2024
Efficacy and safety of ritlecitinib in vitiligo patients across Fitzpatrick skin types with biomarker analyses
Peeva E, Yamaguchi Y, Ye Z, King B, Picardo M, Sloan A, Ezzedine K, Del Duca E, Estrada Y, Hassan‐Zahraee M, He W, Hyde C, Bar J, Facheris P, Guttman‐Yassky E. Efficacy and safety of ritlecitinib in vitiligo patients across Fitzpatrick skin types with biomarker analyses. Experimental Dermatology 2024, 33: e15177. PMID: 39304339, DOI: 10.1111/exd.15177.Peer-Reviewed Original ResearchConceptsFitzpatrick skin typeNonsegmental vitiligoSerum levelsFacial Vitiligo Area Scoring IndexTreatment-emergent adverse eventsWeek 4Fitzpatrick skin types I-IIIFitzpatrick skin types IV-VINonsegmental vitiligo patientsResponders to therapySkin typeIL-22 expression levelsDark skinImmune dysregulationAdverse eventsIL-9No significant changesVitiligo patientsRe-pigmentationRitlecitinibIL-22Score indexPatientsCLM-1WeeksA 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 discontinuation
2023
Efficacy 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 profile
2020
Development 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 scaleSymptomsBaselineAAMeasuresThe 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 cliniciansBaricitinib 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 perforation
2019
Janus kinase inhibition induces disease remission in cutaneous sarcoidosis and granuloma annulare
Damsky W, Thakral D, McGeary MK, Leventhal J, Galan A, King B. Janus kinase inhibition induces disease remission in cutaneous sarcoidosis and granuloma annulare. Journal Of The American Academy Of Dermatology 2019, 82: 612-621. PMID: 31185230, PMCID: PMC7590533, DOI: 10.1016/j.jaad.2019.05.098.Peer-Reviewed Original ResearchConceptsGranuloma annulareCutaneous sarcoidosisPathway activationCutaneous granulomatous disordersRecalcitrant cutaneous sarcoidosisSkin biopsy specimensSignal regulatory protein αJAK-STAT pathway activationTranscription (JAK/STAT) pathway activationRegulatory protein αRecalcitrant sarcoidosisSarcoidosis activityDisease remissionConsecutive patientsGranulomatous disorderProspective evaluationBiopsy specimensHistologic resolutionSkin biopsiesMean improvementSarcoidosisImmunohistochemical analysisJAK inhibitorsJAK inhibitionPatientsRule of thumb: A simple tool to estimate 1% scalp surface area
Wambier CG, King BA. Rule of thumb: A simple tool to estimate 1% scalp surface area. Journal Of The American Academy Of Dermatology 2019, 81: 630-631. PMID: 30682394, DOI: 10.1016/j.jaad.2019.01.022.Peer-Reviewed Original Research
2018
Response to tofacitinib therapy of eyebrows and eyelashes in alopecia areata
Liu LY, King BA. Response to tofacitinib therapy of eyebrows and eyelashes in alopecia areata. Journal Of The American Academy Of Dermatology 2018, 80: 1778-1779. PMID: 30502414, DOI: 10.1016/j.jaad.2018.11.037.Peer-Reviewed Original ResearchRuxolitinib for the treatment of severe alopecia areata
Liu LY, King BA. Ruxolitinib for the treatment of severe alopecia areata. Journal Of The American Academy Of Dermatology 2018, 80: 566-568. PMID: 30195572, DOI: 10.1016/j.jaad.2018.08.040.Peer-Reviewed Original ResearchRapid Repigmentation of Vitiligo Using Tofacitinib Plus Low-Dose, Narrowband UV-B Phototherapy
Kim R, Heaton H, Liu LY, King BA. Rapid Repigmentation of Vitiligo Using Tofacitinib Plus Low-Dose, Narrowband UV-B Phototherapy. JAMA Dermatology 2018, 154: 370-371. PMID: 29387870, DOI: 10.1001/jamadermatol.2017.5778.Peer-Reviewed Original ResearchAlopecia areata is associated with impaired health-related quality of life: A survey of affected adults and children and their families
Liu LY, King BA, Craiglow BG. Alopecia areata is associated with impaired health-related quality of life: A survey of affected adults and children and their families. Journal Of The American Academy Of Dermatology 2018, 79: 556-558.e1. PMID: 29425723, DOI: 10.1016/j.jaad.2018.01.048.Peer-Reviewed Original Research
2017
Successful treatment of moderate-to-severe alopecia areata improves health-related quality of life
Liu LY, Craiglow BG, King BA. Successful treatment of moderate-to-severe alopecia areata improves health-related quality of life. Journal Of The American Academy Of Dermatology 2017, 78: 597-599.e2. PMID: 29128459, DOI: 10.1016/j.jaad.2017.10.046.Peer-Reviewed Original ResearchTofacitinib 2% ointment, a topical Janus kinase inhibitor, for the treatment of alopecia areata: A pilot study of 10 patients
Liu LY, Craiglow BG, King BA. Tofacitinib 2% ointment, a topical Janus kinase inhibitor, for the treatment of alopecia areata: A pilot study of 10 patients. Journal Of The American Academy Of Dermatology 2017, 78: 403-404.e1. PMID: 29108908, DOI: 10.1016/j.jaad.2017.10.043.Peer-Reviewed Original ResearchLack of efficacy of apremilast in 9 patients with severe alopecia areata
Liu LY, King BA. Lack of efficacy of apremilast in 9 patients with severe alopecia areata. Journal Of The American Academy Of Dermatology 2017, 77: 773-774. PMID: 28917463, DOI: 10.1016/j.jaad.2017.05.034.Peer-Reviewed Original ResearchAdolescentAdultAge FactorsAgedAlopecia AreataAnti-Inflammatory Agents, Non-SteroidalDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansMaleMiddle AgedNeeds AssessmentRetrospective StudiesRisk AssessmentSampling StudiesSeverity of Illness IndexSex FactorsThalidomideTreatment FailureYoung AdultRepigmentation in vitiligo using the Janus kinase inhibitor tofacitinib may require concomitant light exposure
Liu LY, Strassner JP, Refat MA, Harris JE, King BA. Repigmentation in vitiligo using the Janus kinase inhibitor tofacitinib may require concomitant light exposure. Journal Of The American Academy Of Dermatology 2017, 77: 675-682.e1. PMID: 28823882, PMCID: PMC6233876, DOI: 10.1016/j.jaad.2017.05.043.Peer-Reviewed Original ResearchConceptsTreatment of vitiligoJAK inhibitorsConsecutive patientsInhibitor tofacitinibJanus kinase inhibitor tofacitinibJAK inhibitor monotherapyRetrospective case seriesUltraviolet B phototherapyT-cell mediatorsBody surface areaJanus kinase inhibitorSeverity of diseaseB phototherapyInhibitor monotherapyCase seriesAutoimmune responseCell mediatorsAutoimmune diseasesCutaneous depigmentationLight exposureRetrospective natureStudy populationExisting therapiesControl groupTofacitinib