Remicade - Side Effects & Drug Interactions

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Most of these cases of tuberculosis occurred within the first two months after initiation of therapy with infliximab and may reflect recrudescence of latent disease (see WARNINGS, RISK OF INFECTIONS). In the RA trials at 1 year, 5.3% of patients receiving infliximab and MTX every 8 weeks developed serious infections as compared to 3.4% of placebo patients receiving MTX. Of 924 patients receiving infliximab, 1.7% developed pneumonia and 0.4% developed TB, when compared to 0.3% and 0.0% in the placebo arm respectively. During the 54 weeks Crohn’s II Study, 15% of patients with fistulizing Crohn’s disease developed a new fistula-related abscess. In post-marketing experience, infections have been observed with various pathogens including viral, bacterial, fungal, and protozoal organisms.

Infections have been noted in all organ systems and have been reported in patients receiving REMICADE alone or in combination with immunosuppressive agents.

Autoantibodies/Lupus-like Syndrome

Approximately half of infliximab-treated patients in clinical trials who were antinuclear antibody (ANA) negative at baseline developed a positive ANA during the trial compared with approximately one-fifth of placebo-treated patients. Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients. Reports of lupus and lupus-like syndromes, however, remain uncommon.

Malignancies

Among 2410 patients with moderately to severely active rheumatoid arthritis and Crohn's disease treated with REMICADE in clinical trials with a median of 1.1 years of follow-up, 3 patients developed lymphomas, for a rate of 0.07 cases per 100 patient-years of followup in patients with rheumatoid arthritis and 0.12 cases per 100 patient-years of follow up in the combined clinical trial data for rheumatoid arthritis and Crohn’s disease patients. This is approximately 3-fold higher in the RA clinical trial population and 6-fold higher in the overall clinical trial population than expected in an age-, gender-, and race-matched general population based on the Surveillance, Epidemiology and End Results Database. Rates in clinical trials for