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An infusion reaction was defined in clinical trials as any adverse event occurring during an infusion or within 1 to 2 hours after an infusion. Approximately 20% of Remicade-treated patients in all clinical studies experienced an infusion reaction compared to approximately 10% of placebo-treated patients. Among all Remicade - infliximab infusions, 3% were accompanied by nonspecific symptoms such as fever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain, hypotension, hypertension or dyspnea), and < 1% were accompanied by pruritus, urticaria, or the combined symptoms of pruritus/urticaria and cardiopulmonary reactions.
Serious infusion reactions occurred in < 1% of patients and included anaphylaxis, convulsions, erythematous rash and hypotension. Approximately 3% of patients discontinued Remicade (infliximab) because of infusion reactions, and all patients recovered with treatment and/or discontinuation of the infusion. Remicade infusions beyond the initial infusion were not associated with a higher incidence of reactions.
The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis study. In other psoriasis study, the rates were variable over time and somewhat higher following the final infusion than after the initial infusion. Across the 3 psoriasis studies, the percent of total infusions resulting in infusion reactions (i.e. an adverse event occurring within 1 to 2 hours) was 7% in the 3 mg/kg group, 4% in the 5 mg/kg group, and 1% in the placebo group.
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