Original Article
Clinical Responses of Patients with Kawasaki Disease to Different Brands of Intravenous Immunoglobulin

https://doi.org/10.1016/j.jpeds.2005.08.024Get rights and content

Objective

To determine whether different brands of intravenous immunoglobulin (IVIG) administered to children with Kawasaki disease (KD) result in different outcomes.

Study design

We analyzed children with KD and divided them into 4 groups according to the brand of IVIG. A coronary artery abnormality (CAA) was defined as having a lumen diameter (inner border to inner border) of ≥3 mm in KD cases <5 years old and ≥4 mm in cases ≥5 years old, and giant aneurysm was defined as a lumen diameter ≥8 mm. Patients were considered nonresponsive to IVIG therapy if fever persisted longer than 2 days after completion of treatment and needed retreatment with IVIG.

Results

We collected 437 cases, 29 (6.6%) were nonresponsive, 17 (3.9%) had CAA at convalescence, and 3 (0.7%) had giant aneurysm, 2 of whom had development of myocardial infarcts. Patients receiving Brand C IVIG, prepared with β-propiolactone, had higher rates (10%, 9/93, P = .01) of CAA at convalescence and nonresponsiveness (13%, 12/93, P = .001); giant aneurysm occurred in 3/93 (3%) receiving Brand C IVIG and in 0/344 who received the other 3 brands (P = .008).

Conclusions

IVIG, prepared with β-propiolactone, was most significantly associated with nonresponsiveness, CAA at convalescence, and giant aneurysm. Physicians should be cautious when using IVIG prepared with β-propiolactone or enzyme digestion to treat KD.

Section snippets

Case Collection

This study was approved by Institutional Review Board of Chang Gung Memorial Hospital. We retrospectively reviewed the charts of all the children who were diagnosed as having KD and who were treated with IVIG at Chang Gung Children's Hospital from February 1994 to July 2003. KD was defined as an acute febrile illness with fever for at least 5 days plus at least 4 of the following criteria: bilateral nonpurulent bulbar conjunctivitis, red lips with fissure or strawberry tongue, indurative edema

Demography and Clinical Profiles

A total of 437 cases of KD in 435 patients were collected in this study as users of 1 of 4 brands of IVIG: Brand A 91 cases, Brand B 182, Brand C 93, and Brand D 71. Two patients had recurrent KD: one recurred 2 months after the first episode and the other recurred 3 months after the first episode. Two hundred seventy-six (63%) of patients with KD were male, and the mean age was 18.7 months (range 1-108 months, median age 13 months) at the time of diagnosis. Table II presents the data on the 4

Discussion

Our study suggests that the different preparations of IVIG may result in different clinical outcomes of children with KD. In this study patients receiving Brand C IVIG had a significantly higher rate of CAA at convalescence and a significantly higher rate of IVIG nonresponsiveness compared with those receiving the other 3 IVIG brands. Three patients had development of giant aneurysms, 2 of whom had a myocardial infarction. Our multivariate analysis found being treated with Brand C IVIG to be

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