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
2017
Janus Kinase Inhibitors
Kim A, Strober B. Janus Kinase Inhibitors. 2017, 187-198. DOI: 10.1007/978-3-319-66884-0_19.Peer-Reviewed Original ResearchAutoinflammatory disordersJanus kinase inhibitorNovel drug classJanus kinaseMedication classesAtopic dermatitisRheumatoid arthritisAlopecia areataHematologic disordersClinical dataDrug classesPolycythemia veraTherapeutic benefitJAK inhibitorsNew agentsJAK-STAT pathwayClinical useJakinibsKinase inhibitorsActivator of transcriptionDisordersPreliminary findingsSignal transducerInhibitorsHuman useGreater Efficacy with Secukinumab Treatment is Associated with Greater Psoriasis Symptom Relief: Results from Secukinumab Clinical Trial Data
Gottlieb A, Strober B, Lebwohl M, Kaufmann R, Pariser D, Narbutas R, Nyirady J, Zhao Y, Herrera V, McLeod L, Odom D, Elewski B. Greater Efficacy with Secukinumab Treatment is Associated with Greater Psoriasis Symptom Relief: Results from Secukinumab Clinical Trial Data. Journal Of Psoriasis And Psoriatic Arthritis 2017, 2: 73-80. DOI: 10.1177/247553031700200206.Peer-Reviewed Original ResearchPsoriasis-related itchingWeek 12Disease severityBenefits of secukinumabInterleukin-17A antagonistSevere plaque psoriasisPatient-reported symptomsClinical trial dataDisease severity scoreQuality of lifeTraditional clinical measuresBackground PsoriasisPASI responseSecukinumab treatmentPlaque psoriasisComplete reliefSymptom reliefSeverity scoreClinical dataResponder statusClinical measuresGreater efficacyTrial dataSecukinumabTreatment effects
2013
Dose Response and Pharmacokinetics of Tofacitinib (CP‐690,550), an Oral Janus Kinase Inhibitor, in the Treatment of Chronic Plaque Psoriasis
Tan H, Gupta P, Harness J, Wolk R, Chapel S, Menter A, Strober B, Langley R, Krishnaswami S, Papp K. Dose Response and Pharmacokinetics of Tofacitinib (CP‐690,550), an Oral Janus Kinase Inhibitor, in the Treatment of Chronic Plaque Psoriasis. CPT Pharmacometrics & Systems Pharmacology 2013, 2: 1-8. PMCID: PMC3674331, DOI: 10.1038/psp.2013.22.Peer-Reviewed Original ResearchBody weightPlacebo-controlled dose-ranging studyOral Janus kinase inhibitorPhase III clinical trialsPharmacokinetics of tofacitinibChronic plaque psoriasisDose-ranging studyPlaque psoriasis treatmentJanus kinase inhibitorNonlinear mixed-effects modelingTofacitinib 2Tofacitinib 5Confirmatory phase III clinical trialDose-response profilesPlaque psoriasisSystemic exposurePsoriasis treatmentSubgroup analysisMixed-effects modelingClinical trialsClinical dataTofacitinibPsoriasisKinase inhibitorsReduced efficacy