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 periodDeucravacitinib 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 ratePsoriasis52671 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 improvementTrialsApremilastBimekizumab 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 lifeMental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials
Blauvelt A, Armstrong A, Merola J, Strober B, de Cuyper D, Peterson L, Davies O, Stark J, Lebwohl M. Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials. Journal Of The American Academy Of Dermatology 2024, 91: 72-81. PMID: 38447700, DOI: 10.1016/j.jaad.2024.02.039.Peer-Reviewed Original ResearchModerate to severe psoriasisColumbia-Suicide Severity Rating ScaleSevere psoriasisIncreased risk of suicidal ideationRisk of suicidal ideationModerate to severe plaque psoriasisClinical trialsSeverity Rating ScaleFood and Drug Administration approvalRating scale responsesGeneral psoriasis populationPsoriasis patient populationPatient Health Questionnaire-9Placebo-treated patientsSevere plaque psoriasisMental health outcomesMental health changesPhase 2/3 trialsEuropean Medicines Agency approvalInterleukin (IL)-17ADrug Administration approvalPatient Health Questionnaire-9 scoresSuicidal ideationMeasure depressionRating ScaleMeaningful 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 VIVIDEfficacy of long‐term risankizumab treatment for moderate‐to‐severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial)
Strober B, Bachelez H, Crowley J, Elewski B, Gooderham M, Menter A, Strohal R, Chen M, Wu T, Zhan T, Photowala H, Armstrong A. Efficacy of long‐term risankizumab treatment for moderate‐to‐severe plaque psoriasis: Subgroup analyses by baseline characteristics and psoriatic disease manifestations through 256 weeks (LIMMitless trial). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 864-872. PMID: 38179809, DOI: 10.1111/jdv.19748.Peer-Reviewed Original ResearchSevere plaque psoriasisLong-term efficacyPlaque psoriasisDisease manifestationsWeek 256Palmoplantar psoriasisSubgroup analysisDurable long-term efficacyOpen-label extension studyBaseline patient characteristicsProportion of patientsBody mass indexInflammatory skin diseaseMultiple clinical manifestationsPASI 90/100Psoriatic manifestationsRisankizumab treatmentBaseline characteristicsPatient characteristicsPsoriasis AreaSkin psoriasisMass indexClinical manifestationsArthritis statusPatient subgroups
2023
Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders
Blauvelt A, Armstrong A, Merola J, Strober B, De Cuyper D, Peterson L, Davies O, Stark J, Lebwohl M. Bimekizumab in Patients with Moderate to Severe Plaque Psoriasis: Analysis of Mental Health and Associated Disorders. SKIN The Journal Of Cutaneous Medicine 2023, 7: s300. DOI: 10.25251/skin.7.supp.300.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsPHQ-9 scoresPHQ-9Severe plaque psoriasisLonger-term depressionPlaque psoriasisModerate-severe depressionRisk of depressionSuicidal ideationPatient Health Questionnaire (PHQ)-9Moderate to severe plaque psoriasisPHQ-9 dataElevated PHQ-9 scoresGeneral psoriasis populationAnalysis of mental healthDepressionMental healthHigher scoresSuicideLong-term incidence rateAdverse eventsPsoriasis populationScore 0Adjudication committeeWk16Deucravacitinib 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 2023, 7: s240. DOI: 10.25251/skin.7.supp.240.Peer-Reviewed Original ResearchSevere plaque psoriasisPlaque psoriasisParent trialDay 1Exposure-adjusted incidence ratesLong-term extension trialsMajor adverse cardiovascular eventsAdverse cardiovascular eventsConsistent safety profileTreatment of adultsNonresponder imputationOral placeboSerious AEsWeek 148Cardiovascular eventsEfficacy outcomesVenous thromboembolismWeek 52Herpes zosterSystemic therapyDurable efficacySafety profileExtension trialIncidence rateEfficacy resultsDeucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Sofen H, Strober B, Imafuku S, Paul C, Gooderham M, Spelman L, Seo S, Passeron T, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Augustin M, Stein Gold L, Alexis A, Thaçi D, Blauvelt A, Lebwohl M. Deucravacitinib in Plaque Psoriasis: Maintenance of Response Over 3 Years in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s241. DOI: 10.25251/skin.7.supp.241.Peer-Reviewed Original ResearchPASI 75 respondersSevere plaque psoriasisPASI 75PASI 90Week 148Plaque psoriasisWeek 52Week 16Week 24Parent trialClinical efficacyDay 1Response rateLong-term extension trialsNew safety signalsPhase 3 trialSubset of patientsMaintenance of responseLong-term efficacyLong-term effectivenessNonresponder imputationOral placeboPsoriasis AreaExtension trialSafety signalsDeucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Lebwohl M, Strober B, Scharnitz T, Linaberry M, Hoyt K, Banerjee S, Kisa R, Martin G. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s244. DOI: 10.25251/skin.7.supp.244.Peer-Reviewed Original ResearchExposure-adjusted incidence ratesSevere plaque psoriasisAdverse eventsPlaque psoriasisCPK levelsWeek 52CTCAE gradeElevated CPKCPK elevationWeek 16Apremilast-treated patientsPooled safety analysisPotential inciting eventsCreatine phosphokinase elevationProportion of patientsTreatment of adultsCreatine phosphokinase levelsKinase 2 inhibitorTyrosine kinase 2 inhibitorLow gradeOral placeboSystemic therapyInciting eventWeeks 0Incidence rate