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Remicade Responders Maintain Improvement

through week 22 (ACT 2) or week 46 (ACT 1). Patients were allowed to continue to receive conventional therapy.

Patients who had benefited from treatment with REMICADE and, in the investigators opinion, could enroll in the extension trials; 118 patients entered the ACT 1 extension and 111 patients entered the ACT 2 extension. During the extension, patients continued to receive REMICADE 5 mg/kg or REMICADE 10 mg/kg every 8 weeks. Patients in the extension trials were assessed using the PGA, which is 1 of 4 measures of disease activity included in the Mayo score. Of these 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, but were discontinued upon unblinding.

Over the course of the extension trials subjects were allowed to adjust corticosteroid use as required. When corticosteroid use during the extension in all participants (which included subjects previously on corticosteroids and those that had not used corticosteroids) was examined, a smaller proportion of the subjects who had completed follow-up through Weeks 56 and 104 were using corticosteroids. At weeks 8, 56 and 104 of the ACT extension trials, 80 percent, 88 percent and 98 percent of patients, respectively, were corticosteroid-free.

Overall, side effects were generally well tolerated with less than five percent of patients discontinuing therapy due to an adverse event (AE). As previously reported, other notable serious adverse events (SAEs) included: prostate cancer, breast cancer, pneumonia, sarcoidosis, abscess and a death following Histoplasmosis pneumonia.


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