an infusion reaction during the induction period, 9% experienced an infusion reaction duringthe maintenance period.
Among all infliximab infusions, 3% were accompanied by nonspecific symptoms such asfever or chills, 1% were accompanied by cardiopulmonary reactions (primarily chest pain,hypotension, hypertension or dyspnea), and <1% were accompanied by pruritus, urticaria, orthe combined symptoms of pruritus/urticaria and cardiopulmonary reactions. Serious infusionreactions occurred in <1% of patients and included anaphylaxis, convulsions, erythematousrash and hypotension. Approximately 3% of patients discontinued infliximab because ofinfusion reactions, and all patients recovered with treatment and/or discontinuation of theinfusion. Infliximab infusions beyond the initial infusion were not associated with a higherincidence of reactions. The infusion reaction rates remained stable in psoriasis through 1 year in psoriasis Study I. In psoriasis Study II, the rates were variable over time and somewhathigher 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 eventoccurring within 1 hour) was 7% in the 3 mg/kg group, 4% in the 5 mg/kg group, and 1% inthe placebo group.
Patients who became positive for antibodies to infliximab were more likely (approximatelytwo-to three-fold) to have an infusion reaction than were those who were negative. Use ofconcomitant immunosuppressant agents appeared to reduce the frequency of both antibodiesto infliximab and infusion reactions [see Adverse Reactions (6.1) and Drug Interactions(7.4)].
Infusion reactions following re-administration
In a clinical trial of patients with moderate to severe psoriasis designed to assess the efficacyof long-term maintenance therapy versus re-treatment with an induction regimen ofinfliximab following disease flare, 4% (8/219) of patients in the re-treatment therapy armexperienced serious infusion reactions versus < 1% (1/222) in the maintenance therapy arm.
Patients enrolled in this trial did not receive any concomitant immunosuppressant therapy. Inthis study, the majority of serious infusion reactions occurred during the second infusion atWeek 2. Symptoms included, but were not limited to, dyspnea, urticaria, facial edema, andhypotension. In all cases, infliximab treatment was discontinued and/or other treatmentinstituted with complete resolution of signs and symptoms.
Delayed Reactions/Reactions Following Re-administration
In psoriasis studies, approximately 1% of infliximab-treated patients experienced a possibledelayed hypersensitivity reaction, generally reported as serum sickness or a combination ofarthralgia and/or myalgia with fever and/or rash. These reactions generally occurred within 2weeks after repeat infusion.
Infections
In infliximab clinical studies, treated infections were reported in 36% of infliximab-treatedpatients (average of 51 weeks of follow-up) and in 25% of placebo-treated patients (averageof 37 weeks of follow-up). The infections most frequently reported were respiratory tractinfections (including sinusitis, pharyngitis, and bronchitis) and urinary tract infections.
Among infliximab-treated patients, serious infections included pneumonia, cellulitis, abscess,skin ulceration, sepsis, and bacterial infection. In clinical trials, 7 opportunistic |
