of Medicine at Mount Sinai, New York, NY.

Andrew E Pink (AE)

St John's Institute of Dermatology, Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom.

Kenji Kabashima (K)

Kyoto University Graduate School of Medicine, Kyoto, Japan.

Mark Boguniewicz (M)

National Jewish Health and University of Colorado School of Medicine, Denver, Colo.

Roman J Nowicki (RJ)

Medical University of Gdańsk, Pomorskie, Poland.

Hernan Valdez (H)

Pfizer, Inc, New York, NY.

Fan Zhang (F)

Pfizer, Inc, Groton, Conn.

Marco DiBonaventura (M)

Pfizer, Inc, New York, NY.

Michael C Cameron (MC)

Pfizer, Inc, New York, NY.

Claire Clibborn (C)

Pfizer Ltd, Tadworth, Surrey, United Kingdom. Electronic address: Claire.Clibborn@pfizer.com.

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Classifications MeSH