Evidence map›Paper›PMID 38904749›Full record

ArticleDermatology and therapy2024

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.

Brittany Craiglow, Yang Won Lee, Sergio Vañó-Galván, Alexander Egeberg, Yves Dutronc, Frederick Durand, Evangeline Pierce, Guanglei Yu, Yun-Fei Chen, Arash Mostaghimi

Erratum issued 2 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03570749 phase2 / phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Operationally Seamless, Adaptive Phase 2/3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

TypeinterventionalSponsorEli Lilly and CompanyRan2018 to 2025Enrolled784ConditionsAlopecia AreataArmsBaricitinib, Placebo
NCT03899259 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib in Adult Patients With Severe or Very Severe Alopecia Areata

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2024Enrolled606ConditionsAlopecia AreataArmsBaricitinib, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Brittany CraiglowYale School of Medicine, New Haven, CT, USA. brittany.craiglow@yale.edu.
Yang Won LeeDepartment of Dermatology, Konkuk University School of Medicine, Seoul, Republic of Korea.
Sergio Vañó-GalvánRamón y Cajal University Hospital, Madrid, Spain.
Alexander EgebergDepartment of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark.
Yves DutroncEli Lilly and Company, Indianapolis, USA.
Frederick DurandEli Lilly and Company, Indianapolis, USA.
Evangeline PierceEli Lilly and Company, Indianapolis, USA.
Guanglei YuEli Lilly and Company, Indianapolis, USA.
Yun-Fei ChenEli Lilly and Company, Indianapolis, USA.
Arash MostaghimiBrigham and Women's Hospital, Boston, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAlopecia 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.

methodsThis 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.

resultsIn 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.

conclusionThis 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.

Indexed as

Alopecia areataBaricitinibHair loss disorderHealth-related quality of life

Identifiers

PMID38904749
PMCPMC11265044

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.