2024
Meaningful 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
Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001)
Silverberg J, Strober B, Feinstein B, Xu J, Guttman-Yassky E, Simpson E, Li P, Longphre M, Song J, Guo J, Yun J, Williams B, Pan W, Ho S, Collazo R, Wei Z. Efficacy and safety of rademikibart (CBP-201), a next-generation mAb targeting IL-4Rα, in adults with moderate to severe atopic dermatitis: A phase 2 randomized trial (CBP-201-WW001). Journal Of Allergy And Clinical Immunology 2023, 153: 1040-1049.e12. PMID: 38157942, DOI: 10.1016/j.jaci.2023.11.924.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsEczema Area Severity IndexSevere atopic dermatitisSecondary endpointsAtopic dermatitisWeek 16Serious treatment-emergent adverse eventsNext-generation monoclonal antibodiesPhase 2 trialInjection site reactionsSignificant percent reductionQ4w dosingPrimary endpointTreatment discontinuationAdverse eventsCurrent therapiesLower incidenceQ2WIL-4RαUnspecified causesPandemic-related restrictionsQ4WTrial conductPlaceboMonoclonal antibodiesDeucravacitinib, 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 analysisPlaceboDeucravacitinib 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 rateOrismilast 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: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials
Lebwohl M, Strober B, Linaberry M, Hoyt K, Banerjee S, Kisa R, Mehta N. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s115. DOI: 10.25251/skin.7.supp.115.Peer-Reviewed Original ResearchSevere plaque psoriasisHDL cholesterolTotal cholesterolWeek 16Plaque psoriasisLDL cholesterolTriglyceride levelsLipid parametersWeeks 0Tyrosine kinase 2Treatment groupsDouble-blind trialBaseline triglyceride levelsLDL cholesterol levelsMean triglyceride levelsTreatment of adultsOral placeboMean triglyceridesAdverse eventsSerum lipidsSystemic therapyDL increasePsoriasis pathogenesisCholesterol levelsMean changeDeucravacitinib in moderate to severe plaque psoriasis: liver transaminase results from the phase 3 POETYK PSO program
Lebwohl M, Egeberg A, Linaberry M, Hoyt K, Banerjee S, Kisa R, Strober B. Deucravacitinib in moderate to severe plaque psoriasis: liver transaminase results from the phase 3 POETYK PSO program. SKIN The Journal Of Cutaneous Medicine 2023, 7: s116. DOI: 10.25251/skin.7.supp.116.Peer-Reviewed Original ResearchSevere plaque psoriasisAlanine aminotransferasePlaque psoriasisConcomitant medicationsWeeks 0Week 16Multiple laboratory parametersCommon Terminology CriteriaMean levelsTreatment of adultsWeeks of treatmentPatient-level dataOral placeboTerminology CriteriaAST elevationLiver transaminasesAminotransferase levelsCTCAE gradeLiver dysfunctionSystemic therapyLaboratory parametersAST levelsTreatment armsLiver conditionsSeverity gradeSafety 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 findingsOral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets
Warren R, Strober B, Silverberg J, Guttman E, Andres P, Felding J, Tutkunkardas D, Kjøller K, Sommer M, French L. Oral orismilast: Efficacy and safety in moderate‐to‐severe psoriasis and development of modified release tablets. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 711-720. PMID: 36478476, DOI: 10.1111/jdv.18812.Peer-Reviewed Original ResearchConceptsPhase 1 trialPhase 2a trialSevere psoriasisAdverse eventsIR formulationPK propertiesWeek 16Psoriasis Area Severity Index (PASI) scorePlacebo-controlled trialSeverity Index scoreHigh-fat mealLow-fat mealPhosphodiesterase 4 inhibitorSimilar PK propertiesImmediate-release formulationGI disordersMR groupPlaceboFood effectPhase 2aIndex scorePsoriasisPharmacokinetic propertiesHealthy participantsMR formulation
2022
Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*
Blauvelt A, Kimball A, Augustin M, Okubo Y, Witte M, Capriles C, Sontag A, Arora V, Osuntokun O, Strober B. Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*. British Journal Of Dermatology 2022, 187: 866-877. PMID: 35791755, PMCID: PMC10087045, DOI: 10.1111/bjd.21743.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 16Week 52PASI 100Secondary endpointsAdult patientsSafety profileLarge phase III trialsStatic Physician's Global AssessmentGlobal assessmentPhase II clinical trialInterleukin-23 inhibitorsKey secondary endpointNew safety signalsPhysician global assessmentSerious adverse eventsPatient-reported qualityPhase III trialsFavorable safety profilePathogenesis of psoriasisPASI 90PASI 75Coprimary endpointsIII trialsBimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial
Strober B, Tada Y, Mrowietz U, Lebwohl M, Foley P, Langley R, Barker J, Wang M, Vanvoorden V, Szilagyi B, Ciaravino V, Paul C. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. SKIN The Journal Of Cutaneous Medicine 2022, 6: s65. DOI: 10.25251/skin.6.supp.65.Peer-Reviewed Original ResearchDeucravacitinib 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 inhibitorAB0890 Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials
Warren R, Armstrong A, Gooderham M, Strober B, Thaçi D, Imafuku S, Sofen H, Spelman L, Korman N, Zheng M, Colston E, Throup J, Kundu S, Kisa R, Banerjee S, Blauvelt A. AB0890 Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: 52-Week Efficacy Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials. Annals Of The Rheumatic Diseases 2022, 81: 1570-1571. DOI: 10.1136/annrheumdis-2022-eular.1377.Peer-Reviewed Original ResearchSevere plaque psoriasisGrant/research supportDermatology Life Quality IndexBristol-Myers SquibbPASI 75 responseSanofi GenzymeWeek 52PASI 75Plaque psoriasisGlobal assessment scoreWeek 16LEO PharmaPersonal feesKyowa Hakko KirinWeek 24Tyrosine kinase 2Boehringer IngelheimLecture feesPASI 90Psoriasis RegistrySymptom scoresSpeakers bureauEli LillyStatic Physician's Global Assessment scorePhysician Global Assessment score
2021
Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*
Reich K, Gordon K, Strober B, Armstrong A, Miller M, Shen Y, You Y, Han C, Yang Y, Foley P, Griffiths C. Five‐year maintenance of clinical response and health‐related quality of life improvements in patients with moderate‐to‐severe psoriasis treated with guselkumab: results from VOYAGE 1 and VOYAGE 2*. British Journal Of Dermatology 2021, 185: 1146-1159. PMID: 34105767, DOI: 10.1111/bjd.20568.Peer-Reviewed Original ResearchConceptsVOYAGE 2Health-related qualityPatient-reported outcomesWeek 252VOYAGE 1Clinical responseSevere psoriasisWeek 52Open-label guselkumabNew safety signalsProportion of patientsMental component scoreShort Form-36Long-term therapyGuselkumab 100Guselkumab groupHRQOL endpointsWeek 264Week 100Form-36Randomized withdrawalWeek 28Week 16Chronic diseasesLife endpointsPOS1042 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 (TYK2) INHIBITOR, COMPARED WITH PLACEBO AND APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS: RESULTS FROM THE PHASE 3 POETYK PSO-1 STUDY
Armstrong A, Gooderham M, Warren R, Papp K, Strober B, Thaçi D, Colston E, Throup J, Kundu S, Banerjee S, Blauvelt A. POS1042 EFFICACY AND SAFETY OF DEUCRAVACITINIB, AN ORAL, SELECTIVE TYROSINE KINASE 2 (TYK2) INHIBITOR, COMPARED WITH PLACEBO AND APREMILAST IN MODERATE TO SEVERE PLAQUE PSORIASIS: RESULTS FROM THE PHASE 3 POETYK PSO-1 STUDY. Annals Of The Rheumatic Diseases 2021, 80: 795.1-796. DOI: 10.1136/annrheumdis-2021-eular.1002.Peer-Reviewed Original ResearchSevere plaque psoriasisKyowa Hakko KirinGrant/research supportBristol-Myers SquibbCommon adverse eventsCorrona Psoriasis RegistryPlaque psoriasisAdverse eventsSanofi GenzymeWeek 16Merck SeronoLEO PharmaPASI 75Meiji Seika PharmaPersonal feesTyrosine kinase 2Boehringer IngelheimMerck SharpPsoriasis RegistryWeek 24Psoriatic arthritisSpeakers bureauEli LillyJanssen-CilagUpper respiratory tract infectionBimekizumab versus Secukinumab in Plaque Psoriasis
Reich K, Warren R, Lebwohl M, Gooderham M, Strober B, Langley R, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 142-152. PMID: 33891380, DOI: 10.1056/nejmoa2102383.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 48Week 16Bimekizumab groupSecukinumab groupPASI scoreInterleukin-17AOral candidiasisGreater skin clearanceInterleukin-17 inhibitorsPASI 100 responsePhase 3b trialSafety of bimekizumabPrimary end pointSeverity Index scoreMonoclonal IgG1 antibodySkin clearanceSevere psoriasisPsoriasis AreaLarge trialsBimekizumabSecukinumabWeek 4Patients