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Ankylosing Spondylitis

April 5, 2004

Celltech Group reported positive preliminary results from a phase III trial investigating CDP870 for the treatment of rheumatoid arthritis (RA). Results showed the study met its primary endpoint, determined by the number of subjects achieving a 20% reduction in the American College of Rheumatology score ACR20 at 24 weeks. A significant ACR20 response was seen at week 1 and was maintained for the duration of the study. The six-month study (Study 014) was designed to test the safety and efficacy of CDP870 in combination with methotrexate on signs and symptoms of disease over a six month period. They trial enrolled subjects who had active moderate to severe RA despite treatment with methotrexate and other disease modifying anti-rheumatic drugs. In addition, Celltech announced plans to develop CDP870 for new indications, such as psoriasis, psoriatic arthritis and ankylosing spondylitis.

November 10, 2003

Centocor and Schering-Plough reported positive results from a phase III trial investigating Remicade (infliximab), a necrosis factor alpha therapy for the treatment of ankylosing spondylitis (AS). Results showed that subjects achieved a higher reduction in signs and symptoms associated with their disease when treated with Remicade compared with placebo. Data showed that 61.2% achieved an ASAS 20 in the infliximab group, compared with 19.2% placebo. The multi-center, randomized, placebo-controlled, double-blind study called ASSERT (Anklyosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) enrolled 279 subjects at 30 sites in North America and Europe. Subjects were given Remicade monotherapy 5 mg/kg infusions at weeks 0, 2, 6, followed by infusions every six weeks. The primary endpoint was the proportion of subjects demonstrating a 20% or greater improvement in signs and symptoms as measured by the ankylosing spondylitis assessment (ASAS 20) at 24 weeks.