A randomised controlled trial of etanercept and methotrexate to induce remission in early inflammatory arthritis: the EMPIRE trial
- 11 March 2014
- journal article
- research article
- Published by BMJ in Annals Of The Rheumatic Diseases
- Vol. 73 (6), 1027-1036
- https://doi.org/10.1136/annrheumdis-2013-204882
Abstract
Objective To compare the efficacy of etanercept (ETN) and methotrexate (MTX) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis. Methods In a 78-week multicentre randomised placebo-controlled superiority trial, 110 DMARD-naïve patients with early clinical synovitis (≥1 tender and swollen joint, and within 3 months of diagnosis) and either rheumatoid factor, anticitrullinated protein antibodies or shared epitope positive were randomised 1:1 to receive MTX+ETN or MTX+placebo (PBO) for 52 weeks. Injections (ETN or PBO) were stopped in all patients at week 52. In those with no tender or swollen joints (NTSJ) for >26 weeks, injections were stopped early. If patients had NTSJ >12 weeks after stopping the injections, MTX was weaned. The primary endpoint was NTSJ at week 52. Results No statistically significant difference was seen for the primary endpoint (NTSJ at week 52 (32.5% vs 28.1% [adjusted OR 1.32 (0.56 to 3.09), p=0.522]) in the MTX+ETN and MTX+PBO groups, respectively). The secondary endpoints did not differ between groups at week 52 or 78. Exploratory analyses showed a higher proportions of patients with DAS28-CRPConclusions In this group of patients with early inflammatory arthritis, almost a third had no tender, swollen joints after 1 year. MTX+ETN was not superior to MTX monotherapy in achieving this outcome. Clinical responses, however, including DAS28-CRPTrial registration number The EMPIRE trial is registered on the following trial registries: Eudract-2005-005467-29; ISRCTN 55428162 (http://www.controlled-trials.com/ISRCTN55428162/EMPIRE). The full trial protocol can be obtained from the corresponding author.Keywords
This publication has 31 references indexed in Scilit:
- An immunological biomarker to predict MTX response in early RAAnnals Of The Rheumatic Diseases, 2013
- Induction therapy with adalimumab plus methotrexate for 24 weeks followed by methotrexate monotherapy up to week 48 versus methotrexate therapy alone for DMARD-naïve patients with early rheumatoid arthritis: HIT HARD, an investigator-initiated studyAnnals Of The Rheumatic Diseases, 2012
- American College of Rheumatology/European League Against Rheumatism Provisional Definition of Remission in Rheumatoid Arthritis for Clinical TrialsAnnals Of The Rheumatic Diseases, 2011
- 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiativeAnnals Of The Rheumatic Diseases, 2010
- Validation of the 28-joint Disease Activity Score (DAS28) and European League Against Rheumatism response criteria based on C-reactive protein against disease progression in patients with rheumatoid arthritis, and comparison with the DAS28 based on erythrocyte sedimentation rateAnnals Of The Rheumatic Diseases, 2008
- Efficacy of methotrexate treatment in patients with probable rheumatoid arthritis: A double‐blind, randomized, placebo‐controlled trialArthritis & Rheumatism, 2007
- Presentation and analysis of radiographic data in clinical trials and observational studiesAnnals Of The Rheumatic Diseases, 2005
- Deciding on progression of joint damage in paired films of individual patients: smallest detectable difference or changeAnnals Of The Rheumatic Diseases, 2005
- Very early treatment with infliximab in addition to methotrexate in early, poor‐prognosis rheumatoid arthritis reduces magnetic resonance imaging evidence of synovitis and damage, with sustained benefit after infliximab withdrawal: Results from a twelve‐month randomized, double‐blind, placebo‐controlled trialArthritis & Rheumatism, 2005
- Autoantibodies to cyclic citrullinated peptides predict progression to rheumatoid arthritis in patients with undifferentiated arthritis: A prospective cohort studyArthritis & Rheumatism, 2004