The European Commission of the European Union (EU), which is similar to the Food and Drug Administration (FDA) in the United States, has approved the first and only anti-tumor necrosis factor antagonist (TNF-a) medication for treatment of ankylosing spondylitis (AS). Remicade (infliximab) is now the only TNF-a treatment approved in the EU for rheumatoid arthritis, Crohn's disease, and AS.

"The approval of Remicade in the EU represents a significant advance in the treatment of AS, a serious disease that affects a relatively young group of patients and has a significant impact on quality of life and overall function," said Jurgen Braun, M.D., lead investigator and medical director of Rheumazentrum Ruhrgebiet in Herne, Germany, and professor of rheumatology at the Free University in Berlin, Germany. "Until now available treatment was limited to pain medications and NSAIDS. The positive clinical outcomes demonstrated with Remicade show that treating AS patients with this therapy has a significant and sustained impact on the signs and symptoms of this debilitating disease," he added.

AS is characterized by inflammation of the spinal joints, which can cause painful stiffening of the spine and eventually may lead to fusion of the vertebrae. Other joints and tendons in the body may also be affected by the inflammation process. Now, Remicade is approved in the EU for the treatment of AS patients who have severe axial symptoms, elevated serological (SED) markers of inflammatory activity and who have responded inadequately to conventional therapy.

"With this approval, AS patients have an important treatment alternative for a disease that has limited medical options," said Thomas C. Lauda, executive vice president, Schering-Plough Pharmaceuticals (the corporation that markets Remicade around the world). "Remicade continues to demonstrate its effectiveness in treating serious immune disorders and we are committed to further studying its benefits in order to maximize its value for patients," he added.

The EU approved Remicade for use in AS based mainly on results of a one-year study that showed improvement in disease activity in over 50% of the AS patients taking the medication. Many of these patients noticed improvement within 2 weeks of taking the first Remicade dose, and the majority of responding patients maintained improvement through week 54. Physical function and qualify of life were also improved.