2024
Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis For Up to 3 Years
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Vaile J, Berger V, Vritzali E, Hoyt K, Colombo M, Scotto J, Banerjee S, Strober B, Thaçi D, Blauvelt A. Safety and Efficacy of Deucravacitinib in Moderate to Severe Plaque Psoriasis For Up to 3 Years. JAMA Dermatology 2024, 161 PMID: 39602111, DOI: 10.1001/jamadermatol.2024.4688.Peer-Reviewed Original ResearchLong-term extension trialsExposure-adjusted incidence ratesSevere plaque psoriasisLong-term extensionModerate to severe plaque psoriasisAdverse eventsPlaque psoriasisDouble-blind phase 3 trialStatic Physician's Global Assessment scoreDiscontinuation due to adverse eventsDay 1Physician Global Assessment scoreIncidence rateEffective long-term treatmentUpper respiratory tract infectionClinical response rateGlobal Assessment scorePhase 3 trialRespiratory tract infectionsWeeks of treatmentYear of treatmentLong-term treatmentAdverse cardiovascular eventsLong-term safetyCumulative periodBrodalumab: Six-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Yoon S, Rawnsley N, Goehring E, Mangin G, Jacobson A. Brodalumab: Six-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 1-10. PMID: 39589679, DOI: 10.1007/s13555-024-01304-y.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyUS patientsCase of Candida infectionSafety profile of brodalumabSafety of brodalumabMajor adverse cardiovascular eventsInterleukin-17 receptorAdverse cardiovascular eventsLong-term safetyFungal infection rateCandida infectionsPlaque psoriasisSafety profileAdult patientsBrodalumabCardiovascular eventsBox warningPharmacovigilance reportsFungal infectionsClinical trialsPatientsPharmacovigilance dataMedDRA QueriesClinical practiceCriteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America.
Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M. Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America. Journal Of Psoriasis And Psoriatic Arthritis 2024, 24755303241302070. PMID: 39583219, PMCID: PMC11583168, DOI: 10.1177/24755303241302070.Peer-Reviewed Original ResearchBody surface areaInternational Psoriasis CouncilSystemic therapySystemic psoriasis treatmentsDisease severity criteriaTopical therapyPsoriasis treatmentTherapy candidatesCorEvitas Psoriasis RegistrySystemic therapy initiationTreatment-naive patientsSeverity criteriaReal-world studyCross-sectional studyDisease severity indicatorsPatient-reported outcome measuresPlaque psoriasisPsoriasis RegistryTherapy initiationSystemic treatmentRegistry visitPASI scoreClinical characteristicsClinical decision-makingPsoriasis severityDeucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s423. DOI: 10.25251/skin.8.supp.423.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateParent trialAdverse cardiovascular eventsTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsCardiovascular eventsSafety signalsPatientsResponse rateIncidence ratePsoriasisMatching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis
Armstrong A, Soliman A, Gisondi P, Fang S, Patel M, Strober B. Matching-Adjusted Indirect Comparison of Risankizumab Versus Deucravacitinib in Patients with Moderate-to-Severe Plaque Psoriasis. Dermatology And Therapy 2024, 14: 3071-3081. PMID: 39453596, PMCID: PMC11557788, DOI: 10.1007/s13555-024-01293-y.Peer-Reviewed Original ResearchDermatology Life Quality IndexSkin clearanceIndirect comparisonsStatic Physician's Global AssessmentRisankizumab-treated patientsPhysician global assessmentTreatment of psoriasisMatching-adjusted indirect comparisonIndividual patient dataLife Quality IndexPlaque psoriasisPsoriasis AreaRisankizumabDeucravacitinibNew therapiesIntroductionDespite advancesPsO.Global assessmentQuality of lifePsoriasisPatientsPropensity scorePatient dataClearanceHealthcare providers52671 Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, Pinto J, Gisondi P. 52671 Bimekizumab safety and tolerability in moderate to severe plaque psoriasis: Pooled analysis from up to 4 years of treatment in 5 phase 3/3b clinical trials. Journal Of The American Academy Of Dermatology 2024, 91: ab145. DOI: 10.1016/j.jaad.2024.07.577.Peer-Reviewed Original Research52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials
Strober B, Krueger J, Magnolo N, Vender R, Boehncke W, Hong H, Tilt N, Staelens F, Wiegratz S, Paul C. 52675 Bimekizumab efficacy across subgroups of patients with moderate to severe plaque psoriasis: Pooled analysis from up to 3 years of treatment in 5 phase 3/3b clinical trials. Journal Of The American Academy Of Dermatology 2024, 91: ab142. DOI: 10.1016/j.jaad.2024.07.572.Peer-Reviewed Original ResearchBimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, López Pinto J, Gisondi P. Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s404. DOI: 10.25251/skin.8.supp.404.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsSevere plaque psoriasisOpen-label extensionPlaque psoriasisOral candidiasisPatient yrModerate to severe plaque psoriasisUpper respiratory tract infectionLong-term safety of treatmentRespiratory tract infectionsNext scheduled visitYear of treatmentSafety of treatmentLong-term safetySafety findingsTract infectionsLong-term managementBimekizumabSafety profileAdverse eventsPooled analysisClinical trialsQ8WSafety dataPsoriasisDeucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s406. DOI: 10.25251/skin.8.supp.406.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsSafety signalsPatientsContinuous treatmentResponse rateIncidence rateParent trialPsoriasisAllosteric TYK2 inhibitorDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaci D, Lebwohl M, Issa N, Cameron M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 4 Years in the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s407. DOI: 10.25251/skin.8.supp.407.Peer-Reviewed Original ResearchLong-term extensionModerate to severe plaque psoriasisSevere plaque psoriasisPlaque psoriasisLong-term extension trialsResponse rateModified nonresponder imputationMaintenance of responseYears of continuous treatmentPhase 3 trialLong-term efficacyNonresponder imputationPrimary endpointPsoriasis AreaResponse assessmentClinical efficacyDeucravacitinibPASISafety signalsTreatment durabilityPatientsContinuous treatmentPsoriasisLong-term effectsParent trialDeucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials
Korman N, Warren R, Bagel J, Armstrong A, Gooderham M, Strober B, Thaçi D, Morita A, Imafuku S, Foley P, Sofen H, Zheng M, Hippeli L, Kisa R, Banerjee S, Blauvelt A. Deucravacitinib onset of action and maintenance of response in phase 3 plaque psoriasis trials. Journal Of Dermatological Treatment 2024, 35: 2371045. PMID: 38945549, DOI: 10.1080/09546634.2024.2371045.Peer-Reviewed Original ResearchConceptsMaintenance of responseModerate to severe plaque psoriasisOnset of actionSevere plaque psoriasisPlaque psoriasisApremilast-treated patientsEfficacy measuresOral placeboClinical responseCoprimary endpointsDeucravacitinibPsoriasis trialsWeek 8PlaceboPASIPatientsWeek 1WeeksEfficacyPsoriasisSPGABaselineSignificant improvementTrialsApremilastA randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis
Ehst B, Strober B, Blauvelt A, Maslin D, Macaro D, Carpenter N, Bodmer M, McHale D. A randomized, double-blinded, phase 2 trial of EDP1815, an oral immunomodulatory preparation of Prevotella histicola, in adults with mild-to-moderate plaque psoriasis. Frontiers In Medicine 2024, 11: 1292406. PMID: 38813388, PMCID: PMC11133679, DOI: 10.3389/fmed.2024.1292406.Peer-Reviewed Original ResearchPASI-50Double-blindMild to moderate plaque psoriasisMild to moderate psoriasisOff-treatment responseWeeks of follow-upChronic inflammatory skin diseaseParallel-group studySystemic anti-inflammatory responsePhase 2 trialInflammatory skin diseaseAnti-inflammatory responsePlaque psoriasisPlacebo-controlledPsoriasis AreaEfficacy outcomesImmunomodulatory approachesSafety profileAdverse eventsEvaluate safetyFollow-upTreatment periodTherapeutic benefitPsoriasisSkin diseasesBrodalumab: 5-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Martin G, Rawnsley N, Goehring E, Jacobson A. Brodalumab: 5-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 14: 1349-1357. PMID: 38724839, PMCID: PMC11116300, DOI: 10.1007/s13555-024-01162-8.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyInterleukin-17 receptor A antagonistPharmacovigilance dataPsoriasis Longitudinal AssessmentMajor adverse cardiovascular eventsLong-term clinical trialsUS prescribing informationAdverse cardiovascular eventsPlaque psoriasisReported malignanciesSafety profileAdult patientsCardiovascular eventsBrodalumabBox warningUS patientsPharmacovigilance reportsFungal infectionsClinical trialsPrescribing informationSafety signalsSuspected COVID-19 casesPatientsPackage insertsBimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials
Lebwohl M, Merola J, Strober B, Armstrong A, Yoshizaki A, Gisondi P, Szilagyi B, Peterson L, de Cuyper D, Cross N, Davies O, Gottlieb A. Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials. Journal Of The American Academy Of Dermatology 2024, 91: 281-289. PMID: 38588819, DOI: 10.1016/j.jaad.2024.03.041.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsAdverse eventsModerate to severe plaque psoriasisIncidence of transaminase elevationsLiver parametersMarkers of liver fibrosisAlanine aminotransferaseHepatic adverse eventsSevere plaque psoriasisLiver function abnormalitiesChronic alcohol consumptionControl study periodAspartate aminotransferaseStudy periodAPRI scorePlaque psoriasisTransaminase elevationFibrosis riskHepatic eventsFIB-4Hepatic dysfunctionLaboratory elevationsClinical markersFunctional abnormalitiesLiver fibrosisDeucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s366. DOI: 10.25251/skin.8.supp.366.Peer-Reviewed Original ResearchModified nonresponder imputationPlaque psoriasisModerate to severe plaque psoriasisDiscontinuations due to AEsExposure-adjusted incidence ratesSevere plaque psoriasisParent trialAdverse cardiovascular eventsLong-term extensionTreatment of adultsSystemic therapyNonresponder imputationEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsResponse rateIncidence ratePsoriasisAllosteric TYK2 inhibitorEfficacyBimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials
Han G, Gottlieb A, Armstrong A, Strober B, Soung J, Herr H, Davis L, Lebwohl M. Bimekizumab Efficacy through Year 1 in Patients with Moderate to Severe Plaque Psoriasis Who Had Not Achieved a PASI 90 Response by Week 16: A Pooled Analysis from Four Phase 3/3B Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s369. DOI: 10.25251/skin.8.supp.369.Peer-Reviewed Original ResearchOpen-label extensionSevere plaque psoriasisPASI responseBaseline PASIPlaque psoriasisSkin clearanceModerate to severe plaque psoriasisInhibits interleukin (IL)-17FLevels of skin clearanceDouble-blind periodPhase 3b trialPhase 3 trialProportion of patientsInterleukin (IL)-17FAssociated with improved quality of lifeMonoclonal IgG1 antibodyHigher PASIMaintenance dosePsoriasis AreaBimekizumabAssociated with improved qualityPooled analysisPASIPatientsQuality of lifeDeucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2)
Strober B, Blauvelt A, Warren R, Papp K, Armstrong A, Gordon K, Morita A, Alexis A, Lebwohl M, Foley P, Kisa R, Colston E, Wang T, Banerjee S, Thaçi D. Deucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 1543-1554. PMID: 38451052, DOI: 10.1111/jdv.19925.Peer-Reviewed Original ResearchPhase 3 trialPlaque psoriasisAdverse eventsTyrosine kinase 2Exposure-adjusted incidence ratesPooled safety dataRate of adverse eventsIncidence rate of adverse eventsVenous thromboembolic eventsExposure-adjusted incidence rates of adverse eventsAdverse cardiovascular eventsOral placeboDiscontinuation ratesLaboratory parametersThromboembolic eventsHerpes zosterDeucravacitinibCardiovascular eventsPooled analysisSafety signalsSafety dataPooled safetyPlaceboApremilastPsoriasisMeaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary
Papp K, Gordon K, Strober B, Zhuo J, Becker B, Zhong Y, Beaumont J, Pham T, Kisa R, Napoli A, Banerjee S, Armstrong A. Meaningful Change Thresholds for the Psoriasis Symptoms and Signs Diary. JAMA Dermatology 2024, 160: 204-209. PMID: 38117487, PMCID: PMC10733845, DOI: 10.1001/jamadermatol.2023.5058.Peer-Reviewed Original ResearchSevere plaque psoriasisPatient Global ImpressionClinical trialsPsoriasis symptomsScore changeSigns DiaryPlaque psoriasisGlobal ImpressionWeek 16MAIN OUTCOMEPatient-reported end pointsPlacebo-controlled phase 3 clinical trialPhase 3 clinical trialsPatient-reported assessmentsPhase 3 programMeaningful change thresholdCategory improvementDisease burdenMeaningful score changesSelective TYK2 inhibitorsPatient changeBaseline scoresPsoriasisPatientsEnd pointBimekizumab 3-year Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from Five Phase 3/3b Trials
Lebwohl M, Strober B, Langley R, Okubo Y, Foley P, Warren R, Peterson L, Cross N, Wiegratz S, Deherder D, Thaçi D. Bimekizumab 3-year Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from Five Phase 3/3b Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s305. DOI: 10.25251/skin.8.supp.305.Peer-Reviewed Original ResearchBimekizumab Efficacy Through 3 Years in Patients with Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from BE BRIGHT
Lebwohl M, Strober B, Foley P, Langley R, Tada Y, Hampton P, Davis L, Wiegratz S, Hoepken B, Lambert J, Kokolakis G. Bimekizumab Efficacy Through 3 Years in Patients with Moderate to Severe Plaque Psoriasis: Long-term Pooled Analysis from BE BRIGHT. SKIN The Journal Of Cutaneous Medicine 2024, 8: s307. DOI: 10.25251/skin.8.supp.307.Peer-Reviewed Original ResearchOpen-label extensionDermatology Life Quality IndexSevere plaque psoriasisPhase 3 trialPlaque psoriasisPooled analysisDermatology Life Quality Index 0/1Discontinued treatment due to lackModerate to severe plaque psoriasisOLE weekPooled analysis of patientsTreatment-related adverse eventsPhase 3 clinical trialsEfficacy of bimekizumabPlaque psoriasis patientsTreatment due to lackAnalysis of patientsLong-term treatment efficacyProportion of patientsNext scheduled visitNon-responder imputationLoss of responseQuality of life responsesLife Quality IndexBE VIVID