Barcelona, Spain, 13 June 2007 -- New data demonstrating the safety and efficacy of Enbrel® (etanercept) in the treatment of rheumatoid arthritis (RA) patients over the long-term were presented today at the EULAR (European League Against Rheumatism) congress (1). Over 2,000 patients receiving this biologic treatment for up to nine years, saw improvements in disability whilst safety was also sustained over the long-term.
Biologics, such as etanercept, work by blocking the action of a naturally occurring protein in the body called ‘tumor necrosis factor’ that is involved in causing inflammation (2). When combined with methotrexate, etanercept, also known as an anti-TNF therapy, has been shown to halt radiographic damage in patients with moderate RA activity over multiple years – which means the disease is halted at that stage (3).
Professor Lars Klareskog of Karolinska Institute Karolinska University Sweden, said, “These strong data should give doctors the confidence to consider a biologic earlier in patients with aggressive and progressive rheumatoid arthritis, and patients should now have the prospect of less disability with a treatment which has also proven to have a good long-term safety”.
The analysis includes over nine thousand patient years of data from a total of 2,054 patients who were monitored for serious adverse events (SAEs), serious and opportunistic infections, sepsis, malignancies and lymphomas. Overall rates of SAE’s were similar to control groups (0.11 pt-yr and 0.17 pt/yr vs 0.11-0.20/pt yr), as were serious infections, and reports of opportunistic infection were rare (1).
Professor Emilio Martin Mola of the Rheumatology Unit at Hospital Universitario La Paz, Spain added: “With both earlier and continuous use of Enbrel we can prevent the debilitating affects of RA taking hold and maintain this response for many years. It’s critical that appropriate funding for biologics is sourced to continue the fight against serious inflammatory diseases, such as RA.”
The economic burden created by RA in Europe is significant due to costs from work disability and 20-30% of patients become permanently disabled during the first two or three years of the disease (4). This latest study adds to the clinical evidence highlighting the role of prevention of disease progression through earlier anti-TNF treatment. Given the significant social and economical burden of this disease this makes good sense for patients and healthcare systems alike.
Enbrel has a well characterized safety profile and is well tolerated. Although a rare event, a higher than expected rate of lymphoma was observed in the analysis. However, further study is required to establish whether this is related to TNF antagonist exposure or reflects the elevated risk of lymphoma in patients with RA.
EMBARGOED UNTIL 00:01 CET 13th June 2007
About Rheumatoid Arthritis (RA)
Rheumatoid arthritis (RA) is a chronic inflammatory disease that typically affects the hands and feet although any joint lining may be affected (5). If the condition persists over time, it can cause permanent damage to tendons, ligaments, cartilage and bone, resulting in potential destruction and deformity (5). Potential irreversible joint damage may lead to loss of function and premature death (6). RA is also associated with serious morbidities including coronary artery disease infection and lymphoma (7).
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1) Klareskog L. Safety and Efficacy of Over 9 Years of Continuous Etanercept Therapy in Patients with Rheumatoid Arthritis in North America and Europe, EULAR Congress 2007, Poster No. THU0170
2) Weaver, A L, the Impact of new biologicals in the treatment of Rheumatoid Arthritis Rheumatology 2004;43 (Suppl.3):iii17-iii23
3) van der Heijde, D. et al. Combination etanercept and methotrexate halts radiographic damage in patients with moderate RA activity on methotrexate, EULAR Congress 2007, Poster No. THU0213
4) Sokka T. Work disability in early rheumatoid arthritis. Clinical and Experimental Rheumatology 2003;21 (Suppl.31) S71-S74
5) Lee DM, Weinblatt ME. Rheumatoid arthritis Lancet 2001; 358: 903-911
6) Callahan LF, Pincus T. Mortality in the rheumatic diseases. Arthritis Care Res 1995;8:229-41
7) Gabriel SE. The epidemiology of rheumatoid arthritis. Rheum. Dis. Clin. North Am. 2001;27:269-281