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' qualityPharmacokinetic 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
2016
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])
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
2013
Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment
Strober B, Buonanno M, Clark J, Kawabata T, Tan H, Wolk R, Valdez H, Langley R, Harness J, Menter A, Papp K. Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment. British Journal Of Dermatology 2013, 169: 992-999. PMID: 23855761, DOI: 10.1111/bjd.12517.Peer-Reviewed Original ResearchConceptsPhase IIb trialJanus kinase inhibitorDose-dependent decreaseTofacitinib 2IIb trialCell countNatural killer cell countsReversible dose-dependent decreaseSevere chronic plaque psoriasisHaematological parametersKinase inhibitorsB-cell countsChronic plaque psoriasisEffects of tofacitinibShort-term administrationClear dose-dependent effectTreatment of psoriasisRed blood cell countBlood cell countWhite blood cellsDose-dependent effectDose-dependent changesHaematology dataPlaque psoriasisLymphocyte countLong‐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
2012
Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study
Papp K, Menter A, Strober B, Langley R, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness J. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study. British Journal Of Dermatology 2012, 167: 668-677. PMID: 22924949, DOI: 10.1111/j.1365-2133.2012.11168.x.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultChronic DiseaseDermatologic AgentsDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansJanus Kinase 3MalePiperidinesPsoriasisPyrimidinesPyrrolesTreatment OutcomeConceptsOral Janus kinase inhibitorSafety of tofacitinibDose-ranging studyJanus kinase inhibitorPlaque psoriasisAdverse eventsWeek 12Mean serum high density lipoproteinPlacebo-controlled dose-ranging studyResponse ratePASI 75 response ratesSevere chronic plaque psoriasisKinase inhibitorsPASI 75 responseTwice daily groupChronic plaque psoriasisSerum high-density lipoproteinSevere plaque psoriasisProportion of patientsSignificant clinical improvementSeverity Index scoreTreatment of psoriasisDose-dependent increaseShort-term treatmentHigh-density lipoprotein
2011
Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
Lebwohl M, Leonardi C, Griffiths C, Prinz J, Szapary P, Yeilding N, Guzzo C, Li S, Hsu M, Strober B. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. Journal Of The American Academy Of Dermatology 2011, 66: 731-741. PMID: 21930328, DOI: 10.1016/j.jaad.2011.06.011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsEtanerceptEvaluation Studies as TopicFemaleFollow-Up StudiesHumansImmunoglobulin GMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorRisk AssessmentSafety ManagementSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsRate of AEsUstekinumab-treated patientsAdverse eventsSerious AEsSevere psoriasisSafety profileLong-term safety experiencePrevious short-term reportsCumulative safety dataGeneral safety parametersPlacebo-controlled periodSerious adverse eventsYears of treatmentShort-term reportsCases of demyelinationUstekinumab exposureIL-23Clinical trialsOverall infectionSafety dataACCEPT trialPatientsSimilar findingsSafety experienceTrials
2010
Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study.
Leonardi C, Strober B, Gottlieb A, Elewski B, Ortonne J, van de Kerkhof P, Chiou C, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. Journal Of Drugs In Dermatology 2010, 9: 928-37. PMID: 20684143.Peer-Reviewed Original ResearchConceptsLong-term safetyExtension studyOpen-label etanercept treatmentPrevious phase 3 studyOpen-label extension studyEfficacy of etanerceptOpen-label studySevere plaque psoriasisPhase 3 studySymptoms of psoriasisEligible patientsEtanercept treatmentInterrupted therapySubcutaneous etanerceptEtanercept therapyPlaque psoriasisAdverse eventsPsoriatic patientsEtanerceptPatientsSkin diseasesPsoriasisWeeksYears of experiencePredetermined criteria
2009
Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study
Strober B, Menon K, McMichael A, Hordinsky M, Krueger G, Panko J, Siu K, Lustgarten J, Ross E, Shapiro J. Alefacept for Severe Alopecia Areata: A Randomized, Double-blind, Placebo-Controlled Study. JAMA Dermatology 2009, 145: 1262-1266. PMID: 19917955, DOI: 10.1001/archdermatol.2009.264.Peer-Reviewed Original ResearchMeSH KeywordsAcademic Medical CentersAdolescentAdultAgedAlefaceptAlopecia AreataDermatologic AgentsDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansInjections, IntramuscularMaleMiddle AgedNew York CityProbabilityRecombinant Fusion ProteinsRisk AssessmentSeverity of Illness IndexStatistics, NonparametricTreatment OutcomeYoung AdultConceptsSevere alopecia areataAlopecia areataPlacebo-controlled clinical trialEfficacy of alefaceptPlacebo-receiving groupSevere plaque psoriasisMain outcome measuresPlaque psoriasisPrevious therapyAlopecia ToolClinical trialsAlefaceptOutcome measuresUS FoodDrug AdministrationConsecutive weeksBiologic inhibitorsScalp hairAreataTreatmentWeeksSignificant improvementMulticenterPlaceboPsoriasis
2008
Efalizumab-Associated Guillain-Barré Syndrome
Victor F, Menon K, Latkowski J, Fernandez-Obregon A, Strober B. Efalizumab-Associated Guillain-Barré Syndrome. JAMA Dermatology 2008, 144: 1396-1397. PMID: 18936412, DOI: 10.1001/archderm.144.10.1396.Peer-Reviewed Original ResearchAn open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*
Gottlieb A, Strober B, Krueger J, Rohane P, Zeldis J, Hu C, Kipnis C. An open-label, single-arm pilot study in patients with severe plaque-type psoriasis treated with an oral anti-inflammatory agent, apremilast*. Current Medical Research And Opinion 2008, 24: 1529-1538. PMID: 18419879, DOI: 10.1185/030079908x301866.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAnti-Inflammatory AgentsBiopsy, NeedleConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEpidermisFemaleFollow-Up StudiesHumansImmunohistochemistryMaleMiddle AgedPhosphodiesterase 4 InhibitorsPilot ProjectsPsoriasisSeverity of Illness IndexThalidomideTreatment OutcomeConceptsSevere plaque-type psoriasisPlaque-type psoriasisAdverse eventsTumor necrosis factor-alpha levelsAbnormal laboratory test resultsStatic Physician's Global AssessmentOpen-label pilot studyNecrosis factor-alpha levelsGlobal assessmentSingle-arm pilot studyOral anti-inflammatory agentsPilot studyClinical efficacy scoresMultiple inflammatory factorsPhysician global assessmentLesional skin biopsiesPathogenesis of psoriasisBody surface areaAnti-inflammatory agentsPhosphodiesterase 4 inhibitorCD11c cellsInflammatory markersPASI scorePsoriasis AreaInflammatory factors
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
2004
Etanercept for the treatment of psoriasis: combination therapy with other modalities.
Strober B, Clarke S. Etanercept for the treatment of psoriasis: combination therapy with other modalities. Journal Of Drugs In Dermatology 2004, 3: 270-2. PMID: 15176161.Peer-Reviewed Original ResearchMeSH KeywordsAcitretinAdultAnti-Inflammatory Agents, Non-SteroidalAntirheumatic AgentsArthritis, PsoriaticCyclosporineDose-Response Relationship, DrugDrug Therapy, CombinationEtanerceptFemaleHumansImmunoglobulin GKeratolytic AgentsMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorRecombinant Fusion ProteinsConceptsTumor necrosis factorTumor necrosis factor receptorWeekly doseRheumatoid arthritisPatients of psoriasisPlacebo-controlled studySevere plaque psoriasisSelf-administered medicationsJuvenile rheumatoid arthritisTreatment of psoriasisHuman fusion proteinNecrosis factor receptorPlaque psoriasisContinuous therapyPsoriasis AreaPsoriatic arthritisSystemic therapyPsoriasis patientsTreatment regimenClinical efficacyCombination therapyMedical historyClinical trialsNecrosis factorEtanercept