Comparative safety and efficacy of two immune globulin products in Kawasaki disease.

OBJECTIVE

To compare the safety and efficacy of various intravenously administered immune globulin (IVGG) products in patients with Kawasaki disease.

METHODS

We performed a retrospective matched-pair study of 45 pairs of patients, matched by age, gender, hospital, and illness day when IVGG therapy was initiated. All patients received aspirin, 80 to 100 mg/kg per day; one of each pair received Venoglobulin, 2 gm/kg (product A), and the other received Iveegam, 2 gm/kg (product B). Safety was assessed during and after IVGG infusion by recording rigors, pruritus, hypotension, urticaria, and nausea. Treatment efficacy was evaluated by posttreatment height and duration of fever, and subsequent echocardiographic changes.

RESULTS

Untoward reactions during infusions occurred more often with product A (25%) than with product B (2%) (p < 0.025); most reactions were rigors (18% vs 2%) (p < 0.05). Therapy was completed in all patients. Height of fever and proportion of patients febrile each day after product A or B did not differ significantly. No differences were found in the frequency of coronary artery abnormalities 1 year after illness.

CONCLUSIONS

No significant differences in efficacy appeared between the two IVGG products, but they differed significantly in non-life-threatening adverse reactions, especially infusion-related rigors. Other IVGG products should be evaluated in a similar fashion.