2018
Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis
Ma G, Xie R, Strober B, Langley R, Ito K, Krishnaswami S, Wolk R, Valdez H, Rottinghaus S, Tallman A, Gupta P. Pharmacokinetic Characteristics of Tofacitinib in Adult Patients With Moderate to Severe Chronic Plaque Psoriasis. Clinical Pharmacology In Drug Development 2018, 7: 587-596. PMID: 29856518, DOI: 10.1002/cpdd.471.Peer-Reviewed Original ResearchConceptsSeparate phase 1 studySevere chronic plaque psoriasisOral Janus kinase inhibitorPharmacokinetics of tofacitinibChronic plaque psoriasisApparent oral clearancePhase 1 studyVd/FCL/FJanus kinase inhibitorFull covariate modelZero-order absorptionOne-compartment modelBaseline PASITofacitinib pharmacokineticsPlaque psoriasisRenal impairmentAdult patientsOral clearancePatient factorsBaseline variablesPharmacokinetic characteristicsBody weightApparent volumeInterindividual variability
2017
No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis
Strober B, Langley R, Menter A, Magid M, Porter B, Fox T, Safi J, Papavassilis C. No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 178: e105-e107. PMID: 28991372, DOI: 10.1111/bjd.16051.Peer-Reviewed Original Research
2016
Effects 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 PressureC-Reactive ProteinCardiovascular DiseasesCholesterolClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicComorbidityDyslipidemiasFemaleGlycated 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
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