2024
Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata
King B, Ko J, Kwon O, Vañó-Galván S, Piraccini B, Dutronc Y, Yu G, Liu C, Somani N, Ball S, Mesinkovska N. Baricitinib Withdrawal and Retreatment in Patients With Severe Alopecia Areata. JAMA Dermatology 2024, 160 PMID: 39141364, PMCID: PMC11325239, DOI: 10.1001/jamadermatol.2024.2734.Peer-Reviewed Original ResearchSevere alopecia areataProportion of patientsAlopecia areataHair regrowthSevere AATreatment benefitWeeks of treatment withdrawalClinical trialsPhase 3 randomized clinical trialLoss of treatment benefitRandomized withdrawal periodDose of baricitinibRerandomized to placeboWithdrawal of therapyFollow-up observation periodYear of treatmentRandomized clinical trialsWithdrawal periodRelapsing conditionBaricitinib doseRecapture responsePlacebo-controlledSALT scoreContinuous therapyDose groupEfficacy 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 lifePatientsPatient-Reported Satisfaction with Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results from ALLEGRO-2b/3.
Sinclair R, Law E, Zhang X, Zhang F, Napatalung L, Zwillich S, King B, Mesinkovska N. Patient-Reported Satisfaction with Hair Regrowth in a Study of Ritlecitinib in Alopecia Areata: Results from ALLEGRO-2b/3. Dermatology 2024, 1-11. PMID: 38934147, DOI: 10.1159/000539536.Peer-Reviewed Original ResearchPatient-reported satisfactionProportion of patientsAlopecia areataPost hoc analysisPatient satisfactionEvaluate patient-reported satisfactionProportions of placebo patientsHair growthPre-specified analysisScalp hair lossScalp hair growthPatient-reported outcomesEvaluate patient satisfactionPlacebo patientsPlacebo groupRitlecitinibPlaceboHair regrowthPatientsHoc analysisHair lossAA treatmentModerately/veryWeeksPost-hocLong-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata
Piliang M, Soung J, King B, Shapiro J, Rudnicka L, Farrant P, Magnolo N, Piraccini B, Luo X, Woodworth D, Schaefer G, Lejeune A, Wolk R. Long-Term Efficacy of Ritlecitinib up to Month 24 From the ALLEGRO Phase 2b/3 and Long-Term Phase 3 Clinical Studies in Alopecia Areata. SKIN The Journal Of Cutaneous Medicine 2024, 8: s394. DOI: 10.25251/skin.8.supp.394.Peer-Reviewed Original ResearchProportion of patientsAlopecia areataResponse ratePhase 3 clinical studiesDaily loading dosesOpen-label studyLong-term efficacyPatient-reported efficacyLong-term safetyScalp hair lossPhase 2b/3Long-term useSevere AAData cutoffLoading dosePGI-CRitlecitinibPatientsHair lossMonthsInterim efficacy resultsAreataEfficacyAlopeciaPhase 3Long‐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
Outcomes of Down-Titration in Patients With Severe Scalp Alopecia Areata Treated With Baricitinib: An Update Through Week 152 From BRAVE-AA2
King B, Ohyama M, Senna M, Shapiro J, Dutronc Y, Kolodsick J, Yu G, Liu C, Chiasserini C, Piraccini B. Outcomes of Down-Titration in Patients With Severe Scalp Alopecia Areata Treated With Baricitinib: An Update Through Week 152 From BRAVE-AA2. SKIN The Journal Of Cutaneous Medicine 2023, 7: s296. DOI: 10.25251/skin.7.supp.296.Peer-Reviewed Original ResearchSevere alopecia areataWeek 52Alopecia areataSALT scoreWeek 104Treatment benefitClinical responseLong-term efficacy outcomesScalp alopecia areataWeeks of retreatmentProportion of patientsHalf of patientsTreatment of patientsDown-titrationEfficacy outcomesWeek 36Greater worseningSustained responseBaricitinibPatientsRetreatmentLoss of benefitEli LillyAreataLast observationEfficacy 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