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 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 intensityPatient-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-hocCorrection to: 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. Correction to: 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: 689-689. PMID: 38789821, PMCID: PMC11193833, DOI: 10.1007/s40257-024-00864-1.Peer-Reviewed Original ResearchLong-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 discontinuationIntegrated 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 cohortsVisualizing Severity of Alopecia Tool (SALT) scores in the clinical setting using patient images from a clinical trial
Mesinkovska N, King B, Vañó‐Galván S, Shimomura Y, Jedynak J, McCollam J, Pierce E, Ellinwood A, Sinclair R. Visualizing Severity of Alopecia Tool (SALT) scores in the clinical setting using patient images from a clinical trial. JEADV Clinical Practice 2024, 3: 528-535. DOI: 10.1002/jvc2.327.Peer-Reviewed Original ResearchSeverity of Alopecia Tool scoreSeverity of Alopecia ToolSALT scoreAlopecia areataClinical trialsSevere AAPatient imagesTime of clinical responseEligibility criteriaClinical trials of adultsWeeks of therapyHair lossPhase 2/3 studyClinical settingTrials of adultsCourse of treatmentPattern of hair lossClinical responseSystemic treatmentFemale patientsTherapeutic responseTreatment decisionsPatientsMonitor treatment progressClinicians
2023
Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata
Senna M, Kwon O, Piraccini B, Sinclair R, Ball S, Ding Y, Chen Y, Dutronc Y, King B. Clinical Benefits of Baricitinib Therapy According to Scalp Hair Regrowth in Patients with Severe Alopecia Areata. Dermatology And Therapy 2023, 13: 3209-3220. PMID: 37991697, PMCID: PMC10689319, DOI: 10.1007/s13555-023-01063-2.Peer-Reviewed Original ResearchHair regrowthClinical benefitAlopecia areataClinical meaningful improvementSevere alopecia areataWeeks of treatmentEmotional distressQuality of lifeBaricitinib treatmentAlopecia ToolClinical outcomesResponder subgroupHospital AnxietySkindex-16Depression ScaleSecondary measuresPatientsMeaningful improvementsIntermediate responseScalp hairWeeksSustained Scalp, Eyebrow, and Eyelash Hair Regrowth with Ritlecitinib Through Week 48 in Patients with Alopecia Areata: Post-Hoc Analysis of the ALLEGRO Phase 2b/3 Study
Piliang M, Lynde C, King B, Mirmirani P, Sinclair R, Wolk R, Zwillich S, Tran H, Zhang F, Takiya L. Sustained Scalp, Eyebrow, and Eyelash Hair Regrowth with Ritlecitinib Through Week 48 in Patients with Alopecia Areata: Post-Hoc Analysis of the ALLEGRO Phase 2b/3 Study. SKIN The Journal Of Cutaneous Medicine 2023, 7: s293. DOI: 10.25251/skin.7.supp.293.Peer-Reviewed Original ResearchOutcomes 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 observationIntegrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata (AA) From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program
King B, Soung J, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Anway S, Wajsbrot D, Lejeune A, Zwillich S. Integrated Safety Analysis of Ritlecitinib for the Treatment of Alopecia Areata (AA) From the Phase 2 and Phase 3 ALLEGRO Clinical Trial Program. SKIN The Journal Of Cutaneous Medicine 2023, 7: s291. DOI: 10.25251/skin.7.supp.291.Peer-Reviewed Original ResearchIntegrated Safety Analysis of Ritlecitinib in Adolescent Patients with Alopecia Areata from the Randomized, Placebo-Controlled ALLEGRO Phase 2b/3 and Ongoing Open-Label Phase 3 ALLEGRO-LT Studies
Soung J, King B, Tziotzios C, Rudnicka L, Joly P, Gooderham M, Sinclair R, Wajsbrot D, Tran H, Wolk R. Integrated Safety Analysis of Ritlecitinib in Adolescent Patients with Alopecia Areata from the Randomized, Placebo-Controlled ALLEGRO Phase 2b/3 and Ongoing Open-Label Phase 3 ALLEGRO-LT Studies. SKIN The Journal Of Cutaneous Medicine 2023, 7: s294. DOI: 10.25251/skin.7.supp.294.Peer-Reviewed Original ResearchInhibition of T-cell activity in alopecia areata: recent developments and new directions
Passeron T, King B, Seneschal J, Steinhoff M, Jabbari A, Ohyama M, Tobin D, Randhawa S, Winkler A, Telliez J, Martin D, Lejeune A. Inhibition of T-cell activity in alopecia areata: recent developments and new directions. Frontiers In Immunology 2023, 14: 1243556. PMID: 38022501, PMCID: PMC10657858, DOI: 10.3389/fimmu.2023.1243556.Peer-Reviewed Original ResearchConceptsT cell-signaling pathwaysAlopecia areataT cellsEtiopathogenesis of AAPathogenesis of AATreatment of AAImmune privilege collapseOnly US FoodHair folliclesSevere alopecia areataT cell activityT cell receptor recognitionLoss of scalpSystemic medicationsAA therapyCytotoxic CD8Inflammatory pathogenesisAutoimmune diseasesTreatment optionsHair lossLimited efficacyTherapeutic pathwaysClinical developmentJAK inhibitionUS Food67 Patterns of clinical response in patients with alopecia areata (AA) treated with ritlecitinib in the ALLEGRO phase 2b/3 and ongoing, phase 3, ALLEGRO-LT studies
King B, Mirmirani P, Sicco K, Ramot Y, Sinclair R, Asfour L, Ezzedine K, Paul C, Edwards R, Kerkmann U, Wajsbrot D, Zwillich S, Lejeune A. 67 Patterns of clinical response in patients with alopecia areata (AA) treated with ritlecitinib in the ALLEGRO phase 2b/3 and ongoing, phase 3, ALLEGRO-LT studies. Journal Of Investigative Dermatology 2023, 143: s344. DOI: 10.1016/j.jid.2023.09.075.Peer-Reviewed Original ResearchISIDLB1697 - Individual SALT score trajectories of de novo patients with alopecia areata (AA) treated with ritlecitinib in the ongoing phase 3, long-term, open-label ALLEGRO-LT study
King B, Mirmirani P, Lo Sicco K, Ramot Y, Sinclair R, A. Edwards R, Kerkmann U, Wajsbrot D, Zwillich S, Lejeune A. ISIDLB1697 - Individual SALT score trajectories of de novo patients with alopecia areata (AA) treated with ritlecitinib in the ongoing phase 3, long-term, open-label ALLEGRO-LT study. 2023 DOI: 10.26226/m.6437c1212973c5001292d126.Peer-Reviewed Original ResearchAlopecia areataPhase 3Efficacy 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