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 lifePatientsLong‐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 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 infectionRitlecitinib (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 profile