2024
A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata
Anderson S, Cavaletti G, Hood L, Polydefkis M, Herrmann D, Rance G, King B, McMichael A, Senna M, Kim B, Napatalung L, Wolk R, Zwillich S, Schaefer G, Gong Y, Sisson M, Posner H. A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata. Pharmacology Research & Perspectives 2024, 12: e1204. PMID: 38969959, PMCID: PMC11226387, DOI: 10.1002/prp2.1204.Peer-Reviewed Original ResearchConceptsIntraepidermal nerve fibersWave V amplitudeInterwave latenciesI-V interwave latencyV amplitudeMonth 9Placebo-controlled phasePhase 2a studyAxonal swellingsIENF densityPlacebo groupBAEP changesLoading doseAdverse eventsRitlecitinibAlopecia areataKinase inhibitorsPrimary outcomeHuman doseToxicity findingsBAEPClinical relevanceNerve fibersPhase 2aStimulus intensityLong‐term efficacy and safety of baricitinib in patients with severe alopecia areata: 104‐week results from BRAVE‐AA1 and BRAVE‐AA2
Senna M, Mostaghimi A, Ohyama M, Sinclair R, Dutronc Y, Wu W, Yu G, Chiasserini C, Somani N, Holzwarth K, King B. Long‐term efficacy and safety of baricitinib in patients with severe alopecia areata: 104‐week results from BRAVE‐AA1 and BRAVE‐AA2. Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 583-593. PMID: 38391212, DOI: 10.1111/jdv.19665.Peer-Reviewed Original ResearchConceptsSafety of baricitinibSALT scoreSevere alopecia areataPhase 3 trialAlopecia areataSevere AATract infectionsFrequent treatment-emergent adverse eventsMixed respondersWeeks of continuous therapyTreatment-emergent adverse eventsCreatine phosphokinase increaseUpper respiratory tract infectionUrinary tract infectionMaintenance of efficacyProportion of patientsRespiratory tract infectionsTreated with 2 mgLong-term efficacyLong-term treatmentJanus kinase inhibitorsJanus kinaseEyelash regrowthWeek-52Treatment discontinuationIntegrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program
King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Mesinkovska N, Paul C, Gong Y, Anway S, Tran H, Wolk R, Zwillich S, Lejeune A. Integrated Safety Analysis of Ritlecitinib, an Oral JAK3/TEC Family Kinase Inhibitor, for the Treatment of Alopecia Areata from the ALLEGRO Clinical Trial Program. American Journal Of Clinical Dermatology 2024, 25: 299-314. PMID: 38263353, PMCID: PMC10867086, DOI: 10.1007/s40257-024-00846-3.Peer-Reviewed Original ResearchConceptsAdverse eventsAlopecia areataIncidence rateKinase inhibitorsTreatment of alopecia areataPlacebo-controlled cohortAdverse cardiovascular eventsClinical trial programIntegrated safety analysisOpportunistic infectionsPlacebo groupPlacebo-controlledLaboratory abnormalitiesHerpes zosterSafety profileSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Cardiovascular eventsRespiratory syndrome coronavirus 2RitlecitinibObjectiveThe objectivePhase 2aTrial programPatientsMethodsTwo cohorts
2023
Inhibition of T-cell activity in alopecia areata: recent developments and new directions
Passeron T, King B, Seneschal J, Steinhoff M, Jabbari A, Ohyama M, Tobin D, Randhawa S, Winkler A, Telliez J, Martin D, Lejeune A. Inhibition of T-cell activity in alopecia areata: recent developments and new directions. Frontiers In Immunology 2023, 14: 1243556. PMID: 38022501, PMCID: PMC10657858, DOI: 10.3389/fimmu.2023.1243556.Peer-Reviewed Original ResearchConceptsT cell-signaling pathwaysAlopecia areataT cellsEtiopathogenesis of AAPathogenesis of AATreatment of AAImmune privilege collapseOnly US FoodHair folliclesSevere alopecia areataT cell activityT cell receptor recognitionLoss of scalpSystemic medicationsAA therapyCytotoxic CD8Inflammatory pathogenesisAutoimmune diseasesTreatment optionsHair lossLimited efficacyTherapeutic pathwaysClinical developmentJAK inhibitionUS FoodEfficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial
King B, Zhang X, Harcha W, Szepietowski J, Shapiro J, Lynde C, Mesinkovska N, Zwillich S, Napatalung L, Wajsbrot D, Fayyad R, Freyman A, Mitra D, Purohit V, Sinclair R, Wolk R. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b–3 trial. The Lancet 2023, 401: 1518-1529. PMID: 37062298, DOI: 10.1016/s0140-6736(23)00222-2.Peer-Reviewed Original ResearchConceptsAlopecia areataPrimary endpointWeek 24Loading doseExtension periodBaseline disease severitySuitable treatment optionScalp hair lossPatients placeboPlacebo groupWeek 48Systemic therapyAlopecia ToolTreatment optionsPlaceboHair lossPatientsAreataResponse rateDisease severityKinase inhibitorsBody hairMulticentreAfrican AmericansTreatmentEfficacy 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)
Kwon O, Senna M, Sinclair R, Ito T, Dutronc Y, Lin C, Yu G, Chiasserini C, McCollam J, Wu W, King B. 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). American Journal Of Clinical Dermatology 2023, 24: 443-451. PMID: 36855020, PMCID: PMC9974384, DOI: 10.1007/s40257-023-00764-w.Peer-Reviewed Original ResearchConceptsSevere alopecia areataSafety of baricitinibPhase III trialsLong-term treatmentAlopecia areataWeek 52III trialsTract infectionsContinuous therapyFrequent treatment-emergent adverse eventsJanus kinase inhibitor baricitinibTreatment-emergent adverse eventsUpper respiratory tract infectionAlopecia Tool (SALT) scoreWeek 52 resultsCreatine phosphokinase elevationNew safety signalsProportion of patientsRespiratory tract infectionsPermanent treatment discontinuationUrinary tract infectionCoronavirus disease 2019 (COVID-19) pandemicMaximum clinical benefitScalp hair lossCOVID-19 infection
2022
Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials
King B, Mostaghimi A, Shimomura Y, Zlotogorski A, Choi G, Blume-Peytavi U, Passeron T, Holzwarth K, Dutronc Y, McCollam J, Yang F, Stanley S, Wu W, Sinclair R. Integrated safety analysis of baricitinib in adults with severe alopecia areata from two randomized clinical trials. British Journal Of Dermatology 2022, 188: 218-227. PMID: 36763878, DOI: 10.1093/bjd/ljac059.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsSevere alopecia areataPlacebo-controlled periodAlopecia areataIncidence rateIntegrated safety analysisCreatine phosphokinaseBaricitinib 2Adverse eventsIII trialsClinical trialsSafety dataPhase II/III trialsMajor adverse cardiovascular eventsUpper respiratory tract infectionLong-term extension periodAbnormal laboratory changesDose of baricitinibElevated creatine phosphokinaseAdverse cardiovascular eventsPhase III trialsProportion of patientsRespiratory tract infectionsBlood creatine phosphokinaseOverall safety profileEfficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial
Ezzedine K, Peeva E, Yamaguchi Y, Cox L, Banerjee A, Han G, Hamzavi I, Ganesan A, Picardo M, Thaçi D, Harris J, Bae J, Tsukamoto K, Sinclair R, Pandya A, Sloan A, Yu D, Gandhi K, Vincent M, King B. Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial. Journal Of The American Academy Of Dermatology 2022, 88: 395-403. PMID: 36370907, DOI: 10.1016/j.jaad.2022.11.005.Peer-Reviewed Original ResearchConceptsNonsegmental vitiligoLoading doseScoring IndexPercent changePhase 2b clinical trialExtension periodPhase 2b trialPrimary efficacy endpointSerious adverse eventsChronic autoimmune disorderDose-dependent trendEfficacy endpointAdverse eventsWeek 24Autoimmune disordersClinical trialsStable vitiligoPatientsVitiligoSignificant differencesTreatmentDoseBaselineTrialsWeeks
2021
It is all alopecia areata: It is time to abandon the terms alopecia totalis and alopecia universalis
Peterson D, Craiglow BG, Mesinkovska NA, Ko J, Senna MM, King B. It is all alopecia areata: It is time to abandon the terms alopecia totalis and alopecia universalis. Journal Of The American Academy Of Dermatology 2021, 87: e149-e151. PMID: 34678234, DOI: 10.1016/j.jaad.2021.09.056.Peer-Reviewed Original Research
2020
Ultraviolet light in combination with other therapies for vitiligo: Synergy or necessity?
Peterson D, King B. Ultraviolet light in combination with other therapies for vitiligo: Synergy or necessity? Journal Of The American Academy Of Dermatology 2020, 84: e63-e64. PMID: 32891783, DOI: 10.1016/j.jaad.2020.08.120.Peer-Reviewed Original ResearchDevelopment of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata
Wyrwich KW, Kitchen H, Knight S, Aldhouse NVJ, Macey J, Nunes FP, Dutronc Y, Mesinkovska N, Ko JM, King BA. Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata. American Journal Of Clinical Dermatology 2020, 21: 725-732. PMID: 32803546, PMCID: PMC7473969, DOI: 10.1007/s40257-020-00545-9.Peer-Reviewed Original ResearchConceptsSigns/symptomsAlopecia areataPRO measuresNail appearanceEyelash lossOutcome measuresHair lossEye irritationPatient-reported outcome measuresClinician-reported outcomesNorth American patientsDevelopment of cliniciansNail assessmentEyebrow lossNail involvementAmerican patientsClinical trialsPatientsNail damageSymptomsAreataObjectivesOur objectiveOutcomesEyelashesDermatologistsDevelopment of the Scalp Hair Assessment PRO™ measure for alopecia areata
Wyrwich K, Kitchen H, Knight S, Aldhouse N, Macey J, Nunes F, Dutronc Y, Mesinkovska N, Ko J, King B. Development of the Scalp Hair Assessment PRO™ measure for alopecia areata. British Journal Of Dermatology 2020, 183: 1065-1072. PMID: 32163589, PMCID: PMC7754291, DOI: 10.1111/bjd.19024.Peer-Reviewed Original ResearchConceptsScalp hair lossHair lossPRO measuresValid patient-reported outcome measurePatient-reported outcome measuresAlopecia areata treatmentInvestigator's Global AssessmentHair regrowthAlopecia areataTreatment successOutcome measuresQualitative semistructured interviewsPatientsGlobal assessmentAA treatmentClinical expertsScalp hairSemistructured interviewsTreatmentAreataResponse scaleSymptomsBaselineAAMeasuresReply: Calm before the storm: Understanding the role of Janus kinase inhibitors in COVID-19
Peterson D, Damsky W, King B. Reply: Calm before the storm: Understanding the role of Janus kinase inhibitors in COVID-19. Journal Of The American Academy Of Dermatology 2020, 83: e67-e68. PMID: 32344070, PMCID: PMC7194643, DOI: 10.1016/j.jaad.2020.04.097.Peer-Reviewed Original ResearchThe use of Janus kinase inhibitors in the time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Peterson D, Damsky W, King B. The use of Janus kinase inhibitors in the time of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Journal Of The American Academy Of Dermatology 2020, 82: e223-e226. PMID: 32278797, PMCID: PMC7144601, DOI: 10.1016/j.jaad.2020.03.099.Peer-Reviewed Original ResearchMeSH KeywordsArthritis, RheumatoidAzetidinesBetacoronavirusColitis, UlcerativeCoronavirus InfectionsCOVID-19CytokinesDermatitis, AtopicHeterocyclic Compounds, 3-RingHumansImmunomodulationJanus KinasesNitrilesPandemicsPiperidinesPneumonia, ViralPrimary MyelofibrosisPurinesPyrazolesPyrimidinesPyrrolesRandomized Controlled Trials as TopicSARS-CoV-2STAT Transcription FactorsSulfonamidesThe Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials
Wyrwich K, Kitchen H, Knight S, Aldhouse N, Macey J, Nunes F, Dutronc Y, Mesinkovska N, Ko J, King B. The Alopecia Areata Investigator Global Assessment scale: a measure for evaluating clinically meaningful success in clinical trials. British Journal Of Dermatology 2020, 183: 702-709. PMID: 31970750, PMCID: PMC7586961, DOI: 10.1111/bjd.18883.Peer-Reviewed Original ResearchConceptsInvestigator's Global AssessmentScalp hair lossAlopecia areataTreatment successGlobal assessmentAlopecia ToolClinical trialsClinician's perspectiveScalp hairTreatment studiesInvestigator's Global Assessment (IGA) scaleSigns/symptomsScalp hair growthGlobal Assessment ScaleMost patientsAdolescent patientsHair regrowthClinical evaluationExpert dermatologistsSuccessful treatmentClinical consensusTreatment outcomesPatient insightTreatment responseAdditional cliniciansThe Promise of JAK Inhibitors for Treatment of Sarcoidosis and Other Inflammatory Disorders with Macrophage Activation: A Review of the Literature.
Wang A, Singh K, Ibrahim W, King B, Damsky W. The Promise of JAK Inhibitors for Treatment of Sarcoidosis and Other Inflammatory Disorders with Macrophage Activation: A Review of the Literature. The Yale Journal Of Biology And Medicine 2020, 93: 187-195. PMID: 32226347, PMCID: PMC7087061.Peer-Reviewed Original ResearchConceptsInflammatory disordersMacrophage activationJAK inhibitorsCertain inflammatory disordersTreatment of sarcoidosisFormation of granulomasCrohn's diseaseClinical evidenceNecrobiosis lipoidicaInflammatory cytokinesDependent cytokinesGranuloma annulareGranuloma formationInterferon gammaJAK inhibitionJAK-STAT pathwaySarcoidosisDisordersCytokinesInhibitorsConstitutive activationDiseaseActivationDramatic improvementGranulomasDupilumab as a novel therapy for bullous pemphigoid: A multicenter case series
Abdat R, Waldman RA, de Bedout V, Czernik A, Mcleod M, King B, Gordon S, Ahmed R, Nichols A, Rothe M, Rosmarin D. Dupilumab as a novel therapy for bullous pemphigoid: A multicenter case series. Journal Of The American Academy Of Dermatology 2020, 83: 46-52. PMID: 32179082, DOI: 10.1016/j.jaad.2020.01.089.Peer-Reviewed Original ResearchConceptsBullous pemphigoidDisease clearanceCase seriesSatisfactory responseMulticenter case seriesAutoimmune blistering disorderLesional skin biopsiesSeries of patientsPrevious conventional therapyEnzyme-linked immunosorbentStandardized assessment toolsAdverse eventsDisease improvementConventional therapyClinician documentationTotal clearanceSkin biopsiesNovel therapiesDirect immunofluorescencePatient's desireEosin stainingAdequate treatmentAverage agePatientsAcademic centersThe Alopecia Areata Consensus of Experts (ACE) study: Results of an international expert opinion on treatments for alopecia areata
Meah N, Wall D, York K, Bhoyrul B, Bokhari L, Sigall DA, Bergfeld WF, Betz RC, Blume-Peytavi U, Callender V, Chitreddy V, Combalia A, Cotsarelis G, Craiglow B, Donovan J, Eisman S, Farrant P, Green J, Grimalt R, Harries M, Hordinsky M, Irvine AD, Itami S, Jolliffe V, King B, Lee WS, McMichael A, Messenger A, Mirmirani P, Olsen E, Orlow SJ, Piraccini BM, Rakowska A, Reygagne P, Roberts JL, Rudnicka L, Shapiro J, Sharma P, Tosti A, Vogt A, Wade M, Yip L, Zlotogorski A, Sinclair R. The Alopecia Areata Consensus of Experts (ACE) study: Results of an international expert opinion on treatments for alopecia areata. Journal Of The American Academy Of Dermatology 2020, 83: 123-130. PMID: 32165196, DOI: 10.1016/j.jaad.2020.03.004.Peer-Reviewed Original ResearchConceptsAlopecia areataSystemic therapyTreatment-specific questionsInternational consensus statementInternational patient registriesInternational expert opinionNonprescription therapiesSystemic treatmentIntralesional treatmentPatient RegistryTopical treatmentConsensus statementExpert consensusSystematic reviewTherapyDelphi processLeast consensusTreatmentAreataHair expertsExpert opinionRobust evidenceFurther researchFirst roundConsensusBaricitinib in patients with moderate‐to‐severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials
Simpson E, Lacour J, Spelman L, Galimberti R, Eichenfield L, Bissonnette R, King B, Thyssen J, Silverberg J, Bieber T, Kabashima K, Tsunemi Y, Costanzo A, Guttman‐Yassky E, Beck L, Janes J, DeLozier A, Gamalo M, Brinker D, Cardillo T, Nunes F, Paller A, Wollenberg A, Reich K. Baricitinib in patients with moderate‐to‐severe atopic dermatitis and inadequate response to topical corticosteroids: results from two randomized monotherapy phase III trials. British Journal Of Dermatology 2020, 183: 242-255. PMID: 31995838, DOI: 10.1111/bjd.18898.Peer-Reviewed Original ResearchConceptsSevere ADBREEZE-AD1BREEZE-AD2Topical corticosteroidsInadequate responseWeek 1Global assessmentConcomitant topical corticosteroidsSafety of baricitinibSignificant haematological changesCommon adverse eventsPhase II studyPrimary end pointSevere atopic dermatitisAtopic dermatitis severityInvestigator's Global AssessmentPhase III trialsSelective Janus kinase 1Weeks of treatmentNight-time awakeningsNew safety concernsDaily placeboMonotherapy trialsCardiovascular eventsGastrointestinal perforationTreatment of severe lichen planus with the JAK inhibitor tofacitinib
Damsky W, Wang A, Olamiju B, Peterson D, Galan A, King B. Treatment of severe lichen planus with the JAK inhibitor tofacitinib. Journal Of Allergy And Clinical Immunology 2020, 145: 1708-1710.e2. PMID: 32018031, DOI: 10.1016/j.jaci.2020.01.031.Peer-Reviewed Original Research