2024
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
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 providersEffect 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 scores
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 trialsUtilization 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 cohortDeucravacitinib 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
Effect 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 analysis
2020
BMS-986165, an Oral, Selective TYK2 Inhibitor, in the Treatment of Moderate to Severe Psoriasis as Assessed by the Static Physician's Global Assessment (sPGA)/Body Surface Area (BSA) Composite Tool (sPGAxBSA), a Clinically Useful Alternative to PASI
Gottlieb A, Strober B, Thaçi D, Gordon K, Kundu S, Kisa R, Wei L, Banerjee S, Merola J. BMS-986165, an Oral, Selective TYK2 Inhibitor, in the Treatment of Moderate to Severe Psoriasis as Assessed by the Static Physician's Global Assessment (sPGA)/Body Surface Area (BSA) Composite Tool (sPGAxBSA), a Clinically Useful Alternative to PASI. SKIN The Journal Of Cutaneous Medicine 2020, 4: s29. DOI: 10.25251/skin.4.supp.29.Peer-Reviewed Original ResearchPGAxBSA 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
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
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 patients
2018
Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials
Strober B, Gottlieb A, Kerkhof P, Puig L, Bachelez H, Chouela E, Imafuku S, Thaçi D, Tan H, Valdez H, Gupta P, Kaur M, Frajzyngier V, Wolk R. Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials. British Journal Of Dermatology 2018, 180: 67-75. PMID: 30188571, PMCID: PMC7379291, DOI: 10.1111/bjd.17149.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAgedAged, 80 and overChronic DiseaseDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentSeverity of Illness IndexYoung AdultConceptsSevere chronic plaque psoriasisChronic plaque psoriasisEfficacy end pointBenefit-risk profileSevere psoriasisPlaque psoriasisWeek 16Dermatology Life Quality Index scoresLong-term extension studyOral Janus kinase inhibitorGlobal assessmentLife Quality Index scoresEnd pointDepression Scale depression scorePhysician global assessmentImproved patients' qualitySystemic psoriasis therapiesJanus kinase inhibitorQuality Index scoresTofacitinib 5Tofacitinib exposurePsoriasis AreaSystemic treatmentTofacitinib treatmentPatients' quality
2017
Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis
Viswanathan H, Mutebi A, Milmont C, Gordon K, Wilson H, Zhang H, Klekotka P, Revicki D, Augustin M, Kricorian G, Nirula A, Strober B. Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis. Value In Health 2017, 20: 1174-1179. PMID: 28964451, DOI: 10.1016/j.jval.2016.11.020.Peer-Reviewed Original ResearchConceptsStatic Physician's Global AssessmentDermatology Life Quality IndexPsoriasis Symptom InventorySevere plaque psoriasisBody surface areaPsoriasis signsPlaque psoriasisPsoriasis-affected body surface areaForm Health Survey version 2Global assessmentPatient-reported outcome instrumentsPhysician global assessmentLife Quality IndexMeasurement propertiesElectronic daily diaryPSI total scoreDLQI responsesPASI responsePsoriasis AreaBodily painWeek 12Clinical trialsWeek 8Outcome measuresOutcome instruments
2015
Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis
Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nyirady J, Papavassilis C, Nelson LM, McLeod LD, Mordin M, Gottlieb AB, Elewski BE, Lebwohl M. Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis. International Journal Of Dermatology 2015, 55: e147-e155. PMID: 26518255, DOI: 10.1111/ijd.13117.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicDermatologic AgentsFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPatient Reported Outcome MeasuresPsoriasisPsychometricsQuality of LifeRandomized Controlled Trials as TopicReproducibility of ResultsSelf ReportSeverity of Illness IndexSurveys and QuestionnairesSymptom AssessmentYoung AdultConceptsDermatology Life Quality IndexChronic plaque psoriasisInvestigator's Global AssessmentPhase III studyPlaque psoriasisIII studySymptom diarySevere chronic plaque psoriasisMulticenter phase III studyGlobal assessmentSafety of secukinumabSevere plaque psoriasisPatient Global ImpressionPercentage of respondersHealth Status QuestionnaireLife Quality IndexHigh intraclass coefficientsPlacebo armPsoriasis AreaTest-retest reliabilityWeek 12Global ImpressionStatus QuestionnaireTreatment decisionsMean difference
2013
Item-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary
Strober B, Nyirady J, Mallya U, Guettner A, Papavassilis C, Gottlieb A, Elewski B, Turner-Bowker D, Shields A, Gwaltney C, Lebwohl M. Item-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary. Value In Health 2013, 16: 1014-1022. PMID: 24041351, DOI: 10.1016/j.jval.2013.07.002.Peer-Reviewed Original ResearchConceptsSymptom diaryClinical trialsSevere chronic plaque-type psoriasisChronic plaque-type psoriasisGlobal assessmentDermatology Life Quality IndexPhase 2 clinical trialChronic plaque psoriasisInvestigator's Global AssessmentPatient Global ImpressionPlaque-type psoriasisFuture clinical trialsLife Quality IndexPsychometric propertiesPlaque psoriasisPsoriasis AreaWeek 12Global ImpressionResponder definitionAdult outpatientsNew patientsItem-level psychometric propertiesStudy weekDiary assessmentsDiary items
2012
Sleep quality and other patient‐reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open‐label Phase IIIB trial
Strober B, Sobell J, Duffin K, Bao Y, Guérin A, Yang H, Goldblum O, Okun M, Mulani P. Sleep quality and other patient‐reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open‐label Phase IIIB trial. British Journal Of Dermatology 2012, 167: 1374-1381. PMID: 22897348, DOI: 10.1111/bjd.12000.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesDermatology Life Quality IndexHealth-related qualitySleep impairmentSleep qualityAdalimumab treatmentSuboptimal responseWork productivitySleep measuresMedical Outcomes Study Sleep ScalePoor health-related qualityGlobal assessmentPhase IIIb trialChronic plaque psoriasisPhysician global assessmentEffect of adalimumabDisease-related painVisual analog scaleLife Quality IndexIIIb trialPrior therapyPsoriasis signsPlaque psoriasisPresence of PSAPsoriasis AreaA randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis
Gottlieb A, Langley R, Strober B, Papp K, Klekotka P, Creamer K, Thompson E, Hooper M, Kricorian G. A randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis. British Journal Of Dermatology 2012, 167: 649-657. PMID: 22533447, PMCID: PMC3504074, DOI: 10.1111/j.1365-2133.2012.11015.x.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisCombination therapyAdverse eventsWeek 24Etanercept monotherapyMonotherapy groupPlaque psoriasisWeek 12Necrosis factor inhibitor therapyStatic Physician's Global AssessmentGlobal assessmentMethotrexate combination therapyPhysician global assessmentPlacebo-controlled studySerious adverse eventsCombination therapy groupProportion of patientsAddition of methotrexatePASI 50PASI 75PASI 90Primary endpointSevere psoriasisAcceptable tolerabilityPsoriasis Area
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance treatmentEfficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis
Strober B, Crowley J, Yamauchi P, Olds M, Williams D. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. British Journal Of Dermatology 2011, 165: 661-668. PMID: 21574984, DOI: 10.1111/j.1365-2133.2011.10419.x.Peer-Reviewed Original ResearchConceptsPhysician global assessmentPlacebo-treated patientsProportion of patientsWeek 12Severe psoriasisWeeks 0Tumor necrosis factor-α antagonists etanerceptCo-primary efficacy endpointsSevere chronic plaque psoriasisSeverity Index (PASI) 75 responseGlobal assessmentEffective psoriasis therapiesEffective psoriasis treatmentEtanercept-treated patientsPASI 75 responseChronic plaque psoriasisPhase II studySerious adverse eventsPhase IIIEfficacy endpointPlacebo injectionsPlaque psoriasisAdverse eventsII studyPsoriasis AreaSwitching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study
Strober B, Poulin Y, Kerdel F, Langley R, Gu Y, Gupta S, Okun M, Papp K. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study. Journal Of The American Academy Of Dermatology 2011, 64: 671-681. PMID: 21414495, DOI: 10.1016/j.jaad.2010.03.009.Peer-Reviewed Original ResearchConceptsPhysician global assessmentSuboptimal responseSuboptimal therapyWeek 16Global assessmentPhase IIIb trialChronic plaque psoriasisOpen-label designOpen-label studyPrimary end pointPercentage of patientsNB-UVB phototherapySeverity Index scorePsoriasis clinical trialsTreatment of psoriasisDosage taperingIIIb trialPrior therapyPlaque psoriasisPsoriasis AreaPsoriasis flarePsoriasis patientsSafety profilePatient enrollmentClinical trials
2010
Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
Griffiths C, Strober B, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley L, Goldstein N, Menter A. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. New England Journal Of Medicine 2010, 362: 118-128. PMID: 20071701, DOI: 10.1056/nejmoa0810652.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsImmunosuppressive AgentsInterleukin-12Interleukin-23MaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorSeverity of Illness IndexTumor Necrosis Factor-alphaUstekinumabConceptsHigh-dose etanerceptPhysician global assessmentWeek 12Global assessmentSevere psoriasisAdverse eventsBiologic agentsMinimal diseaseRelative benefit-risk profilesEnd pointMore adverse eventsPrimary end pointSecondary end pointsProportion of patientsSerious adverse eventsTreatment of psoriasisBenefit-risk profileNew therapeutic optionsPsoriasis AreaTherapeutic optionsSuch therapySubcutaneous injectionUstekinumabEtanerceptPatients