"These diseases are devastating to patients and their loved ones and we are excited to see more and better therapies become available to ease their suffering," said Richard J. Geswell, President, Crohn's & Colitis Foundation of America.
About the ACT Long-Term Extension
Patients with moderate to severe UC, defined as a baseline Mayo score 6 and 12, who were unresponsive to or intolerant to at least one standard therapy, including corticosteroids, immunosuppressants or 5ASAs, were enrolled in ACT 1 (n=364) or ACT 2 (n=364). The 728 patients were randomized to receive REMICADE 5 mg/kg, REMICADE 10 mg/kg or placebo at weeks 0, 2, 6 and every subsequent 8 weeks through week 22 (ACT 2) or week 46 (ACT 1). Patients were allowed to continue to receive conventional therapy.
Patients who completed treatment through the final infusion visit and who, in the opinion of the investigator, could benefit from continued treatment with REMICADE could enroll in the extension trials. Across multiple sites, one hundred and eighteen (118) patients were entered into the ACT 1 extension and 111 patients were entered into the ACT 2 extension.
During the extension, patients continued to receive the study drug to which they were originally randomized (REMICADE 5 mg/kg, REMICADE 10 mg/kg or placebo) every 8 weeks. Patients in the extension trials were assessed using the Physicians Global Assessment (PGA), which is 1 of 4 measures of disease activity included in the Mayo score. Of the 229 patients who entered the extension, 181 have been followed through one year, and 92 have completed two years. Patients who had responded to placebo also enrolled in
the extension to maintain the blind and continued to receive placebo every 8 weeks.
Overall, REMICADE was generally well tolerated in the long-term extensions, with less than five percent of patients discontinuing therapy due to an adverse event (AE). As previously rep
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