2024
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)
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 differencesTreatmentDoseBaselineTrialsWeeks33304 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 Research33183 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 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“‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata
Aldhouse NVJ, Kitchen H, Knight S, Macey J, Nunes FP, Dutronc Y, Mesinkovska N, Ko JM, King BA, Wyrwich KW. “‘You lose your hair, what’s the big deal?’ I was so embarrassed, I was so self-conscious, I was so depressed:” a qualitative interview study to understand the psychosocial burden of alopecia areata. Journal Of Patient-Reported Outcomes 2020, 4: 76. PMID: 32914253, PMCID: PMC7483696, DOI: 10.1186/s41687-020-00240-7.Peer-Reviewed Original ResearchHair lossPsychosocial burdenGreater disease awarenessSigns/symptomsScalp hair lossExpert clinician inputAvoidance of activitySemi-structured interview guidePhysical signs/symptomsAlopecia ToolDisease recurrenceAA diagnosisAlopecia areataQualitative interview studyEffective treatmentEfficacious treatmentDisease awarenessAreataPatient experienceClinician inputImpair patientsPatientsPsychosocial effectsPsychological impactInterview guideDevelopment of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata
Wyrwich KW, Kitchen H, Knight S, Aldhouse NVJ, Macey J, Nunes FP, Dutronc Y, Mesinkovska N, Ko JM, King BA. Development of Clinician-Reported Outcome (ClinRO) and Patient-Reported Outcome (PRO) Measures for Eyebrow, Eyelash and Nail Assessment in Alopecia Areata. American Journal Of Clinical Dermatology 2020, 21: 725-732. PMID: 32803546, PMCID: PMC7473969, DOI: 10.1007/s40257-020-00545-9.Peer-Reviewed Original ResearchConceptsSigns/symptomsAlopecia areataPRO measuresNail appearanceEyelash lossOutcome measuresHair lossEye irritationPatient-reported outcome measuresClinician-reported outcomesNorth American patientsDevelopment of cliniciansNail assessmentEyebrow lossNail involvementAmerican patientsClinical trialsPatientsNail damageSymptomsAreataObjectivesOur objectiveOutcomesEyelashesDermatologistsDevelopment of the Scalp Hair Assessment PRO™ measure for alopecia areata
Wyrwich K, Kitchen H, Knight S, Aldhouse N, Macey J, Nunes F, Dutronc Y, Mesinkovska N, Ko J, King B. Development of the Scalp Hair Assessment PRO™ measure for alopecia areata. British Journal Of Dermatology 2020, 183: 1065-1072. PMID: 32163589, PMCID: PMC7754291, DOI: 10.1111/bjd.19024.Peer-Reviewed Original ResearchConceptsScalp hair lossHair lossPRO measuresValid patient-reported outcome measurePatient-reported outcome measuresAlopecia areata treatmentInvestigator's Global AssessmentHair regrowthAlopecia areataTreatment successOutcome measuresQualitative semistructured interviewsPatientsGlobal assessmentAA treatmentClinical expertsScalp hairSemistructured interviewsTreatmentAreataResponse scaleSymptomsBaselineAAMeasuresDupilumab as a novel therapy for bullous pemphigoid: A multicenter case series
Abdat R, Waldman RA, de Bedout V, Czernik A, Mcleod M, King B, Gordon S, Ahmed R, Nichols A, Rothe M, Rosmarin D. Dupilumab as a novel therapy for bullous pemphigoid: A multicenter case series. Journal Of The American Academy Of Dermatology 2020, 83: 46-52. PMID: 32179082, DOI: 10.1016/j.jaad.2020.01.089.Peer-Reviewed Original ResearchConceptsBullous pemphigoidDisease clearanceCase seriesSatisfactory responseMulticenter case seriesAutoimmune blistering disorderLesional skin biopsiesSeries of patientsPrevious conventional therapyEnzyme-linked immunosorbentStandardized assessment toolsAdverse eventsDisease improvementConventional therapyClinician documentationTotal clearanceSkin biopsiesNovel therapiesDirect immunofluorescencePatient's desireEosin stainingAdequate treatmentAverage agePatientsAcademic centers