Randomized trial of pulsed corticosteroid therapy for primary treatment of Kawasaki disease.
BACKGROUND
Treatment of acute Kawasaki disease with intravenous immune globulin and aspirin reduces the risk of coronary-artery abnormalities and systemic inflammation, but despite intravenous immune globulin therapy, coronary-artery abnormalities develop in some children. Studies have suggested that primary corticosteroid therapy might be beneficial and that adverse events are infrequent with short-term use.


METHODS
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to determine whether the addition of intravenous methylprednisolone to conventional primary therapy for Kawasaki disease reduces the risk of coronary-artery abnormalities. Patients with 10 or fewer days of fever were randomly assigned to receive intravenous methylprednisolone, 30 mg per kilogram of body weight (101 patients), or placebo (98 patients). All patients then received conventional therapy with intravenous immune globulin, 2 g per kilogram, as well as aspirin, 80 to 100 mg per kilogram per day until they were afebrile for 48 hours and 3 to 5 mg per kilogram per day thereafter.


RESULTS
At week 1 and week 5 after randomization, patients in the two study groups had similar coronary dimensions, expressed as z scores adjusted for body-surface area, absolute dimensions, and changes in dimensions. As compared with patients receiving placebo, patients receiving intravenous methylprednisolone had a somewhat shorter initial period of hospitalization (P=0.05) and, at week 1, a lower erythrocyte sedimentation rate (P=0.02) and a tendency toward a lower C-reactive protein level (P=0.07). However, the two groups had similar numbers of days spent in the hospital, numbers of days of fever, rates of retreatment with intravenous immune globulin, and numbers of adverse events.


CONCLUSIONS
Our data do not provide support for the addition of a single pulsed dose of intravenous methylprednisolone to conventional intravenous immune globulin therapy for the routine primary treatment of children with Kawasaki disease. (ClinicalTrials.gov number, NCT00132080 [ClinicalTrials.gov].)
Newburger
Jane W
JW
Department of Cardiology, Children's Hospital and Harvard Medical School, Boston, MA 02115, USA. jane.newburger@cardio.chboston.org
Sleeper
Lynn A
LA
McCrindle
Brian W
BW
Minich
L LuAnn
LL
Gersony
Welton
W
Vetter
Victoria L
VL
Atz
Andrew M
AM
Li
Jennifer S
JS
Takahashi
Masato
M
Baker
Annette L
AL
Colan
Steven D
SD
Mitchell
Paul D
PD
Klein
Gloria L
GL
Sundel
Robert P
RP
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003324:Coronary Artery Disease / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000188:drug therapy; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000627:therapeutic use; D007155:Immunologic Factors / Q000627:therapeutic use; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D009080:Mucocutaneous Lymph Node Syndrome / Q000150:complications / Q000188:drug therapy*; D020551:Pulse Therapy, Drug
D000894:Anti-Inflammatory Agents, Non-Steroidal; D005938:Glucocorticoids; D016756:Immunoglobulins, Intravenous; D007155:Immunologic Factors; D001241:Aspirin; D008775:Methylprednisolone