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Etanercept (Enbrel) Shows Long-term Efficacy and Safety for Rheumatoid Arthritis: Presented at ACR

By Bruce Sylvester

SAN ANTONIO, TX -- October 22, 2004 -- In patients on long-term therapy for rheumatoid arthritis (RA), etanercept (Enbrel) continues to be both effective and safe, according to research presented here on October 20th at the 68th Annual Scientific Meeting of the American College of Rheumatology.

In addition, long-term use of etanercept allows patients to reduce their background corticosteroid doses, reported investigator Michael Weinblatt, MD, associate director of the Center for Arthritis and Joint Diseases, Brigham and Women's Hospital, Boston, Massachusetts.

The study pooled data on 207 patients with early RA (up to 3 years disease duration) who had received etanercept 25 mg twice weekly, and in 644 patients with long-standing RA (more than 3 years disease duration). The researchers also evaluated data from the subjects with early RA who continued to receive the same dosage for more than 6 years, and for subjects with long-standing RA who received the same dosage for more than 7 years.

The subjects were allowed to use other DMARDs, including methotrexate, during the extension studies.

The researchers evaluated safety and persistence data for all subjects receiving etanercept (all dosages) in early RA studies (n = 558) and long-standing RA studies (n = 884, including 69 pediatric patients).

They reported that patients achieved statistically significant improvements in multiple measures of disease activity, and the improvements were sustained for up to 7 years of treatment.

Patients with early RA received etanercept for a median of 5.5 years, and those with long-standing RA received the drug for a median of 5.6 years. Of the 558 early RA patients, 58% continue treatment with etanercept, as do 44% of the 884 long-standing RA patients.

Adverse events accounted for the highest percentage of discontinuations, 10% among early RA subjects and 12% among long-standing RA subjects. Subject refusal of treatment (7% early RA and 8% long-standing RA) and lack of efficacy (6% early RA and 10% long-standing RA) accounted for additional terminations.

The investigators reported that rates of adverse events and serious adverse events remained low over time and were consistent with rates observed in the placebo groups from the controlled phase of the studies.

The researchers also noted that most subjects were able to stop use of concomitant corticosteroid and methotrexate therapy while using etanercept.

Mortality rate in the entire cohort was 3.4% in early RA patients and 3.3% in long-standing RA patients, including 4 from malignancy and 4 from cardiac disease. The researchers had estimated that 53 patients would die. Two deaths resulted from sepsis, out of a total of 11 reported cases (early RA, n= 3 and long-standing RA, n = 8).

In up to 7 years of etanercept treatment, lymphoma was diagnosed in 2 early RA patients and 7 long-standing RA patients; 2 cases were expected. There have been no cases of tuberculosis or opportunistic infections.

"These results demonstrate the durability of response of etanercept in relieving the signs and symptoms of RA," the authors concluded. "Improvements in multiple measures of efficacy were sustained for up to 7 years of therapy, and the safety profile of etanercept appears to be unchanged with long-term treatment."

Etanercept is a self-injectable biologic response modifier that suppresses the tumor necrosis factor (TNF) proteins associated with joint inflammation. The United States Food and Drug Administration approved the drug in 1998 for reducing the signs and symptoms of moderately to severely active RA, to slow the progression of structural damage and to improve physical function. It is used as monotherapy or with methotrexate.


[Presentation title: Efficacy and Safety of Over 7 Years of Etanercept (EnbrelŪ) Therapy in North American Patients With Early and Long-Standing Rheumatoid Arthritis. Abstract 356]

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