2022
Long‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis
Gooderham M, Pinter A, Ferris L, Warren R, Zhan T, Zeng J, Soliman A, Kaufmann C, Kaplan B, Photowala H, Strober B. Long‐term, durable, absolute Psoriasis Area and Severity Index and health‐related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate‐to‐severe plaque psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2022, 36: 855-865. PMID: 35174556, PMCID: PMC9314097, DOI: 10.1111/jdv.18010.Peer-Reviewed Original ResearchConceptsDermatology Life Quality IndexSevere plaque psoriasisHealth-related qualityRisankizumab treatmentPlaque psoriasisAbsolute PASIDLQI 0/1Psoriasis AreaDLQI scoreAbsolute PASI scoreAbsolute Psoriasis AreaUstekinumab-treated patientsMean DLQI scoreSeverity Index (PASI) improvementLife Quality IndexHigh ratePASI levelsPatients' HRQoL.PASI scoreMedian timeDurable efficacyPat ientsRisankizumabPASIPatients
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
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
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