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REMICADE cannot be compared to rates of clinical trials of otherTNF blockers and may not predict rates observed in a broader patient population. An increased rate of lymphoma up to several fold hasbeen reported in the Crohn's disease and rheumatoid arthritis patient populations, and may be further increased in patients with moresevere disease activity. Other than lymphoma, 13 patients developed malignancies, which was similar in number to what would beexpected in the general population. Of these, the most common malignancies were breast, colorectal, and melanoma. (see WARNINGS, Malignancies.) Malignancies, including non-Hodgkin’s lymphoma and Hodgkin’s disease, have also been reported in patients receiving REMICADE duringpost-approval use.Patients with Heart FailureIn a randomized study evaluating REMICADE in moderate to severe heart failure (NYHA Class III/IV; left ventricular ejection fraction=35%), 150 patients were randomized to receive treatment with 3 infusions of REMICADE 10 mg/kg, 5 mg/kg, or placebo, at 0, 2, and 6weeks. Higher incidences of mortality and hospitalization due to worsening heart failure were observed in patients receiving the 10 mg/kgREMICADE dose. At 1 year, 8 patients in the 10 mg/kg REMICADE group had died compared with 4 deaths each in the 5 mg/kgREMICADE and the placebo groups. There were trends towards increased dyspnea, hypotension, angina, and dizziness in both the 10 mg/kgand 5 mg/kg REMICADE treatment groups, versus placebo. REMICADE has not been studied in patients with mild heart failure (NYHAClass I/II) (see CONTRAINDICATIONS andWARNINGS, Patients with Heart Failure). Text Continues Below
Immunogenicity Treatment with REMICADE can be associated with the development of antibodies to infliximab. The incidence of antibodies to infliximab in patients given a 3-dose induction regimen followed by maintenance dosing was approximately 10% as assessed through one to two years of REMICADE treatment. A higher incidence of antibodies to infliximab was observed in Crohn’s disease patients receiving REMICADE after drug free intervals >16 weeks. The majority of antibody-positive patients had low titers. Patients who were antibody positive were more likely to have higher rates of clearance, reduced efficacy and to experience an infusion reaction (see ADVERSE REACTIONS, Infusion-related Reactions) than were patients who were antibody negative. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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