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.