2023
42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials
Papp K, Lebwohl M, Hong H, Kircik L, Pariser D, Strober B, Krueger G, Krupa D, Burnett P, Berk D, Higham R. 42828 Efficacy and safety of roflumilast cream 0.3% in patients with chronic plaque psoriasis: pooled PASI and PASI-HD results from the DERMIS-1 and DERMIS-2 Phase 3 Trials. Journal Of The American Academy Of Dermatology 2023, 89: ab156. DOI: 10.1016/j.jaad.2023.07.625.Peer-Reviewed Original Research
2019
Tofacitinib benefit‐risk profile in chronic plaque psoriasis
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. Tofacitinib benefit‐risk profile in chronic plaque psoriasis. British Journal Of Dermatology 2019, 180: e19-e19. DOI: 10.1111/bjd.17373.Peer-Reviewed Original ResearchBiologic treatmentSevere psoriasisPlaque psoriasisHigh doseChronic plaque psoriasisHerpes zoster infectionSevere plaque psoriasisAcceptable safety profileBenefit-risk profileNew oral drugsZoster infectionPatient yearsTofacitinib treatmentUlcerative colitisPatients' qualityRheumatoid arthritisSafety profileAppearance of skinClinical trialsOral drugsEffective treatmentSide effectsPsoriasisPatientsDrugs
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 variabilitySafety of Certolizumab Pegol in Chronic Plaque Psoriasis: Cumulative Data Over 48 Weeks' Exposure from Phase 3, Multicenter, Randomized, Placebo-Controlled Studies
Blauvelt A, Strober B, Langley R, Burge D, Pisenti L, Yassine M, Kavanagh S, Arendt C, Rolleri R, Reich K. Safety of Certolizumab Pegol in Chronic Plaque Psoriasis: Cumulative Data Over 48 Weeks' Exposure from Phase 3, Multicenter, Randomized, Placebo-Controlled Studies. SKIN The Journal Of Cutaneous Medicine 2018, 2: s16. DOI: 10.25251/skin.2.supp.16.Peer-Reviewed Original Research
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
2014
Changes in C‐reactive protein in patients with moderate‐to‐severe psoriasis switched to adalimumab therapy after suboptimal response to etanercept, methotrexate or phototherapy
Strober B, Poulin Y, Teller C, Wang Y, Williams D, Goldblum O. Changes in C‐reactive protein in patients with moderate‐to‐severe psoriasis switched to adalimumab therapy after suboptimal response to etanercept, methotrexate or phototherapy. Journal Of The European Academy Of Dermatology And Venereology 2014, 28: 1701-1706. PMID: 24422992, DOI: 10.1111/jdv.12372.Peer-Reviewed Original ResearchConceptsC-reactive proteinPrevious therapySuboptimal responseCRP reductionClinical responseAssociation of CRPNarrow-band ultraviolet B phototherapyBaseline C-reactive proteinC-reactive protein levelsInflammatory biomarker C-reactive proteinChronic plaque psoriasisUltraviolet B phototherapyBiomarkers C-reactive proteinAdalimumab therapyAdalimumab treatmentPlaque psoriasisSevere psoriasisB phototherapyBaseline characteristicsFinal visitObese patientsPsoriasis AreaPsoriatic arthritisNormal weightCRP decrease
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 countItem-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary
Strober B, Nyirady J, Mallya U, Guettner A, Papavassilis C, Gottlieb A, Elewski B, Turner-Bowker D, Shields A, Gwaltney C, Lebwohl M. Item-Level Psychometric Properties for a New Patient-Reported Psoriasis Symptom Diary. Value In Health 2013, 16: 1014-1022. PMID: 24041351, DOI: 10.1016/j.jval.2013.07.002.Peer-Reviewed Original ResearchConceptsSymptom diaryClinical trialsSevere chronic plaque-type psoriasisChronic plaque-type psoriasisGlobal assessmentDermatology Life Quality IndexPhase 2 clinical trialChronic plaque psoriasisInvestigator's Global AssessmentPatient Global ImpressionPlaque-type psoriasisFuture clinical trialsLife Quality IndexPsychometric propertiesPlaque psoriasisPsoriasis AreaWeek 12Global ImpressionResponder definitionAdult outpatientsNew patientsItem-level psychometric propertiesStudy weekDiary assessmentsDiary itemsDose 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 efficacyThe Psoriasis Symptom Diary: development and content validity of a novel patient‐reported outcome instrument
Lebwohl M, Swensen A, Nyirady J, Kim E, Gwaltney C, Strober B. The Psoriasis Symptom Diary: development and content validity of a novel patient‐reported outcome instrument. International Journal Of Dermatology 2013, 53: 714-722. PMID: 23557000, DOI: 10.1111/j.1365-4632.2012.05798.x.Peer-Reviewed Original ResearchMeSH KeywordsAdaptation, PhysiologicalAdaptation, PsychologicalAdolescentAdultAge FactorsAgedCohort StudiesFemaleHumansMaleMiddle AgedObserver VariationPsoriasisPsychometricsQuality of LifeSelf ReportSeverity of Illness IndexSex FactorsSickness Impact ProfileSurveys and QuestionnairesTreatment OutcomeYoung AdultConceptsSymptom diaryPatient experienceNovel patient-reported outcome instrumentContent validityPatient-reported outcome instrumentsPsoriasis-related symptomsQuantitative psychometric testingChronic plaque psoriasisImpact of symptomsQualitative patient interviewsVariety of symptomsPatient's daily lifeNew PRO instrumentAppearance of plaquesPlaque psoriasisEfficacy endpointPsoriasis treatmentPatient interviewsClinical trialsNew patientsPatient understandingOutcome instrumentsImportant symptomKey patient experiencesPRO instruments
2012
Sleep quality and other patient‐reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open‐label Phase IIIB trial
Strober B, Sobell J, Duffin K, Bao Y, Guérin A, Yang H, Goldblum O, Okun M, Mulani P. Sleep quality and other patient‐reported outcomes improve after patients with psoriasis with suboptimal response to other systemic therapies are switched to adalimumab: results from PROGRESS, an open‐label Phase IIIB trial. British Journal Of Dermatology 2012, 167: 1374-1381. PMID: 22897348, DOI: 10.1111/bjd.12000.Peer-Reviewed Original ResearchConceptsPatient-reported outcomesDermatology Life Quality IndexHealth-related qualitySleep impairmentSleep qualityAdalimumab treatmentSuboptimal responseWork productivitySleep measuresMedical Outcomes Study Sleep ScalePoor health-related qualityGlobal assessmentPhase IIIb trialChronic plaque psoriasisPhysician global assessmentEffect of adalimumabDisease-related painVisual analog scaleLife Quality IndexIIIb trialPrior therapyPsoriasis signsPlaque psoriasisPresence of PSAPsoriasis AreaEfficacy 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 lipoproteinPsoriasis and Down syndrome: a report of three cases and a potential pathophysiologic link.
Marmon S, De Souza A, Strober B. Psoriasis and Down syndrome: a report of three cases and a potential pathophysiologic link. Dermatology Online Journal 2012, 18: 13. PMID: 22747937, DOI: 10.5070/d305m5f4bx.Peer-Reviewed Original ResearchConceptsDown syndromeSerum levelsIFN-gammaChronic plaque psoriasisPotential pathophysiologic linksHigher serum levelsCases of patientsProduction of cytokinesTumor necrosis factorTh1 lineage cellsPathophysiologic linkPlaque psoriasisTh17 cellsTh17 pathwayPatient populationIL-2Healthy controlsNecrosis factorGreater prevalencePsoriasisSyndromeIFN systemPatientsLineage cellsCells
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 treatmentAssociation Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials
Ryan C, Leonardi C, Krueger J, Kimball A, Strober B, Gordon K, Langley R, de Lemos J, Daoud Y, Blankenship D, Kazi S, Kaplan D, Friedewald V, Menter A. Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events: A Meta-analysis of Randomized Controlled Trials. JAMA 2011, 306: 864-871. PMID: 21862748, DOI: 10.1001/jama.2011.1211.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCardiovascular DiseasesDouble-Blind MethodEtanerceptHumansImmunoglobulin GImmunologic FactorsInfliximabInterleukin-12Interleukin-23Middle AgedMyocardial InfarctionPlacebosPsoriasisRandomized Controlled Trials as TopicReceptors, Tumor Necrosis FactorRiskStrokeTumor Necrosis Factor-alphaUstekinumabYoung AdultConceptsMajor adverse cardiovascular eventsChronic plaque psoriasisAnti-IL-12/23 agentsPlacebo-controlled phaseΑ agentsCardiovascular eventsPlaque psoriasisBiologic therapyControlled TrialsAnti-tumor necrosis factor α agentsRate of MACEAnti-IL-12/ILMantel-Haenszel fixed-effect methodAnti-IL-12/23 therapyAdverse cardiovascular eventsCochrane Central RegisterComposite end pointAbsolute risk differencePrimary outcome measureRandomized Controlled TrialsSignificant differencesCardiovascular deathMonotherapy studiesΑ treatmentCentral RegisterEfficacy 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 AreaSwitching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study
Strober B, Poulin Y, Kerdel F, Langley R, Gu Y, Gupta S, Okun M, Papp K. Switching to adalimumab for psoriasis patients with a suboptimal response to etanercept, methotrexate, or phototherapy: Efficacy and safety results from an open-label study. Journal Of The American Academy Of Dermatology 2011, 64: 671-681. PMID: 21414495, DOI: 10.1016/j.jaad.2010.03.009.Peer-Reviewed Original ResearchConceptsPhysician global assessmentSuboptimal responseSuboptimal therapyWeek 16Global assessmentPhase IIIb trialChronic plaque psoriasisOpen-label designOpen-label studyPrimary end pointPercentage of patientsNB-UVB phototherapySeverity Index scorePsoriasis clinical trialsTreatment of psoriasisDosage taperingIIIb trialPrior therapyPlaque psoriasisPsoriasis AreaPsoriasis flarePsoriasis patientsSafety profilePatient enrollmentClinical trials