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 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 ResearchEfficacy 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 3Integrated 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 hairWeeksOutcomes 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 observation67 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 ResearchEfficacy 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 AmericansTreatment
2022
Efficacy 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 ResearchConceptsNonsegmental vitiligoLoading doseScoring IndexPercent changePhase 2b clinical trialExtension periodPhase 2b trialPrimary efficacy endpointSerious adverse eventsChronic autoimmune disorderDose-dependent trendEfficacy endpointAdverse eventsWeek 24Autoimmune disordersClinical trialsStable vitiligoPatientsVitiligoSignificant differencesTreatmentDoseBaselineTrialsWeeks33183 Efficacy of the oral JAK3/TEC inhibitor ritlecitinib (PF-06651600) in patients with alopecia areata over 48 weeks: Results from the ALLEGRO Phase 2b/3 randomized, double-blind, placebo-controlled trial
Mesinkovska N, Shapiro J, King B. 33183 Efficacy of the oral JAK3/TEC inhibitor ritlecitinib (PF-06651600) in patients with alopecia areata over 48 weeks: Results from the ALLEGRO Phase 2b/3 randomized, double-blind, placebo-controlled trial. Journal Of The American Academy Of Dermatology 2022, 87: ab54. DOI: 10.1016/j.jaad.2022.06.249.Peer-Reviewed Original Research33304 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
Peeva E, Yamaguchi Y, King B. 33304 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. Journal Of The American Academy Of Dermatology 2022, 87: ab105. DOI: 10.1016/j.jaad.2022.06.453.Peer-Reviewed Original Research33774 Baricitinib results in eyebrow and eyelash growth in patients with alopecia areata who do not achieve 20% or less scalp hair loss
Senna M, Kwon O, Piraccini B, Sinclair R, Ball S, Ding Y, Chen Y, Dutronc Y, King B. 33774 Baricitinib results in eyebrow and eyelash growth in patients with alopecia areata who do not achieve 20% or less scalp hair loss. Journal Of The American Academy Of Dermatology 2022, 87: ab144. DOI: 10.1016/j.jaad.2022.06.610.Peer-Reviewed Original Research
2021
26143 Time to scalp hair, eyebrow, and eyelash improvement in patients with alopecia areata treated with baricitinib in the phase 2 portion of the phase 2/3 BRAVE-AA1 study
Senna M, McMichael A, Mayo T, Mackay-Wiggan J, Glashofer M, Sun L, Yu G, Nunes F, McCollam J, Wu W, King B. 26143 Time to scalp hair, eyebrow, and eyelash improvement in patients with alopecia areata treated with baricitinib in the phase 2 portion of the phase 2/3 BRAVE-AA1 study. Journal Of The American Academy Of Dermatology 2021, 85: ab85. DOI: 10.1016/j.jaad.2021.06.365.Peer-Reviewed Original Research27030 Extended safety analysis of baricitinib 2-mg in adult patients with atopic dermatitis: An integrated analysis from 8 randomized clinical trials
King B, Maari C, Lain E, Silverberg J, Issa M, Holzwarth K, Brinker D, Cardillo T, Nunes F, Simpson E. 27030 Extended safety analysis of baricitinib 2-mg in adult patients with atopic dermatitis: An integrated analysis from 8 randomized clinical trials. Journal Of The American Academy Of Dermatology 2021, 85: ab127. DOI: 10.1016/j.jaad.2021.06.525.Peer-Reviewed Original Research
2020
16405 Abrocitinib treatment in patients with moderate to severe atopic dermatitis: Consistency of efficacy responses from randomized, controlled phase 3 and phase 2b clinical trials
Simpson E, Gooderham M, King B, Taylor S, Rosmarin D, Tatulych S, Nduaka C, Williams D, Zhang W, Rojo R. 16405 Abrocitinib treatment in patients with moderate to severe atopic dermatitis: Consistency of efficacy responses from randomized, controlled phase 3 and phase 2b clinical trials. Journal Of The American Academy Of Dermatology 2020, 83: ab62. DOI: 10.1016/j.jaad.2020.06.336.Peer-Reviewed Original Research