2024
Integrated 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 ResearchMeSH KeywordsAlopecia AreataAntineoplastic AgentsCarbazolesHumansJanus Kinase 3Protein Kinase InhibitorsSARS-CoV-2Treatment OutcomeTryptaminesConceptsAdverse 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
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 ResearchMeSH KeywordsAdolescentAdultAlopecia AreataCOVID-19Double-Blind MethodFemaleHumansMaleProtein Kinase InhibitorsTreatment OutcomeConceptsAlopecia areataPrimary endpointWeek 24Loading doseExtension periodBaseline disease severitySuitable treatment optionScalp hair lossPatients placeboPlacebo groupWeek 48Systemic therapyAlopecia ToolTreatment optionsPlaceboHair lossPatientsAreataResponse rateDisease severityKinase inhibitorsBody hairMulticentreAfrican AmericansTreatment
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 ResearchMeSH KeywordsAdultAlopecia AreataDouble-Blind MethodHumansJanus Kinase InhibitorsRandomized Controlled Trials as TopicTreatment OutcomeConceptsTreatment-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 ResearchMeSH KeywordsChronic DiseaseDouble-Blind MethodHumansJanus KinasesProtein Kinase InhibitorsSkinTreatment OutcomeVitiligoConceptsNonsegmental 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
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 objectiveOutcomesEyelashesDermatologistsDupilumab 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 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 inhibitionPatients
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 ResearchRethinking the classification of alopecia areata
Wambier C, King B. Rethinking the classification of alopecia areata. Journal Of The American Academy Of Dermatology 2018, 80: e45. PMID: 30244065, DOI: 10.1016/j.jaad.2018.08.059.Peer-Reviewed Original ResearchTofacitinib for the treatment of alopecia areata in preadolescent children
Craiglow BG, King BA. Tofacitinib for the treatment of alopecia areata in preadolescent children. Journal Of The American Academy Of Dermatology 2018, 80: 568-570. PMID: 30195571, DOI: 10.1016/j.jaad.2018.08.041.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 Research
2016
Tofacitinib for the treatment of alopecia areata and variants in adolescents
Craiglow BG, Liu LY, King BA. Tofacitinib for the treatment of alopecia areata and variants in adolescents. Journal Of The American Academy Of Dermatology 2016, 76: 29-32. PMID: 27816292, DOI: 10.1016/j.jaad.2016.09.006.Peer-Reviewed Original ResearchConceptsAlopecia areataAdverse eventsAdolescent patientsTreatment of AASignificant hair regrowthUse of tofacitinibMonths of treatmentProspective clinical trialsMedian percent changeJanus kinase inhibitorSeverity of diseaseReview of systemsSALT scoreAlopecia ToolLaboratory monitoringPhysical examinationHair regrowthClinical trialsEffective therapyPromising therapyRetrospective natureTofacitinibControl groupPatientsPercent changeTofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients
Liu LY, Craiglow BG, Dai F, King BA. Tofacitinib for the treatment of severe alopecia areata and variants: A study of 90 patients. Journal Of The American Academy Of Dermatology 2016, 76: 22-28. PMID: 27816293, DOI: 10.1016/j.jaad.2016.09.007.Peer-Reviewed Original ResearchConceptsSevere alopecia areataAlopecia areataAlopecia totalisAlopecia universalisPercent changeAlopecia Tool (SALT) scorePatients age 18Primary end pointSerious adverse eventsMonths of treatmentCommon autoimmune disorderSeries of patientsScalp hair lossAdverse eventsClinical responseHigher percent changeAutoimmune disordersRetrospective studyEffective therapyRetrospective natureInclusion criteriaHair lossPotential respondersPatientsTool scoreTopical Ruxolitinib for the Treatment of Alopecia Universalis
Craiglow BG, Tavares D, King BA. Topical Ruxolitinib for the Treatment of Alopecia Universalis. JAMA Dermatology 2016, 152: 490. PMID: 26649829, DOI: 10.1001/jamadermatol.2015.4445.Peer-Reviewed Original Research
2015
Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy
Craiglow BG, King BA. Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy. JAMA Dermatology 2015, 151: 1110-1112. PMID: 26107994, DOI: 10.1001/jamadermatol.2015.1520.Peer-Reviewed Original ResearchConceptsJanus kinase inhibitorTreatment of vitiligoKinase inhibitorsPathogenesis-directed therapyPathogenesis of vitiligoOral JanusSignificant repigmentationTherapeutic optionsCommon conditionEffective treatmentVitiligoAdditional studiesTofacitinib citrateTreatmentInhibitorsPatientsPathogenesisRepigmentationTherapyTreatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate
Levy LL, Urban J, King BA. Treatment of recalcitrant atopic dermatitis with the oral Janus kinase inhibitor tofacitinib citrate. Journal Of The American Academy Of Dermatology 2015, 73: 395-399. PMID: 26194706, DOI: 10.1016/j.jaad.2015.06.045.Peer-Reviewed Original ResearchConceptsSevere atopic dermatitisAtopic dermatitisTofacitinib citrateBody surface area involvementEdema/papulationRecalcitrant atopic dermatitisAD indexSurface area involvementWeeks of treatmentPlacebo control groupAdverse eventsConsecutive patientsArea involvementStandard treatmentControl groupDermatitisSmall sample sizeTreatmentPatientsPossibility of biasSample sizeLichenificationCitrateErythemaScoring
2014
Killing Two Birds with One Stone: Oral Tofacitinib Reverses Alopecia Universalis in a Patient with Plaque Psoriasis
Craiglow BG, King BA. Killing Two Birds with One Stone: Oral Tofacitinib Reverses Alopecia Universalis in a Patient with Plaque Psoriasis. Journal Of Investigative Dermatology 2014, 134: 2988-2990. PMID: 24940651, DOI: 10.1038/jid.2014.260.Peer-Reviewed Original Research