Abstract
Background
Baricitinib is an oral selective Janus kinase 1/2 inhibitor approved for moderate-to-severe atopic dermatitis (AD) in adults.
Objectives
To evaluate absolute Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD) outcomes over 16 weeks and to link disease severity categories to quality of life (QoL) improvements.
Methods
This post-hoc analysis included patients enrolled in Phase3 monotherapy (BREEZE-AD1/AD2) and topical corticosteroid (TCS) combination therapy (BREEZE-AD7) trials and analyzed baricitinib 2 and 4 mg vs. placebo. Categorical outcomes were analyzed using Fisher’s exact test.
Results
Significantly more baricitinib-treated patients reached EASI ≤ 7 and SCORAD < 25 as early as week 1 in monotherapy and week 2 in TCS combination therapy, compared to placebo. Significant response vs. placebo was sustained until week 16 for EASI ≤ 7 (AD1/2 [p-value vs. placebo]: 2 mg = 19.9%, 4 mg = 25.4% [p = 0.001] and AD7: 2 mg = 40.4% [p = 0.087], 4 mg = 48.6% [p = 0.003]) and SCORAD < 25 (AD1/2: 2 mg = 12.2%, 4 mg = 19.4% [p = 0.001] and AD7: 2 mg = 30.3% [p = 0.025], 4 mg = 34.2% [p = 0.004]) severity categories. These effects were accompanied by rapid improvements in QoL.
Conclusion
Baricitinib-treated patients rapidly achieved recommended absolute EASI and SCORAD treatment outcomes which were sustained until week 16. Improvements in QoL were greater than EASI severity categories reflected, indicating that physician-assessed scores do not necessarily correlate with patients’ impression of AD severity.
Baricitinib is an oral selective Janus kinase 1/2 inhibitor approved for moderate-to-severe atopic dermatitis (AD) in adults.
Objectives
To evaluate absolute Eczema Area and Severity Index (EASI) and SCORing of Atopic Dermatitis (SCORAD) outcomes over 16 weeks and to link disease severity categories to quality of life (QoL) improvements.
Methods
This post-hoc analysis included patients enrolled in Phase3 monotherapy (BREEZE-AD1/AD2) and topical corticosteroid (TCS) combination therapy (BREEZE-AD7) trials and analyzed baricitinib 2 and 4 mg vs. placebo. Categorical outcomes were analyzed using Fisher’s exact test.
Results
Significantly more baricitinib-treated patients reached EASI ≤ 7 and SCORAD < 25 as early as week 1 in monotherapy and week 2 in TCS combination therapy, compared to placebo. Significant response vs. placebo was sustained until week 16 for EASI ≤ 7 (AD1/2 [p-value vs. placebo]: 2 mg = 19.9%, 4 mg = 25.4% [p = 0.001] and AD7: 2 mg = 40.4% [p = 0.087], 4 mg = 48.6% [p = 0.003]) and SCORAD < 25 (AD1/2: 2 mg = 12.2%, 4 mg = 19.4% [p = 0.001] and AD7: 2 mg = 30.3% [p = 0.025], 4 mg = 34.2% [p = 0.004]) severity categories. These effects were accompanied by rapid improvements in QoL.
Conclusion
Baricitinib-treated patients rapidly achieved recommended absolute EASI and SCORAD treatment outcomes which were sustained until week 16. Improvements in QoL were greater than EASI severity categories reflected, indicating that physician-assessed scores do not necessarily correlate with patients’ impression of AD severity.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 2216322 |
| Tidsskrift | Journal of Dermatological Treatment |
| Vol/bind | 34 |
| Udgave nummer | 1 |
| Antal sider | 9 |
| ISSN | 0954-6634 |
| DOI | |
| Status | Udgivet - 2023 |
Bibliografisk note
Funding Information:Jacob P. Thyssen has been a consultant for and/or has received grant/research/honorarium support from: Regeneron, Sanofi-Genzyme, LEO Pharma, AbbVie, Eli Lilly and Company, Pfizer. Thomas Bieber was speaker and/or consultant and/or Investigator for AbbVie, Affibody, Almirall, AnaptysBio, Arena, Asana Biosciences, ASLAN pharma, Bayer Health, BioVerSys, Böhringer-Ingelheim, Bristol-Myers Squibb, Connect Pharma, Dermavant, Domain Therapeutics, EQRx, Galderma, Glenmark, GSK, Incyte, Innovaderm, IQVIA, Janssen, Kirin, Kymab, LEO, LG Chem, Lilly, L’Oréal, MSD, Novartis, Numab, OM-Pharma, Pfizer, Pierre Fabre, Q32bio, RAPT, Sanofi/Regeneron, UCB. He is founder and chairman of the board of the non-profit biotech “Davos Biosciences”. C. Elise Kleyn’s conflicts of interest are as follows (including consulting fees, research or institutional support, and educational grants): Almirall, Amgen, Celgene, Eli Lilly and Company, Janssen Pharmaceuticals, La Roche-Posay, LEO Pharma, Novartis, Pfizer, and UCB. Audrey Nosbaum has received grants as an investigator and honoraria for lecturing, or consulting fees from: AbbVie, Celgene, Eli Lilly and Company, Galderma, Janssen Cilag, LEO Pharma, Medac, Novartis, Pierre Fabre, Pfizer, and Sanofi-Regeneron. Susanne Grond is an employee and minor shareholder of Eli Lilly and Company. The study was sponsored by Eli Lilly and Company, under license from Incyte Corporation. Helmut Petto was an employee of Eli Lilly and Company during the development of the publication. Elisabeth Riedl was an employee of Eli Lilly and Company during the development of the publication and has received honoraria for lecturing from Eli Lilly and Company. Her affiliation is Medical University Vienna. Andreas Wollenberg has served as an advisor and/or paid speaker for and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Beiersdorf, Bioderma, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Chugai, Galapagos, Galderma, Janssen-Cilag, LEO, Loreal, Eli Lilly, Novartis, Pfizer, Pierre Fabre, Regeneron, and Sanofi.
Publisher Copyright:
© 2023 The Author(s). Published with license by Taylor & Francis Group, LLC.