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-1WeeksEfficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1)
King B, Senna M, Mesinkovska N, Lynde C, Zirwas M, Maari C, Prajapati V, Sapra S, Brzewski P, Osman L, Hanna S, Wiseman M, Hamilton C, Cassella J. Efficacy and safety of deuruxolitinib, an oral selective Janus kinase inhibitor, in adults with alopecia areata: Results from the Phase 3 randomized, controlled trial (THRIVE-AA1). Journal Of The American Academy Of Dermatology 2024 PMID: 39053611, DOI: 10.1016/j.jaad.2024.06.097.Peer-Reviewed Original ResearchSeverity of Alopecia ToolAlopecia areataPrimary endpointHair regrowthTreatment-emergent adverse eventsOral JAK inhibitorsPlacebo-controlled trialLonger-term safetyProportion of patientsPercentage of patientsJanus kinase inhibitorsJanus kinasePatient-reported outcomesHair loss disorderImpact quality of lifeDouble-blindSecondary endpointsTreatment cessationAdult patientsAdverse eventsKinase inhibitorsJAK inhibitorsControlled trialsQuality of lifePatientsA 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 intensityIntegrated 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
Ritlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows efficacy in patients with active nonsegmental vitiligo and either a lighter or darker Fitzpatrick skin type: results from a phase 2b, randomized, dose-ranging study with an extension period
Peeva E, Yamaguchi Y, King B, Han G, Cox L, Banerjee A, Picardo M, Bae J, Sloan A, Sinclair R, Ezzedine K. Ritlecitinib (PF-06651600), an oral JAK3/TEC inhibitor, shows efficacy in patients with active nonsegmental vitiligo and either a lighter or darker Fitzpatrick skin type: results from a phase 2b, randomized, dose-ranging study with an extension period. British Journal Of Dermatology 2023, 188: ljac106.004. DOI: 10.1093/bjd/ljac106.004.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsDose-ranging periodNonsegmental vitiligoLoading doseFitzpatrick skin typeIncidence of treatment-emergent adverse eventsFacial Vitiligo Area Scoring IndexTreatment-emergent adverse event incidenceLow dosesDarker Fitzpatrick skin typesVitiligo Area Scoring IndexDaily loading dosesRandomized to placeboDose-ranging studyPhase 2b studyPhase 2b trialLow-dose groupCytokine IL-15Skin typePlateau of effectivenessSafety endpointsIL-15IFN-gAdverse eventsVitiligo patients
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
2020
Dupilumab 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 centers
2016
Tofacitinib 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 scoreTofacitinib 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 changeSafety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata
Crispin M, Ko JM, Craiglow BG, Li S, Shankar G, Urban JR, Chen JC, Cerise JE, Jabbari A, Winge M, Marinkovich MP, Christiano AM, Oro AE, King BA. Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata. JCI Insight 2016, 1: e89776. PMID: 27699252, PMCID: PMC5033755, DOI: 10.1172/jci.insight.89776.Peer-Reviewed Original ResearchConceptsAlopecia areataAlopecia totalisAlopecia universalisHair lossDisease activity index scoreTreatment of AANational Alopecia Areata FoundationActivity index scoreCompletion of therapySevere alopecia areataSingle-arm trialNational Psoriasis FoundationScalp hair lossNational InstituteVeterans Affairs OfficePan-JAK inhibitorAdverse eventsDrug cessationDurable responsesAlopecia ToolDisease relapseTherapeutic optionsAutoimmune diseasesEffective therapyGrade I
2015
Treatment 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