Wyeth Presents New Analyses Of Data From Three Studies Of ENBREL(R) At The European League Against Rheumatism (EULAR) Annual Meeting

Analyses of data from three studies provide insight into the use of ENBREL®(etanercept) in the treatment of three conditions for which ENBREL is indicated: moderate-to-severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). These analyses, presented this week during the European League Against Rheumatism (EULAR) Annual Meeting in Copenhagen, add to the body of evidence that supports treatment with ENBREL for patients with these conditions.


Analyses from three separate trials of ENBREL -- COMET*, ASCEND** and PRESTA*** -- showed that:


The group of patients with early-active moderate-to-severe RA treated with ENBREL and methotrexate, who achieved and sustained a halt of progressive joint damage, maintained this level at two years, according to the COMETstudy


In patients with AS (including those with and without peripheral joint involvement), ENBREL therapy significantly improved signs, symptoms, function, and mobility when compared to treatment with the DMARD sulfasalazine, according to the ASCEND study


At step-down and usual doses, ENBREL provided significant improvement in joint symptoms compared to baseline in patients with active PsA in addition to achieving clearer skin, according to the PRESTA study



"Inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis significantly impact the daily lives of the patients who live with these conditions. These analyses support the role of etanercept therapy in the management of these diseases. The EULAR congress provides an important platform to present new information regarding ENBREL as a treatment option for patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis," said Maxime Dougados, Professor of Rheumatology, Ren?© Descartes University Paris, France.


*The COMET Study


The COMET (COmbination of Methotrexate and ETanercept in early rheumatoid arthritis) study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy (EM) with methotrexate alone (M) on clinical disease activity and progressive joint damage in patients with early active rheumatoid arthritis. COMET was the first published study to use clinical remission as a primary endpoint.



Subjects were randomised at baseline. Those who completed 1 year of treatment entered year 2 (n=411). The original combination group either continued combination (EM/EM; n=111) or received ENBREL monotherapy (EM/E; n=111) in year 2; the original methotrexate monotherapy group either received combination (M/EM; n=90) or continued monotherapy (M/M; n=99). Efficacy endpoints included clinical remission (DAS28







Following are the year 2 COMET study results:



From the end of year 1 to the end of year 2, fifty percent of patients receiving ENBREL monotherapy achieved clinical remission compared to 35 percent of methotrexate monotherapy patients



The percentage of subjects achieving clinical remission was significantly greater in the groups containing ENBREL (continued combination therapy EM/EM, E/ME and delayed combination M/EM) than in the continued methotrexate monotherapy (M/M) group (using both LOCF and NRI measurements)


Non-progression of joint damage was achieved by a significantly greater percentage in the continued combination group compared with all other groups (P