2024
Deucravacitinib 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 trialA 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 diseasesBimekizumab 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 lifeEfficacy 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
Deucravacitinib 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 signalsOrismilast 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 IndexPS14 Bimekizumab response up to 3 years in patients with moderate-to-severe plaque psoriasis who responded at week 16: post hoc results from the BE BRIGHT open-label extension trial
Warren R, Strober B, Lebwohl M, Foley P, Langley R, Davis L, Hoepken B, Szilagyi B, Ciaravino V, Bewley A. PS14 Bimekizumab response up to 3 years in patients with moderate-to-severe plaque psoriasis who responded at week 16: post hoc results from the BE BRIGHT open-label extension trial. British Journal Of Dermatology 2023, 188: ljad113.366. DOI: 10.1093/bjd/ljad113.366.Peer-Reviewed Original ResearchOpen-label extensionBody surface areaSevere plaque psoriasisWeek 16Plaque psoriasisOpen-label extension trialTreatment-related adverse eventsDermatology Life Quality IndexPASI 90 responseMaintenance of efficacyHealth-related qualityYear 3Long-term efficacyLife Quality IndexLack of efficacyYear 1HRQoL benefitsNonresponder imputationOLE entryPsoriasis AreaResponder rateAdverse eventsWeek 24Study treatmentAnalysed patientsBimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial
Strober B, Tada Y, Mrowietz U, Lebwohl M, Foley P, Langley R, Warren R, Wang M, Vanvoorden V, Szilagyi B, Ciaravino V, Paul C. Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial. British Journal Of Dermatology 2023, 188: 749-759. PMID: 36967713, DOI: 10.1093/bjd/ljad035.Peer-Reviewed Original ResearchConceptsOngoing open-label extensionSevere plaque psoriasisBody surface areaDermatology Life Quality IndexWeek 16Plaque psoriasisNonresponder imputationPASI 100Investigator's Global Assessment 0/1Open-label extension trialDLQI 0/1 responsePASI 90 respondersOpen-label extensionHealth-related qualityLong-term efficacyLife Quality IndexLong-term treatmentLoss of responseYear 3Absolute PASIPASI 90Efficacy outcomesClinical responsePsoriasis AreaExtension trialDeucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: efficacy by baseline body surface area (BSA) involvement and baseline Psoriasis Area and Severity Index (PASI)
Armstrong A, Lebwohl M, Bagel J, Schlesinger T, Banerjee S, Kisa R, Scharnitz T, Hoyt K, Strober B. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: efficacy by baseline body surface area (BSA) involvement and baseline Psoriasis Area and Severity Index (PASI). SKIN The Journal Of Cutaneous Medicine 2023, 7: s120. DOI: 10.25251/skin.7.supp.120.Peer-Reviewed Original ResearchSafety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial
Thaçi D, Vender R, de Rie M, Conrad C, Pariser D, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball A. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. British Journal Of Dermatology 2023, 188: 22-31. PMID: 36689515, DOI: 10.1093/bjd/ljac021.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsOpen-label extensionSevere plaque psoriasisWeek 104Week 24PASI 100PASI 90Plaque psoriasisWeek 16Safety dataCommon treatment-emergent adverse eventsSerious treatment-emergent adverse eventsUpper respiratory tract infectionInitial randomization groupUnexpected safety findingsNew safety signalsRespiratory tract infectionsWeeks of treatmentLong-term resultsBaseline PASIBimekizumab groupBRIGHT trialMaintenance dosingPsoriasis AreaSafety findings
2022
Palmoplantar Pustulosis has a Greater Disease Burden than Plaque Psoriasis: Real-World Evidence From the CorEvitas Psoriasis Registry
Lebwohl M, Medeiros R, Mackey R, Valdecantos W, Brodovicz K, Lertratanakul A, Strober B. Palmoplantar Pustulosis has a Greater Disease Burden than Plaque Psoriasis: Real-World Evidence From the CorEvitas Psoriasis Registry. Journal Of Psoriasis And Psoriatic Arthritis 2022, 8: 56-65. DOI: 10.1177/24755303221146990.Peer-Reviewed Original ResearchPatient-reported outcomesPalmoplantar pustulosisPlaque psoriasisReal-world evidencePsoriasis RegistryDisease burdenPatient stratificationWorse patient-reported outcomesBody surface area involvementGreater impairmentMean overall painSurface area involvementVisual analog scaleRare skin diseaseReal-world studyQuality of lifeLittle real-world evidenceNeutrophilic pustulesOverall painClinical characteristicsPsoriasis AreaAnalog scaleArea involvementDisease characteristicsEffective therapyBimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials
Kokolakis G, Warren R, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Körber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. British Journal Of Dermatology 2022, 188: 330-340. PMID: 36751950, DOI: 10.1093/bjd/ljac089.Peer-Reviewed Original ResearchConceptsExposure-adjusted incidence ratesTreatment-emergent adverse eventsAdverse eventsDurable improvementMajority of TEAEsDiscontinuation of biologicsNew safety findingsPASI 90 respondersSevere plaque psoriasisHealth-related qualityBody surface areaTime of switchAbsolute PASIIIIb trialPASI 100PASI 90Skin clearancePlaque psoriasisWeek 48Clinical responseEfficacy outcomesPsoriasis AreaSafety findingsWeek 24Week 52Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial
Strober B, Thaçi D, Sofen H, Kircik L, Gordon K, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp K. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. Journal Of The American Academy Of Dermatology 2022, 88: 40-51. PMID: 36115523, DOI: 10.1016/j.jaad.2022.08.061.Peer-Reviewed Original ResearchConceptsGlobal assessment scoreSevere plaque psoriasisStatic Physician's Global Assessment scorePhysician Global Assessment scorePlaque psoriasisAdverse eventsPsoriasis AreaWeek 16Assessment scoresFrequent adverse eventsPhase 3 trialSerious adverse eventsSeverity IndexPhase 3 programSecond trialApremilast patientsWeek 52Laboratory parametersPsoriasis pathogenesisSafety resultsPlaceboDeucravacitinibStudy durationPsoriasisPatientsDeucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Morita A, Szepietowski J, Imafuku S, Colston E, Throup J, Kundu S, Schoenfeld S, Linaberry M, Banerjee S, Blauvelt A. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, placebo-controlled phase 3 POETYK PSO-1 trial. Journal Of The American Academy Of Dermatology 2022, 88: 29-39. PMID: 35820547, DOI: 10.1016/j.jaad.2022.07.002.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisGlobal assessment scorePlaque psoriasisWeek 16Static Physician's Global Assessment scoreResponse ratePhysician Global Assessment scoreCoprimary end pointsAdverse event ratesOne-year durationPASI 75Psoriasis AreaWeek 52Psoriasis treatmentPlaceboSafety resultsDeucravacitinibApremilastEnd pointEvent ratesAssessment scoresPsoriasisSeverity IndexKinase 2 inhibitorTyrosine kinase 2 inhibitorUtilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting
Strober B, Patil D, McLean R, Moore-Clingenpeel M, Guo N, Levi E, Lebwohl M. Utilization Trends and Impact of Secukinumab Treatment on Clinical Outcomes in Biologic-Naive Patients with Psoriasis in a US Real-World Setting. Dermatology And Therapy 2022, 12: 1351-1365. PMID: 35551619, PMCID: PMC9100304, DOI: 10.1007/s13555-022-00740-y.Peer-Reviewed Original ResearchBiologic-naive patientsInvestigator's Global AssessmentBody surface areaClinical outcomesUS real-world settingGlobal assessmentBiologic-experienced patientsEffectiveness of secukinumabMethodsThis observational studyPrior biologic useFirst-line therapyProportion of patientsSeverity Index scoreTreatment of psoriasisSimilar improvementsBiologic experiencePsoriasis RegistryResultsBetween 2015Secukinumab treatmentIGA scoreBiologic useClinical characteristicsPatient characteristicsPsoriasis AreaPatient cohortLong‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis
Gooderham M, Pinter A, Ferris L, Warren R, Zhan T, Zeng J, Soliman A, Kaufmann C, Kaplan B, Photowala H, Strober B. Long‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2022, 36: 855-865. PMID: 35174556, PMCID: PMC9314097, DOI: 10.1111/jdv.18010.Peer-Reviewed Original ResearchConceptsDermatology Life Quality IndexSevere plaque psoriasisHealth-related qualityRisankizumab treatmentPlaque psoriasisAbsolute PASIDLQI 0/1Psoriasis AreaDLQI scoreAbsolute PASI scoreAbsolute Psoriasis AreaUstekinumab-treated patientsMean DLQI scoreSeverity Index (PASI) improvementLife Quality IndexHigh ratePASI levelsPatients' HRQoL.PASI scoreMedian timeDurable efficacyPat ientsRisankizumabPASIPatientsDeucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial
Thaçi D, Strober B, Gordon K, Foley P, Gooderham M, Morita A, Papp K, Puig L, Menter M, Colombo M, Elbez Y, Kisa R, Ye J, Napoli A, Wei L, Banerjee S, Merola J, Gottlieb A. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatology And Therapy 2022, 12: 495-510. PMID: 35025062, PMCID: PMC8850503, DOI: 10.1007/s13555-021-00649-y.Peer-Reviewed Original ResearchDermatology Life Quality IndexSevere plaque psoriasisPhase 2 trialPlaque psoriasisStatic Physician's Global AssessmentBody surface area involvementGlobal assessmentPhase 2 clinical trialLife outcomesComplete skin clearanceMethodsPost-hoc analysisPhysician global assessmentSurface area involvementNew oral therapiesLife Quality IndexMost efficacy measuresPromising new oral therapyGreater improvementSkin clearanceSevere psoriasisOral therapyPsoriasis AreaInvestigator assessmentClinical outcomesWeek 12
2021
27596 Improvement in absolute psoriasis area and severity index through 5 years of continuous treatment with guselkumab in the VOYAGE 1 trial
Puig L, Strober B, Tsai T, Thaçi D, Gooderham M, Miller M, Yang Y, You Y, Shen Y, Blauvelt A. 27596 Improvement in absolute psoriasis area and severity index through 5 years of continuous treatment with guselkumab in the VOYAGE 1 trial. Journal Of The American Academy Of Dermatology 2021, 85: ab154. DOI: 10.1016/j.jaad.2021.06.629.Peer-Reviewed Original ResearchEffect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis
Reich K, Mrowietz U, Menter A, Griffiths C, Bagel J, Strober B, Gomez N, Shi R, Guerette B, Lebwohl M. Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis. Journal Of The European Academy Of Dermatology And Venereology 2021, 35: 2409-2414. PMID: 34255891, DOI: 10.1111/jdv.17520.Peer-Reviewed Original ResearchConceptsDermatology Life Quality IndexWeek 32Treatment targetsPooled analysisNail Psoriasis Severity IndexGlobal assessmentPhysician global assessmentSevere plaque psoriasisBaseline disease severitySeverity IndexPsoriasis Severity IndexLong-term outcomesLife Quality IndexSevere skin diseaseImportant clinical conceptsESTEEM 1Plaque psoriasisDisease durationMost patientsPsoriasis AreaModerate diseasePsoriasis severityDisease characteristicsPsoriasis guidelinesSubgroup analysisThe Proposed PASI-HD Provides More Precise Assessment of Plaque Psoriasis Severity in Anatomical Regions with a Low Area Score
Papp K, Lebwohl M, Kircik L, Pariser D, Strober B, Krueger G, Berk D, Navale L, Higham R. The Proposed PASI-HD Provides More Precise Assessment of Plaque Psoriasis Severity in Anatomical Regions with a Low Area Score. Dermatology And Therapy 2021, 11: 1079-1083. PMID: 34236691, PMCID: PMC8322185, DOI: 10.1007/s13555-021-00572-2.Peer-Reviewed Original Research