2024
Deucravacitinib 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 improvementTrialsApremilast
2023
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patientsEfficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial
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. Efficacy and safety of subcutaneous spesolimab for the prevention of generalised pustular psoriasis flares (Effisayil 2): an international, multicentre, randomised, placebo-controlled trial. The Lancet 2023, 402: 1541-1551. PMID: 37738999, DOI: 10.1016/s0140-6736(23)01378-8.Peer-Reviewed Original ResearchConceptsPhysician Global Assessment scoreGPP flaresGlobal assessment scoreFlare preventionDose-response relationshipPrimary endpointAssessment scoresPhase 2b trialPustular psoriasis flarePlacebo-controlled trialReceptor monoclonal antibodyEligible study participantsQuality of lifeDose-response curveSubcutaneous placeboPlacebo groupWeek 48Pustular psoriasisPrimary outcomePsoriasis flareTreatment armsPatient groupHypersensitivity reactionsPatient morbiditySpesolimabTreatment 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 number
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 trialsDeucravacitinib 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 inhibitorOne-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial
Strober B, Stein Gold L, Bissonnette R, Armstrong A, Kircik L, Tyring S, Piscitelli S, Brown P, Rubenstein D, Tallman A, Lebwohl M. One-year safety and efficacy of tapinarof cream for the treatment of plaque psoriasis: Results from the PSOARING 3 trial. Journal Of The American Academy Of Dermatology 2022, 87: 800-806. PMID: 35772599, DOI: 10.1016/j.jaad.2022.06.1171.Peer-Reviewed Original ResearchConceptsOpen-label treatmentRemittive effectsPlaque psoriasisUpper respiratory tract infectionPhysician Global Assessment scoreComplete disease clearanceOne-year safetyFrequent adverse eventsSevere plaque psoriasisNew safety signalsPhase 3 trialRespiratory tract infectionsDurability of responseForms of psoriasisGlobal assessment scoreLong-term safetyEligible patientsTapinarof creamDisease clearanceAdverse eventsTract infectionsMean durationSafety signalsContact dermatitisCream 1Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis
Strober B, Mallya U, Yang M, Ganguli S, Gadkari A, Wang J, Sierka D, Delevry D, Kimball A. Treatment Outcomes Associated With Dupilumab Use in Patients With Atopic Dermatitis. JAMA Dermatology 2022, 158: 142-150. PMID: 34910086, DOI: 10.1001/jamadermatol.2021.4778.Peer-Reviewed Original ResearchConceptsAtopic Dermatitis Control ToolHealth-related qualityPatient-reported outcomesAtopic dermatitisMonth 12Disease controlCohort studySkin symptomsMonths 1AD therapyDermatology Life Quality IndexStand-alone questionsActivity Impairment QuestionnaireSevere atopic dermatitisClinical trial populationsNumerical rating scaleLife Quality IndexPatient support programQuality of lifeAdequate disease controlDupilumab useSystemic corticosteroidsImpairment QuestionnaireMost patientsTreatment satisfaction
2021
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis
Lebwohl M, Stein Gold L, Strober B, Papp K, Armstrong A, Bagel J, Kircik L, Ehst B, Hong H, Soung J, Fromowitz J, Guenthner S, Piscitelli S, Rubenstein D, Brown P, Tallman A, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 2219-2229. PMID: 34879448, DOI: 10.1056/nejmoa2103629.Peer-Reviewed Original ResearchConceptsPrimary end pointPatient-reported outcomesTapinarof creamGlobal assessment scoreBody surface areaPlaque psoriasisWeek 12End pointPGA responseAdverse eventsPGA scoreMean changeSkin barrier protein filaggrinSecondary efficacy end pointsUpper respiratory tract infectionPhysician Global Assessment scoreNumeric rating scale scoreTotal body surface areaTotal scoreEfficacy end pointIdentical phase 3Local adverse eventsSymptom diary scoresProportion of patientsSecondary end pointsBimekizumab 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 4PatientsDrug survival of ixekizumab, TNF inhibitors, and other IL‐17 inhibitors in real‐world patients with psoriasis: The Corrona Psoriasis Registry
Lockshin B, Cronin A, Harrison R, McLean R, Anatale‐Tardiff L, Burge R, Zhu B, Malatestinic W, Atiya B, Murage M, Gallo G, Strober B, Van Voorhees A. Drug survival of ixekizumab, TNF inhibitors, and other IL‐17 inhibitors in real‐world patients with psoriasis: The Corrona Psoriasis Registry. Dermatologic Therapy 2021, 34: e14808. PMID: 33491259, PMCID: PMC8047872, DOI: 10.1111/dth.14808.Peer-Reviewed Original ResearchConceptsCorrona Psoriasis RegistryIL-17 inhibitorsIL-17iTNF inhibitorsReal-world patientsDrug survivalHazard ratioPsoriasis RegistryDrug discontinuationDrug initiationLower riskBiologic experienceIxekizumab groupsPsO patientsSevere PsONaïve patientsMean ageIxekizumabPatientsReal-world settingDiscontinuationPsoriasisSurvivalRegistryInhibitors
2020
PGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis
Gold L, Hansen J, Patel D, Veverka K, Strober B. PGAxBSA composite versus PASI: Comparison across disease severities and as therapeutic response measure for Cal/BD foam in plaque psoriasis. Journal Of The American Academy Of Dermatology 2020, 83: 131-138. PMID: 32430142, DOI: 10.1016/j.jaad.2020.02.077.Peer-Reviewed Original ResearchConceptsCal/BD foamSevere psoriasisWeek 4Disease severityPhysician global assessmentProportion of patientsBody surface areaSpearman correlationTherapeutic response measuresCalcipotriol/Dipropionate foamMild psoriasisPlaque psoriasisPsoriasis AreaBland-Altman plotsPsoriasis severityTherapeutic responseMean improvementWeek 1PsoriasisGlobal assessmentSeverity IndexInterrater reliabilitySeverityPASI
2019
Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry
Van Voorhees A, Mason M, Harrold L, Guo N, Guana A, Tian H, Herrera V, Strober B. Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2019, 32: 302-309. PMID: 31581919, DOI: 10.1080/09546634.2019.1656797.Peer-Reviewed Original ResearchConceptsAnti-tumor necrosis factor therapyCorrona Psoriasis RegistryNecrosis factor therapySevere psoriasisPsoriasis RegistryBiologic therapyFactor therapyAnti-TNF initiatorsEnrollment of patientsUnmet treatment needLogistic regression modelingReal-world studyPatient demographicsInsufficient respondersShort followDisease characteristicsFemale sexTreatment needsInsufficient responsePatientsUnmet needPsoriasisDecreased likelihoodTherapySmall sample sizeApremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study
Strober B, Alikhan A, Lockshin B, Shi R, Cirulli J, Schafer P. Apremilast mechanism of efficacy in systemic-naive patients with moderate plaque psoriasis: Pharmacodynamic results from the UNVEIL study. Journal Of Dermatological Science 2019, 96: 126-133. PMID: 31787506, DOI: 10.1016/j.jdermsci.2019.09.003.Peer-Reviewed Original ResearchConceptsModerate plaque psoriasisIL-17APlaque psoriasisIL-22Week 16T cellsRegulatory T cell numbersT helper 17 (Th17) cellsEfficacy of apremilastIL-23 levelsTotal T cellsPlasma cytokine levelsRegulatory T cellsT cell numbersMedian percentage reductionPathogenesis of psoriasisSevere psoriasisCardiometabolic biomarkersClinical improvementCytokine levelsInflammatory biomarkersIL-17FWeeks 0Clinical trialsWeek 4Feasibility and Utility of the Psoriasis Symptom Inventory (PSI) in Clinical Care Settings: A Study from the International Psoriasis Council
Strober B, van de Kerkhof P, Callis Duffin K, Poulin Y, Warren R, de la Cruz C, van der Walt J, Stolshek B, Martin M, de Carvalho A. Feasibility and Utility of the Psoriasis Symptom Inventory (PSI) in Clinical Care Settings: A Study from the International Psoriasis Council. American Journal Of Clinical Dermatology 2019, 20: 699-709. PMID: 31228013, PMCID: PMC6764927, DOI: 10.1007/s40257-019-00458-2.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overClinical Decision-MakingCommunicationCross-Sectional StudiesFeasibility StudiesFemaleHumansInternational CooperationMaleMiddle AgedPatient Reported Outcome MeasuresPhysician-Patient RelationsPsoriasisQuality of LifeSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeYoung AdultConceptsPsoriasis Symptom InventoryStatic Physician's Global AssessmentBody surface areaPsoriasis-affected body surface areaSymptom InventoryPatient-reported outcome measuresPatient treatment prioritiesPhysician global assessmentPatient-physician communicationClinical care settingsInternational Psoriasis CouncilPSI total scorePatient-physician relationshipMild psoriasisPsoriasis signsSevere psoriasisUntreated patientsModerate psoriasisDermatology clinicPsoriasis severityPatient visitsSame visitTreatment decisionsCare settingsOutcome measuresUS real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry
Strober B, Germino R, Guana A, Greenberg J, Litman H, Guo N, Lebwohl M. US real-world effectiveness of secukinumab for the treatment of psoriasis: 6-month analysis from the Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2019, 31: 333-341. PMID: 31035822, DOI: 10.1080/09546634.2019.1603361.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesCorrona Psoriasis RegistryGlobal assessment scoreBody surface areaReal-world effectivenessPsoriasis RegistryReal-world studySecukinumab treatmentDisease severityInvestigator's Global Assessment scoreMajority of patientsTreatment of psoriasisQuality of lifeEligible patientsSecukinumabPatientsSignificant improvementFollowAssessment scoresRegistryVisitsWork productivityPsoriasisDaily activitiesTreatmentImpact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry
Strober B, Greenberg J, Karki C, Mason M, Guo N, Hur P, Zhao Y, Herrera V, Lin F, Lebwohl M. Impact of psoriasis severity on patient-reported clinical symptoms, health-related quality of life and work productivity among US patients: real-world data from the Corrona Psoriasis Registry. BMJ Open 2019, 9: e027535. PMID: 31005939, PMCID: PMC6500315, DOI: 10.1136/bmjopen-2018-027535.Peer-Reviewed Original ResearchMeSH KeywordsAdultBiological ProductsBody Surface AreaCross-Sectional StudiesEfficiencyFemaleHumansLinear ModelsMaleMiddle AgedMultivariate AnalysisPainPain MeasurementPatient Reported Outcome MeasuresPsoriasisQuality of LifeRegistriesSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeUnited StatesConceptsPatient-reported outcomesBody surface areaCorrona Psoriasis RegistrySevere psoriasisPsoriasis severityPsoriasis RegistryReal-world settingPatient-reported clinical symptomsWorse patient-reported outcomesGlobal assessmentMore severe psoriasisSystemic psoriasis treatmentsInvestigator's Global AssessmentHealth-related qualityMultivariable regression analysisMultivariable regression modelsCross-sectional analysisWPAI domainsWPAI scoresIGA scoreProspective registryAdult patientsIgA levelsDLQI scoreUS patientsUtilization of the validated Psoriasis Epidemiology Screening Tool to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross‐sectional analysis from the US‐based Corrona Psoriasis Registry
Mease P, Palmer J, Hur P, Strober B, Lebwohl M, Karki C, Reed G, Etzel C, Greenberg J, Helliwell P. Utilization of the validated Psoriasis Epidemiology Screening Tool to identify signs and symptoms of psoriatic arthritis among those with psoriasis: a cross‐sectional analysis from the US‐based Corrona Psoriasis Registry. Journal Of The European Academy Of Dermatology And Venereology 2019, 33: 886-892. PMID: 30663130, PMCID: PMC6593969, DOI: 10.1111/jdv.15443.Peer-Reviewed Original ResearchConceptsPsoriasis Epidemiology Screening ToolRegistry patientsPsoriatic arthritisActivity impairmentWorse health-related qualityDermatology Life Quality IndexScreening toolCorrona Psoriasis RegistryUndiagnosed psoriatic arthritisHealth-related qualityPatient-reported outcomesLife Quality IndexWorse health statusFive-item questionnaireChi-squared testCross-sectional analysisPsoriasis RegistryClinical characteristicsHigher BMIPatientsHealth statusPSAPEST scoresCategorical variablesArthritis