Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label 英文参考文献.docVIP

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Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label 英文参考文献.doc

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Rates of, and risk factors for, severe infections in patients with systemic autoimmune diseases receiving biological agents off-label 英文参考文献

Díaz-Lagaresetal.ArthritisResearchTherapy2011,13:R112 /content/13/4/R112 RESEARCH ARTICLE OpenAccess Ratesof,andriskfactorsfor,severeinfectionsin patientswithsystemicautoimmunediseases receivingbiologicalagentsoff-label CándidoDíaz-Lagares1?,RobertoPérez-Alvarez2?,FranciscoJGarcía-Hernández3,MaríaMAyala-Gutiérrez4, JoséLuisCallejas5,AgustínMartínez-Berriotxoa6,JavierRascón7,LuisCaminal-Montero8,AlbertSelva-O’Callaghan9, JoaquimOristrell10,CarmenHidalgo11,RicardoGómez-de-la-Torre12,LuisSáez13,JesúsCanora-Lebrato14, María-TeresaCamps4,NorbertoOrtego-Centeno5,María-JesúsCastillo-Palma3andManuelRamos-Casals1* for theBIOGEASStudyGroup Abstract Introduction:Thepurposeofthisobservationalstudywastoanalyzetherates,characteristicsandassociatedrisk factorsofsevereinfectionsinpatientswithsystemicautoimmunediseases(SAD)whoweretreatedoff-labelwith biologicalagentsindailypractice. Methods:TheBIOGEASregistryisanongoingSpanishprospectivecohortstudyinvestigatingthelong-termsafety andefficacyoftheoff-labeluseofbiologicalagentsinadultpatientswithsevere,refractorySAD.Severeinfections weredefinedaccordingtopreviousstudiesasthosethatrequiredintravenoustreatmentorthatledto hospitalizationordeath.Patientscontributedperson-yearsoffollow-upfortheperiodinwhichtheyweretreated withbiologicalagents. Results:Atotalof344patientswithSADtreatedwithbiologicalagentsoff-labelwereincludedintheRegistryuntil July2010.Thefirstbiologicaltherapiesincludedrituximabin264(77%)patients,infliximabin37(11%),etanerceptin21 (6%),adalimumabin19(5%),and‘other’agentsin3(1%).Forty-fivesevereinfectionsoccurredin37patientsaftera meanfollow-upof26.76months.Theseinfectionsresultedinfourdeaths.Thecruderateofsevereinfectionswas90.9 events/1000person-years(112.5forrituximab,76.9forinfliximab,66.9foradalimumaband30.5foretanercept respectively).Inpatientstreatedwithmorethantwocoursesofrituximab,thecruderateofsevereinfectionwas226.4 events/1000person-years.Apathogenwasidentifiedin24(53%)severeinfections.Themostcommonsiteso