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 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."