Baricitinib provides rapid and sustained improvements in absolute EASI and SCORAD outcomes in adults with moderate-to-severe atopic dermatitis

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.

Keywords:

• Atopic dermatitis
• baricitinib
• Eczema Area and Severity Index (EASI)
• SCORing of Atopic Dermatitis (SCORAD)

Acknowledgments

The authors would like to thank Gabrielle Stack, PhD and Joyce O’Grady, PhD, medical writers and employees of Eli Lilly and Company, for writing and editorial support.

Disclosure statement

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.

Data availability statement

Lilly provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance, whichever is later. No expiration date for data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, blank or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at https://vivli.org/.

Additional information

Funding

This work was supported by Eli Lilly and Company, which contributed to study design, data collection, data analysis, data interpretation, manuscript preparation, and publication decisions.