2024
Measuring GPPGA, Pain, Symptom, and Quality of Life Index Scores in Untreated Generalized Pustular Psoriasis: Results from the Placebo Group of the Effisayil-2 Trial
Strober B, Mostaghimi A, Anadkat M, Thoma C, Tang M, Guercio J, Lebwohl M. Measuring GPPGA, Pain, Symptom, and Quality of Life Index Scores in Untreated Generalized Pustular Psoriasis: Results from the Placebo Group of the Effisayil-2 Trial. SKIN The Journal Of Cutaneous Medicine 2024, 8: s361. DOI: 10.25251/skin.8.supp.361.Peer-Reviewed Original ResearchGeneralized Pustular Psoriasis Physician Global AssessmentGeneralized pustular psoriasis flaresGeneralized pustular psoriasisPsoriasis Symptom ScalePlacebo-treated patientsVisual analog scalePlacebo groupDermatology Quality of Life IndexPain scoresPustular psoriasisPain visual analog scaleQuality of lifeMajority of patientsPhysician global assessmentDisease burdenLife-threatening skin diseaseQuality of Life Index scoreModerate painSevere painSterile pustulesAcute flaresAnalog scaleDisease activityQuality of Life IndexGPP flaresMental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials
Blauvelt A, Armstrong A, Merola J, Strober B, de Cuyper D, Peterson L, Davies O, Stark J, Lebwohl M. Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials. Journal Of The American Academy Of Dermatology 2024, 91: 72-81. PMID: 38447700, DOI: 10.1016/j.jaad.2024.02.039.Peer-Reviewed Original ResearchModerate to severe psoriasisColumbia-Suicide Severity Rating ScaleSevere psoriasisIncreased risk of suicidal ideationRisk of suicidal ideationModerate to severe plaque psoriasisClinical trialsSeverity Rating ScaleFood and Drug Administration approvalRating scale responsesGeneral psoriasis populationPsoriasis patient populationPatient Health Questionnaire-9Placebo-treated patientsSevere plaque psoriasisMental health outcomesMental health changesPhase 2/3 trialsEuropean Medicines Agency approvalInterleukin (IL)-17ADrug Administration approvalPatient Health Questionnaire-9 scoresSuicidal ideationMeasure depressionRating Scale
2023
Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis
Strober B, Coates L, Lebwohl M, Deodhar A, Leibowitz E, Rowland K, Kollmeier A, Miller M, Wang Y, Li S, Chakravarty S, Chan D, Shawi M, Yang Y, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Safety 2023, 47: 39-57. PMID: 37906417, PMCID: PMC10764399, DOI: 10.1007/s40264-023-01361-w.Peer-Reviewed Original ResearchConceptsGuselkumab-treated patientsPlacebo-controlled periodBody mass indexPrior biologic usePsoriatic diseaseAE ratesSerious AEsBiologic usePsoriatic arthritisOpportunistic infectionsSerious infectionsPsoriasis studiesWeeks 0Clinical studiesWeek 4Phase II/III studyPhase II/III clinical studiesMajor adverse cardiovascular eventsLong-term safety profileBenefit/risk profileFavorable AE profilePlacebo-treated patientsAdverse cardiovascular eventsActive psoriatic arthritisSubgroup of patientsE088 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
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
2011
A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis
Gordon K, Langley R, Gottlieb A, Papp K, Krueger G, Strober B, Williams D, Gu Y, Valdes J. A Phase III, Randomized, Controlled Trial of the Fully Human IL-12/23 mAb Briakinumab in Moderate-to-Severe Psoriasis. Journal Of Investigative Dermatology 2011, 132: 304-314. PMID: 22011907, DOI: 10.1038/jid.2011.304.Peer-Reviewed Original ResearchConceptsPlacebo-treated patientsSevere psoriasisWeek 52Adverse eventsWeek 12Placebo-controlled phase III studyMajor adverse cardiovascular eventsPrevious phase II trialGlobal assessmentPlacebo-controlled periodAdverse cardiovascular eventsPhysician global assessmentPhase II trialPhase III studyNonmelanoma skin cancerNonresponder imputationPASI 75Vs. 4.5Cardiovascular eventsII trialIII studyPsoriasis AreaControlled TrialsIL-12/23Maintenance treatmentEfficacy 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
2007
Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial
Menter A, Tyring S, Gordon K, Kimball A, Leonardi C, Langley R, Strober B, Kaul M, Gu Y, Okun M, Papp K. Adalimumab therapy for moderate to severe psoriasis: A randomized, controlled phase III trial. Journal Of The American Academy Of Dermatology 2007, 58: 106-115. PMID: 17936411, DOI: 10.1016/j.jaad.2007.09.010.Peer-Reviewed Original ResearchConceptsSevere psoriasisPlacebo-treated patientsSafety of adalimumabChronic plaque psoriasisPercentage of patientsPhase III trialsSeverity Index scorePathogenesis of psoriasisKey proinflammatory cytokinesTumor necrosis factorHuman monoclonal antibodyInterrupted therapyAdalimumab therapyPlaque psoriasisWeek 52III trialsPASI scorePsoriasis AreaActive comparatorClinical efficacyMulticenter studyProinflammatory cytokinesWeek 16Necrosis factorAdalimumab