A randomised efficacy and discontinuation study of etanercept versus adalimumab (RED SEA) for rheumatoid arthritis: a pragmatic, unblinded, non-inferiority study of first TNF inhibitor use: outcomes over 2 years.

ABSTRACT:

Objective

To compare adalimumab versus etanercept in patients with active rheumatoid arthritis (RA) to test the hypothesis that adalimumab was not inferior to etanercept in terms of drug continuation by a margin of 15% after 52 weeks of treatment.

Design

Pragmatic, randomised, parallel group, multicentre, unblinded and non-inferiority trial. Randomisation stratified by baseline use of methotrexate.

Participants

125 adults with active RA despite treatment with two disease-modifying drugs (DMARDs), including methotrexate randomised (1 : 1) to adalimumab 40 mg alternate weeks or etanercept 50 mg weekly, added to existing medication.

Measurements

The primary outcome was proportion of patients continuing treatment after 52 weeks. Secondary outcomes included: disease

SUBMITTER: Jobanputra P 

PROVIDER: S-EPMC3532970 | biostudies-literature | 2012

REPOSITORIES: biostudies-literature