2018
Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis
Leonardi C, Papp K, Strober B, Thaçi D, Warren R, Tyring S, Arikan D, Karunaratne M, Valdecantos W. Comprehensive long‐term safety of adalimumab from 18 clinical trials in adult patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2018, 180: 76-85. PMID: 30169904, DOI: 10.1111/bjd.17084.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultAnti-Inflammatory AgentsClinical Trials as TopicDatasets as TopicFemaleHeadacheHumansIncidenceInjections, SubcutaneousLong-Term CareMaleMiddle AgedNasopharyngitisNeoplasmsOpportunistic InfectionsPsoriasisSeverity of Illness IndexTime FactorsTuberculosisTumor Necrosis Factor-alphaConceptsNonmelanoma skin cancerStandardized incidence ratiosStandardized mortality ratioAdverse eventsLong-term safetyPlaque psoriasisClinical trialsIncidence rateIncidence of NMSCSevere chronic plaque psoriasisTreatment-emergent adverse eventsAE incidence ratesChronic plaque psoriasisCommon adverse eventsSevere plaque psoriasisNew safety signalsUpper respiratory infectionIncidence of malignancyAnalysis of patientsTumor necrosis factorHuman monoclonal antibodyAdalimumab doseAdalimumab exposureLast doseAdult patientsBenefit–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' qualityEfficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials
Gordon K, Strober B, Lebwohl M, Augustin M, Blauvelt A, Poulin Y, Papp K, Sofen H, Puig L, Foley P, Ohtsuki M, Flack M, Geng Z, Gu Y, Valdes J, Thompson E, Bachelez H. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet 2018, 392: 650-661. PMID: 30097359, DOI: 10.1016/s0140-6736(18)31713-6.Peer-Reviewed Original ResearchConceptsSevere chronic plaque psoriasisSafety of risankizumabChronic plaque psoriasisSevere plaque psoriasisCo-primary endpointsPlaque psoriasisGlobal assessment scoreWeek 16PASI 90SPGA 0Treatment groupsStatic Physician's Global Assessment scoreTreatment-emergent adverse event profilesActive comparator-controlled trialsDouble-blind treatment periodHumanised IgG1 monoclonal antibodyTreatment-emergent adverse eventsPhysician Global Assessment scorePsoriasis Area Severity IndexComparator-controlled trialsUnexpected safety findingsAdverse event profileNecrosis factor inhibitorsPhase 3 trialProportion of patientsPharmacokinetic 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
2015
Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis
Strober B, Zhao Y, Tran MH, Gnanasakthy A, Nyirady J, Papavassilis C, Nelson LM, McLeod LD, Mordin M, Gottlieb AB, Elewski BE, Lebwohl M. Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis. International Journal Of Dermatology 2015, 55: e147-e155. PMID: 26518255, DOI: 10.1111/ijd.13117.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicDermatologic AgentsFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPatient Reported Outcome MeasuresPsoriasisPsychometricsQuality of LifeRandomized Controlled Trials as TopicReproducibility of ResultsSelf ReportSeverity of Illness IndexSurveys and QuestionnairesSymptom AssessmentYoung AdultConceptsDermatology Life Quality IndexChronic plaque psoriasisInvestigator's Global AssessmentPhase III studyPlaque psoriasisIII studySymptom diarySevere chronic plaque psoriasisMulticenter phase III studyGlobal assessmentSafety of secukinumabSevere plaque psoriasisPatient Global ImpressionPercentage of respondersHealth Status QuestionnaireLife Quality IndexHigh intraclass coefficientsPlacebo armPsoriasis AreaTest-retest reliabilityWeek 12Global ImpressionStatus QuestionnaireTreatment decisionsMean difference
2013
Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment
Strober B, Buonanno M, Clark J, Kawabata T, Tan H, Wolk R, Valdez H, Langley R, Harness J, Menter A, Papp K. Effect of tofacitinib, a Janus kinase inhibitor, on haematological parameters during 12 weeks of psoriasis treatment. British Journal Of Dermatology 2013, 169: 992-999. PMID: 23855761, DOI: 10.1111/bjd.12517.Peer-Reviewed Original ResearchConceptsPhase IIb trialJanus kinase inhibitorDose-dependent decreaseTofacitinib 2IIb trialCell countNatural killer cell countsReversible dose-dependent decreaseSevere chronic plaque psoriasisHaematological parametersKinase inhibitorsB-cell countsChronic plaque psoriasisEffects of tofacitinibShort-term administrationClear dose-dependent effectTreatment of psoriasisRed blood cell countBlood cell countWhite blood cellsDose-dependent effectDose-dependent changesHaematology dataPlaque psoriasisLymphocyte count
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
2011
The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis
Leonardi C, Papp K, Strober B, Reich K, Asahina A, Gu Y, Beason J, Rozzo S, Tyring S. The Long-Term Safety of Adalimumab Treatment in Moderate to Severe Psoriasis. American Journal Of Clinical Dermatology 2011, 12: 321-337. PMID: 21834597, DOI: 10.2165/11587890-000000000-00000.Peer-Reviewed Original ResearchConceptsAdverse event incidence ratesAdalimumab-treated patientsEvent incidence ratesAdverse event ratesPlacebo-controlled periodEvents/100 PYLong-term safetyClinical trialsAdverse eventsIncidence rateSevere psoriasisEvent ratesSafety dataSerious infectious adverse eventsSevere chronic plaque psoriasisFavorable benefit-risk profileCumulative safety dataInfectious adverse eventsPYs of exposureChronic plaque psoriasisSerious adverse eventsSubset of patientsPsoriasis clinical trialsBenefit-risk profileYears of treatmentEfficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis
Strober B, Crowley J, Yamauchi P, Olds M, Williams D. Efficacy and safety results from a phase III, randomized controlled trial comparing the safety and efficacy of briakinumab with etanercept and placebo in patients with moderate to severe chronic plaque psoriasis. British Journal Of Dermatology 2011, 165: 661-668. PMID: 21574984, DOI: 10.1111/j.1365-2133.2011.10419.x.Peer-Reviewed Original ResearchConceptsPhysician global assessmentPlacebo-treated patientsProportion of patientsWeek 12Severe psoriasisWeeks 0Tumor necrosis factor-α antagonists etanerceptCo-primary efficacy endpointsSevere chronic plaque psoriasisSeverity Index (PASI) 75 responseGlobal assessmentEffective psoriasis therapiesEffective psoriasis treatmentEtanercept-treated patientsPASI 75 responseChronic plaque psoriasisPhase II studySerious adverse eventsPhase IIIEfficacy endpointPlacebo injectionsPlaque psoriasisAdverse eventsII studyPsoriasis Area