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Study Reinforces Safety of Long-term Biologic Treatment for Rheumatoid Arthritis

A new study has emphasised the safety and efficacy of Enbrel (etanercept) in the long-term treatment of rheumatoid arthritis (RA) patients .

Biologics, such as etanercept, work by blocking the action of a naturally occurring protein in the body called tumour necrosis factor that is involved in causing inflammation. When combined with methotrexate, etanercept, also known as an anti-TNF therapy, etanercept has shown to halt radiographic damage in patients with moderate RA activity over multiple years, which means the disease is halted at that stage.

The study was conducted by a team of researchers at Wyeth Pharmaceuticals.

As part of the study, researchers analysed 2,054 patients receiving this biologic treatment for up to nine years by monitoring them for serious adverse events (SAEs), serious and opportunistic infections, sepsis, malignancies and lymphomas.

Researchers found that the overall rates of SAEs 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, that means that there were improvements in disability whilst safety was also sustained over the long-term in the patients.

The 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.

These strong data should give doctors the confidence to consider a biologic earlier in patients with aggressi ve 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, Professor Lars Klareskog of Karolinska Institute Karolinska University Sweden, said.

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. Its critical that appropriate funding for biologics is sourced to continue the fight against serious inflammatory diseases, such as RA.

The findings of the study were presented at the EULAR (European League Against Rheumatism) congress.


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