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Changes in Hemoglobin Concentrations Post-immunoglobulin Therapy in Patients with Kawasaki Disease: A Population-Based Study Using a Claims Database in Japan

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Abstract

Background

We sought to quantify the degree of anemia after high-dose intravenous immunoglobulin (IVIG) therapy in patients with Kawasaki disease (KD) by assessing hemoglobin (Hb) dynamics and determining the risk of transfusion.

Methods

We analyzed data from a database containing inpatient data collected from 230 hospitals in Japan. In addition to administrative records, this database included laboratory results for some patients. We searched for individuals aged ≤ 18 years with a diagnosis of KD (International Statistical Classification of Diseases and Related Health Problems, 10th revision, code M30.3) who had received high-dose (≥ 1 g/kg) IVIG therapy. The primary outcome measure was post-IVIG therapy Hb dynamics in patients for whom laboratory findings were available. Secondary outcomes included the proportion of patients whose Hb value decreased below a specified threshold (e.g., 1 g/dL) and the number who received red blood cell transfusions, identified by a Japanese administrative code, in the whole cohort.

Results

Laboratory data were available for 979 of 8262 patients with KD receiving high-dose IVIG. Hb dynamics assessed on spline curves showed that mild anemia commonly occurred 1–2 days after IVIG infusion and returned to the baseline thereafter. Declines of Hb > 1 g/dL and > 2 g/dL were found in 21.8% and 4.3% of patients, respectively. Two of the 8262 individuals with KD had received transfusions after IVIG therapy (incidence rate 0.024%; 95% confidence interval 0.003–0.087), but the indication for transfusion could not be determined from our records.

Conclusions

Although mild anemia commonly occurred post-IVIG therapy in Japanese individuals with KD, severe anemia necessitating transfusion was rare in these patients.

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Acknowledgments

We thank Dr. Trish Reynolds, MBBS, FRACP, from Edanz Group (www.edanzediting.com/ac) for editing a draft of this manuscript.

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Authors and Affiliations

  1. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Yoshidakonoe-cho, Sakyo-ku, Kyoto, 606-8501, Japan

    Masato Takeuchi & Koji Kawakami

  2. Department of Pediatrics, Graduate School of Medicine, Yokohama City University, Yokohama, Japan

    Shuichi Ito

  3. Medical Data Vision, Tokyo, Japan

    Masaki Nakamura

Authors
  1. Masato Takeuchi
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  2. Shuichi Ito
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  3. Masaki Nakamura
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  4. Koji Kawakami
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Contributions

MT and KK conceptualized and designed the study. KK coordinated and supervised data collection. NM was responsible for data collection, data cleaning and extracting data of eligible cases. MT analyzed data and wrote the first draft. KK and SI critically reviewed the draft. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Koji Kawakami.

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Funding

No funding was received specifically for this study.

Conflict of interest

SI. has received lecture fees from Japan Blood Products Organization (Tokyo, Japan), Mitsubishi Tanabe Pharma Corporation (Tokyo, Japan), Nihon Pharmaceutical (Tokyo, Japan), and Teijin (Tokyo, Japan); these companies are manufacturers or distributors of immunoglobulin product. S.I. also received research/educational support from Japan Blood Products Organization and Teijin. M.N. is an employee of the vendor that analyzed the data in this study. M.T. and K.K. have no conflicts of interest relevant to this study to disclose.

Research involving human participants

The protocol of this study was approved by the Institutional Review Board of Kyoto University (R0599). This was a retrospective study of anonymized data so did not require consent for participation.

Data sharing and accessibility

The datasets generated during and/or analyzed during the current study are not publicly available due to the policy of MDV, but are available from the corresponding author on reasonable request.

Electronic supplementary material

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Takeuchi, M., Ito, S., Nakamura, M. et al. Changes in Hemoglobin Concentrations Post-immunoglobulin Therapy in Patients with Kawasaki Disease: A Population-Based Study Using a Claims Database in Japan. Pediatr Drugs 20, 585–591 (2018). https://doi.org/10.1007/s40272-018-0316-y

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  • DOI: https://doi.org/10.1007/s40272-018-0316-y

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