Infliximab Now Approved for Use in Ankylosing Spondylitis; Centocor Updates Warning Labels
Infliximab (Remicade®), currently an approved treatment for rheumatoid arthritis and Chron's disease, is now FDA approved for reducing signs and symptoms in active ankylosing spondylitis. Approved for treatment in AS in Europe since 2003, the U.S. approval is based primarily on the 24-week results of the ASSERT (Ankylosing Spondylitis Study for the Evaluation of Recombinant Infliximab Therapy) trial, which demonstrated that AS patients treated with Remicade achieved significant improvement in signs and symptoms associated with their disease, including reduced spinal pain and increased physical function.
Additionally, as a result of post-marketing reports, Centocor has annouced that they will update their warning label to include an increased risk of pneumonia and hepatotxicity associated with use of infliximab. Thus, while infliximab therapy can offer sustained reduction in the signs and symptoms of ankylosing spondylitis, as with any treatment, patients need to be monitored closely for the development of any potential side effects.