2018
Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials
Strober B, Gottlieb A, Kerkhof P, Puig L, Bachelez H, Chouela E, Imafuku S, Thaçi D, Tan H, Valdez H, Gupta P, Kaur M, Frajzyngier V, Wolk R. Benefit–risk profile of tofacitinib in patients with moderate‐to‐severe chronic plaque psoriasis: pooled analysis across six clinical trials. British Journal Of Dermatology 2018, 180: 67-75. PMID: 30188571, PMCID: PMC7379291, DOI: 10.1111/bjd.17149.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdolescentAdultAgedAged, 80 and overChronic DiseaseDose-Response Relationship, DrugFemaleHumansMaleMiddle AgedPiperidinesProtein Kinase InhibitorsPsoriasisPyrimidinesPyrrolesQuality of LifeRandomized Controlled Trials as TopicRisk AssessmentSeverity of Illness IndexYoung AdultConceptsSevere chronic plaque psoriasisChronic plaque psoriasisEfficacy end pointBenefit-risk profileSevere psoriasisPlaque psoriasisWeek 16Dermatology Life Quality Index scoresLong-term extension studyOral Janus kinase inhibitorGlobal assessmentLife Quality Index scoresEnd pointDepression Scale depression scorePhysician global assessmentImproved patients' qualitySystemic psoriasis therapiesJanus kinase inhibitorQuality Index scoresTofacitinib 5Tofacitinib exposurePsoriasis AreaSystemic treatmentTofacitinib treatmentPatients' qualityPharmacokinetic 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
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
2012
Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study
Papp K, Menter A, Strober B, Langley R, Buonanno M, Wolk R, Gupta P, Krishnaswami S, Tan H, Harness J. Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomized placebo‐controlled dose‐ranging study. British Journal Of Dermatology 2012, 167: 668-677. PMID: 22924949, DOI: 10.1111/j.1365-2133.2012.11168.x.Peer-Reviewed Original ResearchConceptsOral Janus kinase inhibitorSafety of tofacitinibDose-ranging studyJanus kinase inhibitorPlaque psoriasisAdverse eventsWeek 12Mean serum high density lipoproteinPlacebo-controlled dose-ranging studyResponse ratePASI 75 response ratesSevere chronic plaque psoriasisKinase inhibitorsPASI 75 responseTwice daily groupChronic plaque psoriasisSerum high-density lipoproteinSevere plaque psoriasisProportion of patientsSignificant clinical improvementSeverity Index scoreTreatment of psoriasisDose-dependent increaseShort-term treatmentHigh-density lipoprotein