2023
Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS)
Warren R, French L, Blauvelt A, Langley R, Egeberg A, Mrowietz U, Hunter H, Gooderham M, Soerensen P, Andres P, Sommer M, Carlsson A, Kjøller K, Strober B. Orismilast in moderate-to-severe psoriasis: Efficacy and safety from a 16-week, randomized, double-blinded, placebo-controlled, dose-finding, and phase 2b trial (IASOS). Journal Of The American Academy Of Dermatology 2023, 90: 494-503. PMID: 37951245, DOI: 10.1016/j.jaad.2023.11.005.Peer-Reviewed Original ResearchSevere psoriasisWeek 16PDE4 inhibitionPhase 2b trialSevere plaque psoriasisDose-ranging studyModified-release formulationTolerability effectsPlaque psoriasisBaseline characteristicsEfficacy endpointPrimary endpointPsoriasis AreaSafety findingsSafety profileStudy populationPhase 2bPotential treatmentPsoriasisDisease proportionsGreater efficacyPlaceboPercentage changeSmall sample sizeSeverity Index
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