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
2013
Long‐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
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