Improvement in Measures of Quality of Life and Symptoms of Anxiety and Depression in Patients with Severe Alopecia Areata Achieving Sustained Scalp Hair Regrowth with Baricitinib
Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
Alopecia areata (AA) is an autoimmune disease associated with high rates of emotional and psychosocial distress. The analysis reported here describes the evolution of measures assessing health-related quality of life (HRQoL) and symptoms of anxiety and depression up to week 104 in patients who achieved sustained scalp hair regrowth during treatment with baricitinib in the BRAVE-AA phase III trials.
Methods
This post-hoc analysis included data from the double-blind, parallel-group, randomized, placebo-controlled phase III trials BRAVE-AA1 (ClinicalTrials.gov number: NCT03570749) and BRAVE-AA2 (ClinicalTrials.gov number: NCT03899259). Adults with severe AA (defined as a Severity of Alopecia Tool [SALT] score ≥ 50) randomized to baricitinib 4 mg or baricitinib 2 mg at baseline who achieved SALT score ≤ 20 by week 36 and maintained SALT score ≤ 20 through week 104 on the same dose of baricitinib were included in this analysis of integrated data. Scalp hair regrowth (SALT score) and improvements in Skindex-16 AA Scale and Hospital Anxiety and Depression Scale (HADS) domain scores were analyzed over the 104-week period using descriptive statistics.
Results
In total, 131 patients (88 on baricitinib 4 mg and 43 on baricitinib 2 mg) were included in this analysis. Across the two groups, the mean age (standard deviation) was 37.2 years (12.7), and 84 (64.1%) patients were female. The interquartile range) for time to achieve a SALT score ≤ 20 for patients treated with baricitinib 4 mg and baricitinib 2 mg was 13.1 and 19.6 weeks, respectively. By week 104, 91% (baricitinib 2 mg) and 96% (baricitinib 4 mg) of patients had achieved a SALT score ≤ 10 on baricitinib treatment. In both groups, progressive improvements in the Skindex-16 AA and HADS domain scores were observed up to week 104.
Conclusion
This analysis of adults with severe AA treated with baricitinib revealed that achievement of sustained clinically meaningful scalp hair regrowth (SALT score ≤ 20) was associated with improvements in both measures of HRQoL and symptoms of anxiety and depression up to week 104.
| Originalsprog | Engelsk |
|---|---|
| Tidsskrift | Dermatology and Therapy |
| ISSN | 2193-8210 |
| DOI | |
| Status | Accepteret/In press - 2024 |
Bibliografisk note
Funding Information:
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. Eli Lilly and Company are responsible for the Rapid service fees associated with the publication of this manuscript.
Funding Information:
Brittany Craiglow has received support for medical writing from Eli Lilly; consulting fees from Dermavant, Eli Lilly, Incyte, Pfizer, Concert Pharmaceuticals, Regeneron, Sanofi-Genzyme; payment and/or honoraria from Abbvie, Eli Lilly and Company, Incyte Corporation, Pfizer, Regeneron, and Sanofi Genzyme; support for attending meetings/travel from Eli Lilly and Pfizer; and is a member of the Board of Directors and Medical and Scientific Advisory Board and of the Foundation for Ichthyosis and Related Skin Types. Yang Won Lee has received support for the clinical trial from Eli Lilly and Company. Sergio Va\u00F1\u00F3\u2011Galv\u00E1n reports consulting fees and payment/honoraria from Eli Lilly and Company and Pfizer. Alexander Egeberg has received research funding from Abbvie, Danish National Psoriasis Foundation, Eli Lilly, Janssen, Kgl. Hofbundtmager Aage Bangs Foundation, Novartis, Pfizer, Boehringer Ingelheim, Bristol-Myers Squibb, Almirall, Simon Spies Foundation; consulting fees from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Galapagos NV, Galderma, Janssen, LEO Pharma, Mylan, Novartis, Pfizer, Samsung Bioepis, Boehringer Ingelheim, UCB, UNION Therapeutics, Horizon Therapeutics; payment/honoraria from AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, Galderma, Janssen, LEO Pharma, Mylan, Novartis, Pfizer, Samsung Bioepis, UCB; and support for attending congresses from Abbvie, Eli Lilly, Bristol-Myers Squibb, Janssen. He has participated on a data safety monitoring board/advisory boards from Samsung Bioepis and Horizon Therapeutics; and has stock options from LEO Pharma; Alexander Egeberg is an employee of LEO Pharma. Yves Dutronc, Frederick Durand, Evangeline Pierce, Guanglei Yu, and Yun\u2011Fei Chen are employees and shareholders of Eli Lilly and Company. Arash Mostaghimi has been a consultant for Hims and Hers, Abbvie, Sun Pharmaceuticals, Pfizer, Digital Diagnostics, Aslan, Boehringer Ingelheim, ACOM and Olaplex; received support for materials from Lilly; received royalties for the BELA, BETA, and ALFA scales outside of this work; received payment or honoraria from Lilly; received support for travel from Lilly; and is Secretary/Treasurer for the Medical Dermatology Society.
Publisher Copyright:
© The Author(s) 2024.
ID: 396992977