TY - JOUR
T1 - Magnitude and Time Course of Response to Abrocitinib for Moderate-to-Severe Atopic Dermatitis
AU - Reich, Kristian
AU - Lio, Peter A.
AU - Bissonnette, Robert
AU - Alexis, Andrew F.
AU - Lebwohl, Mark G.
AU - Pink, Andrew E.
AU - Kabashima, Kenji
AU - Boguniewicz, Mark
AU - Nowicki, Roman J.
AU - Valdez, Hernan
AU - Zhang, Fan
AU - DiBonaventura, Marco
AU - Cameron, Michael C.
AU - Clibborn, Claire
N1 - Funding Information:
This study was funded by Pfizer, Inc.Data sharing: Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions, and exceptions, Pfizer may also provide access to the related individual deidentified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information. Conflicts of interest: K. Reich has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by Pfizer, Inc, AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Forward Pharma, Gilead, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, Lilly, Medac, Novartis, Ocean Pharma, Sanofi, and UCB; and is cofounder of Moonlake Immunotherapeutics. P. A. Lio has served as advisor and/or paid speaker for and/or participated in clinical trials sponsored by Pfizer, Inc, AbbVie, Almirall, Altus Labs, Amyris, AOBiome, ASLAN Pharmaceuticals, Bodewell, Dermavant, Eli Lilly, Exeltis, Galderma, IntraDerm, Johnson & Johnson, LEO Pharma, Menlo Therapeutics, Micreos Pierre-Fabre, Realm Therapeutics, Regeneron/Sanofi-Genzyme, Theraplex, and UCB. R. Bissonnette is an investigator, advisory board member, speaker, consultant for and/or has received honoraria or grants from Pfizer, Inc, AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, GlaxoSmithKline-Stiefel, Immune Tolerance, Incyte, Janssen, Kineta, LEO Pharma, Merck, Novartis, and XenoPort, and is a shareholder of Innovaderm Research. A. F. Alexis has served as an investigator (research grant to department) for Almirall, Amgen, Arcutis, Bristol Myers Squibb, Cara, LEO Pharma, Galderma, Menlo, Novartis, and Valeant (Bausch Health); an advisory board member (honoraria) for Pfizer, Inc, AbbVie, Allergan, Almirall, Arcutis, Beiersdorf, Bristol Myers Squibb, Cassiopea, Dermavant, Foamix, Galderma, Janssen, LEO Pharma, L'Oréal, Menlo, Novartis, Regeneron, Sanofi/Genzyme, Scientis, Sol-Gel, UCB, and Valeant (Bausch Health); and a speaker (honoraria) for Pfizer, Inc, AstraZeneca, Sanofi-Genzyme, and Regeneron. M. G. Lebwohl is an employee of Mount Sinai, which receives research funds from Pfizer, Inc, AbbVie, Amgen, Arcutis, Boehringer Ingelheim, Dermavant, Eli Lilly, Incyte, Janssen Research & Development, LLC, LEO Pharma, Ortho Dermatologics, and UCB; and is a consultant for Pfizer, Inc, Aditum Bio, Allergan, Almirall, Arcutis, Avotres Therapeutics, BirchBioMed, Inc, BMD Skincare, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Corrona, Dermavant Sciences, Evelo, Facilitate International Dermatologic Education, Foundation for Research and Education in Dermatology, Inozyme Pharma, LEO Pharma, Meiji Seika Pharma, Menlo, Mitsubishi, NeuroDerm, Promius/Dr. Reddy's Laboratories, Serono, Theravance, and Verrica. A. E. Pink has acted as an advisor/speaker/investigator or received educational support from Pfizer, Inc, AbbVie, Almirall, Amgen, Bristol Myers Squibb, Eli Lilly, Janssen, La Roche-Posay, LEO Pharma, Novartis, Sanofi, and UCB. K. Kabashima has received honoraria for invited lectures from and served on consultant and/or advisory boards for Chugai, Kyowa Hakko Kirin, LEO Pharma, Mitsubishi Tanabe, Maruho, POLA, and Regeneron-Sanofi and was principal investigator for clinical trials with Japan Tobacco, Maruho, and Regeneron-Sanofi. M. Boguniewicz has done clinical research for Regeneron and Incyte and has been an advisor for Pfizer, Inc, AbbVie, Janssen, Lilly, LEO Pharma, Regeneron, and Sanofi-Genzyme. R. J. Nowicki has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by Pfizer, Inc, Galderma, Eli Lilly, Novartis, Sanofi-Genzyme, and UCB. M. C. Cameron is a former employee and shareholder of Pfizer, Inc, and has served as a scientific advisor for Incyte and Abbvie. H. Valdez, F. Zhang, M. DiBonaventura, and C. Clibborn are employees and stockholders of Pfizer, Inc.
Funding Information:
Editorial and medical writing support under the guidance of authors was provided by Renee Gordon, PhD, CMPP, at ApotheCom, San Francisco, Calif, and was funded by Pfizer, Inc, New York, NY, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-4).
Funding Information:
This study was funded by Pfizer , Inc.
Publisher Copyright:
© 2022 The Authors
PY - 2022/12
Y1 - 2022/12
N2 - 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: To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points. 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: 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: A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms.
AB - 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: To examine JADE COMPARE (NCT03720470) data using stringent efficacy end points. 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: 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: A greater proportion of patients treated with abrocitinib than placebo had almost complete control of AD signs and symptoms.
KW - Abrocitinib
KW - Atopic dermatitis
KW - Dupilumab
KW - Janus kinase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85139321281&partnerID=8YFLogxK
U2 - 10.1016/j.jaip.2022.08.042
DO - 10.1016/j.jaip.2022.08.042
M3 - Article
C2 - 36108923
AN - SCOPUS:85139321281
SN - 2213-2198
VL - 10
SP - 3228-3237.e2
JO - Journal of Allergy and Clinical Immunology: In Practice
JF - Journal of Allergy and Clinical Immunology: In Practice
IS - 12
ER -