Remicade - Clinical Pharmacology

(Page 4)

(Table 1).

In Study RA II, after 54 weeks of treatment, both doses of REMICADE + MTX resulted in statistically significantly greater response in signs and symptoms compared to MTX alone as measured by the proportion of patients achieving ACR 20, 50 and 70 responses (Table 1). More patients treated with REMICADE reached a major clinical response than placebo-treated patients (Table 1).

Physical function response

Physical function and disability were assessed using the Health Assessment Questionnaire (HAQ) and the general health-related quality of life questionnaire SF-36.

In Study RA I, all doses/schedules of REMICADE + MTX showed significantly greater improvement from baseline in HAQ and SF-36 physical component summary score averaged over time through week 54 compared to placebo + MTX, and no worsening in the SF-36 mental component summary score. The median (interquartile range) improvement from baseline to week 54 in HAQ was 0.1 (-0.1, 0.5) for the placebo + MTX group and 0.4 (0.1, 0.9) for REMICADE + MTX (p<0.001). Both HAQ and SF-36 effects were maintained through week 102. Approximately 80% of patients in all doses/schedules of REMICADE + MTX remained in the trial through 102 weeks.

In Study RA II, both REMICADE treatment groups showed greater improvement in HAQ from baseline averaged over time through week 54 compared to MTX alone; 0.7 for REMICADE + MTX vs. 0.6 for MTX alone (p=0.001). No worsening in the SF-36 mental component summary score was observed.

Active Crohn’s Disease

The safety and efficacy of single and multiple doses of REMICADE were assessed in two randomized, double-blind, placebo-controlled clinical studies in 653 patients with moderate to severely active Crohn’s disease [Crohn’s Disease Activity Index (CDAI) =220 and =400] with an inadequate response to prior conventional therapies. Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 92% of patients continued to receive at least one of these medications.