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 difference
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 itemsThe 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