6533b857fe1ef96bd12b514c

RESEARCH PRODUCT

Safety profile of the interleukin-1 inhibitors anakinra and canakinumab in real life clinical practice: a nationwide multicenter retrospective observational study

J SotaA VitaleA InsalacoP SfrisoG LopalcoG EmmiM CattaliniR MannaR CimazR PrioriR TalaricoG De MarchiM FrassiR GallizziA SorianoM AlessioD CammelliMc MaggioS GentileschiR MarcolongoF La TorreC FabianiS ColafrancescoF RicciP GalozziO ViapianaE VerrecchiaM PardeoL CerritoE CavallaroAn OlivieriG PaolazziG VitielloA MaierE SilvestriC StagnaroG ValesiniM MoscaS De VitaA TincaniG LapadulaB FredianiF De BenedettiF IannoneL PunziC SalvaraniM GaleazziR AngottiM MessinaGm TosiD RiganteL CantariniRheumatology). “Working Group” Of Systemic Autoinflammatory Diseases Of Sir (Italian Society Of

subject

Anakinra; Autoinflammatory disorders; Canakinumab; Interleukin-1; Safety profile0301 basic medicineMaleSettore MED/16 - REUMATOLOGIAAutoinflammatory disorders0302 clinical medicineRetrospective StudieAnakinra; Autoinflammatory disorders; Canakinumab; Interleukin-1; Safety profile; RheumatologyChildAntibodies MonoclonalGeneral MedicineMiddle AgedAnakinraTreatment OutcomeAutoinflammationFemaleCohort studymedicine.drugHumanAdultmedicine.medical_specialtyAdolescentLogistic ModelCanakinumabNeutropeniaAntibodies Monoclonal HumanizedAutoimmune DiseaseAutoimmune Diseases03 medical and health sciencesYoung AdultRheumatologyInternal medicineInjection site reactionmedicineHumansAnakinra Autoinflammatory disorders Canakinumab Interleukin-1 Safety profile Adolescent Adult Antibodies Monoclonal Antibodies Monoclonal Humanized Autoimmune Diseases Child Female Humans Interleukin 1 Receptor Antagonist Protein Logistic Models Male Middle Aged Retrospective Studies Treatment Outcome Young AdultAdverse effectRetrospective Studies030203 arthritis & rheumatologyAnakinrabusiness.industryRetrospective cohort studymedicine.diseaseCanakinumabInterleukin 1 Receptor Antagonist ProteinLogistic Models030104 developmental biologyAutoinflammatory disorderSafety profileObservational studybusinessInterleukin-1

description

A few studies have reported the safety profile of interleukin (IL)-1 blockers from real life. The aim of this study is to describe anakinra (ANA) and canakinumab (CAN) safety profile in children and adults, based on data from a real-life setting. Demographic, clinical, and therapeutic data from patients treated with ANA and CAN were retrospectively collected and analyzed. Four hundred and seventy five patients were enrolled; ANA and CAN were prescribed in 421 and 105 treatment courses, respectively. During a mean follow-up of 24.39 ± 27.04 months, 89 adverse events (AE) were recorded; 13 (14.61%) were classified as serious AE (sAE). The overall estimated rate of AE and sAE was 8.4 per 100 patients/year. Safety concerns were more frequent among patients aged ≥ 65 years compared with patients  0.05 CAN). Treatment duration was the only variable associated with onset of AE (OR = 0.399 [C.I. 0.250–0.638], p = 0.0001). ANA and CAN have shown an excellent safety profile; the risk for AE and sAE tends to decrease over time from the start of IL-1 inhibition.

yearjournalcountryeditionlanguage
2018-01-01
10.1007/s10067-018-4119-xhttp://hdl.handle.net/10807/124142