2019
Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs
Ghosh S, Gensler L, Yang Z, Gasink C, Chakravarty S, Farahi K, Ramachandran P, Ott E, Strober B. Correction to: Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn’s Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Safety 2019, 42: 809-809. PMID: 31012051, PMCID: PMC6520476, DOI: 10.1007/s40264-019-00816-3.Peer-Reviewed Original ResearchUstekinumab 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
2013
SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis
Papp K, Griffiths C, Gordon K, Lebwohl M, Szapary P, Wasfi Y, Chan D, Shen Y, Ho V, Ghislain P, Strober B, Reich K. SAT0287 Long-Term Safety Of Ustekinumab: 5 Years of Follow-Up from the Psoriasis Clinical Development Program Including Patients with Psoriatic Arthritis. Annals Of The Rheumatic Diseases 2013, 72: a680. DOI: 10.1136/annrheumdis-2013-eular.2012.Peer-Reviewed Original ResearchGrant/research supportLong-term safetyAEs of interestOverall populationJanssen ResearchSafety endpointEvent ratesOpen-label long-term extensionLong-term safety experienceLow potency topical steroidsPooled safety dataOverall study populationPhase 3 developmentMajority of ptsClinical development programLong-term extensionHistory of PsAAbsence of PSAPsO patientsSevere PsOTopical steroidsPASI scorePsoriatic arthritisBiologic agentsMedian age