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 practiceCriteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America.
Strober B, Zhong Y, Sima A, Beeghly A, Eckmann T, Balagula E, Zhuo J, Lebwohl M. Criteria for Identifying Candidates for Systemic Psoriasis Treatment in the Real World: Application of the International Psoriasis Council Guidelines in Patients in North America. Journal Of Psoriasis And Psoriatic Arthritis 2024, 24755303241302070. PMID: 39583219, PMCID: PMC11583168, DOI: 10.1177/24755303241302070.Peer-Reviewed Original ResearchBody surface areaInternational Psoriasis CouncilSystemic therapySystemic psoriasis treatmentsDisease severity criteriaTopical therapyPsoriasis treatmentTherapy candidatesCorEvitas Psoriasis RegistrySystemic therapy initiationTreatment-naive patientsSeverity criteriaReal-world studyCross-sectional studyDisease severity indicatorsPatient-reported outcome measuresPlaque psoriasisPsoriasis RegistryTherapy initiationSystemic treatmentRegistry visitPASI scoreClinical characteristicsClinical decision-makingPsoriasis severityDeucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s423. DOI: 10.25251/skin.8.supp.423.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateParent trialAdverse cardiovascular eventsTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsCardiovascular eventsSafety signalsPatientsResponse rateIncidence ratePsoriasisSpesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial
Merola J, Strober B, Gottlieb A, Mostaghimi A, Hawkes J, Guercio J, Tang M, Thoma C, Lebwohl M. Spesolimab decreases generalized pustular psoriasis (GPP) body surface area (BSA) over time in patients switching from conventional systemic treatments: Results from the EFFISAYIL® 2 trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s488. DOI: 10.25251/skin.8.supp.488.Peer-Reviewed Original ResearchGeneralized pustular psoriasisBody surface areaBody surface area involvementSystemic medicationsConventional systemic treatmentsAverage body surface areaTreating generalized pustular psoriasisLife-threatening skin diseaseSignificant patient burdenYears of ageSystemic therapyDosing regimenSystemic treatmentPediatric patientsPustular psoriasisExtent of involvementSpesolimabWeek 4Skin symptomsPatientsMonoclonal antibodiesLower extremitiesSkin diseasesPatient burdenUpper extremityDeucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Morita A, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Colombo M, Vaile J, Vritzali E, Hoyt K, Daamen C, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 4-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1, PSO-2, and LTE Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s406. DOI: 10.25251/skin.8.supp.406.Peer-Reviewed Original ResearchAssess adverse eventsLong-term extensionModerate to severe plaque psoriasisExposure-adjusted incidence ratesSevere plaque psoriasisPlaque psoriasisLong-term extension trialsClinical response rateTreatment of adultsSystemic therapyEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismAdverse eventsDeucravacitinibEfficacy resultsSafety signalsPatientsContinuous treatmentResponse rateIncidence rateParent trialPsoriasisAllosteric TYK2 inhibitorBrodalumab: 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 insertsDeucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-year Safety and Efficacy Results from the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s366. DOI: 10.25251/skin.8.supp.366.Peer-Reviewed Original ResearchModified nonresponder imputationPlaque psoriasisModerate to severe plaque psoriasisDiscontinuations due to AEsExposure-adjusted incidence ratesSevere plaque psoriasisParent trialAdverse cardiovascular eventsLong-term extensionTreatment of adultsSystemic therapyNonresponder imputationEfficacy outcomesHerpes zosterSafety profileVenous thromboembolismDeucravacitinibCardiovascular eventsEfficacy resultsPatientsResponse rateIncidence ratePsoriasisAllosteric TYK2 inhibitorEfficacy
2023
Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials
Armstrong A, Lebwohl M, Warren R, Sofen H, Imafuku S, Ohtsuki M, Spelman L, Passeron T, Papp K, Kisa R, Berger V, Vritzali E, Hoyt K, Colombo M, Banerjee S, Strober B, Thaçi D, Blauvelt A. Deucravacitinib in Plaque Psoriasis: 3-Year Safety and Efficacy Results From the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s240. DOI: 10.25251/skin.7.supp.240.Peer-Reviewed Original ResearchSevere plaque psoriasisPlaque psoriasisParent trialDay 1Exposure-adjusted incidence ratesLong-term extension trialsMajor adverse cardiovascular eventsAdverse cardiovascular eventsConsistent safety profileTreatment of adultsNonresponder imputationOral placeboSerious AEsWeek 148Cardiovascular eventsEfficacy outcomesVenous thromboembolismWeek 52Herpes zosterSystemic therapyDurable efficacySafety profileExtension trialIncidence rateEfficacy resultsDeucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials
Lebwohl M, Strober B, Scharnitz T, Linaberry M, Hoyt K, Banerjee S, Kisa R, Martin G. Deucravacitinib, an Oral, Selective, Allosteric Tyrosine Kinase 2 Inhibitor, in Moderate to Severe Plaque Psoriasis: Evaluation of Creatine Phosphokinase Elevations in the Phase 3 POETYK PSO-1 and PSO-2 Trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s244. DOI: 10.25251/skin.7.supp.244.Peer-Reviewed Original ResearchExposure-adjusted incidence ratesSevere plaque psoriasisAdverse eventsPlaque psoriasisCPK levelsWeek 52CTCAE gradeElevated CPKCPK elevationWeek 16Apremilast-treated patientsPooled safety analysisPotential inciting eventsCreatine phosphokinase elevationProportion of patientsTreatment of adultsCreatine phosphokinase levelsKinase 2 inhibitorTyrosine kinase 2 inhibitorLow gradeOral placeboSystemic therapyInciting eventWeeks 0Incidence rateDeucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials
Lebwohl M, Strober B, Linaberry M, Hoyt K, Banerjee S, Kisa R, Mehta N. Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate to severe plaque psoriasis: evaluation of lipid parameters in the phase 3 POETYK PSO-1 and PSO-2 trials. SKIN The Journal Of Cutaneous Medicine 2023, 7: s115. DOI: 10.25251/skin.7.supp.115.Peer-Reviewed Original ResearchSevere plaque psoriasisHDL cholesterolTotal cholesterolWeek 16Plaque psoriasisLDL cholesterolTriglyceride levelsLipid parametersWeeks 0Tyrosine kinase 2Treatment groupsDouble-blind trialBaseline triglyceride levelsLDL cholesterol levelsMean triglyceride levelsTreatment of adultsOral placeboMean triglyceridesAdverse eventsSerum lipidsSystemic therapyDL increasePsoriasis pathogenesisCholesterol levelsMean changeDeucravacitinib in moderate to severe plaque psoriasis: liver transaminase results from the phase 3 POETYK PSO program
Lebwohl M, Egeberg A, Linaberry M, Hoyt K, Banerjee S, Kisa R, Strober B. Deucravacitinib in moderate to severe plaque psoriasis: liver transaminase results from the phase 3 POETYK PSO program. SKIN The Journal Of Cutaneous Medicine 2023, 7: s116. DOI: 10.25251/skin.7.supp.116.Peer-Reviewed Original ResearchSevere plaque psoriasisAlanine aminotransferasePlaque psoriasisConcomitant medicationsWeeks 0Week 16Multiple laboratory parametersCommon Terminology CriteriaMean levelsTreatment of adultsWeeks of treatmentPatient-level dataOral placeboTerminology CriteriaAST elevationLiver transaminasesAminotransferase levelsCTCAE gradeLiver dysfunctionSystemic therapyLaboratory parametersAST levelsTreatment armsLiver conditionsSeverity grade
2021
Tofacitinib for the Treatment of Refractory Palmoplantar Psoriasis: A Case Series
Muzumdar S, Leonardi C, Strober B. Tofacitinib for the Treatment of Refractory Palmoplantar Psoriasis: A Case Series. Journal Of Psoriasis And Psoriatic Arthritis 2021, 6: 93-98. DOI: 10.1177/2475530321995516.Peer-Reviewed Original ResearchPalmoplantar psoriasisCase seriesEfficacy of tofacitinibRecalcitrant palmoplantar psoriasisSubtypes of psoriasisPsoriasis refractorySystemic therapyPatients' qualityNew medicationsEffective therapyPsoriasis phenotypesSpecific cytokinesPsoriasisTofacitinibTherapyTreatmentMedicationsPatientsCytokinesSubtypes
2020
Successful Treatment of Guttate Psoriasis With Ixekizumab: A Case Series
Fogel A, Strober B. Successful Treatment of Guttate Psoriasis With Ixekizumab: A Case Series. Journal Of Psoriasis And Psoriatic Arthritis 2020, 6: 12-15. DOI: 10.1177/2475530320970538.Peer-Reviewed Original Research
2019
Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council
Strober B, Ryan C, van de Kerkhof P, van der Walt J, Kimball A, Barker J, Blauvelt A, Members and Councilors I, Bourcier M, Carvalho A, Cohen A, Foley P, Evans C, Gisondi P, Griffiths C, El-Sayed M, Eschevarria C, Finlay A, Kalb R, Leonardi C, Lynde C, Murphy R, Murakami M, Okubo Y, Prens E, Puig L, Seyger M, Skov L, Terui T, Valenzuela F, Ward N, Wu J, Zheng M. Recategorization of psoriasis severity: Delphi consensus from the International Psoriasis Council. Journal Of The American Academy Of Dermatology 2019, 82: 117-122. PMID: 31425723, DOI: 10.1016/j.jaad.2019.08.026.Peer-Reviewed Original ResearchConceptsPsoriasis severityInternational Psoriasis CouncilSystemic therapyTopical therapyConsensus statementUndertreatment of psoriasisBody surface areaPast treatment historyPsoriasis involvementPsoriasis patientsClinical studiesTreatment decisionsDelphi consensusEligibility criteriaTreatment historyPatientsSevere categoryTherapySeverity categoriesSeverity definitionsSeverityDichotomous definitionSeverity classificationDelphi approachUndertreatment
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
Treatment of Moderate to Severe Pediatric Psoriasis: A Retrospective Case Series
Klufas D, Wald J, Strober B. Treatment of Moderate to Severe Pediatric Psoriasis: A Retrospective Case Series. Pediatric Dermatology 2016, 33: 142-149. PMID: 26871417, DOI: 10.1111/pde.12782.Peer-Reviewed Original ResearchConceptsSevere pediatric psoriasisRetrospective case seriesPediatric psoriasisCase seriesSevere psoriasisSystemic therapySide effectsDisease responseSimilar side effect profilePhysician Global Assessment scaleComprehensive safety profileSmall sample sizeSingle referral centerSubjective side effectsSide effect profileSafety of treatmentMultiple treatment optionsAdverse event occurrenceComparison of efficacyGlobal Assessment ScalePaucity of dataAdult psoriasisImmunomodulating therapiesAdverse eventsReferral centerSecukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. International Journal Of Dermatology 2016, 55: 401-407. PMID: 26866518, DOI: 10.1111/ijd.13236.Peer-Reviewed Original ResearchConceptsWeek 12Multicenter phase 3 studyPlacebo-controlled clinical trialInterleukin-17A antagonistPsoriasis-related itchingPlacebo treatment groupsSevere plaque psoriasisPhase 3 studyWeeks of treatmentProportion of subjectsPlaque psoriasisSevere psoriasisPsoriasis symptomsSystemic therapySymptom diaryClinical trialsSecukinumabTreatment responsePlaceboItchingPainTreatment groupsPhase 3PsoriasisAdults
2015
The Use of Methotrexate, Alone or in Combination With Other Therapies, for the Treatment of Palmoplantar Psoriasis.
Wald J, Klufas D, Strober B. The Use of Methotrexate, Alone or in Combination With Other Therapies, for the Treatment of Palmoplantar Psoriasis. Journal Of Drugs In Dermatology 2015, 14: 888-92. PMID: 26267735.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalCyclosporineDermatologic AgentsDrug Therapy, CombinationEtanerceptFemaleFoot DermatosesHand DermatosesHumansImmunosuppressive AgentsInfliximabMaleMethotrexateMiddle AgedMycophenolic AcidPsoriasisSeverity of Illness IndexThalidomideUstekinumabYoung AdultCurrent and Future Oral Systemic Therapies for Psoriasis
Kelly J, Foley P, Strober B. Current and Future Oral Systemic Therapies for Psoriasis. Dermatologic Clinics 2015, 33: 91-109. PMID: 25412786, DOI: 10.1016/j.det.2014.09.008.Peer-Reviewed Original ResearchMeSH KeywordsAcitretinAnti-Inflammatory Agents, Non-SteroidalAntimetabolitesCyclosporineFumaratesHumansHydroxyureaImmunosuppressive AgentsIsoxazolesKeratolytic AgentsLeflunomideMethotrexateMycophenolic AcidPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesSulfasalazineThalidomideThioguanine