2023
E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis
Strober B, Coates L, Yu J, Rowland K, Leibowitz E, Miller M, Kollmeier A, Li S, Wang Y, Chan D, Chakravarty S, Yang Y, Shawi M, Lebwohl M, Rahman P. E088 Safety of guselkumab in patients with psoriatic disease: an integrated analysis of 11 Phase 2 and 3 clinical studies in psoriasis and psoriatic arthritis. Rheumatology 2023, 62 DOI: 10.1093/rheumatology/kead104.337.Peer-Reviewed Original ResearchGuselkumab-treated patientsJanssen Scientific AffairsGrant/research supportPlacebo-controlled periodPlacebo-treated patientsAdverse eventsBristol-Myers SquibbBoehringer IngelheimOpportunistic infectionsIncidence rateMeiji Seika PharmaSafety dataLEO PharmaEli LillyUCB PharmaMajor adverse cardiovascular eventsSafety eventsScientific AffairsAdverse cardiovascular eventsOverall adverse eventsSerious adverse eventsSevere plaque psoriasisPhase 2/3 studyActive psoriatic arthritisPharmaceutical companies
2022
Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*
Blauvelt A, Kimball A, Augustin M, Okubo Y, Witte M, Capriles C, Sontag A, Arora V, Osuntokun O, Strober B. Efficacy and safety of mirikizumab in psoriasis: results from a 52‐week, double‐blind, placebo‐controlled, randomized withdrawal, phase III trial (OASIS‐1)*. British Journal Of Dermatology 2022, 187: 866-877. PMID: 35791755, PMCID: PMC10087045, DOI: 10.1111/bjd.21743.Peer-Reviewed Original ResearchConceptsSevere plaque psoriasisPlaque psoriasisWeek 16Week 52PASI 100Secondary endpointsAdult patientsSafety profileLarge phase III trialsStatic Physician's Global AssessmentGlobal assessmentPhase II clinical trialInterleukin-23 inhibitorsKey secondary endpointNew safety signalsPhysician global assessmentSerious adverse eventsPatient-reported qualityPhase III trialsFavorable safety profilePathogenesis of psoriasisPASI 90PASI 75Coprimary endpointsIII trialsDeucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial
Strober B, Thaçi D, Sofen H, Kircik L, Gordon K, Foley P, Rich P, Paul C, Bagel J, Colston E, Throup J, Kundu S, Sekaran C, Linaberry M, Banerjee S, Papp K. Deucravacitinib versus placebo and apremilast in moderate to severe plaque psoriasis: Efficacy and safety results from the 52-week, randomized, double-blinded, phase 3 Program fOr Evaluation of TYK2 inhibitor psoriasis second trial. Journal Of The American Academy Of Dermatology 2022, 88: 40-51. PMID: 36115523, DOI: 10.1016/j.jaad.2022.08.061.Peer-Reviewed Original ResearchConceptsGlobal assessment scoreSevere plaque psoriasisStatic Physician's Global Assessment scorePhysician Global Assessment scorePlaque psoriasisAdverse eventsPsoriasis AreaWeek 16Assessment scoresFrequent adverse eventsPhase 3 trialSerious adverse eventsSeverity IndexPhase 3 programSecond trialApremilast patientsWeek 52Laboratory parametersPsoriasis pathogenesisSafety resultsPlaceboDeucravacitinibStudy durationPsoriasisPatients
2018
Systematic 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 ResearchConceptsMajor 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
2016
Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data
Strober B, Leonardi C, Papp KA, Mrowietz U, Ohtsuki M, Bissonnette R, Ferris LK, Paul C, Lebwohl M, Braun DK, Mallbris L, Wilhelm S, Xu W, Ljungberg A, Acharya N, Reich K. Short- and long-term safety outcomes with ixekizumab from 7 clinical trials in psoriasis: Etanercept comparisons and integrated data. Journal Of The American Academy Of Dermatology 2016, 76: 432-440.e17. PMID: 27889292, DOI: 10.1016/j.jaad.2016.09.026.Peer-Reviewed Original ResearchConceptsTreatment-emergent adverse eventsIxekizumab-treated patientsSerious adverse eventsAdverse eventsIncidence rateClinical trialsMore treatment-emergent adverse eventsExposure-adjusted incidence ratesEtanercept-treated patientsIntegrated safety dataSafety of ixekizumabUnexpected safety findingsAcceptable safety profileLong-term safety outcomesSafety of biologicsAdditional long-term dataSafety findingsSafety profileCandida infectionsSafety dataSafety outcomesIxekizumabPatientsPsoriasisTrials
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 ratesTopical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides
Lessin S, Duvic M, Guitart J, Pandya A, Strober B, Olsen E, Hull C, Knobler E, Rook A, Kim E, Naylor M, Adelson D, Kimball A, Wood G, Sundram U, Wu H, Kim Y. Topical Chemotherapy in Cutaneous T-cell Lymphoma: Positive Results of a Randomized, Controlled, Multicenter Trial Testing the Efficacy and Safety of a Novel Mechlorethamine, 0.02%, Gel in Mycosis Fungoides. JAMA Dermatology 2013, 149: 25-32. PMID: 23069814, PMCID: PMC3662469, DOI: 10.1001/2013.jamadermatol.541.Peer-Reviewed Original ResearchConceptsIndex Lesion SeverityClinical end pointsMycosis fungoidesResponse rateMechlorethamine gelAdverse eventsMulticenter trialTreatment armsLesion severityDrug-related serious adverse eventsSeverity-Weighted Assessment ToolPrimary clinical end pointCutaneous T-cell lymphomaEnd pointSecondary clinical end pointsIIA mycosis fungoidesSerious adverse eventsSubset of patientsTreatment of patientsSerum drug levelsT-cell lymphomaComposite assessmentCarmustine therapyStudy medicationTopical mechlorethamine
2012
A 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
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 treatmentLong-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 experienceTrialsEfficacy 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
Use of etanercept for psoriatic arthritis in the dermatology clinic: The Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) study
Gottlieb A, Kircik L, Eisen D, Jackson J, Boh E, Strober B, Frankel E, Xia H, Stevens S. Use of etanercept for psoriatic arthritis in the dermatology clinic: The Experience Diagnosing, Understanding Care, and Treatment with Etanercept (EDUCATE) study. Journal Of Dermatological Treatment 2006, 17: 343-352. PMID: 17853307, DOI: 10.1080/09546630600967166.Peer-Reviewed Original ResearchConceptsPsoriatic arthritisDermatology clinicBody surface area involvementGlobal assessmentTolerability of etanerceptPatient global assessmentPhysician global assessmentSerious adverse eventsUse of etanerceptSurface area involvementActive psoriatic arthritisWeeks of treatmentBody surface areaEtanercept treatmentExperience diagnosingEtanercept therapyPlaque psoriasisAdverse eventsJoint painArea involvementJoint diseaseDisease scorePatientsArthritisPsoriasis