MAIDENHEAD, England, June 12 /PRNewswire/ --
-- Study Results Provide Further Evidence That Early Treatment of Rheumatoid Arthritis With Enbrel(R) Plus Methotrexate in Moderate to Severe Patients can Stop the Disease From Progressing, and Helps Patients Return to More Normal and Productive Lives
Data presented today show that 80% of patients with early active rheumatoid arthritis achieved radiographic remission (or non-progression defined as a change in TSS is less than or equal to 0.5) at one year when treated with Enbrel (etanercept) and methotrexate, compared to 59% when treated with methotrexate alone(1). COMET* (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) is the first major trial to use remission as its primary endpoint in patients with early active rheumatoid arthritis treated with a biologic. Data from the landmark COMET study were presented today at the European League Against Rheumatism (EULAR) Annual Meeting in Paris.
The COMET trial also showed that 50% of patients taking this Enbrel combination achieved clinical remission (DAS28<2.6), and nearly 55% achieved functional remission (HAQ <0.5), compared to 28% and 39% respectively when treated by methotrexate alone(1).
"Until recently, we did not know whether remission was a realistic or even achievable goal", said Professor Paul Emery, lead COMET trial investigator and Professor of Rheumatology, University of Leeds, UK. "We now have results which show that not only is clinical remission achievable in a significant number of patients, but radiographic and functional remission are also achievable. These exciting results lead to the next therapeutic step in aiming for multiple measures of remission as our treatment goal, no longer just one. Given that these levels of remission have not previously been seen and represent the optimal goal, these results will lead to the need for treatment of RA with an anti-TNF treatment option such as etanercept at the earliest appropriate opportunity to halt disease progression."
Enbrel's ability to achieve remission in many of the patients treated, irrespective of how it is measured, provides real-life benefits for the patient by stopping the disease from progressing whilst at the same time helping them to continue normal day-to-day functioning. Further data from the COMET trial show that the number of lost work days in patients treated with the Enbrel combination was approximately half that of patients receiving methotrexate alone(2).
No differences were observed in rates of serious infections or malignancies among patients in the Enbrel plus methotrexate group compared with the methotrexate-only group.
The economic data from another study called DART** were also presented at the EULAR Annual Meeting(3), complementing the results from the COMET study. DART trial investigator Professor Robert Moots, Professor of Rheumatology, University of Liverpool, United Kingdom commented: "The DART study confirms that whilst all of the TNF inhibitors are highly effective in reducing disease activity in RA, in normal clinical usage there may be a need to increase the dose of infliximab and adalimumab, but not etanercept, to maintain this beneficial effect. Similarly, the COMET results also demonstrate Enbrel's value by enabling more patients to stay at work than those taking methotrexate alone. In conclusion, these results, coupled with previous studies, demonstrate that Enbrel can not only protect joints from further damage but also permit optimisation of the long-term management of patients with RA, due to a predictable dosing and hence more predictable cost."
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Notes to editors
About ENBREL(4)
ENBREL is a fully human soluble tumour necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and has since been used in nearly 500,000 patients worldwide across indications.
ENBREL in the EU is approved for the following indications:
Rheumatoid arthritis
Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Polyarticular juvenile idiopathic arthritis
Treatment of active polyarticular juvenile idiopathic arthritis in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Enbrel has not been studied in children aged less than 4 years.
Psoriatic arthritis
Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Ankylosing spondylitis
Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Plaque psoriasis
Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA
*COMET study details:
This study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with early active rheumatoid arthritis. Patients in this study had disease duration of less than or equal to 2 years, had not previously received methotrexate, and had active disease based on DAS28 (more than or equal to 3.2) and elevation of erythrocyte sedimentation rate (more than or equal to 28 mm/hr) or C-reactive protein levels (more than or equal to 20 mg/L). Patients were randomised to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268). Primary efficacy endpoints were:
1) The radiographic change at week 52 from baseline assessed by using an X-ray measurement of changes in joint damage, the modified Total Sharp Score (mTSS). Radiographic remission was assessed with the TSS, with non-progression defined as a change in TSS less than or equal to 0.5. Patients receiving Enbrel with methotrexate experienced significantly less progression of joint damage with a 0.27 unit mean change from baseline at one year in TSS, compared with a 2.44 unit mean change in those treated with methotrexate alone which translates into nine times less joint damage with the Enbrel combination versus methotrexate alone (1).
(CONTINUA)
