Journal article
Efficacy and safety of abatacept in lupus nephritis: A twelve-month, randomized, double-blind study
R Furie, K Nicholls, TT Cheng, F Houssiau, R Burgos-Vargas, SL Chen, JL Hillson, S Meadows-Shropshire, M Kinaszczuk, JT Merrill
Arthritis and Rheumatology | Published : 2014
DOI: 10.1002/art.38260
Abstract
Objective. To compare the efficacy and safety of intravenous (IV) abatacept, a selective T cell costimulation modulator, versus placebo for the treatment of active class III or IV lupus nephritis, when used on a background of mycophenolate mofetil and glucocorticoids. Methods. This was a 12-month, randomized, phase II/III, multicenter, international, double-blind study. A total of 298 patients were treated in 1 of 3 IV treatment arms: placebo, abatacept at the standard weight-tiered dose (approximating 10 mg/kg), or abatacept at 30 mg/kg for 3 months, followed by the standard weight-tiered dose (abatacept 30/10). The primary end point, time to confirmed complete response, was a composite mea..
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Funding Acknowledgements
Supported by Bristol-Myers Squibb.Dr. Furie has received consulting fees from Bristol-Myers Squibb (less than $10,000). Dr. Houssiau has received consulting fees, speaking fees, and/or honoraria from Human Genome Sciences, GlaxoSmithKline, and UCB (less than $10,000 each). Dr. Burgos-Vargas has received consulting fees, speaking fees, and/or honoraria from Abbvie, Bristol-Myers Squibb, Jannsen, Pfizer, Roche, and UCB (less than $10,000 each). Dr. Hillson, Ms. Meadows-Shropshire, and Mr. Kinaszczuk own stock or stock options in Bristol-Myers Squibb. Dr. Merrill has received consulting fees, speaking fees, and/or honoraria from Bristol-Myers Squibb (less than $10,000).