2024
Deucravacitinib 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 ratePsoriasisSpesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial
Gottlieb A, Strober B, Merola J, Mostaghimi A, Farberg A, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab increases the percentage of generalized pustular psoriasis (GPP) patients with clear skin over time as measured by the Physician’s Global Assessment for GPP (GPPGA): Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s490. DOI: 10.25251/skin.8.supp.490.Peer-Reviewed Original ResearchGeneralized pustular psoriasisPhysician global assessmentSkin symptomsPustular psoriasisGlobal assessmentProportion of patientsPercentage of patientsTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageDosing regimenPediatric patientsClear skinSpesolimabPatientsContinuous treatmentMonoclonal antibodiesSkin diseasesPatient burdenSymptomsPsoriasisTotal scoreSkinTreatmentMatching-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 providers52675 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 dataPsoriasisSpesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial
Gottlieb A, Strober B, Kokolakis G, Merola J, Zheng M, Langley R, Tang M, Hofmann P, Thoma C, Warren R. Spesolimab Rapidly Improves Quality of Life in Patients with Generalized Pustular Psoriasis, as per Dermatology Life Quality Index Scores: Data from the Effisayil 2 Trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s409. DOI: 10.25251/skin.8.supp.409.Peer-Reviewed Original ResearchGeneralized pustular psoriasisDermatology Life Quality IndexDermatology Life Quality Index scoresGeneralized pustular psoriasis flaresPustular psoriasisVisits up to weekWeek 4Results Baseline characteristicsLength of diseaseLife Quality IndexLife-threatening diseasePlacebo groupHigh-doseSkin pustulesBaseline characteristicsSpesolimabFlare preventionPlaceboDLQI scoreQuality of lifePatientsWeeksPsoriasisScoresDiseaseDeucravacitinib 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 diseasesSpesolimab treatment for the prevention of flares in people with generalized pustular psoriasis (GPP): a plain language summary of the Effisayil™ 2 study
Morita A, Strober B, Burden A, Choon S, Anadkat M, Marrakchi S, Tsai T, Gordon K, Thaçi D, Zheng M, Hu N, Haeufel T, Thoma C, Lebwohl M. Spesolimab treatment for the prevention of flares in people with generalized pustular psoriasis (GPP): a plain language summary of the Effisayil™ 2 study. Future Rare Diseases 2024, 4: frd57. DOI: 10.2217/frd-2023-0023.Peer-Reviewed Original ResearchGeneralized pustular psoriasisGeneralized pustular psoriasis flaresPustular psoriasisHigh dosesQuality of lifePrevention of flaresCompared to placeboLife-threatening diseasePrevent flaresSpesolimabGPP flaresClinical studiesMedium doseSkin symptomsDoseUnwanted effectsPlaceboPsoriasisSymptomsDrugPustulesWeeksDiseaseDeucravacitinib 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 inhibitorEfficacyDeucravacitinib 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 safetyPlaceboApremilastPsoriasisAssociation of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis
McGonagle D, Kavanaugh A, McInnes I, Kristensen L, Merola J, Strober B, Bolce R, Lisse J, Pustizzi J, Sapin C, Ritchlin C. Association of the clinical components in the distal interphalangeal joint synovio-entheseal complex and subsequent response to ixekizumab or adalimumab in psoriatic arthritis. Rheumatology 2024, 63: 3115-3123. PMID: 38341669, PMCID: PMC11534097, DOI: 10.1093/rheumatology/keae060.Peer-Reviewed Original ResearchNail psoriasisJoint involvementPsoriatic arthritisJoint tendernessTargeting IL-17ADistal interphalangeal joint involvementPost hoc analysisPost-baseline assessmentSPIRIT-H2HInhibitor adalimumabIL-17AAdalimumabStudy cohortTNF-aDrug classesMusculoskeletal outcomesPsoriasisPatientsHoc analysisDistal interphalangealIxekizumabSynovio-entheseal complexWeeksAdjacent nailPSAMeaningful 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 point
2023
Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis
Blauvelt A, Rich P, Sofen H, Strober B, Merola J, Lebwohl M, Morita A, Szepietowski J, Lambert J, Hippeli L, Colston E, Balagula E, Banerjee S, Thaçi D. Deucravacitinib, a selective, allosteric tyrosine kinase 2 inhibitor, in scalp psoriasis: A subset analysis of two phase 3 randomized trials in plaque psoriasis. Journal Of The American Academy Of Dermatology 2023, 90: 775-782. PMID: 38122848, DOI: 10.1016/j.jaad.2023.11.060.Peer-Reviewed Original ResearchPsoriasis Scalp Severity IndexSevere scalp psoriasisScalp psoriasisPlaque psoriasisSeverity IndexWeek 16Physician's Global Assessment 0/1Physician Global Assessment scoreGlobal phase 3Double-blinded trialEntire study populationGlobal assessment scorePhase 3Pooled secondary analysisOral placeboScalp involvementSevere psoriasisAdverse eventsSubset analysisStudy populationPsoriasisDeucravacitinibResponse rateSecondary analysisPlaceboOrismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)
Warren R, French L, Blauvelt A, Langley R, Egeberg A, Mrowietz U, Hunter H, Gooderham M, Soerensen P, Andres P, Sommer M, Carlsson A, Kjøller K, Strober B. Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS). Journal Of The American Academy Of Dermatology 2023, 90: 494-503. PMID: 37951245, DOI: 10.1016/j.jaad.2023.11.005.Peer-Reviewed Original ResearchSevere psoriasisWeek 16PDE4 inhibitionPhase 2b trialSevere plaque psoriasisDose-ranging studyModified-release formulationTolerability effectsPlaque psoriasisBaseline characteristicsEfficacy endpointPrimary endpointPsoriasis AreaSafety findingsSafety profileStudy populationPhase 2bPotential treatmentPsoriasisDisease proportionsGreater efficacyPlaceboPercentage changeSmall sample sizeSeverity IndexReal-world effectiveness of risankizumab in patients with moderate-to-severe psoriasis using the CorEvitas Psoriasis Registry
Strober B, Ferris L, Callis Duffin K, Janak J, Sima A, Eckmann T, Patel M, Photowala H, Garg V, Armstrong A. Real-world effectiveness of risankizumab in patients with moderate-to-severe psoriasis using the CorEvitas Psoriasis Registry. Journal Of The American Academy Of Dermatology 2023, 90: 82-90. PMID: 37739267, DOI: 10.1016/j.jaad.2023.08.097.Peer-Reviewed Original ResearchDermatology Life Quality Index scoresLife Quality Index scoresPsoriasis RegistryQuality Index scoresSevere psoriasisPsoriasis symptomsClear skinIndex scoreReal-world treatment effectivenessPrior biologic treatmentSevere plaque psoriasisInflammatory skin diseasePatient-reported outcomesEntire study populationReal-world effectivenessSignificant reductionPlaque psoriasisEligible adultsPatient adherenceBiologic treatmentActivity impairmentObservational studyStudy populationRisankizumabPsoriasis42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials
Papp K, Lebwohl M, Hong H, Kircik L, Pariser D, Strober B, Krueger G, Krupa D, Burnett P, Berk D, Higham R. 42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials. Journal Of The American Academy Of Dermatology 2023, 89: ab156. DOI: 10.1016/j.jaad.2023.07.625.Peer-Reviewed Original Research43778 Bimekizumab maintenance of response and safety in patients with moderate to severe plaque psoriasis: Results from the open-label extension period (Weeks 48–144) of the BE RADIANT phase 3b trial
Strober B, Puig L, Blauvelt A, Thaçi D, Elewski B, Wang M, Vanvoorden V, Deherder D, Staelens F, Wiegratz S, Paul C. 43778 Bimekizumab maintenance of response and safety in patients with moderate to severe plaque psoriasis: Results from the open-label extension period (Weeks 48–144) of the BE RADIANT phase 3b trial. Journal Of The American Academy Of Dermatology 2023, 89: ab21. DOI: 10.1016/j.jaad.2023.07.092.Peer-Reviewed Original Research