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Remicade Two Year Data in Ankylosing Spondylitis Show Improvement,in Spinal Mobility and Spinal Inflammation

acebo-treated patients achieved a clinically meaningful improvement in BASMI (P < 0.01). The improvement seen at week 24 was maintained through week 102 in those patients who continued in the trial extension (N=161). Furthermore, after crossing over to receive treatment with REMICADE at week 24 following initial treatment with placebo, patients experienced similar improvements in BASMI and chest expansion scores as patients in the REMICADE group at weeks 54, 78 and 102.

"Ankylosing spondylitis can limit spinal mobility and significantly impair a patient's quality of life. These data demonstrate that treatment with REMICADE improved spinal mobility. Over time, this improvement can be maintained when REMICADE is coupled with physiotherapy," said Professor Jurgen Braun, M.D., lead physician at the Rheumazentrum Ruhrgebiet and Professor of Rheumatology at the Free University of Berlin. "In studying the same group of patients, REMICADE therapy also had a positive effect on spinal inflammation, a common and debilitating manifestation of ankylosing spondylitis."

In ASSERT spinal inflammation as detected by MRI was examined. Patients receiving REMICADE showed improvement in MRI Activity scores at week 24, which was sustained through week 102 in those patients who continued in the trial extension (N=161). Patients initially in the placebo group showed no change in MRI Activity scores at week 24, but scores improved after crossing over to receive treatment with REMICADE. The relationship of spinal inflammation as measured by activity scores on MRI to long-term structural damage in AS is unknown.

About ASSERT

In ASSERT (Ankylosing Spondylitis [AS] Study for the Evaluation of Recombinant Infliximab Therapy), 279 patients with AS for at least three months, radiographic evidence of sacroiliitis and symptoms of active disease (BASDAI of at least 4 and visual analog scale for spinal pain of at least 4, each on a scale of one to 10) were randomized to rec
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