2023
Immunogenicity and pharmacokinetics of guselkumab among patients with moderate‐to‐severe psoriasis in VOYAGE‐1 and VOYAGE‐2
Armstrong A, Eyerich K, Conrad C, Zhu Y, Yang Y, Miller M, You Y, Shen Y, Foley P, Griffiths C, Strober B. Immunogenicity and pharmacokinetics of guselkumab among patients with moderate‐to‐severe psoriasis in VOYAGE‐1 and VOYAGE‐2. Journal Of The European Academy Of Dermatology And Venereology 2023, 37: e1375-e1379. PMID: 37415560, DOI: 10.1111/jdv.19309.Peer-Reviewed Original ResearchSafety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial
Thaçi D, Vender R, de Rie M, Conrad C, Pariser D, Strober B, Vanvoorden V, Wang M, Madden C, de Cuyper D, Kimball A. Safety and efficacy of bimekizumab through 2 years in patients with moderate-to-severe plaque psoriasis: longer-term results from the BE SURE randomized controlled trial and the open-label extension from the BE BRIGHT trial. British Journal Of Dermatology 2023, 188: 22-31. PMID: 36689515, DOI: 10.1093/bjd/ljac021.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsOpen-label extensionSevere plaque psoriasisWeek 104Week 24PASI 100PASI 90Plaque psoriasisWeek 16Safety dataCommon treatment-emergent adverse eventsSerious treatment-emergent adverse eventsUpper respiratory tract infectionInitial randomization groupUnexpected safety findingsNew safety signalsRespiratory tract infectionsWeeks of treatmentLong-term resultsBaseline PASIBimekizumab groupBRIGHT trialMaintenance dosingPsoriasis AreaSafety findings
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 52Super‐response to guselkumab treatment in patients with moderate‐to‐severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance
Reich K, Gordon K, Strober B, Langley R, Miller M, Yang Y, Shen Y, You Y, Zhu Y, Foley P, Blauvelt A. Super‐response to guselkumab treatment in patients with moderate‐to‐severe psoriasis: age, body weight, baseline Psoriasis Area and Severity Index, and baseline Investigator's Global Assessment scores predict complete skin clearance. Journal Of The European Academy Of Dermatology And Venereology 2022, 36: 2393-2400. PMID: 35920762, DOI: 10.1111/jdv.18474.Peer-Reviewed Original ResearchConceptsGlobal assessment scoreInvestigator's Global Assessment scoreSevere psoriasisGuselkumab treatmentChronic immune-mediated inflammatory skin diseaseBody weightImmune-mediated inflammatory skin diseaseAssessment scoresStepwise logistic regression analysisBaseline Psoriasis AreaComplete skin clearanceEarly clinical responseLess obese patientsVOYAGE 2 studiesBaseline body weightSubset of patientsInflammatory skin diseaseLogistic regression analysisHuman monoclonal antibodyPASI 100PASI 75Skin clearanceBaseline characteristicsBaseline demographicsClinical responseSwitching 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 success
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 ResearchConceptsMajor 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
2019
Hidradenitis suppurativa Current and emerging treatments
Goldburg S, Strober B, Payette M. Hidradenitis suppurativa Current and emerging treatments. Journal Of The American Academy Of Dermatology 2019, 82: 1061-1082. PMID: 31604100, DOI: 10.1016/j.jaad.2019.08.089.Peer-Reviewed Original ResearchConceptsHidradenitis suppurativaPathogenesis of HSNumerous clinical trialsPotential therapeutic roleMedical education seriesAnticytokine therapyTreatment optionsHS pathogenesisClinical trialsTherapeutic roleNovel therapiesNew therapiesTherapyPathogenesisEducation seriesRecent studiesTreatmentSuppurativaSurgeryCytokinesEtiologyTrialsJoint 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 evidenceCareTreatmentGuidelinesPatientsDermatologistsDiseaseBiologics
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 patientsSystematic review of the real‐world evidence of adalimumab safety in psoriasis registries
Strober B, Crowley J, Langley R, Gordon K, Menter A, Leonardi C, Arikan D, Valdecantos W. Systematic review of the real‐world evidence of adalimumab safety in psoriasis registries. Journal Of The European Academy Of Dermatology And Venereology 2018, 32: 2126-2133. PMID: 30067882, DOI: 10.1111/jdv.15203.Peer-Reviewed Original ResearchMeSH KeywordsAdalimumabCardiovascular DiseasesDermatologic AgentsHumansInfectionsNeoplasmsPsoriasisRegistriesConceptsMajor cardiac eventsAdverse eventsPsoriasis RegistryReal-world evidenceAdalimumab safetySerious AEsAdult patientsCardiac eventsClinical studiesSafety dataLong-term safety profileCardiovascular-related eventsSerious adverse eventsSerious cardiovascular eventsReal-world safetyLong-term safetyRate of infectionEnglish language manuscriptsCardiovascular eventsSafety profileSerious infectionsAdalimumabClinical practiceEligible papersRegistry
2017
Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Philipp S, Spelman L, Zhang N, Strober B. Clinical similarity of the biosimilar ABP 501 compared with adalimumab after single transition: long‐term results from a randomized controlled, double‐blind, 52‐week, phase III trial in patients with moderate‐to‐severe plaque psoriasis. British Journal Of Dermatology 2017, 177: 1562-1574. PMID: 28755394, DOI: 10.1111/bjd.15857.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisBody surface areaABP 501Week 16Adverse eventsAntidrug antibodiesPlaque psoriasisBiosimilar ABP 501New safety signalsPercentage of patientsPhase III trialsSimilar clinical efficacySeverity Index scorePercentage body surface areaLong-term resultsEuropean Medicines AgencyPASI 50PASI improvementWeek 52III trialsPsoriasis AreaAdalimumab patientsImmunogenicity profileClinical efficacyPatient populationClinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study
Papp K, Bachelez H, Costanzo A, Foley P, Gooderham M, Kaur P, Narbutt J, Philipp S, Spelman L, Weglowska J, Zhang N, Strober B. Clinical similarity of biosimilar ABP 501 to adalimumab in the treatment of patients with moderate to severe plaque psoriasis: A randomized, double-blind, multicenter, phase III study. Journal Of The American Academy Of Dermatology 2017, 76: 1093-1102. PMID: 28291552, DOI: 10.1016/j.jaad.2016.12.014.Peer-Reviewed Original ResearchConceptsABP 501Week 16Psoriasis AreaClinical similaritiesBiosimilar ABP 501Biosimilars of adalimumabSevere plaque psoriasisDouble-blind studySeverity Index scoreTreatment of patientsAntibody incidencePlaque psoriasisSevere psoriasisAdalimumabIndex scoreEquivalence marginPatientsImmunogenicityConfidence intervalsTreatment differencesPercent improvementPsoriasisSame treatmentBaselineMore improvement
2016
Why Biologic Therapies Sometimes Lose Efficacy.
Strober B. Why Biologic Therapies Sometimes Lose Efficacy. Seminars In Cutaneous Medicine And Surgery 2016, 35: s78-80. PMID: 27525443, DOI: 10.12788/j.sder.2016.022.Peer-Reviewed Original ResearchTreatment 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
The 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
2014
Tumor necrosis factor inhibitors in psoriasis: an update.
Kerdel F, Strober B. Tumor necrosis factor inhibitors in psoriasis: an update. Seminars In Cutaneous Medicine And Surgery 2014, 33: s31-6. PMID: 24979543, DOI: 10.12788/j.sder.0066.Peer-Reviewed Original ResearchConceptsTumor necrosis factorTNF inhibitorsNecrosis factor inhibitorsTreatment of psoriasisCertolizumab pegolPlaque psoriasisPsoriatic arthritisFactor inhibitorsClinical trialsNecrosis factorPsoriasisRecent evidenceInhibitorsEfficacyGolimumabInfliximabPegolAdalimumabEtanerceptArthritisImmunogenicityChanges 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
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 Area
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 treatment