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