Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the phase 3b, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period
Annals of the Rheumatic DiseasesPublished 4 November 2014Open access
Paul Emery, Gerd R Burmester, Vivian P. Bykerk, Bernard Combe, Daniel E. Fürst, Emilie Barré
Citations232
SJR quartileQ1
SJR score5.73
SNIP4.44
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TL;DR
The achievement of sustained remission following withdrawal of all RA therapy suggests an effect of abatacept's mechanism on autoimmune processes, as well as a safety profile comparable with MTX alone.
Abstract
NCT01142726.
Keywords
Medicine
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