RESEARCH - Safety and efficacy of adding Enbrel to MTX or MTX to Enbrel in moderately active RA patients previously treated with monotherapy

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Published Online First: 29 August 2007. doi:10.1136/ard.2007.076166

ls of the Rheumatic Diseases 2008;67:182-188

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EXTENDED REPORTS

The safety and efficacy of adding etanercept to methotrexate or methotrexate

to etanercept in moderately active rheumatoid arthritis patients previously

treated with monotherapy

D van der Heijde 6, G Burmester 1, J Melo-Gomes 2, C Codreanu 3, E

Mola 4, R Pedersen 5, B Freundlich 5, D J Chang 5, for the Etanercept Study

400 Investigators

1 Charité Hospital, Humboldt University, Berlin, Germany

2 SERVIMED, Lisbon, Portugal

3 Centrul de Boli Reumatismale, Bucharest, Romania

4 Hospital La Paz, Madrid, Spain

5 Wyeth Research, Collegeville, PA, USA

6 Leiden University Medical Center, 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.

http://ard.bmj.com/cgi/content/abstract/67/2/182

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