Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis
Langley R, Papp K, Gottlieb A, Krueger G, Gordon K, Williams D, Valdes J, Setze C, Strober B. Safety results from a pooled analysis of randomized, controlled phase II and III clinical trials and interim data from an open‐label extension trial of the interleukin‐12/23 monoclonal antibody, briakinumab, in moderate to severe psoriasis. Journal Of The European Academy Of Dermatology And Venereology 2012, 27: 1252-1261. PMID: 23157612, DOI: 10.1111/j.1468-3083.2012.04705.x.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCarcinoma, Basal CellCarcinoma, Squamous CellCardiovascular DiseasesClinical Trials as TopicFemaleHumansInterleukin-12Interleukin-23MaleMiddle AgedPrevalencePsoriasisRandomized Controlled Trials as TopicSeverity of Illness IndexSkin Diseases, InfectiousSkin NeoplasmsTreatment OutcomeConceptsOpen-label extension studyMajor adverse cardiovascular eventsPotential safety signalsSevere psoriasisAdverse eventsParent studyClinical trialsSafety signalsSafety resultsAnti-IL-12/23 treatmentInterleukin-12/23 monoclonal antibodyOpen-label extension trialPhase IIAdverse cardiovascular eventsCardiovascular risk factorsBaseline blood pressureBody mass indexRate of infectionCardiovascular eventsFirst doseSafety findingsBlood pressureIL-12/23Mass indexExtension trial