FDAnews
www.fdanews.com/articles/82638-bms-reports-phase-ii-abatacept-data

BMS REPORTS PHASE II ABATACEPT DATA

November 22, 2005

Patients with rheumatoid arthritis who have not responded adequately to methotrexate monotherapy appear to have improved quality of life, sleep, and fatigue when they are treated with Bristol-Myers Squibb's (BMS) abatacept, according to new study data.

A one-year, double-blind, placebo-controlled Phase II trial assessed fixed-dose abatacept at a dose approximating 10 mg/kg in combination with methotrexate or placebo. In the trial, patients received abatacept 10 mg/kg with methotrexate or with placebo for up to one year, followed by abatacept at a dose approximating 10 mg/kg for the remainder of the study.