2023
Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial
Strober B, Paul C, Blauvelt A, Thaçi D, Puig L, Lebwohl M, White K, Vanvoorden V, Deherder D, Gomez N, Eyerich K. Bimekizumab efficacy and safety in patients with moderate to severe plaque psoriasis: Two-year interim results from the open-label extension of the randomized BE RADIANT phase 3b trial. Journal Of The American Academy Of Dermatology 2023, 89: 486-495. PMID: 37182701, DOI: 10.1016/j.jaad.2023.04.063.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalCOVID-19Double-Blind MethodHumansPandemicsPsoriasisSeverity of Illness IndexTreatment OutcomeConceptsOpen-label extensionPASI 100 responseSevere plaque psoriasisWeek 96Plaque psoriasisWeek 48Common adverse eventsComplete skin clearanceDouble-blinded periodPhase 3b trialUrinary tract infectionTreatment of psoriasisMonoclonal IgG1 antibodySecukinumab patientsSkin clearanceAdverse eventsTract infectionsMore patientsSafety profilePhase 3bBimekizumabOral candidiasisSafety dataPatientsIgG1 antibodiesBimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial
Strober B, Tada Y, Mrowietz U, Lebwohl M, Foley P, Langley R, Warren R, Wang M, Vanvoorden V, Szilagyi B, Ciaravino V, Paul C. Bimekizumab maintenance of response through 3 years in patients with moderate-to-severe plaque psoriasis: results from the BE BRIGHT open-label extension trial. British Journal Of Dermatology 2023, 188: 749-759. PMID: 36967713, DOI: 10.1093/bjd/ljad035.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalDouble-Blind MethodHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeConceptsOngoing open-label extensionSevere plaque psoriasisBody surface areaDermatology Life Quality IndexWeek 16Plaque psoriasisNonresponder imputationPASI 100Investigator's Global Assessment 0/1Open-label extension trialDLQI 0/1 responsePASI 90 respondersOpen-label extensionHealth-related qualityLong-term efficacyLife Quality IndexLong-term treatmentLoss of responseYear 3Absolute PASIPASI 90Efficacy outcomesClinical responsePsoriasis AreaExtension trial
2022
Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials
Kokolakis G, Warren R, Strober B, Blauvelt A, Puig L, Morita A, Gooderham M, Körber A, Vanvoorden V, Wang M, de Cuyper D, Madden C, Gomez N, Lebwohl M. Bimekizumab efficacy and safety in patients with moderate-to-severe plaque psoriasis who switched from adalimumab, ustekinumab or secukinumab: results from phase III/IIIb trials. British Journal Of Dermatology 2022, 188: 330-340. PMID: 36751950, DOI: 10.1093/bjd/ljac089.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAntibodies, MonoclonalBiological ProductsHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsExposure-adjusted incidence ratesTreatment-emergent adverse eventsAdverse eventsDurable improvementMajority of TEAEsDiscontinuation of biologicsNew safety findingsPASI 90 respondersSevere plaque psoriasisHealth-related qualityBody surface areaTime of switchAbsolute PASIIIIb trialPASI 100PASI 90Skin clearancePlaque psoriasisWeek 48Clinical responseEfficacy outcomesPsoriasis AreaSafety findingsWeek 24Week 52Long‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis
Gooderham M, Pinter A, Ferris L, Warren R, Zhan T, Zeng J, Soliman A, Kaufmann C, Kaplan B, Photowala H, Strober B. Long‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2022, 36: 855-865. PMID: 35174556, PMCID: PMC9314097, DOI: 10.1111/jdv.18010.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsDermatology Life Quality IndexSevere plaque psoriasisHealth-related qualityRisankizumab treatmentPlaque psoriasisAbsolute PASIDLQI 0/1Psoriasis AreaDLQI scoreAbsolute PASI scoreAbsolute Psoriasis AreaUstekinumab-treated patientsMean DLQI scoreSeverity Index (PASI) improvementLife Quality IndexHigh ratePASI levelsPatients' HRQoL.PASI scoreMedian timeDurable efficacyPat ientsRisankizumabPASIPatients
2020
Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies
Strober B, Menter A, Leonardi C, Gordon K, Lambert J, Puig L, Photowala H, Longcore M, Zhan T, Foley P. Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies. Journal Of The European Academy Of Dermatology And Venereology 2020, 34: 2830-2838. PMID: 32320088, PMCID: PMC7818271, DOI: 10.1111/jdv.16521.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalBiological TherapyDemographyDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsPrior biologic exposureSevere plaque psoriasisBaseline patient demographicsEfficacy of risankizumabPhase 3 trialDisease characteristicsWeek 16Logistic regression analysisPlaque psoriasisPatient demographicsBiologic exposureSuperior efficacyPlacebo-controlled phase 3 trialHumanized IgG monoclonal antibodyPrior biologic therapyProportion of patientsBody mass indexRegression analysisBaseline characteristicsBaseline demographicsBiologic therapyPsoriasis AreaWeek 52Patient characteristicsIgG monoclonal antibodies
2019
Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry
Van Voorhees A, Mason M, Harrold L, Guo N, Guana A, Tian H, Herrera V, Strober B. Characterization of insufficient responders to anti-tumor necrosis factor therapies in patients with moderate to severe psoriasis: real-world data from the US Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2019, 32: 302-309. PMID: 31581919, DOI: 10.1080/09546634.2019.1656797.Peer-Reviewed Original ResearchConceptsAnti-tumor necrosis factor therapyCorrona Psoriasis RegistryNecrosis factor therapySevere psoriasisPsoriasis RegistryBiologic therapyFactor therapyAnti-TNF initiatorsEnrollment of patientsUnmet treatment needLogistic regression modelingReal-world studyPatient demographicsInsufficient respondersShort followDisease characteristicsFemale sexTreatment needsInsufficient responsePatientsUnmet needPsoriasisDecreased likelihoodTherapySmall sample sizeJoint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics
Menter A, Strober BE, Kaplan DH, Kivelevitch D, Prater EF, Stoff B, Armstrong AW, Connor C, Cordoro KM, Davis DMR, Elewski BE, Gelfand JM, Gordon KB, Gottlieb AB, Kavanaugh A, Kiselica M, Korman NJ, Kroshinsky D, Lebwohl M, Leonardi CL, Lichten J, Lim HW, Mehta NN, Paller AS, Parra SL, Pathy AL, Rupani RN, Siegel M, Wong EB, Wu JJ, Hariharan V, Elmets CA. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal Of The American Academy Of Dermatology 2019, 80: 1029-1072. PMID: 30772098, DOI: 10.1016/j.jaad.2018.11.057.Peer-Reviewed Original ResearchConceptsTreatment of psoriasisAAD-NPF GuidelinesInflammatory multisystem diseaseImportant clinical questionsBiologic agentsPsoriasis managementMultisystem diseaseTreatment recommendationsClinical questionsUS populationPsoriasisAvailable evidenceCareTreatmentGuidelinesPatientsDermatologistsDiseaseBiologicsUstekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Safety 2019, 42: 751-768. PMID: 30739254, PMCID: PMC6520311, DOI: 10.1007/s40264-019-00797-3.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalArthritis, PsoriaticCrohn DiseaseFemaleHumansMaleMethotrexateMiddle AgedPsoriasisSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsPlacebo-treated patientsPsoriatic arthritisRegistrational trialsCrohn's diseaseMajor adverse cardiovascular eventsUstekinumab-treated patientsAdverse cardiovascular eventsSevere plaque psoriasisConsistent safety profileSevere Crohn's diseaseActive psoriatic arthritisClinical development programUstekinumab doseCardiovascular eventsPlaque psoriasisBiologic agentsPsoriatic patientsInduction doseSafety profileIncidence rateSafety dataPatientsDiseaseSafety eventsWeeks
2018
Secukinumab in pregnancy: outcomes in psoriasis, psoriatic arthritis and ankylosing spondylitis from the global safety database
Warren R, Reich K, Langley R, Strober B, Gladman D, Deodhar A, Bachhuber T, Bao W, Altemeyer E, Hussain S, Safi J. Secukinumab in pregnancy: outcomes in psoriasis, psoriatic arthritis and ankylosing spondylitis from the global safety database. British Journal Of Dermatology 2018, 179: 1205-1207. PMID: 29927479, DOI: 10.1111/bjd.16901.Peer-Reviewed Original ResearchEfficacy 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 patients
2017
No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis
Strober B, Langley R, Menter A, Magid M, Porter B, Fox T, Safi J, Papavassilis C. No elevated risk for depression, anxiety or suicidality with secukinumab in a pooled analysis of data from 10 clinical studies in moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 178: e105-e107. PMID: 28991372, DOI: 10.1111/bjd.16051.Peer-Reviewed Original ResearchMeasurement 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 resultsClearanceSecukinumab 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
Anti-interleukin-17 treatment of psoriasis
Jinna S, Strober B. Anti-interleukin-17 treatment of psoriasis. Journal Of Dermatological Treatment 2016, 27: 311-315. PMID: 26943806, DOI: 10.3109/09546634.2015.1115816.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClinical Trials, Phase III as TopicHumansInterleukin-17PsoriasisConceptsTreatment of psoriasisPlaque psoriasisTumor necrosis factor alphaIL-17 inhibitorsPhase 3 trialIL-17 receptor subunitNecrosis factor alphaEffective therapeutic targetIL-17Cytokine antagonistsInflammatory dermatosesIL-17RAFactor alphaSafety resultsTherapeutic targetPsoriasisFavorable responseUS populationReceptor subunitsMonoclonal antibodiesDependent pathwayTreatmentTrialsAntibodiesEfficacySecukinumab 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 differenceInterleukin‐23 inhibition for the treatment of psoriasis: the next frontier for high‐efficacy biologic therapy
Strober B. Interleukin‐23 inhibition for the treatment of psoriasis: the next frontier for high‐efficacy biologic therapy. British Journal Of Dermatology 2015, 173: 887-888. PMID: 26511822, DOI: 10.1111/bjd.14095.Peer-Reviewed Original ResearchPhase 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 ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexConceptsSevere 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