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 ResearchMeSH KeywordsAdultArthritis, PsoriaticBiological ProductsHumansNeoplasmsPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsGuselkumab-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 patients
2022
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
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 ResearchMeSH KeywordsAdalimumabAntibodies, MonoclonalBiological ProductsHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsExposure-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 52Impact of secukinumab on patient-reported 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. Impact of secukinumab on patient-reported outcomes in biologic-naive patients with psoriasis in a US real-world setting. Journal Of Dermatological Treatment 2022, 33: 3178-3187. PMID: 36026543, DOI: 10.1080/09546634.2022.2116266.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedBiological ProductsHumansPatient Reported Outcome MeasuresPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsPatient-reported outcomesBiologic-naive patientsDermatology Life Quality IndexUS real-world settingEuroQol visual analogue scaleImpact of secukinumabVisual analog scaleLife Quality IndexPatient's treatment journeyReal-world studyPsoriasis RegistrySecukinumab treatmentBaseline characteristicsClinical characteristicsAnalog scaleSkin painActivity impairmentMean improvementSecukinumabTreatment journeyPatientsPsoriasisReal-world settingFollowPotential biologic
2021
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR
Bissonnette R, Gottlieb A, Langley R, Leonardi C, Papp K, Pariser D, Uy J, Lafferty K, Langholff W, Fakharzadeh S, Berlin J, Brouwer E, Greenspan A, Strober B. Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR. Drug Safety 2021, 44: 699-709. PMID: 34075572, PMCID: PMC8184557, DOI: 10.1007/s40264-021-01065-z.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabBiological ProductsHumansInfliximabObservational Studies as TopicPsoriasisRegistriesUstekinumabConceptsMajor adverse cardiovascular eventsHazard ratioIncident usersObservational studyCox model regression analysisAdjusted hazard ratioAdverse cardiovascular eventsReal-world registryInternational observational studyLong-term observational studyDisease-based registryRelevant clinical dataMACE riskUstekinumab exposureCardiovascular eventsPatient characteristicsPsoriasis patientsTreatment cohortsMethodological limitationsComparator groupSafety registryClinical dataRegistry dataModel regression analysisConclusionOur results
2020
Comparative Effectiveness Studies for Psoriasis—The Methods Matter
Strober B, Gordon K. Comparative Effectiveness Studies for Psoriasis—The Methods Matter. JAMA Dermatology 2020, 156: 253-255. PMID: 32022830, DOI: 10.1001/jamadermatol.2019.4025.Peer-Reviewed Original Research
2019
Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients
Menter A, Cordoro KM, Davis DMR, Kroshinsky D, Paller AS, Armstrong AW, Connor C, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kaplan DH, Kavanaugh A, Kiselica M, Kivelevitch D, Korman NJ, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Parra SL, Pathy AL, Farley Prater E, Rupani RN, Siegel M, Stoff B, Strober BE, Wong EB, Wu JJ, Hariharan V, Elmets CA. Joint American Academy of Dermatology–National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. Journal Of The American Academy Of Dermatology 2019, 82: 161-201. PMID: 31703821, DOI: 10.1016/j.jaad.2019.08.049.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdrenal Cortex HormonesAnthralinBiological ProductsCalcineurin InhibitorsCardiovascular DiseasesChildChild, PreschoolCoal TarComorbidityCyclosporineDermatologic AgentsDyslipidemiasEvidence-Based MedicineHumansInfantInfant, NewbornInflammatory Bowel DiseasesInsulin ResistanceMental HealthMetabolic SyndromeMethotrexateNicotinic AcidsObesityPhotochemotherapyPsoriasisRetinoidsConceptsPediatric patientsDermatology–National Psoriasis Foundation guidelinesTreatment of psoriasisImportant clinical questionsEvidence-based recommendationsJoint American AcademyPsoriasis managementInflammatory diseasesFoundation guidelinesClinical questionsPatientsAmerican AcademyPsoriasisProvider interactionsGuideline sectionsUnique physiologyGuidelinesPharmacokineticsDiseaseCareMultisystemImpact 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 patientsJoint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics
Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kavanaugh A, Kiselica M, Korman NJ, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Rupani RN, Siegel M, Wong EB, Wu JJ, Hariharan V, Elmets CA. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal Of The American Academy Of Dermatology 2019, 80: 1029-1072. PMID: 30772098, DOI: 10.1016/j.jaad.2018.11.057.Peer-Reviewed Original ResearchConceptsTreatment of psoriasisAAD-NPF GuidelinesInflammatory multisystem diseaseImportant clinical questionsBiologic agentsPsoriasis managementMultisystem diseaseTreatment recommendationsClinical questionsUS populationPsoriasisAvailable evidenceCareTreatmentGuidelinesPatientsDermatologistsDiseaseBiologics
2017
Depressive symptoms, depression, and the effect of biologic therapy among patients in Psoriasis Longitudinal Assessment and Registry (PSOLAR)
Strober B, Gooderham M, de Jong EMGJ, Kimball AB, Langley RG, Lakdawala N, Goyal K, Lawson F, Langholff W, Hopkins L, Fakharzadeh S, Srivastava B, Menter A. Depressive symptoms, depression, and the effect of biologic therapy among patients in Psoriasis Longitudinal Assessment and Registry (PSOLAR). Journal Of The American Academy Of Dermatology 2017, 78: 70-80. PMID: 29102053, DOI: 10.1016/j.jaad.2017.08.051.Peer-Reviewed Original ResearchConceptsImpact of treatmentPsoriasis Longitudinal AssessmentConventional therapyAdverse eventsDepressive symptomsIncidence rateLongitudinal assessmentConventional systemic therapiesSevere psoriasisBiologic therapySystemic therapyLower incidenceStudy populationPatientsTherapySymptomsPsoriasisRegistryBiologicsPhototherapyDepressionIncidenceMultivariate modelingRiskTreatmentCharacterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry
Strober B, Karki C, Mason M, Guo N, Holmgren S, Greenberg J, Lebwohl M. Characterization of disease burden, comorbidities, and treatment use in a large, US-based cohort: Results from the Corrona Psoriasis Registry. Journal Of The American Academy Of Dermatology 2017, 78: 323-332. PMID: 29051036, DOI: 10.1016/j.jaad.2017.10.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAnti-Inflammatory Agents, Non-SteroidalBiological ProductsBody Surface AreaComorbidityCost of IllnessCross-Sectional StudiesFatigueFemaleHumansInterleukin-12Interleukin-17Interleukin-23MaleMiddle AgedPainPatient Reported Outcome MeasuresProspective StudiesPsoriasisQuality of LifeRegistriesSeverity of Illness IndexThalidomideTumor Necrosis Factor-alphaUnited StatesConceptsCorrona Psoriasis RegistryPsoriasis RegistryDisease durationComparative safetyBody surface area involvementTumor necrosis factor inhibitorsIL-12/23 inhibitorsInterleukin-17A inhibitorInvestigator's Global AssessmentNecrosis factor inhibitorsSurface area involvementLonger disease durationCross-sectional studyLong-term safetyEfficacy of treatmentPsoriatic arthritis diagnosisQuality of lifeEfficacy of foodMultiple comorbiditiesRegistry cohortSystemic medicationsSystemic therapyFactor inhibitorsArea involvementBiologic treatment
2016
Psoriasis in adults and children: Kids are not just little people
de Moll EH, Chang MW, Strober B. Psoriasis in adults and children: Kids are not just little people. Clinics In Dermatology 2016, 34: 717-723. PMID: 27968931, DOI: 10.1016/j.clindermatol.2016.07.006.Peer-Reviewed Original ResearchConceptsPediatric psoriasisPediatric populationLimited therapeutic armamentariumPrimary care providersCommon skin disorderAdult psoriasisYounger patientsTherapeutic armamentariumTreatment optionsSchool-aged childrenAppropriate treatmentCare providersPsoriasisSkin disordersIncurable diseasePsychosocial ramificationsPatientsAge childrenChildrenInherent risksPresentationChronicInfantsTherapyPopulationWhy Biologic Therapies Sometimes Lose Efficacy.
Strober B. Why Biologic Therapies Sometimes Lose Efficacy. Seminars In Cutaneous Medicine And Surgery 2016, 35: s78-80. PMID: 27525443, DOI: 10.12788/j.sder.2016.022.Peer-Reviewed Original ResearchComparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR])
Strober B, Bissonnette R, Fiorentino D, Kimball A, Naldi L, Shear N, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl M. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). Journal Of The American Academy Of Dermatology 2016, 74: 851-861.e4. PMID: 26853180, DOI: 10.1016/j.jaad.2015.12.017.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultBiological ProductsConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEtanerceptFemaleFollow-Up StudiesGlobal HealthHumansInfliximabLongitudinal StudiesMaleMiddle AgedOdds RatioPatient SatisfactionProspective StudiesPsoriasisQuality of LifeRegistriesSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsPhysician Global Assessment scoreGlobal assessment scoreBody surface areaReal-world settingAssessment scoresPsoriasis Longitudinal AssessmentProportion of patientsTreatment of psoriasisEffectiveness of biologicsTreatment selection biasTumor necrosis factorBiologic agentsEfficacy dataTherapeutic responseTumor necrosisNecrosis factorObservational studyTreatment decisionsAnalysis of covarianceEtanerceptComparative effectivenessAdalimumabInfliximabLongitudinal assessmentLogistic regression
2012
Ethical considerations when prescribing biologics in dermatology
Santoro F, Rothe M, Strober B. Ethical considerations when prescribing biologics in dermatology. Clinics In Dermatology 2012, 30: 492-495. PMID: 22902219, DOI: 10.1016/j.clindermatol.2011.06.018.Peer-Reviewed Original ResearchBiopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know
Strober B, Armour K, Romiti R, Smith C, Tebbey P, Menter A, Leonardi C. Biopharmaceuticals and biosimilars in psoriasis: What the dermatologist needs to know. Journal Of The American Academy Of Dermatology 2012, 66: 317-322. PMID: 22243723, DOI: 10.1016/j.jaad.2011.08.034.Peer-Reviewed Original ResearchConceptsTreatment of psoriasisOptimal therapy managementImmune-mediated disordersBiosimilar formPsoriasis populationAppropriate therapyTopical agentsTherapy managementBiosimilar agentsClinical relevanceGeneric therapiesPatient careTherapyPsoriasisImportant interventionDevelopment of biosimilarsPatientsBiosimilarsDermatologistsTreatmentBiopharmaceutical therapiesAgentsImportant differencesPrescribersRegulatory guidelines
2010
The treatment of moderate-to-severe psoriasis: prescreening and monitoring psoriatic patients on biologics.
Levine D, Strober B. The treatment of moderate-to-severe psoriasis: prescreening and monitoring psoriatic patients on biologics. Seminars In Cutaneous Medicine And Surgery 2010, 29: 28-34. PMID: 20430305, DOI: 10.1016/j.sder.2010.02.003.Peer-Reviewed Original ResearchMeSH KeywordsAnti-Inflammatory AgentsBiological ProductsDermatologic AgentsDrug MonitoringHumansImmunologic FactorsPsoriasisConceptsSevere psoriasisUS FoodDrug AdministrationTumor necrosis factor-alpha inhibitorsNecrosis factor-alpha inhibitorsInterleukin-12/23 inhibitorsShort-term safetyT-cell modulatorDevelopment of biologicsBiologic therapyPsoriasis patientsPsoriatic patientsClinical trialsTherapeutic monitoringSpecific patientPatientsBiologicsMedicationsPsoriasisLong-term dataAdministrationTreatmentCurrent bodyInhibitorsEvidence
2007
From the Medical Board of the National Psoriasis Foundation: Monitoring and vaccinations in patients treated with biologics for psoriasis
Lebwohl M, Bagel J, Gelfand J, Gladman D, Gordon K, Hsu S, Kalb R, Kimball A, Korman N, Krueger G, Mease P, Morison W, Paller A, Pariser D, Ritchlin C, Strober B, Van Voorhees A, Weinstein G, Young M, Horn L. From the Medical Board of the National Psoriasis Foundation: Monitoring and vaccinations in patients treated with biologics for psoriasis. Journal Of The American Academy Of Dermatology 2007, 58: 94-105. PMID: 17980456, DOI: 10.1016/j.jaad.2007.08.030.Peer-Reviewed Original ResearchConceptsLiver function testsBiologic therapyNational Psoriasis FoundationCD4 countAntinuclear antibodiesFunction testsPlatelet countPhysical examinationVaccination practicesTumor necrosis factor blockersNecrosis factor blockersTuberculin skin testTreatment of psoriasisBlood cell countEvidence-based studiesMedical boardsFactor blockersPsoriatic arthritisSkin testBlood countConsensus conferenceParticular therapyBlood chemistryPatientsLive vaccine