Evidence map›Paper›PMID 36855020›Full record

Trial reportAmerican journal of clinical dermatology2023

Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2).

Ohsang Kwon, Maryanne M Senna, Rodney Sinclair, Taisuke Ito, Yves Dutronc, Chen-Yen Lin, Guanglei Yu, Chiara Chiasserini, Jill McCollam, Wen-Shuo Wu and 1 more

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in American journal of clinical dermatology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 62 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 4 pooled it
39.5field-weighted citation impact, top 1% of its field
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

62 citing papers in PubMed, 4 syntheses or guidelines pooled it, 133 citations in OpenAlex.

  1. Pooled it
  2. S3 guideline diagnostics and therapy in alopecia areata - Part 2: Therapy, psychosocial and cosmetic support.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026
    Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Article
  10. Review
  11. Dermatologic Toxicities Induced by JAK Inhibitors.American journal of clinical dermatology · 2026
    Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 6 countries.

Ohsang KwonDepartment of Dermatology, Seoul National University College of Medicine, 103 Daehak-ro, Ihwa-dong, Jongno-gu, Seoul, 03080, Republic of Korea. oskwon@snu.ac.kr.ORCID http://orcid.org/0000-0003-0464-5124
Maryanne M SennaDivision of Dermatology, Lahey Hospital and Medical Center, and Harvard Medical School, Boston, MA, USA.
Rodney SinclairSinclair Dermatology, Melbourne, VIC, Australia.
Taisuke ItoHamamatsu University School of Medicine, Hamamatsu, Shizuoka, Japan.
Yves DutroncEli Lilly and Company, Indianapolis, IN, USA.
Chen-Yen LinEli Lilly and Company, Indianapolis, IN, USA.
Guanglei YuEli Lilly and Company, Indianapolis, IN, USA.
Chiara ChiasseriniEli Lilly and Company, Indianapolis, IN, USA.
Jill McCollamEli Lilly and Company, Indianapolis, IN, USA.
Wen-Shuo WuEli Lilly and Company, Indianapolis, IN, USA.
Brett KingYale School of Medicine, New Haven, CT, USA.
Eli Lilly (United States) · USHamamatsu University School of Medicine · JPHarvard University · USSeoul National University · KRSinclair Dermatology · AUYale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundThe oral Janus kinase (JAK) inhibitor baricitinib has demonstrated efficacy for severe alopecia areata (AA) over 36 weeks. There are limited data on the longer-term treatment of AA.

objectiveThe aim of this study was to evaluate the efficacy and safety of baricitinib for AA in adults with ≥50% scalp hair loss through 52 weeks of continuous therapy in two phase III trials (BRAVE-AA1 and BRAVE-AA2).

methodsPatients randomized to baricitinib at baseline in BRAVE-AA1 (N = 465) and BRAVE-AA2 (N = 390) retained their treatment allocation through Week 52. Efficacy outcomes included the proportion of patients achieving a Severity of Alopecia Tool (SALT) score ≤ 20 (≤ 20% scalp hair loss). Data were censored after permanent treatment discontinuation or if collected remotely due to the coronavirus disease 2019 (COVID-19) pandemic.

resultsResponse rates for hair regrowth increased over the 52-week period. Of patients treated with baricitinib 4 mg and 2 mg, respectively, 40.9% and 21.2% in BRAVE-AA1 and 36.8% and 24.4% in BRAVE-AA2 achieved a SALT score ≤ 20 at Week 52. The most frequent treatment-emergent adverse events included upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, creatine phosphokinase elevation, and COVID-19 infection. LIMITATION: There were no comparisons with placebo.

conclusionEfficacy of baricitinib for adults with severe AA continuously improved over 52 weeks, indicating that long-term treatment may be necessary to observe maximum clinical benefit. There were no new safety signals. CLINICALTRIALS REGISTRATION: ClinicalTrials.gov NCT03570749 and NCT03899259. Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata: Week-52 Results from BRAVE-AA1 and BRAVE-AA2.

Indexed as

Alopecia AreataCOVID-19Janus Kinase InhibitorsAdultAzetidinesCOVID-19 Drug TreatmentHumansPurinesPyrazolesSulfonamidesAzetidinesbaricitinibJanus Kinase InhibitorsPurinesPyrazolesSulfonamides

Identifiers

PMID36855020
PMCPMC9974384
OpenAlexW4322621664

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.