2024
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
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 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 improvementTrialsApremilastEffect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis
Strober B, Augustin M, Tada Y, Garg A, Jullien D, Gottlieb A, Gudjonsson J, Hu N, Hofmann P, Thoma C, Marzano A. Effect of High-Dose Subcutaneous Spesolimab on Skin Manifestations: Results from the Pivotal Effisayil 2 Trial of Flare Prevention in Generalized Pustular Psoriasis. SKIN The Journal Of Cutaneous Medicine 2024, 8: s371. DOI: 10.25251/skin.8.supp.371.Peer-Reviewed Original ResearchGeneralized pustular psoriasisProportion of patientsGeneralized pustular psoriasis flaresWeek 4Pustular psoriasisGeneralized Pustular Psoriasis Physician Global AssessmentPhysician global assessmentTotal scoreLife-threatening skin diseaseRandomized controlled trialsPlacebo groupMaintenance doseLoading doseSterile pustulesSkin manifestationsSpesolimabApproved treatmentPlaceboTreatment periodGlobal assessmentPatientsMonoclonal antibodiesTreatment groupsSkin diseasesBaseline scoresDeucravacitinib 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 safetyPlaceboApremilastPsoriasisSpesolimab 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 effectsPlaceboPsoriasisSymptomsDrugPustulesWeeksDisease
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 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 IndexTreatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary
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. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-1 study): a plain language summary. Immunotherapy 2023, 15: 963-973. PMID: 37150952, DOI: 10.2217/imt-2023-0061.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksStudy treatment phaseCommon side effectsMonths of treatmentSymptoms of psoriasisPsoriasis plaquesDaily pillPsoriasis treatmentAcceptable safetyClinical trialsPsoriasisTreatment phasePlaceboDeucravacitinibNasal passagesLarger studyApremilastSkin appearanceEmotional distressTreatmentPillsTreatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary
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. Treatment of plaque psoriasis with deucravacitinib (POETYK PSO-2 study): a plain language summary. Immunotherapy 2023, 15: 787-797. PMID: 37150956, DOI: 10.2217/imt-2023-0062.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksCommon side effectsMonths of treatmentUndesirable side effectsPatch of skinDaily pillPsoriasis treatmentClinical trialsPlaceboPsoriasisDeucravacitinibLarger studyTreatmentApremilastGreater improvementMore participantsSimilar ratesPillsMedical journalsParticipantsSimilar numberOral 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
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
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 inhibitor
2021
Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared With Placebo and Apremilast in Moderate to Severe Psoriasis: Integrated Laboratory Parameter Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials
Thaci D, Gordon K, Gooderham M, Strober B, Korman N, Banerjee S, Banerjee S, Colston E, Kim J, Throup J, Morita A. Deucravacitinib, an Oral, Selective Tyrosine Kinase 2 (TYK2) Inhibitor, Compared With Placebo and Apremilast in Moderate to Severe Psoriasis: Integrated Laboratory Parameter Results From the Phase 3 POETYK PSO-1 and POETYK PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2021, 5: s37. DOI: 10.25251/skin.5.supp.37.Peer-Reviewed Original Research
2019
Safety of Certolizumab Pegol in Plaque Psoriasis: Pooled 96-Week Data from Three Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1, CIMPASI-2 and CIMPACT)
Blauvelt A, Strober B, Langley R, Kavanagh S, Arendt C, Boehnlein M, Lebwohl M, Reich K. Safety of Certolizumab Pegol in Plaque Psoriasis: Pooled 96-Week Data from Three Phase 3, Multicenter, Randomized, Placebo-Controlled Studies (CIMPASI-1, CIMPASI-2 and CIMPACT). SKIN The Journal Of Cutaneous Medicine 2019, 3: s39. DOI: 10.25251/skin.3.supp.39.Peer-Reviewed Original Research
2018
Safety of Certolizumab Pegol in Chronic Plaque Psoriasis: Cumulative Data Over 48 Weeks' Exposure from Phase 3, Multicenter, Randomized, Placebo-Controlled Studies
Blauvelt A, Strober B, Langley R, Burge D, Pisenti L, Yassine M, Kavanagh S, Arendt C, Rolleri R, Reich K. Safety of Certolizumab Pegol in Chronic Plaque Psoriasis: Cumulative Data Over 48 Weeks' Exposure from Phase 3, Multicenter, Randomized, Placebo-Controlled Studies. SKIN The Journal Of Cutaneous Medicine 2018, 2: s16. DOI: 10.25251/skin.2.supp.16.Peer-Reviewed Original Research
2016
Secukinumab Provides Clearer Skin and Better Control on Patient-Reported Psoriasis Symptoms of Itching, Pain, and Scaling than Placebo and Etanercept
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski B, Gottlieb A, Zhao Y, Herrera V, Mordin M, Odom D, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab Provides Clearer Skin and Better Control on Patient-Reported Psoriasis Symptoms of Itching, Pain, and Scaling than Placebo and Etanercept. Journal Of Psoriasis And Psoriatic Arthritis 2016, 1: 167-174. DOI: 10.1177/247553031600100406.Peer-Reviewed Original ResearchPsoriasis-related itchingSevere plaque psoriasisPhase 3 studyComplete symptom reliefWeeks of treatmentProportion of respondersGreater symptom improvementSymptom respondersPlaque psoriasisPsoriasis symptomsSymptom reliefComplete reliefSustained efficacySymptom improvementPsoriasis treatmentResults SubjectsSecukinumabEtanerceptItchingPainClear skinPlaceboMonoclonal antibodiesTreatment effectsPatientsSecukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. International Journal Of Dermatology 2016, 55: 401-407. PMID: 26866518, DOI: 10.1111/ijd.13236.Peer-Reviewed Original ResearchConceptsWeek 12Multicenter phase 3 studyPlacebo-controlled clinical trialInterleukin-17A antagonistPsoriasis-related itchingPlacebo treatment groupsSevere plaque psoriasisPhase 3 studyWeeks of treatmentProportion of subjectsPlaque psoriasisSevere psoriasisPsoriasis symptomsSystemic therapySymptom diaryClinical trialsSecukinumabTreatment responsePlaceboItchingPainTreatment groupsPhase 3PsoriasisAdults
2009
Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study
Strober B, Menon K, McMichael A, Hordinsky M, Krueger G, Panko J, Siu K, Lustgarten J, Ross E, Shapiro J. Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study. JAMA Dermatology 2009, 145: 1262-1266. PMID: 19917955, DOI: 10.1001/archdermatol.2009.264.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentAdultAgedAlefaceptAlopecia AreataDermatologic AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, IntramuscularMaleMiddle AgedNew York CityProbabilityRecombinant Fusion ProteinsRisk AssessmentSeverity of Illness IndexStatistics, NonparametricTreatment OutcomeYoung AdultConceptsSevere alopecia areataAlopecia areataPlacebo-controlled clinical trialEfficacy of alefaceptPlacebo-receiving groupSevere plaque psoriasisMain outcome measuresPlaque psoriasisPrevious therapyAlopecia ToolClinical trialsAlefaceptOutcome measuresUS FoodDrug AdministrationConsecutive weeksBiologic inhibitorsScalp hairAreataTreatmentWeeksSignificant improvementMulticenterPlaceboPsoriasis