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
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 resultsLong-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patientsE088 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
2021
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR
Bissonnette R, Gottlieb A, Langley R, Leonardi C, Papp K, Pariser D, Uy J, Lafferty K, Langholff W, Fakharzadeh S, Berlin J, Brouwer E, Greenspan A, Strober B. Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR. Drug Safety 2021, 44: 699-709. PMID: 34075572, PMCID: PMC8184557, DOI: 10.1007/s40264-021-01065-z.Peer-Reviewed Original ResearchConceptsMajor adverse cardiovascular eventsHazard ratioIncident usersObservational studyCox model regression analysisAdjusted hazard ratioAdverse cardiovascular eventsReal-world registryInternational observational studyLong-term observational studyDisease-based registryRelevant clinical dataMACE riskUstekinumab exposureCardiovascular eventsPatient characteristicsPsoriasis patientsTreatment cohortsMethodological limitationsComparator groupSafety registryClinical dataRegistry dataModel regression analysisConclusionOur results
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 eventsWeeks
2012
Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis
Langley R, Papp K, Gottlieb A, Krueger G, Gordon K, Williams D, Valdes J, Setze C, Strober B. Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2012, 27: 1252-1261. PMID: 23157612, DOI: 10.1111/j.1468-3083.2012.04705.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Basal CellCarcinoma, Squamous CellCardiovascular DiseasesClinical Trials as TopicFemaleHumansInterleukin-12Interleukin-23MaleMiddle AgedPrevalencePsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexSkin Diseases, InfectiousSkin NeoplasmsTreatment OutcomeConceptsOpen-label extension studyMajor adverse cardiovascular eventsPotential safety signalsSevere psoriasisAdverse eventsParent studyClinical trialsSafety signalsSafety resultsAnti-IL-12/23 treatmentInterleukin-12/23 monoclonal antibodyOpen-label extension trialPhase IIAdverse cardiovascular eventsCardiovascular risk factorsBaseline blood pressureBody mass indexRate of infectionCardiovascular eventsFirst doseSafety findingsBlood pressureIL-12/23Mass indexExtension trialPSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents.
Papp K, Strober B, Augustin M, Calabro S, Londhe A, Chevrier M. PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents. Journal Of Drugs In Dermatology 2012, 11: 1210-7. PMID: 23134986.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticBody Mass IndexBody Surface AreaCardiovascular DiseasesData Interpretation, StatisticalFemaleHumansImmunologic FactorsInfliximabMaleMiddle AgedObesityPhototherapyProduct Surveillance, PostmarketingProspective StudiesPsoriasisRegistriesUstekinumabConceptsDisease-based registryBiologic agentsObservational studyMajor adverse cardiovascular eventsConventional systemic treatmentsGeneral psoriasis populationPsoriasis Longitudinal AssessmentAdverse cardiovascular eventsOverweight/obeseLong-term observational studyBody surface areaPsoriasis populationCardiovascular eventsCause mortalityAdverse eventsPsoriatic arthritisRegistry studySystemic agentsSystemic therapySystemic treatmentMedication historyDisease characteristicsSerious infectionsMean durationEfficacy data
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance treatmentAssociation Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials
Ryan C, Leonardi C, Krueger J, Kimball A, Strober B, Gordon K, Langley R, de Lemos J, Daoud Y, Blankenship D, Kazi S, Kaplan D, Friedewald V, Menter A. Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials. JAMA 2011, 306: 864-871. PMID: 21862748, DOI: 10.1001/jama.2011.1211.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesDouble-Blind MethodEtanerceptHumansImmunoglobulin GImmunologic FactorsInfliximabInterleukin-12Interleukin-23Middle AgedMyocardial InfarctionPlacebosPsoriasisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis FactorRiskStrokeTumor Necrosis Factor-alphaUstekinumabYoung AdultConceptsMajor adverse cardiovascular eventsChronic plaque psoriasisAnti-IL-12/23 agentsPlacebo-controlled phaseΑ agentsCardiovascular eventsPlaque psoriasisBiologic therapyControlled TrialsAnti-tumor necrosis factor α agentsRate of MACEAnti-IL-12/ILMantel-Haenszel fixed-effect methodAnti-IL-12/23 therapyAdverse cardiovascular eventsCochrane Central RegisterComposite end pointAbsolute risk differencePrimary outcome measureRandomized Controlled TrialsSignificant differencesCardiovascular deathMonotherapy studiesΑ treatmentCentral Register