2024
A 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 intensity
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