RESEARCH - Efficacy and safety of Enbrel + MTX vs. Enbrel alone: the ADORE study

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Ann Rheum Dis. 2006 Feb 7; [Epub ahead of print]

Efficacy and safety of combination etanercept and methotrexate versus

etanercept alone in patients with rheumatoid arthritis with an inadequate

response to methotrexate: The ADORE study.

van Riel PL, Taggart AJ, Sany J, Gaubitz M, Nab HW, Pedersen R, Freundlich

B, Macpeek D.

University Medical Center Nijmegen, Netherlands.

OBJECTIVE: To evaluate the efficacy and safety of etanercept monotherapy

compared to the combination etanercept and methotrexate therapy in patients

with rheumatoid arthritis whohave had an inadequate response to methotrexate

monotherapy. METHODS: Patients with active rheumatoid arthritiswho were

taking methotrexate >/=12.5 mg/week for >/=3 months were included in this

16-week, randomised, open-label study. Patients were randomly assigned to

either etanercept (25 mgas a subcutaneous injection twice weekly) added to

the baseline dose of methotrexate or etanercept monotherapy. RESULTS: Three

hundredand fifteen (315) patients were randomised to etanercept (n = 160),

or etanercept plus methotrexate (n = 155). The primary endpoint, DAS28 (4)

improvement of >1.2 units, was achieved by 72.8% and 75.2% of etanercept and

etanercept plus methotrexate patients, respectively, which was not

significantlywith no significant difference different.between the two

groups. The European League Against Rheumatism response criteria of good or

moderate response was attained by 80.1%80.0% of patients in the etanercept

group and 82.4% of patients in the etanercept plus methotrexate group. ACR

20%, 50%, and 70% response rates achieved by both groups were also similar:

71.0% v 67.1%, 41.9% v 40.1%, and 17.4% v 18.4%, respectively. The rates of

adverse and serious adverse events were similar between the etanercept and

etanercept plus methotrexate groups.treatment groups.

CONCLUSION: Both the addition of etanercept to methotrexate and the

substitution of etanercept for methotrexate in patients with rheumatoid

arthritis, who had an inadequate response to methotrexate, resulted in

substantial improvements in clinical signs and symptoms and were generally

well-tolerated treatment strategies for improving clinical signs and

symptoms of rheumatoid arthritis.

PMID: 16464988

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6464988 & dopt=Abstract

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