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 ResearchConceptsExposure-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 52Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders
Strober B, Armstrong A, Rubant S, Patel M, Wu T, Photowala H, Crowley J. Switching to risankizumab from ustekinumab or adalimumab in plaque psoriasis patients improves PASI and DLQI outcomes for sub-optimal responders. Journal Of Dermatological Treatment 2022, 33: 2991-2996. PMID: 35839335, DOI: 10.1080/09546634.2022.2095328.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabHumansPsoriasisQuality of LifeSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsPsoriasis Area Severity IndexPASI 75Plaque psoriasis patientsSevere plaque psoriasisSub-optimal respondersPost Hoc AnalysisSignificant safety eventsPASI 50Plaque psoriasisBiologic therapyPASI scorePsoriasis patientsWashout periodIncomplete responsePatientsSafety eventsSeverity IndexPsoriasisDosesSuboptimal resultsSignificant safety riskDLQIAdalimumabPartial successLong‐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
2021
Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR
Bissonnette R, Gottlieb A, Langley R, Leonardi C, Papp K, Pariser D, Uy J, Lafferty K, Langholff W, Fakharzadeh S, Berlin J, Brouwer E, Greenspan A, Strober B. Signal Detection and Methodological Limitations in a Real-World Registry: Learnings from the Evaluation of Long-Term Safety Analyses in PSOLAR. Drug Safety 2021, 44: 699-709. PMID: 34075572, PMCID: PMC8184557, DOI: 10.1007/s40264-021-01065-z.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabBiological ProductsHumansInfliximabObservational Studies as TopicPsoriasisRegistriesUstekinumabConceptsMajor adverse cardiovascular eventsHazard ratioIncident usersObservational studyCox model regression analysisAdjusted hazard ratioAdverse cardiovascular eventsReal-world registryInternational observational studyLong-term observational studyDisease-based registryRelevant clinical dataMACE riskUstekinumab exposureCardiovascular eventsPatient characteristicsPsoriasis patientsTreatment cohortsMethodological limitationsComparator groupSafety registryClinical dataRegistry dataModel regression analysisConclusionOur results
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 ResearchConceptsPrior 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 antibodiesComparative Effectiveness Studies for Psoriasis—The Methods Matter
Strober B, Gordon K. Comparative Effectiveness Studies for Psoriasis—The Methods Matter. JAMA Dermatology 2020, 156: 253-255. PMID: 32022830, DOI: 10.1001/jamadermatol.2019.4025.Peer-Reviewed Original ResearchCharacterization of insufficient responders to ustekinumab in patients with moderate-to-severe psoriasis in 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 ustekinumab in patients with moderate-to-severe psoriasis in the US Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2020, 32: 907-915. PMID: 32027197, DOI: 10.1080/09546634.2020.1720586.Peer-Reviewed Original ResearchMeSH KeywordsBiological TherapyHumansPsoriasisRegistriesSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsCorrona Psoriasis RegistrySevere psoriasisPsoriasis RegistryInsufficient respondersPsoriasis body surface areaBody surface areaLogistic regression modelingReal-world studyBiologic therapyPatient demographicsUS patientsBiologic treatmentDisease characteristicsInadequate responseInsufficient responsePatientsPsoriasisDecreased likelihoodRespondersRegistryVisitsRegression modelingEnrollmentFollowOutcomes
2019
Joint 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 ResearchConceptsPlacebo-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
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
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
2016
Treatment of Moderate to Severe Pediatric Psoriasis: A Retrospective Case Series
Klufas D, Wald J, Strober B. Treatment of Moderate to Severe Pediatric Psoriasis: A Retrospective Case Series. Pediatric Dermatology 2016, 33: 142-149. PMID: 26871417, DOI: 10.1111/pde.12782.Peer-Reviewed Original ResearchConceptsSevere pediatric psoriasisRetrospective case seriesPediatric psoriasisCase seriesSevere psoriasisSystemic therapySide effectsDisease responseSimilar side effect profilePhysician Global Assessment scaleComprehensive safety profileSmall sample sizeSingle referral centerSubjective side effectsSide effect profileSafety of treatmentMultiple treatment optionsAdverse event occurrenceComparison of efficacyGlobal Assessment ScalePaucity of dataAdult psoriasisImmunomodulating therapiesAdverse eventsReferral centerComparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR])
Strober B, Bissonnette R, Fiorentino D, Kimball A, Naldi L, Shear N, Goyal K, Fakharzadeh S, Calabro S, Langholff W, You Y, Galindo C, Lee S, Lebwohl M. Comparative effectiveness of biologic agents for the treatment of psoriasis in a real-world setting: Results from a large, prospective, observational study (Psoriasis Longitudinal Assessment and Registry [PSOLAR]). Journal Of The American Academy Of Dermatology 2016, 74: 851-861.e4. PMID: 26853180, DOI: 10.1016/j.jaad.2015.12.017.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdultBiological ProductsConfidence IntervalsDose-Response Relationship, DrugDrug Administration ScheduleEtanerceptFemaleFollow-Up StudiesGlobal HealthHumansInfliximabLongitudinal StudiesMaleMiddle AgedOdds RatioPatient SatisfactionProspective StudiesPsoriasisQuality of LifeRegistriesSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsPhysician Global Assessment scoreGlobal assessment scoreBody surface areaReal-world settingAssessment scoresPsoriasis Longitudinal AssessmentProportion of patientsTreatment of psoriasisEffectiveness of biologicsTreatment selection biasTumor necrosis factorBiologic agentsEfficacy dataTherapeutic responseTumor necrosisNecrosis factorObservational studyTreatment decisionsAnalysis of covarianceEtanerceptComparative effectivenessAdalimumabInfliximabLongitudinal assessmentLogistic regression
2015
Phase 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 AreaBrodalumabThe Use of Methotrexate, Alone or in Combination With Other Therapies, for the Treatment of Palmoplantar Psoriasis.
Wald J, Klufas D, Strober B. The Use of Methotrexate, Alone or in Combination With Other Therapies, for the Treatment of Palmoplantar Psoriasis. Journal Of Drugs In Dermatology 2015, 14: 888-92. PMID: 26267735.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabAdolescentAdultAgedAged, 80 and overAnti-Inflammatory Agents, Non-SteroidalCyclosporineDermatologic AgentsDrug Therapy, CombinationEtanerceptFemaleFoot DermatosesHand DermatosesHumansImmunosuppressive AgentsInfliximabMaleMethotrexateMiddle AgedMycophenolic AcidPsoriasisSeverity of Illness IndexThalidomideUstekinumabYoung Adult
2013
Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Hsu M, Ho V, Ghislain P, Strober B, Reich K, 1 P. Long‐term safety of ustekinumab in patients with moderate‐to‐severe psoriasis: final results from 5 years of follow‐up. British Journal Of Dermatology 2013, 168: 844-854. PMID: 23301632, DOI: 10.1111/bjd.12214.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedCardiovascular DiseasesClinical Trials, Phase II as TopicClinical Trials, Phase III as TopicDermatologic AgentsDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansInfectionsMaleMiddle AgedNeoplasmsPsoriasisRandomized Controlled Trials as TopicUstekinumabConceptsAdverse eventsSevere psoriasisGeneral U.S. populationSerious AEsOverall mortalityRate of AEsOverall adverse eventsSerious adverse eventsAEs of interestU.S. populationLong-term safetyLong-term safety evaluationPatient management decisionsUstekinumab doseUstekinumab exposureDose groupMore dosesPsoriasis trialsSerious infectionsSafety dataCumulative toxicityCumulative exposurePsoriasisPatientsEvent rates
2012
Inflammatory arthritis following ustekinumab treatment for psoriasis: a report of two cases
de Souza A, Ali‐Shaw T, Reddy S, Fiorentino D, Strober B. Inflammatory arthritis following ustekinumab treatment for psoriasis: a report of two cases. British Journal Of Dermatology 2012, 168: 210-212. PMID: 23278559, DOI: 10.1111/j.1365-2133.2012.11206.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, Monoclonal, HumanizedArthritis, PsoriaticDermatologic AgentsHumansMalePsoriasisUstekinumabConceptsUstekinumab treatmentHuman immunoglobulin G1κ monoclonal antibodyChronic inflammatory skin conditionInflammatory skin conditionT helper 1Common p40 subunitT cell differentiationIL-23Inflammatory arthritisPsoriatic arthritisTh17 pathwayFamily historyP40 subunitSkin conditionsCell activationArthritisPsoriasisMonoclonal antibodiesPatientsTreatmentReportUstekinumabTh1InterleukinAntibodiesPSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents.
Papp K, Strober B, Augustin M, Calabro S, Londhe A, Chevrier M. PSOLAR: design, utility, and preliminary results of a prospective, international, disease-based registry of patients with psoriasis who are receiving, or are candidates for, conventional systemic treatments or biologic agents. Journal Of Drugs In Dermatology 2012, 11: 1210-7. PMID: 23134986.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedArthritis, PsoriaticBody Mass IndexBody Surface AreaCardiovascular DiseasesData Interpretation, StatisticalFemaleHumansImmunologic FactorsInfliximabMaleMiddle AgedObesityPhototherapyProduct Surveillance, PostmarketingProspective StudiesPsoriasisRegistriesUstekinumabConceptsDisease-based registryBiologic agentsObservational studyMajor adverse cardiovascular eventsConventional systemic treatmentsGeneral psoriasis populationPsoriasis Longitudinal AssessmentAdverse cardiovascular eventsOverweight/obeseLong-term observational studyBody surface areaPsoriasis populationCardiovascular eventsCause mortalityAdverse eventsPsoriatic arthritisRegistry studySystemic agentsSystemic therapySystemic treatmentMedication historyDisease characteristicsSerious infectionsMean durationEfficacy data
2011
Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials
Lebwohl M, Leonardi C, Griffiths C, Prinz J, Szapary P, Yeilding N, Guzzo C, Li S, Hsu M, Strober B. Long-term safety experience of ustekinumab in patients with moderate-to-severe psoriasis (Part I of II): Results from analyses of general safety parameters from pooled Phase 2 and 3 clinical trials. Journal Of The American Academy Of Dermatology 2011, 66: 731-741. PMID: 21930328, DOI: 10.1016/j.jaad.2011.06.011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsEtanerceptEvaluation Studies as TopicFemaleFollow-Up StudiesHumansImmunoglobulin GMaleMiddle AgedPsoriasisReceptors, Tumor Necrosis FactorRisk AssessmentSafety ManagementSeverity of Illness IndexTime FactorsTreatment OutcomeUstekinumabConceptsRate of AEsUstekinumab-treated patientsAdverse eventsSerious AEsSevere psoriasisSafety profileLong-term safety experiencePrevious short-term reportsCumulative safety dataGeneral safety parametersPlacebo-controlled periodSerious adverse eventsYears of treatmentShort-term reportsCases of demyelinationUstekinumab exposureIL-23Clinical trialsOverall infectionSafety dataACCEPT trialPatientsSimilar findingsSafety experienceTrialsAssociation 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 RegisterSuccessful Treatment of Subacute Lupus Erythematosus With Ustekinumab
De Souza A, Ali-Shaw T, Strober B, Franks A. Successful Treatment of Subacute Lupus Erythematosus With Ustekinumab. JAMA Dermatology 2011, 147: 896-898. PMID: 21844448, DOI: 10.1001/archdermatol.2011.185.Peer-Reviewed Original Research