2024
Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials
Gordon K, Thaçi D, Gooderham M, Okubo Y, Strober B, Peterson L, Deherder D, López Pinto J, Gisondi P. Bimekizumab Safety and Tolerability in Moderate to Severe Plaque Psoriasis: Pooled Analysis from Up to 4 Years of Treatment in 5 Phase 3/3b Clinical Trials. SKIN The Journal Of Cutaneous Medicine 2024, 8: s404. DOI: 10.25251/skin.8.supp.404.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsSevere plaque psoriasisOpen-label extensionPlaque psoriasisOral candidiasisPatient yrModerate to severe plaque psoriasisUpper respiratory tract infectionLong-term safety of treatmentRespiratory tract infectionsNext scheduled visitYear of treatmentSafety of treatmentLong-term safetySafety findingsTract infectionsLong-term managementBimekizumabSafety profileAdverse eventsPooled analysisClinical trialsQ8WSafety dataPsoriasisDeucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2)
Strober B, Blauvelt A, Warren R, Papp K, Armstrong A, Gordon K, Morita A, Alexis A, Lebwohl M, Foley P, Kisa R, Colston E, Wang T, Banerjee S, Thaçi D. Deucravacitinib in moderate‐to‐severe plaque psoriasis: Pooled safety and tolerability over 52 weeks from two phase 3 trials (POETYK PSO‐1 and PSO‐2). Journal Of The European Academy Of Dermatology And Venereology 2024, 38: 1543-1554. PMID: 38451052, DOI: 10.1111/jdv.19925.Peer-Reviewed Original ResearchPhase 3 trialPlaque psoriasisAdverse eventsTyrosine kinase 2Exposure-adjusted incidence ratesPooled safety dataRate of adverse eventsIncidence rate of adverse eventsVenous thromboembolic eventsExposure-adjusted incidence rates of adverse eventsAdverse cardiovascular eventsOral placeboDiscontinuation ratesLaboratory parametersThromboembolic eventsHerpes zosterDeucravacitinibCardiovascular eventsPooled analysisSafety signalsSafety dataPooled safetyPlaceboApremilastPsoriasis
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 ResearchConceptsOpen-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 antibodiesE088 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 companiesSafety 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
2019
Ustekinumab 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
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 rates
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 experienceTrials
2010
Benefit‐risk assessment of tumour necrosis factor antagonists in the treatment of psoriasis
Langley R, Strober B, Gu Y, Rozzo S, Okun M. Benefit‐risk assessment of tumour necrosis factor antagonists in the treatment of psoriasis. British Journal Of Dermatology 2010, 162: 1349-1358. PMID: 20394634, DOI: 10.1111/j.1365-2133.2010.09707.x.Peer-Reviewed Original ResearchConceptsTumor necrosis factorAdverse eventsTumor necrosis factor antagonistsMalignant adverse eventsOpen-label dataPlacebo-controlled periodAnti-TNF therapyNecrosis factor antagonistsTreatment of psoriasisTreatment effect dataBenefit-risk balanceBenefit-risk assessmentTNF antagonistsNNT valuesEfficacy measuresClinical trialsNecrosis factorSerious toxicitySafety dataFactor antagonistsLower riskEtanerceptPsoriasisAdalimumabInfliximab