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

eive infusions of REMICADE 5 mg/kg at weeks 0, 2 and 6 and every six weeks thereafter through week 96 (n = 201) or placebo (n = 78). The primary endpoint of the trial was a 20 percent decrease in disease activity score on the Assessment in Ankylosing Spondylitis Response Criteria (ASAS 20) at week 24.

At week 24, placebo patients were crossed over to receive treatment with REMICADE 5 mg/kg at weeks 0, 2 and 6 and every six weeks thereafter and continued on REMICADE through the remainder of the study (96 weeks). Starting at week 36, and continuing through week 96, patients initially randomized to receive REMICADE 5 mg/kg had their dose increased to 7.5 mg/kg if they had a BASDAI of at least 3 in two consecutive evaluations to assess the potential for improved response through increased dosing. Using these rather strict criteria, 106 patients (53 percent) received a dose increase some time after week 30.

Nine percent of patients who received REMICADE through week 102 discontinued the study due to adverse events (AEs). During the study, REMICADE was generally well-tolerated. At week 24, the most commonly reported AEs were upper respiratory tract infections, which occurred at a rate of 15 percent in the placebo group, compared with 14 percent in the REMICADE group. The only laboratory abnormalities that occurred more frequently with REMICADE compared with placebo were asymptomatic liver enzyme test elevations. At week 24, serious (AEs) were reported in 4 percent of REMICADE-treated patients, compared with three percent of patients receiving placebo. AEs were generally mild and were consistent with REMICADE prescribing information.

There were no reports of congestive heart failure, tuberculosis or serious infections in the study population. Three malignancies were reported in three patients during the ASSERT study and included squamous cell skin cancer, lung cancer and breast cancer. Please see "Important Safety Information" below.

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