Evidence map›Paper›PMID 35334197›Full record

Trial reportThe New England journal of medicine2022

Two Phase 3 Trials of Baricitinib for Alopecia Areata.

Brett King, Manabu Ohyama, Ohsang Kwon, Abraham Zlotogorski, Justin Ko, Natasha A Mesinkovska, Maria Hordinsky, Yves Dutronc, Wen-Shuo Wu, Jill McCollam and 7 more

4 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 226 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
226citing papers in PubMed, 16 pooled it
87.8field-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
NCT06490757 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 2 Open-label Single-arm Trial of JAK1 Inhibitor for the Treatment of Large Inflammatory Hepatocellular Adenomas

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2024 to 2028Enrolled25ConditionsInflammatory Hepatocellular AdenomaArmsBaricitinib
NCT06545110 phase1active not recruitingnot on this mapstarted 2023, after this paper: background citation

Retinol Binding Protein 4 Expression and Its Genetic Variants in Severe Alopecia Areata Treated With Barcitinib.

TypeinterventionalSponsorSouth Valley UniversityRan2023 to 2024Enrolled120ConditionsAlopecia AreataArmsBaricitinib Oral Tablet
3 · Its place in the literature

Who cites it

226 citing papers in PubMed, 16 syntheses or guidelines pooled it, 422 citations in OpenAlex.

  1. Large-scale meta-analysis of infection risk with JAK-STAT inhibitors in 29,000 patients.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026
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  7. Systematic review and indirect treatment comparisons of ritlecitinib against baricitinib in alopecia areata.Journal of the European Academy of Dermatology and Venereology : JEADV · 2025
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  13. Treatments for alopecia areata: a network meta-analysis.The Cochrane database of systematic reviews · 2023
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166 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 1 institution in 1 country.

Brett KingFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Manabu OhyamaFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Ohsang KwonFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).ORCID 0000-0003-0464-5124
Abraham ZlotogorskiFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Justin KoFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Natasha A MesinkovskaFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Maria HordinskyFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Yves DutroncFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Wen-Shuo WuFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Jill McCollamFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Chiara ChiasseriniFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Guanglei YuFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Sarah StanleyFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Katrin HolzwarthFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Amy M DeLozierFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
Rodney SinclairFrom the Yale School of Medicine, New Haven, CT (B.K.); the Department of Dermatology, Kyorin University Faculty of Medicine, Tokyo (M.O.); the Seoul National University College of Medicine, Seoul, South Korea (O.K.); the Department of Dermatology, Hadassah Medical Center, Hebrew University of Jerusalem, Faculty of Medicine, Jerusalem, Israel (A.Z.); Stanford University School of Medicine, Stanford (J.K.), and the University of California Irvine, Irvine (N.A.M.) - both in California; the Department of Dermatology, University of Minnesota Medical School, Minneapolis (M.H.); Eli Lilly, Indianapolis (Y.D., W.-S.W., J.M., C.C., G.Y., S.S., K.H., A.M.D.); and Sinclair Dermatology, Melbourne, VIC, Australia (R.S.).
BRAVE-AA Investigators
Hebrew University of Jerusalem · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlopecia areata is an autoimmune condition characterized by rapid hair loss in the scalp, eyebrows, and eyelashes, for which treatments are limited. Baricitinib, an oral, selective, reversible inhibitor of Janus kinases 1 and 2, may interrupt cytokine signaling implicated in the pathogenesis of alopecia areata.

methodsWe conducted two randomized, placebo-controlled, phase 3 trials (BRAVE-AA1 and BRAVE-AA2) involving adults with severe alopecia areata with a Severity of Alopecia Tool (SALT) score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). Patients were randomly assigned in a 3:2:2 ratio to receive once-daily baricitinib at a dose of 4 mg, baricitinib at a dose of 2 mg, or placebo. The primary outcome was a SALT score of 20 or less at week 36.

resultsWe enrolled 654 patients in the BRAVE-AA1 trial and 546 in the BRAVE-AA2 trial. The estimated percentage of patients with a SALT score of 20 or less at week 36 was 38.8% with 4-mg baricitinib, 22.8% with 2-mg baricitinib, and 6.2% with placebo in BRAVE-AA1 and 35.9%, 19.4%, and 3.3%, respectively, in BRAVE-AA2. In BRAVE-AA1, the difference between 4-mg baricitinib and placebo was 32.6 percentage points (95% confidence interval [CI], 25.6 to 39.5), and the difference between 2-mg baricitinib and placebo was 16.6 percentage points (95% CI, 9.5 to 23.8) (P<0.001 for each dose vs. placebo). In BRAVE-AA2, the corresponding values were 32.6 percentage points (95% CI, 25.6 to 39.6) and 16.1 percentage points (95% CI, 9.1 to 23.2) (P<0.001 for each dose vs. placebo). Secondary outcomes for baricitinib at a dose of 4 mg but not at a dose of 2 mg generally favored baricitinib over placebo. Acne, elevated levels of creatine kinase, and increased levels of low- and high-density lipoprotein cholesterol were more common with baricitinib than with placebo.

conclusionsIn two phase 3 trials involving patients with severe alopecia areata, oral baricitinib was superior to placebo with respect to hair regrowth at 36 weeks. Longer trials are required to assess the efficacy and safety of baricitinib for alopecia areata. (Funded by Eli Lilly under license from Incyte; BRAVE-AA1 and BRAVE-AA2 ClinicalTrials.gov numbers, NCT03570749 and NCT03899259.).

Indexed as

Alopecia AreataJanus Kinase InhibitorsAdultAzetidinesHumansPurinesPyrazolesSulfonamidesAzetidinesbaricitinibJanus Kinase InhibitorsPurinesPyrazolesSulfonamides

Identifiers

PMID35334197
OpenAlexW4220917957

What OpenQuestion holds

Textmetadata
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.