title: Concomitant Use of Statins in Tocilizumab-Treated Patients with Rheumatoid Arthritis: A Post Hoc Analysis.
abstract: BACKGROUND
  Patients with rheumatoid arthritis (RA) have decreased survival because of increased cardiovascular risk compared with the general population, and treatment with tocilizumab (TCZ) has been shown to increase lipid levels; however, the relationship between lipids and cardiovascular risk is unknown. This post hoc analysis expanded on previously reported 24-week results by characterizing statin use and subsequent changes in lipid parameters in patients with RA treated with intravenous or subcutaneous TCZ (TCZ-IV or TCZ-SC) over 2 years of treatment.
  
  
  METHODS
  Data were collected from patients with moderate to severe active RA who received ≥1 dose of the study drug in seven international, randomized, double-blind, controlled phase 3 and 4 clinical trials of TCZ-IV or TCZ-SC. Lipid levels and safety events were assessed over 2 years of treatment. Data were summarized for all pooled treatment groups of the intention-to-treat populations in the TCZ-IV and TCZ-SC studies, and results were stratified by concomitant statin use.
  
  
  RESULTS
  Data from this descriptive, retrospective, pooled analysis indicated that statins can stabilize lipid levels without a clinically significant increase in adverse events. Approximately 30% of patients in the TCZ treatment arms who never received a statin demonstrated a shift in low-density-lipoprotein cholesterol (LDL-C) from <130 mg/dl at baseline to ≥130 mg/dl at 2 years. However, despite the increased potential cardiovascular risk, <15% of patients with LDL-C ≥100 mg/dl and <35% of patients with a total cholesterol:high-density-lipoprotein cholesterol ratio >5 at 2 years were receiving concomitant statins.
  
  
  CONCLUSIONS
  Concomitant statin use attenuated TCZ-mediated lipid increases; however, a large proportion of TCZ-treated patients potentially at risk of cardiovascular disease were untreated. These findings highlight the need for better understanding of potential risk associated with TCZ-mediated lipid elevations as well as implementation of RA-specific guidelines on the recognition and management of elevated risk of cardiovascular events in patients with RA.
  
  
  BACKGROUND
  F. Hoffmann-La Roche, Ltd.
authors.affiliation: Department of Rheumatology, Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel-Montpied, Clermont-Ferrand, France. msoubrier@chu-clermontferrand.fr.
authors.forename: Martin
authors.initials: M
authors.lastname: Soubrier
authors.affiliation: Genentech, Inc, South San Francisco, CA, USA.
authors.forename: Jinglan
authors.initials: J
authors.lastname: Pei
authors.affiliation: LILLY FRANCE, Neuilly-sur-Seine, France.
authors.forename: Frédérick
authors.initials: F
authors.lastname: Durand
authors.affiliation: Department of Cardiology, Faculty of Medicine, and Oslo University Hospital, University of Oslo, Oslo, Norway.
authors.forename: Lars
authors.initials: L
authors.lastname: Gullestad
authors.affiliation: Genentech, Inc, South San Francisco, CA, USA.
authors.forename: Ani
authors.initials: A
authors.lastname: John
keywords: Biologicals; Cardiovascular; Disease-modifying antirheumatic drugs (DMARDs); Low-density-lipoprotein cholesterol; Rheumatoid arthritis; Statins; Tocilizumab