2023
Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study
Reich K, Silverberg J, Papp K, Deleuran M, Katoh N, Strober B, Beck L, de Bruin‐Weller M, Werfel T, Zhang F, Biswas P, DiBonaventura M, Chan G, Johnson S, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib efficacy and safety in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 2056-2066. PMID: 37335885, DOI: 10.1111/jdv.19280.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials, Phase III as TopicDermatitis, AtopicDouble-Blind MethodHumansImmunoglobulin APruritusSeverity of Illness IndexTreatment OutcomeConceptsTreatment-emergent adverse eventsSevere atopic dermatitisSerious treatment-emergent adverse eventsPhase 3 studyAtopic dermatitisSafety profileAbrocitinib 200Frequent treatment-emergent adverse eventsLong-term extension studyUpper respiratory tract infectionLong-term safety profileChronic atopic dermatitisManageable safety profileProportion of patientsRespiratory tract infectionsFull treatment periodLong-term efficacyLong-term safetyPruritus improvementSkin clearanceEfficacy endpointSafety endpointAdverse eventsTract infectionsAD trialsTreatment 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 ResearchMeSH KeywordsAdultClinical Trials, Phase III as TopicHumansPsoriasisSkinThalidomideTreatment OutcomeConceptsSevere plaque psoriasisPlaque psoriasisSide effectsNew treatmentsBasic everyday tasksCommon side effectsMonths of treatmentUndesirable side effectsPatch of skinDaily pillPsoriasis treatmentClinical trialsPlaceboPsoriasisDeucravacitinibLarger studyTreatmentApremilastGreater improvementMore participantsSimilar ratesPillsMedical journalsParticipantsSimilar number
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 ResearchMeSH KeywordsClinical Trials, Phase III as TopicHumansNail DiseasesPsoriasisQuality of LifeSeverity of Illness IndexThalidomideTreatment OutcomeConceptsDermatology 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
2018
Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis
Ma G, Xie R, Strober B, Langley R, Ito K, Krishnaswami S, Wolk R, Valdez H, Rottinghaus S, Tallman A, Gupta P. Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis. Clinical Pharmacology In Drug Development 2018, 7: 587-596. PMID: 29856518, DOI: 10.1002/cpdd.471.Peer-Reviewed Original ResearchConceptsSeparate phase 1 studySevere chronic plaque psoriasisOral Janus kinase inhibitorPharmacokinetics of tofacitinibChronic plaque psoriasisApparent oral clearancePhase 1 studyVd/FCL/FJanus kinase inhibitorFull covariate modelZero-order absorptionOne-compartment modelBaseline PASITofacitinib pharmacokineticsPlaque psoriasisRenal impairmentAdult patientsOral clearancePatient factorsBaseline variablesPharmacokinetic characteristicsBody weightApparent volumeInterindividual variability
2017
No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis
Strober B, Langley R, Menter A, Magid M, Porter B, Fox T, Safi J, Papavassilis C. No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 178: e105-e107. PMID: 28991372, DOI: 10.1111/bjd.16051.Peer-Reviewed Original ResearchMeasurement 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
2016
Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis
Wu J, Strober B, Hansen P, Ahlehoff O, Egeberg A, Qureshi A, Robertson D, Valdez H, Tan H, Wolk R. Effects of tofacitinib on cardiovascular risk factors and cardiovascular outcomes based on phase III and long-term extension data in patients with plaque psoriasis. Journal Of The American Academy Of Dermatology 2016, 75: 897-905. PMID: 27498960, DOI: 10.1016/j.jaad.2016.06.012.Peer-Reviewed Original ResearchMeSH KeywordsAdultBlood PressureCardiovascular DiseasesCholesterolClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicComorbidityC-Reactive ProteinDyslipidemiasFemaleGlycated HemoglobinHumansMaleMetabolic SyndromeMiddle AgedPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesRisk FactorsTreatment OutcomeTriglyceridesConceptsMajor adverse CV eventsCV risk factorsTotal/HDL cholesterol ratioEffects of tofacitinibHDL cholesterol ratioIncidence rateLow-density lipoproteinRisk factorsPlaque psoriasisCholesterol ratioLong-term extension dataC-reactive protein levelsHigh-density lipoprotein cholesterolAdverse CV eventsCardiovascular risk factorsSystemic inflammatory conditionsDose-dependent increaseCV eventsTofacitinib dosesCardiovascular outcomesLipoprotein cholesterolBlood pressureTofacitinib treatmentTotal cholesterolHemoglobin levelsClinical meaningfulness of complete skin clearance in psoriasis
Strober B, Papp KA, Lebwohl M, Reich K, Paul C, Blauvelt A, Gordon KB, Milmont CE, Viswanathan HN, Li J, Pinto L, Harrison DJ, Kricorian G, Nirula A, Klekotka P. Clinical meaningfulness of complete skin clearance in psoriasis. Journal Of The American Academy Of Dermatology 2016, 75: 77-82.e7. PMID: 27206759, DOI: 10.1016/j.jaad.2016.03.026.Peer-Reviewed Original ResearchMeSH KeywordsAdultClinical Trials, Phase III as TopicErythemaFemaleHumansMaleMiddle AgedPruritusPsoriasisQuality of LifeRemission InductionSeverity of Illness IndexTreatment OutcomeConceptsComplete skin clearanceSkin clearancePASI 100Score 0Dermatology Life Quality IndexNew psoriasis therapiesPsoriasis Symptom InventoryTotal skin clearancePercentage of patientsPhase III trialsHealth-related qualityLife Quality IndexMeaningful end pointsPASI 75PASI 90Psoriasis symptomsPsoriasis therapyTreatment responsePatient's perspectiveInsufficient evidenceClinical meaningfulnessPatientsEnd pointSymptom InventoryClearanceAnti-interleukin-17 treatment of psoriasis
Jinna S, Strober B. Anti-interleukin-17 treatment of psoriasis. Journal Of Dermatological Treatment 2016, 27: 311-315. PMID: 26943806, DOI: 10.3109/09546634.2015.1115816.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicHumansInterleukin-17PsoriasisConceptsTreatment of psoriasisPlaque psoriasisTumor necrosis factor alphaIL-17 inhibitorsPhase 3 trialIL-17 receptor subunitNecrosis factor alphaEffective therapeutic targetIL-17Cytokine antagonistsInflammatory dermatosesIL-17RAFactor alphaSafety resultsTherapeutic targetPsoriasisFavorable responseUS populationReceptor subunitsMonoclonal antibodiesDependent pathwayTreatmentTrialsAntibodiesEfficacy
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
Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Hsu M, Ho V, Ghislain P, Strober B, Reich K, 1 P. Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up. British Journal Of Dermatology 2013, 168: 844-854. PMID: 23301632, DOI: 10.1111/bjd.12214.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedCardiovascular DiseasesClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDermatologic AgentsDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInfectionsMaleMiddle AgedNeoplasmsPsoriasisRandomized Controlled Trials as TopicUstekinumabConceptsAdverse eventsSevere psoriasisGeneral U.S. populationSerious AEsOverall mortalityRate of AEsOverall adverse eventsSerious adverse eventsAEs of interestU.S. populationLong-term safetyLong-term safety evaluationPatient management decisionsUstekinumab doseUstekinumab exposureDose groupMore dosesPsoriasis trialsSerious infectionsSafety dataCumulative toxicityCumulative exposurePsoriasisPatientsEvent rates