Dosing of Intravenous Tocilizumab in a Real-World Setting of Rheumatoid Arthritis: Analyses from the Corrona Registry.

Abstract

In the United States, the recommended starting dose of intravenous tocilizumab (TCZ) is 4mg/kg every 4weeks, with an increase to 8mg/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. 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 4mg/kg were categorized into 1 of 2 groups: those who remained on TCZ 4mg/kg at 3months (Group1) and those who escalated to TCZ 8mg/kg by or at 3months (Group2). Changes in clinical disease activity measures were provided. Of the 213 patients who were eligible for analysis, 86 (40.4%) remained on their initial dose of TCZ 4mg/kg (Group1) and 110 (51.6%) were escalated to TCZ 8mg/kg by or at 3months (Group2). Baseline demographic and clinical characteristics were similar between the 2 groups; except in Group2, patients were older (58.3 vs. 54.0years) and a lower proportion was female (75.5% vs. 89.4%) than in Group1. Significant improvements in disease activity measures were observed at 3 and 6months in both groups, with the majority of patients in both groups achieving moderate or good European League Against Rheumatism response. 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. ClinicalTrials.gov identifier, NCT01625650.