2024
Brodalumab: Six-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Yoon S, Rawnsley N, Goehring E, Mangin G, Jacobson A. Brodalumab: Six-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 1-10. PMID: 39589679, DOI: 10.1007/s13555-024-01304-y.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyUS patientsCase of Candida infectionSafety profile of brodalumabSafety of brodalumabMajor adverse cardiovascular eventsInterleukin-17 receptorAdverse cardiovascular eventsLong-term safetyFungal infection rateCandida infectionsPlaque psoriasisSafety profileAdult patientsBrodalumabCardiovascular eventsBox warningPharmacovigilance reportsFungal infectionsClinical trialsPatientsPharmacovigilance dataMedDRA QueriesClinical practiceBrodalumab: 5-Year US Pharmacovigilance Report
Lebwohl M, Koo J, Armstrong A, Strober B, Martin G, Rawnsley N, Goehring E, Jacobson A. Brodalumab: 5-Year US Pharmacovigilance Report. Dermatology And Therapy 2024, 14: 1349-1357. PMID: 38724839, PMCID: PMC11116300, DOI: 10.1007/s13555-024-01162-8.Peer-Reviewed Original ResearchAdverse eventsSystemic therapyInterleukin-17 receptor A antagonistPharmacovigilance dataPsoriasis Longitudinal AssessmentMajor adverse cardiovascular eventsLong-term clinical trialsUS prescribing informationAdverse cardiovascular eventsPlaque psoriasisReported malignanciesSafety profileAdult patientsCardiovascular eventsBrodalumabBox warningUS patientsPharmacovigilance reportsFungal infectionsClinical trialsPrescribing informationSafety signalsSuspected COVID-19 casesPatientsPackage inserts
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 trials
2021
Characteristics of Patients with Psoriasis Treated with Apremilast in the Corrona Psoriasis Registry
Gottlieb A, Merola J, Cirulli J, Williams C, Linowski G, Paris M, Litman H, Guo N, Emeanuru K, McLean R, Cronin A, Strober B. Characteristics of Patients with Psoriasis Treated with Apremilast in the Corrona Psoriasis Registry. Dermatology And Therapy 2021, 11: 253-263. PMID: 33475970, PMCID: PMC7858993, DOI: 10.1007/s13555-020-00479-4.Peer-Reviewed Original ResearchCorrona Psoriasis RegistryPsoriasis RegistryMost patientsPsoriatic arthritisRegistry enrollmentApremilast patientsPhase 3 clinical studiesReal-world observational studyConcomitant systemic treatmentPrior biologic exposureCharacteristics of patientsTreatment of psoriasisQuality of lifeHigh rateIndex dateObservational registrySevere psoriasisSystemic medicationsAdult patientsBiologic therapyPatient characteristicsSystemic treatmentBiologic exposureModerate diseasePsoriasis patients
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 patientsLong‐term safety of adalimumab in adult patients with plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Long‐term safety of adalimumab in adult patients with plaque psoriasis. British Journal Of Dermatology 2019, 180: e13-e13. DOI: 10.1111/bjd.17366.Peer-Reviewed Original ResearchNon-melanoma skin cancerPatient yearsLong-term safetyIncidence of NMSCTumor necrosis factor alphaMost common AEsNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsNumber of patientsNecrosis factor alphaDifferent clinical trialsCommon AEsPlaque psoriasisAdult patientsAdverse eventsRespiratory infectionsOpportunistic infectionsSerious infectionsClinical trialsIncidence rateSafety signalsFactor alphaAdalimumab
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 patientsSystematic review of the real‐world evidence of adalimumab safety in psoriasis registries
Strober B, Crowley J, Langley R, Gordon K, Menter A, Leonardi C, Arikan D, Valdecantos W. Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries. Journal Of The European Academy Of Dermatology And Venereology 2018, 32: 2126-2133. PMID: 30067882, DOI: 10.1111/jdv.15203.Peer-Reviewed Original ResearchConceptsMajor cardiac eventsAdverse eventsPsoriasis RegistryReal-world evidenceAdalimumab safetySerious AEsAdult patientsCardiac eventsClinical studiesSafety dataLong-term safety profileCardiovascular-related eventsSerious adverse eventsSerious cardiovascular eventsReal-world safetyLong-term safetyRate of infectionEnglish language manuscriptsCardiovascular eventsSafety profileSerious infectionsAdalimumabClinical practiceEligible papersRegistryPharmacokinetic 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
2006
Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis
Elewski B, Leonardi C, Gottlieb A, Strober B, Simiens M, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. British Journal Of Dermatology 2006, 156: 138-142. PMID: 17199580, DOI: 10.1111/j.1365-2133.2006.07585.x.Peer-Reviewed Original ResearchConceptsPhase 3 studyWeeks of etanerceptGlobal phase 3 studyExtension study baselineExtension studyPK profilesEfficacy endpointStudy baselinePharmacokinetic profileTumor necrosis factor antagonistsOpen-label extension studyDermatology Life Quality IndexGlobal assessmentMean PASI scoreNew safety findingsNecrosis factor antagonistsPhysician global assessmentSevere plaque psoriasisSubset of patientsLife Quality IndexSet of patientsPlaque psoriasisAdult patientsPASI scorePsoriasis Area