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
Efficacy 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 morbiditySpesolimab
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 measuresImpact 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 variablesArthritisUstekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Safety 2019, 42: 751-768. PMID: 30739254, PMCID: PMC6520311, DOI: 10.1007/s40264-019-00797-3.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsPsoriatic arthritisRegistrational trialsCrohn's diseaseMajor adverse cardiovascular eventsUstekinumab-treated patientsAdverse cardiovascular eventsSevere plaque psoriasisConsistent safety profileSevere Crohn's diseaseActive psoriatic arthritisClinical development programUstekinumab doseCardiovascular eventsPlaque psoriasisBiologic agentsPsoriatic patientsInduction doseSafety profileIncidence rateSafety dataPatientsDiseaseSafety eventsWeeks
2018
Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2018, 180: 76-85. PMID: 30169904, DOI: 10.1111/bjd.17084.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultAnti-Inflammatory AgentsClinical Trials as TopicDatasets as TopicFemaleHeadacheHumansIncidenceInjections, SubcutaneousLong-Term CareMaleMiddle AgedNasopharyngitisNeoplasmsOpportunistic InfectionsPsoriasisSeverity of Illness IndexTime FactorsTuberculosisTumor Necrosis Factor-alphaConceptsNonmelanoma skin cancerStandardized incidence ratiosStandardized mortality ratioAdverse eventsLong-term safetyPlaque psoriasisClinical trialsIncidence rateIncidence of NMSCSevere chronic plaque psoriasisTreatment-emergent adverse eventsAE incidence ratesChronic plaque psoriasisCommon adverse eventsSevere plaque psoriasisNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsTumor necrosis factorHuman monoclonal antibodyAdalimumab doseAdalimumab exposureLast doseAdult patientsBenefit–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' qualityEfficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials
Gordon K, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp K, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes J, Thompson E, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet 2018, 392: 650-661. PMID: 30097359, DOI: 10.1016/s0140-6736(18)31713-6.Peer-Reviewed Original ResearchConceptsSevere chronic plaque psoriasisSafety of risankizumabChronic plaque psoriasisSevere plaque psoriasisCo-primary endpointsPlaque psoriasisGlobal assessment scoreWeek 16PASI 90SPGA 0Treatment groupsStatic Physician's Global Assessment scoreTreatment-emergent adverse event profilesActive comparator-controlled trialsDouble-blind treatment periodHumanised IgG1 monoclonal antibodyTreatment-emergent adverse eventsPhysician Global Assessment scorePsoriasis Area Severity IndexComparator-controlled trialsUnexpected safety findingsAdverse event profileNecrosis factor inhibitorsPhase 3 trialProportion of patientsMethotrexate treatment of generalized granuloma annulare: a retrospective case series
Naka F, Strober B. Methotrexate treatment of generalized granuloma annulare: a retrospective case series. Journal Of Dermatological Treatment 2018, 29: 720-724. PMID: 29488435, DOI: 10.1080/09546634.2018.1447075.Peer-Reviewed Original ResearchConceptsGeneralized granuloma annulareRetrospective case seriesCase seriesMethotrexate treatmentGranuloma annulareAdverse effectsFirst-line therapyEfficacy of methotrexateMajority of patientsAvailable therapeutic modalitiesSmall case seriesIndividual case reportsLow internal validityDisease improvementInitial doseTreatment optionsCase reportComplete clearancePartial clearanceHair lossTherapeutic modalitiesPatientsSkin diseasesControl groupDisease severity
2017
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 177: 1562-1574. PMID: 28755394, DOI: 10.1111/bjd.15857.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBody surface areaABP 501Week 16Adverse eventsAntidrug antibodiesPlaque psoriasisBiosimilar ABP 501New safety signalsPercentage of patientsPhase III trialsSimilar clinical efficacySeverity Index scorePercentage body surface areaLong-term resultsEuropean Medicines AgencyPASI 50PASI improvementWeek 52III trialsPsoriasis AreaAdalimumab patientsImmunogenicity profileClinical efficacyPatient populationInfections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis
Papp K, Bachelez H, Blauvelt A, Winthrop K, Romiti R, Ohtsuki M, Acharya N, Braun D, Mallbris L, Zhao F, Xu W, Walls C, Strober B. Infections from seven clinical trials of ixekizumab, an anti‐interleukin‐17A monoclonal antibody, in patients with moderate‐to‐severe psoriasis. British Journal Of Dermatology 2017, 177: 1537-1551. PMID: 28600810, DOI: 10.1111/bjd.15723.Peer-Reviewed Original ResearchConceptsIncidence rateTreatment groupsInfection rateSpecific infection rateSevere psoriasisSerious infectionsExposure-adjusted incidence ratesIRs of infectionsMonoclonal antibodiesWeeks of treatmentOverall infection rateIncidence of infectionOesophageal candidiasisBiological therapyPsoriasis trialsAntifungal therapyClinical trialsIxekizumabCandida infectionsPatientsLong-term exposureInfectionPsoriasisIncidenceTrialsDepressive 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