Scalp hair regrowth is associated with improvements in health-related quality of life and psychological symptoms in patients with severe alopecia areata: results from two randomized controlled trials

Abstract

Introduction

This post hoc analysis assessed association between scalp hair regrowth and improvements in health-related quality of life (HRQoL) and psychological burden in patients with severe alopecia areata (AA).

Methods

Data were pooled from two phase-3 trials (N = 1200). Patients randomized to once-daily placebo, baricitinib 2-mg, or 4-mg were analyzed independently of treatment allocation, and categorized according to scalp hair regrowth (at Week 36): meaningful regrowth (Severity of Alopecia Tool (SALT) score ≤20); intermediate regrowth (≥30% SALT improvement [SALT₃₀] at any post-baseline visit to Week 36, but SALT score > 20 at Week 36); no/minimal regrowth (never achieved SALT₃₀). Skindex-16 for AA score change-from-baseline and proportion of patients with baseline Hospital Anxiety and Depression Scale (HADS) scores ≥8 that shifted to <8 (normal) were assessed.

Results

Patients with meaningful regrowth achieved greater improvements in all Skindex-16 AA domains versus no/minimal regrowth. More patients with meaningful versus no/minimal regrowth shifted from HADS ≥8 to <8 (anxiety:46.8% versus 26.4%; depression:52.3% versus 24.0%). Improvements occurred with intermediate regrowth but to a lesser extent versus meaningful regrowth.

Conclusions

Patients with severe AA and scalp hair regrowth at Week 36 experienced greater improvements in HRQoL and anxiety and depression versus patients with no/minimal regrowth. The highest benefit was observed in patients with meaningful regrowth (SALT score ≤20).ClinicalTrials.gov listing: NCT03570749 and NCT03899259

Keywords:

• Alopecia areata
• baricitinib
• health-related quality of life
• patient-reported outcomes

Acknowledgments

The authors would like to thank all patients, investigators, and study staff who participated in these trials. Medical writing and editorial support were provided by Kathy Oneacre, MA, of Syneos Health, funded by Eli Lilly and Company.

Ethical statement

IRB approval status: BRAVE-AA1 was first approved by Advarra IRB on August 13, 2018. BRAVE-AA2 was first approved by Quorum Review IRB on February 19, 2019. Study participants provided written informed consent prior to the start of study procedures.

Disclosure statement

Bianca Maria Piraccini reports lecture fees from Pierre Fabre-Ducray, Difa Cooper, and Dercos-L’Oreal and advisory fees from Pfizer, Eli Lilly Italy, ISDIN, Legacy Healthcare, and Almirall.

Manabu Ohyama receives lecture fees from Eli Lilly Japan K.K., advisory fees from Eli Lilly Japan K.K., Pfizer Japan Inc., Janssen Pharmaceutical K.K., Taisho Pharmaceutical Co., and RHOTO Pharmaceutical Co., and research grants not related to the current work from Maruho Corp., Sun Pharma Japan Ltd, ADVANTEST Co., and Shiseido Co.

Brittany Craiglow reports honoraria and/or fees from Concert Pharmaceuticals, Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

Anthony Bewley has had ad hoc consultancy agreements with AbbVie, Celgene Corporation, Galderma, Janssen Pharmaceuticals, LEO Pharma, Novartis and Stiefel (a GSK company).

Yuxin Ding, Yun-Fei Chen, Yves Dutronc, Evangeline Pierce, and Frederick Durand are employees and stockholders at Eli Lilly and Company.

Arash Mostaghimi reports consulting fees from Eli Lilly and Company, Pfizer, Equillium, hims and hers, ACOM, Digital Diagnostics, AbbVie, and Concert.

Data availability statement

Eli Lilly and Company 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 European Union, 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, and 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 www.vivli.org.

Additional information

Funding

This study was sponsored by Eli Lilly and Company, under license from Incyte Corporation.