2024
Deucravacitinib 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 inhibitorDeucravacitinib 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 rateThe Epidemiology of Palmoplantar Pustulosis: An Analysis of Multiple Health Insurance Claims and Electronic Health Records Databases
Ramcharran D, Strober B, Gordon K, DeKlotz C, Fakharzadeh S, Yang Y, Swerdel J, Hardin J, Dronavalli S, Paller A. The Epidemiology of Palmoplantar Pustulosis: An Analysis of Multiple Health Insurance Claims and Electronic Health Records Databases. Advances In Therapy 2023, 40: 5090-5101. PMID: 37737889, PMCID: PMC10567878, DOI: 10.1007/s12325-023-02669-w.Peer-Reviewed Original ResearchConceptsElectronic health record databaseHealth record databasePPP patientsRecord databaseHigher baseline useChronic inflammatory conditionsPost-diagnosis treatmentHealth insurance claimsConclusionsThe burdenPotential miscodingPalmoplantar pustulosisSterile pustulesBaseline characteristicsMetabolic syndromeBaseline useInflammatory conditionsIncidence ratePopulation-based approachPrevalence estimatesPPP prevalenceEpidemiologyAdditional studiesPustulosisDisease treatmentPatientsE088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis
Strober B, Coates L, Yu J, Rowland K, Leibowitz E, Miller M, Kollmeier A, Li S, Wang Y, Chan D, Chakravarty S, Yang Y, Shawi M, Lebwohl M, Rahman P. E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis. Rheumatology 2023, 62 DOI: 10.1093/rheumatology/kead104.337.Peer-Reviewed Original ResearchGuselkumab-treated patientsJanssen Scientific AffairsGrant/research supportPlacebo-controlled periodPlacebo-treated patientsAdverse eventsBristol-Myers SquibbBoehringer IngelheimOpportunistic infectionsIncidence rateMeiji Seika PharmaSafety dataLEO PharmaEli LillyUCB PharmaMajor adverse cardiovascular eventsSafety eventsScientific AffairsAdverse cardiovascular eventsOverall adverse eventsSerious adverse eventsSevere plaque psoriasisPhase 2/3 studyActive psoriatic arthritisPharmaceutical companiesAssociation between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib
Kristensen L, Strober B, Poddubnyy D, Leung Y, Jo H, Kwok K, Vranic I, Fleishaker D, Fallon L, Yndestad A, Gladman D. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Therapeutic Advances In Musculoskeletal Disease 2023, 15: 1759720x221149965. PMID: 36777695, PMCID: PMC9909057, DOI: 10.1177/1759720x221149965.Peer-Reviewed Original ResearchMajor adverse cardiovascular eventsAtherosclerotic CV diseaseTofacitinib-treated patientsAdverse cardiovascular eventsCV diseaseASCVD riskHigh blood pressurePsoriatic arthritisHigh riskHeart-related problemsHigher baselineCardiovascular eventsBlood pressureRisk calculatorIncidence rateMore casesBaseline cardiovascular riskBaseline metabolic syndromeCardiovascular disease riskJanus kinase inhibitorDose of tofacitinibGroup of conditionsBaseline MetSPsA trialsTofacitinib exposure
2022
OP0027 ASSOCIATION BETWEEN BASELINE CARDIOVASCULAR RISK AND INCIDENCE RATES OF MAJOR ADVERSE CARDIOVASCULAR EVENTS AND MALIGNANCIES IN PATIENTS WITH PSORIATIC ARTHRITIS AND PSORIASIS RECEIVING TOFACITINIB
Kristensen L, Strober B, Poddubnyy D, Leung Y, Jo H, Kwok K, Vranic I, Fleishaker D, Fallon L, Yndestad A, Gladman D. OP0027 ASSOCIATION BETWEEN BASELINE CARDIOVASCULAR RISK AND INCIDENCE RATES OF MAJOR ADVERSE CARDIOVASCULAR EVENTS AND MALIGNANCIES IN PATIENTS WITH PSORIATIC ARTHRITIS AND PSORIASIS RECEIVING TOFACITINIB. Annals Of The Rheumatic Diseases 2022, 81: 20-20. DOI: 10.1136/annrheumdis-2022-eular.1762.Peer-Reviewed Original ResearchMajor adverse CV eventsASCVD riskCV riskIncidence rateBristol-Myers SquibbGrant/research supportPfizer IncPsoriatic arthritisSpeakers bureauEli LillyMajor adverse cardiovascular eventsRisk categoriesGilead SciencesASCVD risk categoryBaseline cardiovascular riskBaseline CV riskTofacitinib-treated patientsTreatment of PsAAdverse cardiovascular eventsAdverse CV eventsCV disease riskCoronary artery diseaseHigh incidence rateDose of tofacitinibCV events
2019
Ustekinumab 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 eventsWeeksLong‐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 patients
2017
Infections 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 modelingRiskTreatment
2016
Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R, Ferris LK, Paul C, Lebwohl M, Braun DK, Mallbris L, Wilhelm S, Xu W, Ljungberg A, Acharya N, Reich K. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data. Journal Of The American Academy Of Dermatology 2016, 76: 432-440.e17. PMID: 27889292, DOI: 10.1016/j.jaad.2016.09.026.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsIxekizumab-treated patientsSerious adverse eventsAdverse eventsIncidence rateClinical trialsMore treatment-emergent adverse eventsExposure-adjusted incidence ratesEtanercept-treated patientsIntegrated safety dataSafety of ixekizumabUnexpected safety findingsAcceptable safety profileLong-term safety outcomesSafety of biologicsAdditional long-term dataSafety findingsSafety profileCandida infectionsSafety dataSafety outcomesIxekizumabPatientsPsoriasisTrialsEffects 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 levels
2011
The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis
Leonardi C, Papp K, Strober B, Reich K, Asahina A, Gu Y, Beason J, Rozzo S, Tyring S. The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis. American Journal Of Clinical Dermatology 2011, 12: 321-337. PMID: 21834597, DOI: 10.2165/11587890-000000000-00000.Peer-Reviewed Original ResearchConceptsAdverse event incidence ratesAdalimumab-treated patientsEvent incidence ratesAdverse event ratesPlacebo-controlled periodEvents/100 PYLong-term safetyClinical trialsAdverse eventsIncidence rateSevere psoriasisEvent ratesSafety dataSerious infectious adverse eventsSevere chronic plaque psoriasisFavorable benefit-risk profileCumulative safety dataInfectious adverse eventsPYs of exposureChronic plaque psoriasisSerious adverse eventsSubset of patientsPsoriasis clinical trialsBenefit-risk profileYears of treatment