title: Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry.
abstract: BACKGROUND
  In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4 mg/kg every 4 weeks, with an increase to 8 mg/kg based on clinical response for patients with moderate to severe rheumatoid arthritis; however, data on how TCZ dose is escalated in real life are missing. The objective of this analysis was to describe patterns of early intravenous TCZ dose escalation in a real-world setting using data from the Corrona registry.
  
  
  METHODS
  All patients enrolled in the comparative effectiveness substudy (CERTAIN) nested within Corrona who initiated TCZ and completed 3- and 6-month study visits were eligible for inclusion. Patients who initiated TCZ 4 mg/kg were categorized into 1 of 2 groups: those who remained on TCZ 4 mg/kg at 3 months (Group 1) and those who escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Changes in clinical disease activity measures were provided.
  
  
  RESULTS
  Of the 213 patients who were eligible for analysis, 86 (40.4%) remained on their initial dose of TCZ 4 mg/kg (Group 1) and 110 (51.6%) were escalated to TCZ 8 mg/kg by or at 3 months (Group 2). Baseline demographic and clinical characteristics were similar between the 2 groups; except in Group 2, patients were older (58.3 vs. 54.0 years) and a lower proportion was female (75.5% vs. 89.4%) than in Group 1. Significant improvements in disease activity measures were observed at 3 and 6 months in both groups, with the majority of patients in both groups achieving moderate or good European League Against Rheumatism response.
  
  
  CONCLUSIONS
  Real-world data demonstrated that physicians escalate TCZ dose at varying frequencies. The ability to administer TCZ in varying doses allows physicians to tailor TCZ therapy to disease activity.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier, NCT01625650.
authors.affiliation: Columbia University, New York, NY, USA. dpappas@corrona.org.
authors.forename: Dimitrios A
authors.initials: DA
authors.lastname: Pappas
authors.affiliation: Genentech, Inc, South San Francisco, CA, USA.
authors.forename: Ani
authors.initials: A
authors.lastname: John
authors.affiliation: University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Jeffrey R
authors.initials: JR
authors.lastname: Curtis
authors.affiliation: Corrona, LLC, Southborough, MA, USA.|University of Massachusetts Medical School, Worcester, MA, USA.
authors.forename: George W
authors.initials: GW
authors.lastname: Reed
authors.affiliation: Corrona, LLC, Southborough, MA, USA.
authors.forename: Chitra
authors.initials: C
authors.lastname: Karki
authors.affiliation: University of Massachusetts Medical School, Worcester, MA, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Magner
authors.affiliation: Albany Medical College and The Center for Rheumatology, Albany, NY, USA.
authors.forename: Joel M
authors.initials: JM
authors.lastname: Kremer
authors.affiliation: Genentech, Inc, South San Francisco, CA, USA.
authors.forename: Ashwini
authors.initials: A
authors.lastname: Shewade
authors.affiliation: Corrona, LLC, Southborough, MA, USA.|NYU School of Medicine, New York, NY, USA.
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Greenberg
keywords: Biologic agents; Disease-modifying antirheumatic drugs; Prescribing patterns; Registry; Rheumatoid arthritis; Tocilizumab