2023
Abrocitinib effect on patient‐reported outcomes in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study
Reich K, Silverberg J, Papp K, Deleuran M, Katoh N, Strober B, Beck L, de Bruin‐Weller M, Werfel T, Zhang F, Biswas P, DiBonaventura M, Chan G, Farooqui S, Kerkmann U, Clibborn C. Abrocitinib effect on patient‐reported outcomes in patients with moderate‐to‐severe atopic dermatitis: Results from phase 3 studies, including the long‐term extension JADE EXTEND study. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: 2047-2055. PMID: 37319109, DOI: 10.1111/jdv.19254.Peer-Reviewed Original ResearchConceptsSevere atopic dermatitisPatient-reported outcomesAbrocitinib 200Phase 3 studyAtopic dermatitisWeek 48POEM scoresDermatology Life Quality Index scoresLong-term extension studyLife Quality Index scoresEczema Measure scoreManageable safety profilePatient-reported endpointsMean DLQI scorePatient-reported symptomsProportion of patientsPatient-reported responsesFull treatment periodPhase 3Quality Index scoresDLQI 0/1DLQI scoreWeek 12AD trialsSafety profile
2022
Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial
Thaçi D, Strober B, Gordon K, Foley P, Gooderham M, Morita A, Papp K, Puig L, Menter M, Colombo M, Elbez Y, Kisa R, Ye J, Napoli A, Wei L, Banerjee S, Merola J, Gottlieb A. Deucravacitinib in Moderate to Severe Psoriasis: Clinical and Quality-of-Life Outcomes in a Phase 2 Trial. Dermatology And Therapy 2022, 12: 495-510. PMID: 35025062, PMCID: PMC8850503, DOI: 10.1007/s13555-021-00649-y.Peer-Reviewed Original ResearchDermatology Life Quality IndexSevere plaque psoriasisPhase 2 trialPlaque psoriasisStatic Physician's Global AssessmentBody surface area involvementGlobal assessmentPhase 2 clinical trialLife outcomesComplete skin clearanceMethodsPost-hoc analysisPhysician global assessmentSurface area involvementNew oral therapiesLife Quality IndexMost efficacy measuresPromising new oral therapyGreater improvementSkin clearanceSevere psoriasisOral therapyPsoriasis AreaInvestigator assessmentClinical outcomesWeek 12
2021
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis
Lebwohl M, Stein Gold L, Strober B, Papp K, Armstrong A, Bagel J, Kircik L, Ehst B, Hong H, Soung J, Fromowitz J, Guenthner S, Piscitelli S, Rubenstein D, Brown P, Tallman A, Bissonnette R. Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. New England Journal Of Medicine 2021, 385: 2219-2229. PMID: 34879448, DOI: 10.1056/nejmoa2103629.Peer-Reviewed Original ResearchConceptsPrimary end pointPatient-reported outcomesTapinarof creamGlobal assessment scoreBody surface areaPlaque psoriasisWeek 12End pointPGA responseAdverse eventsPGA scoreMean changeSkin barrier protein filaggrinSecondary efficacy end pointsUpper respiratory tract infectionPhysician Global Assessment scoreNumeric rating scale scoreTotal body surface areaTotal scoreEfficacy end pointIdentical phase 3Local adverse eventsSymptom diary scoresProportion of patientsSecondary end points
2017
Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis
Viswanathan H, Mutebi A, Milmont C, Gordon K, Wilson H, Zhang H, Klekotka P, Revicki D, Augustin M, Kricorian G, Nirula A, Strober B. Measurement Properties of the Psoriasis Symptom Inventory Electronic Daily Diary in Patients with Moderate to Severe Plaque Psoriasis. Value In Health 2017, 20: 1174-1179. PMID: 28964451, DOI: 10.1016/j.jval.2016.11.020.Peer-Reviewed Original ResearchConceptsStatic Physician's Global AssessmentDermatology Life Quality IndexPsoriasis Symptom InventorySevere plaque psoriasisBody surface areaPsoriasis signsPlaque psoriasisPsoriasis-affected body surface areaForm Health Survey version 2Global assessmentPatient-reported outcome instrumentsPhysician global assessmentLife Quality IndexMeasurement propertiesElectronic daily diaryPSI total scoreDLQI responsesPASI responsePsoriasis AreaBodily painWeek 12Clinical trialsWeek 8Outcome measuresOutcome instrumentsPsoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab
Elewski B, Puig L, Mordin M, Gilloteau I, Sherif B, Fox T, Gnanasakthy A, Papavassilis C, Strober B. Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab. Journal Of Dermatological Treatment 2017, 28: 492-499. PMID: 28266243, DOI: 10.1080/09546634.2017.1294727.Peer-Reviewed Original ResearchConceptsQuality of lifeSeverity Index (PASI) 90 responseDLQI 0/1 responsePASI 75Skin clearancePASI 90Psoriasis AreaDermatology Life Quality Index responseGreater health-related qualityPatients' QOLGreater skin clearancePhase 3 studyHealth-related qualityNew biological therapiesRelevant therapeutic goalSevere psoriasisWeek 52Psoriasis patientsBiological therapyWeek 12Therapeutic goalsTrial dataSustained levelsIgA resultsClearanceGreater Efficacy with Secukinumab Treatment is Associated with Greater Psoriasis Symptom Relief: Results from Secukinumab Clinical Trial Data
Gottlieb A, Strober B, Lebwohl M, Kaufmann R, Pariser D, Narbutas R, Nyirady J, Zhao Y, Herrera V, McLeod L, Odom D, Elewski B. Greater Efficacy with Secukinumab Treatment is Associated with Greater Psoriasis Symptom Relief: Results from Secukinumab Clinical Trial Data. Journal Of Psoriasis And Psoriatic Arthritis 2017, 2: 73-80. DOI: 10.1177/247553031700200206.Peer-Reviewed Original ResearchPsoriasis-related itchingWeek 12Disease severityBenefits of secukinumabInterleukin-17A antagonistSevere plaque psoriasisPatient-reported symptomsClinical trial dataDisease severity scoreQuality of lifeTraditional clinical measuresBackground PsoriasisPASI responseSecukinumab treatmentPlaque psoriasisComplete reliefSymptom reliefSeverity scoreClinical dataResponder statusClinical measuresGreater efficacyTrial dataSecukinumabTreatment effectsSecukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept
Strober B, Gottlieb A, Sherif B, Mollon P, Gilloteau I, McLeod L, Fox T, Mordin M, Gnanasakthy A, Papavassilis C, Lebwohl M. Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept. Journal Of The American Academy Of Dermatology 2017, 76: 655-661. PMID: 28087133, DOI: 10.1016/j.jaad.2016.11.043.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDermatologic AgentsDouble-Blind MethodEtanerceptFemaleHumansImmunosuppressive AgentsInjections, SubcutaneousInterleukin-17MaleMiddle AgedPatient SatisfactionPsoriasisQuality of LifeRecurrenceSurveys and QuestionnairesTreatment OutcomeTumor Necrosis Factor-alphaConceptsDermatology Life Quality IndexWeek 24Secukinumab treatmentWeek 52Phase III randomized placebo-controlled clinical trialsRandomized placebo-controlled clinical trialPatient-reported health-related qualityPlacebo-controlled clinical trialGreater sustained improvementsGreater clinical responseHealth-related qualityLife Quality IndexProportion of subjectsQuality of lifeSevere psoriasisClinical responsePlacebo comparisonPsoriasis AreaMedian timePatients' qualityWeek 12Chronic conditionsOutcome benefitsSafe treatmentClinical trials
2016
Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials
Strober B, Sigurgeirsson B, Popp G, Sinclair R, Krell J, Stonkus S, Septe M, Elewski BE, Gottlieb AB, Zhao Y, Tran MH, Karpov A, McLeod LD, Mordin M, Papavassilis C, Nyirady J, Lebwohl M. Secukinumab improves patient‐reported psoriasis symptoms of itching, pain, and scaling: results of two phase 3, randomized, placebo‐controlled clinical trials. International Journal Of Dermatology 2016, 55: 401-407. PMID: 26866518, DOI: 10.1111/ijd.13236.Peer-Reviewed Original ResearchConceptsWeek 12Multicenter phase 3 studyPlacebo-controlled clinical trialInterleukin-17A antagonistPsoriasis-related itchingPlacebo treatment groupsSevere plaque psoriasisPhase 3 studyWeeks of treatmentProportion of subjectsPlaque psoriasisSevere psoriasisPsoriasis symptomsSystemic therapySymptom diaryClinical trialsSecukinumabTreatment responsePlaceboItchingPainTreatment groupsPhase 3PsoriasisAdults
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 differencePhase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis
Lebwohl M, Strober B, Menter A, Gordon K, Weglowska J, Puig L, Papp K, Spelman L, Toth D, Kerdel F, Armstrong AW, Stingl G, Kimball AB, Bachelez H, Wu JJ, Crowley J, Langley RG, Blicharski T, Paul C, Lacour JP, Tyring S, Kircik L, Chimenti S, Callis Duffin K, Bagel J, Koo J, Aras G, Li J, Song W, Milmont CE, Shi Y, Erondu N, Klekotka P, Kotzin B, Nirula A. Phase 3 Studies Comparing Brodalumab with Ustekinumab in Psoriasis. New England Journal Of Medicine 2015, 373: 1318-1328. PMID: 26422722, DOI: 10.1056/nejmoa1503824.Peer-Reviewed Original ResearchConceptsPASI 100 response ratesGlobal assessment scoreWeek 12Response rateSevere psoriasisStatic Physician's Global Assessment scorePASI 75 response ratesPhysician Global Assessment scoreRates of neutropeniaSerious infectious episodesPhase 3 studySignificant clinical improvementSeverity Index scoreTreatment of psoriasisEarly clinical studiesAMAGINE-2Brodalumab treatmentSPGA scoreInfectious episodesWeek 52Clinical improvementMaintenance dosePASI scorePsoriasis AreaBrodalumab
2014
Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis
Papp K, Menter A, Strober B, Kricorian G, Thompson E, Milmont C, Nirula A, Klekotka P. Efficacy and safety of brodalumab in subpopulations of patients with difficult-to-treat moderate-to-severe plaque psoriasis. Journal Of The American Academy Of Dermatology 2014, 72: 436-439.e1. PMID: 25553889, DOI: 10.1016/j.jaad.2014.10.026.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBiologic useHistory of PsAPlaque psoriasisDermatology Life Quality Index responseStatic Physician's Global Assessment scorePhysician Global Assessment scoreSafety of brodalumabPlacebo-controlled studySubgroup of patientsSeverity Index scoreSubpopulation of patientsGlobal assessment scoreSelf-reported historyPrior biologicsTreat populationPsoriasis AreaPsoriatic arthritisWeek 12Subset analysisNovel therapiesBrodalumabLife measuresPatientsPsoriasis
2013
Item-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 items
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 lipoproteinA randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis
Gottlieb A, Langley R, Strober B, Papp K, Klekotka P, Creamer K, Thompson E, Hooper M, Kricorian G. A randomized, double‐blind, placebo‐controlled study to evaluate the addition of methotrexate to etanercept in patients with moderate to severe plaque psoriasis. British Journal Of Dermatology 2012, 167: 649-657. PMID: 22533447, PMCID: PMC3504074, DOI: 10.1111/j.1365-2133.2012.11015.x.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisCombination therapyAdverse eventsWeek 24Etanercept monotherapyMonotherapy groupPlaque psoriasisWeek 12Necrosis factor inhibitor therapyStatic Physician's Global AssessmentGlobal assessmentMethotrexate combination therapyPhysician global assessmentPlacebo-controlled studySerious adverse eventsCombination therapy groupProportion of patientsAddition of methotrexatePASI 50PASI 75PASI 90Primary endpointSevere psoriasisAcceptable tolerabilityPsoriasis Area
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance 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
2010
Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis
Griffiths C, Strober B, van de Kerkhof P, Ho V, Fidelus-Gort R, Yeilding N, Guzzo C, Xia Y, Zhou B, Li S, Dooley L, Goldstein N, Menter A. Comparison of Ustekinumab and Etanercept for Moderate-to-Severe Psoriasis. New England Journal Of Medicine 2010, 362: 118-128. PMID: 20071701, DOI: 10.1056/nejmoa0810652.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedEtanerceptFemaleHumansImmunoglobulin GImmunologic FactorsImmunosuppressive AgentsInterleukin-12Interleukin-23MaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorSeverity of Illness IndexTumor Necrosis Factor-alphaUstekinumabConceptsHigh-dose etanerceptPhysician global assessmentWeek 12Global assessmentSevere psoriasisAdverse eventsBiologic agentsMinimal diseaseRelative benefit-risk profilesEnd pointMore adverse eventsPrimary end pointSecondary end pointsProportion of patientsSerious adverse eventsTreatment of psoriasisBenefit-risk profileNew therapeutic optionsPsoriasis AreaTherapeutic optionsSuch therapySubcutaneous injectionUstekinumabEtanerceptPatients
2006
Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris: A Multicenter, Double-blind, Randomized, Parallel-Group Study
Leyden J, Thiboutot D, Shalita A, Webster G, Washenik K, Strober B, Shupack J. Comparison of Tazarotene and Minocycline Maintenance Therapies in Acne Vulgaris: A Multicenter, Double-blind, Randomized, Parallel-Group Study. JAMA Dermatology 2006, 142: 605-612. PMID: 16702498, DOI: 10.1001/archderm.142.5.605.Peer-Reviewed Original ResearchConceptsGreater global improvementMaintenance therapyTazarotene gelGlobal improvementLesion countsAcne vulgarisOpen-label treatment phaseParallel-group studyInflammatory lesion countSevere acne vulgarisOverall disease severityPlacebo capsulesMaintenance regimensReferral centerWeek 24Severe acneVehicle gelAmbulatory patientsWeek 12Minocycline therapyAntibiotic exposureMean reductionTreatment phasePatientsGreater efficacy