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-1Weeks51840 Efficacy of the Oral JAK1/JAK2 Inhibitor Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata: Pooled Results from the Multinational Double-Blind, Placebo-Controlled THRIVE-AA1 and THRIVE-AA2 Phase 3 Trials
Senna M, King B, Mesinkovska N, Mostaghimi A, Hamilton C, Cassella J. 51840 Efficacy of the Oral JAK1/JAK2 Inhibitor Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata: Pooled Results from the Multinational Double-Blind, Placebo-Controlled THRIVE-AA1 and THRIVE-AA2 Phase 3 Trials. Journal Of The American Academy Of Dermatology 2024, 91: ab39. DOI: 10.1016/j.jaad.2024.07.161.Peer-Reviewed Original Research52898 Among scalp non-responder patients with eyebrow/eyelash regrowth in the first year, continued treatment with baricitinib resulted in meaningful scalp responses for patients with severe alopecia areata
Mostaghimi A, Augustin M, Harada K, Senna M, Dutronc Y, Yu G, Ball S, Murage M, Kolodsick J, King B. 52898 Among scalp non-responder patients with eyebrow/eyelash regrowth in the first year, continued treatment with baricitinib resulted in meaningful scalp responses for patients with severe alopecia areata. Journal Of The American Academy Of Dermatology 2024, 91: ab15. DOI: 10.1016/j.jaad.2024.07.071.Peer-Reviewed Original Research49690 Long-term efficacy of baricitinib in alopecia areata: 3-year results from BRAVE-AA1 and BRAVE-AA2
Senna M, Mostaghimi A, Ohyama M, Sinclair R, Chiasserini C, Dutronc Y, Somani N, Yu G, Kolodsick J, King B. 49690 Long-term efficacy of baricitinib in alopecia areata: 3-year results from BRAVE-AA1 and BRAVE-AA2. Journal Of The American Academy Of Dermatology 2024, 91: ab251. DOI: 10.1016/j.jaad.2024.07.996.Peer-Reviewed Original Research52709 Patient-Reported Outcomes for Scalp, Eyebrow and Eyelash Hair Loss in Patients with Severe Alopecia Areata Treated with Baricitinib: 152 Week Results from two Phase 3 Clinical Trials
King B, Mostaghimi A, Ohyama M, Senna M, Chiasserini C, Dutronc Y, Liu C, Yu G, Murage M, Sinclair R. 52709 Patient-Reported Outcomes for Scalp, Eyebrow and Eyelash Hair Loss in Patients with Severe Alopecia Areata Treated with Baricitinib: 152 Week Results from two Phase 3 Clinical Trials. Journal Of The American Academy Of Dermatology 2024, 91: ab69. DOI: 10.1016/j.jaad.2024.07.282.Peer-Reviewed Original Research54022 Pooled Safety Assessments from the Multinational Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials of Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata
King B, Mesinkovska N, Mostaghimi A, Hamilton C, Cassella J. 54022 Pooled Safety Assessments from the Multinational Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials of Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata. Journal Of The American Academy Of Dermatology 2024, 91: ab281. DOI: 10.1016/j.jaad.2024.07.1117.Peer-Reviewed Original Research52874 Timing of eyebrow and eyelash regrowth among subgroups of scalp responders during treatment of severe alopecia areata with baricitinib
King B, Senna M, Ohyama M, Dutronc Y, Lu N, Chiasserini C, Somani N, Piraccini B. 52874 Timing of eyebrow and eyelash regrowth among subgroups of scalp responders during treatment of severe alopecia areata with baricitinib. Journal Of The American Academy Of Dermatology 2024, 91: ab340. DOI: 10.1016/j.jaad.2024.07.1353.Peer-Reviewed Original Research54029 Pooled Patient-Reported Outcomes from the Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials of Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata
Mesinkovska N, King B, Mostaghimi A, Hamilton C, Cassella J. 54029 Pooled Patient-Reported Outcomes from the Phase 3 THRIVE-AA1 and THRIVE-AA2 Trials of Deuruxolitinib in Adult Patients with Moderate to Severe Alopecia Areata. Journal Of The American Academy Of Dermatology 2024, 91: ab71. DOI: 10.1016/j.jaad.2024.07.289.Peer-Reviewed Original Research51436 Safety Analysis of Baricitinib in Adult Patients with Severe Alopecia Areata From 2 Randomized Clinical Trials over a Median of 2.3 years and up to 4 Years of Exposure
King B, Mostaghimi A, Shimomura Y, Piraccini B, Blume-Peytavi U, Sontag A, Dutronc Y, Holzwarth K, Kolodsick J, Lu X, Sinclair R. 51436 Safety Analysis of Baricitinib in Adult Patients with Severe Alopecia Areata From 2 Randomized Clinical Trials over a Median of 2.3 years and up to 4 Years of Exposure. Journal Of The American Academy Of Dermatology 2024, 91: ab82. DOI: 10.1016/j.jaad.2024.07.336.Peer-Reviewed Original ResearchBaricitinib 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
Analyse de la tolérance du baricitinib chez les patients adultes atteints de pelade sévère issus de 2 essais cliniques randomisés sur une période d’exposition médiane de 1,6 années et maximale de 3,6 années
King B, Ko J, Piraccini B, Shimomura Y, Dutronc Y, Wu W, Yang F, Holzwarth K, Chiasserini C, Sinclair R, Leveque C. Analyse de la tolérance du baricitinib chez les patients adultes atteints de pelade sévère issus de 2 essais cliniques randomisés sur une période d’exposition médiane de 1,6 années et maximale de 3,6 années. Annales De Dermatologie Et De Vénéréologie - FMC 2023, 3: a348-a349. DOI: 10.1016/j.fander.2023.09.595.Peer-Reviewed Original ResearchEfficacité à long terme du baricitinib dans le traitement de la pelade : résultats à la semaine 104 des études BRAVE-AA1 et BRAVE-AA2
Senna M, Mostaghimi A, Ohyama M, Sinclair R, Dutronc Y, Wu W, Guanglei Y, Chiasserini C, Somani N, King B, Leveque C. Efficacité à long terme du baricitinib dans le traitement de la pelade : résultats à la semaine 104 des études BRAVE-AA1 et BRAVE-AA2. Annales De Dermatologie Et De Vénéréologie - FMC 2023, 3: a336-a337. DOI: 10.1016/j.fander.2023.09.580.Peer-Reviewed Original Research