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
2012
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.
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