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Risk Stratification in the Decision to Include Prednisolone With Intravenous Immunoglobulin in Primary Therapy of Kawasaki Disease

Kobayashi, Tohru MD*; Inoue, Yoshinari MD*; Otani, Tetsuya MD; Morikawa, Akihiro MD*; Kobayashi, Tomio MD; Takeuchi, Kazuo MD, MPH§; Saji, Tsutomu MD; Sonobe, Tomoyoshi MD; Ogawa, Shunichi MD**; Miura, Masaru MD††; Arakawa, Hirokazu MD*

The Pediatric Infectious Disease Journal: June 2009 - Volume 28 - Issue 6 - p 498-502
doi: 10.1097/INF.0b013e3181950b64
Original Studies

Background: We reported previously that intravenous immunoglobulin (IVIG) plus prednisolone for initial therapy for Kawasaki disease (KD) prevented coronary artery abnormalities (CAA) more effectively than IVIG alone. However, questions remain as to whether PSL has potential benefit in all KD patients. The present study was designed to explore the possibility of stratified initial therapy including PSL in patients with and without a high predicted risk of being an IVIG nonresponder.

Methods: We retrospectively analyzed data from KD patients who received IVIG (n = 896) or IVIG + PSL (n = 110) by scoring the likely risk of being an IVIG nonresponder. We compared clinical and coronary outcomes between treatment-defined groups separately for high- and low-risk patients.

Results: Among low-risk patients (score 0–4), clinical and coronary outcomes were similar. Among high-risk patients (score 5 or more), incidences of treatment failure and coronary artery abnormalities until 1-month follow-up were more frequent in the IVIG than in the IVIG + PSL group. Sex- and score point-adjusted odds ratios for IVIG + PSL were 0.17 (95% confidence interval, 0.08–0.39) for treatment failure and 0.27 (95% confidence interval, 0.07–0.85) for coronary artery abnormalities A among high-risk patients.

Conclusions: IVIG + PSL treatment was associated with improving clinical and coronary outcomes in patients at high risk of being IVIG nonresponders.

From the *Department of Pediatrics, Gunma University Graduate School of Medicine, Maebashi, Gunma, Japan; †Department of Health Policy, National Research Institute for Child Health and Development, Tokyo, Japan; ‡Department of Cardiology, Gunma Children’s Medical Center, Gunma, Japan; §Faculty of Education, Saitama University, Saitama, Japan; ¶The First Department of Pediatrics, Toho University School of Medicine, Tokyo, Japan; ∥Department of Pediatrics, Japan Red Cross Medical Center, Tokyo, Japan; **Department of Pediatrics, Nippon Medical School, Tokyo, Japan; and ††Department of Cardiology, Tokyo Metropolitan Kiyose Children’s Hospital, Tokyo, Japan.

Accepted for publication November 13, 2008.

Supported by Grants-in-Aid for Clinical Research for New Medicine from the Ministry of Health, Labor, and Welfare of Japan.

Address for correspondence: Tohru Kobayashi, MD, Department of Pediatrics, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan. E-mail:

© 2009 Lippincott Williams & Wilkins, Inc.