RESEARCH - The safety and efficacy of adding Enbrel to MTX or MTX to Enbrel in RA

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Ann Rheum Dis. 2008 Feb;67(2):182-8. Epub 2007 Aug 29.

The safety and efficacy of adding etanercept to methotrexate or

methotrexate to etanercept in moderately active rheumatoid arthritis

patients previously treated with monotherapy.

van der Heijde D, Burmester G, Melo-Gomes J, Codreanu C, Mola EM,

Pedersen R, Freundlich B, Chang DJ; Etanercept Study 400

Investigators.

Leiden University Medical Center, PO Box 9600, 2300RC Leiden, The Netherlands.

OBJECTIVE: To determine if adding etanercept (ETN) to methotrexate

(MTX) or MTX to ETN for 52 weeks in rheumatoid arthritis (RA) patients

with moderate disease activity provides higher efficacy. METHODS: All

patients (n = 227) received open-label ETN 25 mg subcutaneously

twice-weekly and MTX orally up to 20 mg weekly for 52 weeks and had

completed a 3-year study in which patients received MTX, ETN or

combination therapy. Endpoints were based on Disease Activity Score

(DAS) and European League Against Rheumatism (EULAR) responses.

RESULTS: Patients previously receiving combination therapy

(Combination group; n = 96) had a lower disease activity at baseline.

The mean DAS for those previously receiving MTX (ETN-added group; n =

55) and previously receiving ETN (MTX-added group; n = 76) were in the

moderate disease activity range at baseline; Combination patients had

a low disease activity. The greatest increase in DAS remission rates

from baseline to week 52 was in the ETN-added group (23.6% to 41.8%,

p<0.01), although Combination (37.6% to 50.0%, p<0.01) and MTX-added

(26.7% to 36.8%, p = NS) also demonstrated improvements. DAS low

disease activity and EULAR responses showed similar results. No new

safety issues were identified.

CONCLUSION: RA patients who were partial responders to long-term MTX

or etanercept monotherapy obtained a higher efficacy with combination

therapy. Responses achieved by patients with combination therapy after

3 years in the previous study were sustained or improved during the

fourth year of treatment. This trial supports the higher therapeutic

effect of combination treatment with etanercept and MTX in RA patients

with moderate disease activity despite monotherapy with one of the two

agents.

PMID: 17728331

http://www.ncbi.nlm.nih.gov/pubmed/17728331

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