., announced today that more than a half million patients worldwide have now been treated with the anti-TNF agent REMICADE® (infliximab) since it was introduced in the United States five years ago. With more than twice as many patients treated versus other TNF inhibitors on the market and through clinical trials conducted over the past 10 years, the safety and efficacy of
REMICADE® have been well established in the approved indications and its position as global market leader among tumor necrosis factor alpha (TNF-a
) therapies has been well maintained. The broad clinical experience with REMICADE® is supported by approvals in 72 countries and is the only biologic drug indicated for the treatment of both rheumatoid arthritis (RA) and Crohn's disease (CD), a serious gastrointestinal disorder, in North America, the European Union and Japan.
"This milestone is an example of the tremendous impact that biologics have had on the treatment of rheumatoid arthritis and Crohn’s Disease," said Jerome A. Boscia, M.D., senior vice president, Clinical Research and Development, Centocor, Inc. "Even with the large scope of this impact, we've only reached a small minority of those patients that could potentially benefit from the promise of biologics. Building on our experiences to date with REMICADE®, we continue to explore its potential in Crohn's Disease and RA and further our commitment in R&D by investigating other inflammatory conditions that share common immune pathways."
REMICADE® is unique among available anti-TNF biologic therapies. Unlike self-administered therapies that require patients to inject themselves frequently, REMICADE® is the only anti-TNF biologic administered directly by caregivers in the clinic or office setting through the nearly 8,500 infusion sites established in the United States. In patients with RA and CD, REMICADE® is typically given every eight weeks, following a standard induction regimen that requires treatment at weeks zero, two and six. As a result, REMICADE® patients may require as few as six treatments each year.
Other important firsts for REMICADE® include:
- In August 1998, REMICADE® became the first anti-TNF therapy introduced to market when it received U.S. Food and Drug Administration approval for the treatment of moderate-to-severe Crohn's disease in patients who had an inadequate response to conventional therapy as well as for the treatment of fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s).
- In August 1999, REMICADE® became the first anti-TNF therapy approved in the European Union (EU) for the short-term treatment of severe, active Crohn's disease and fistulizing, active Crohn's disease in patients who have not responded to conventional therapy.
- In February 2002, REMICADE® became the first anti-TNF agent indicated in the U.S. to improve physical function in patients with moderate to severe RA who have had an inadequate response to methotrexate.
- In June 2002, REMICADE® was the first and only biologic approved in the U.S. to reduce signs and symptoms as well as inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.
- In April 2003, REMICADE® became the first and only anti-TNF agent approved in the U.S. for long-term use in fistulizing Crohn's disease using eight-week maintenance dosing.
REMICADE® is a monoclonal antibody that specifically targets and irreversibly binds to tumor necrosis factor-alpha (TNF-a) on the cell membrane and in the blood. Overproduction of TNF-a is believed to play a role in RA and CD, a serious gastrointestinal disorder, and in a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE® is currently being studied.
REMICADE® is the only anti-TNF biologic therapy that has received marketing authorizations for the treatment of both RA and CD. In the European Union, REMICADE® is also approved for the treatment of ankylosing spondylitis. In most countries, REMICADE®, in combination with methotrexate, is indicated for the treatment of patients with moderately to severely active RA who have had an inadequate response to methotrexate alone. REMICADE® is the only biologic indicated for the treatment of patients with moderately to severely active CD who have had an inadequate response to conventional therapy. REMICADE® is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing CD.