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| |  FDA Approves Enbrel For Rheumatoid Arthritis SEATTLE, WA -- Nov. 3, 1998 -- The United States Food and Drug Administration has approved Immunex Corp.’s and Wyeth-Ayerst Laboratories’ Enbrel(TM) (etanercept) for the treatment of rheumatoid arthritis. The first in a new class of rheumatoid arthritis (RA) drugs known as biologic response modifiers, Enbrel is an entirely new approach to management of moderate to severe RA. In clinical studies of patients with moderate to severe RA, Enbrel has been shown to reduce pain and duration of morning stiffness and improve the number of swollen and tender joints, enabling patients to better participate in daily activities. "Enbrel works in an entirely new way, specifically interrupting the inflammatory process in RA, in which TNF plays a key role," said Dr. Michael Franklin, an ENBREL clinical investigator and chief of rheumatology at Abington Memorial Hospital in Philadelphia, PA. "Enbrel has been shown to provide dramatic symptomatic relief, even in patients who have not been successfully treated with current options." Enbrel is indicated for the reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. The dosage of Enbrel for adult patients with RA is 25 mg given twice weekly as a subcutaneous injection. Enbrel acts by binding tumour necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Enbrel has been studied in more than 1,000 people with RA. At three months, Phase III study results in 234 patients demonstrated that 62 percent of the patients receiving a 25 mg dose of ENBREL reached the primary endpoint of 20 percent improvement by ACR criteria -- a composite score of select measurements of RA symptoms including joint pain, joint swelling and patient and physician global assessment -- compared to 23 percent of the patients in the placebo group. In this study, responses were rapid, often appearing within one to two weeks after initiation of therapy, and nearly always occurred within three months. At six months, the secondary endpoints of this study demonstrated a 69 percent median improvement in pain (versus two percent for placebo), a 71 percent median improvement in tender joint counts (versus six percent for placebo), a 51 percent median improvement in swollen joint counts (versus two percent for placebo) and an 88 percent median reduction in duration of morning stiffness (versus four percent for placebo). Phase III results confirmed earlier Phase II findings. The most frequently reported adverse events in studies with Enbrel were mild to moderate injection site reactions, however, the long-term effects of Enbrel treatment, on the development or course of serious infection, malignancy and autoimmune disease are unknown. Patients with a serious infection, including sepsis, or who are allergic to Enbrel or any of its components should not take Enbrel. If patients develop a serious or unusual infection while on Enbrel, they should talk with their doctor immediately.
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