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 patients43944 Improvements in Manifestations of Active Psoriatic Arthritis With Risankizumab Treatment After Intolerance or Inadequate Response to Prior Biologic Therapy: Subgroup Analyses From the KEEPsAKE 2 Trial
Strober B, Kivitz A, Östör A, Padilla B, Yue C, Photowala H, Merola J. 43944 Improvements in Manifestations of Active Psoriatic Arthritis With Risankizumab Treatment After Intolerance or Inadequate Response to Prior Biologic Therapy: Subgroup Analyses From the KEEPsAKE 2 Trial. Journal Of The American Academy Of Dermatology 2023, 89: ab179. DOI: 10.1016/j.jaad.2023.07.717.Peer-Reviewed Original ResearchE088 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
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