Infusion reactions associated with rituximab treatment for childhood-onset complicated nephrotic syndrome
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Infusion reaction (IR) is defined as an adverse event within 24 h after monoclonal antibody infusion. In non-Hodgkin lymphoma, IR incidence following rituximab treatment is high (77–80%), but there are no data in complicated nephrotic syndrome.
Records of rituximab infusions in patients with complicated nephrotic syndrome between February 2006 and December 2014 at the National Center for Child Health and Development were reviewed. Rituximab was administered at doses of 375 mg/m2. The severity of IR was evaluated using the Common Terminology Criteria for Adverse Events ver. 4.0.
For 309 rituximab infusions in 159 patients (male, 110; median age, 12 years), IR was observed in 165 infusions (53.4%). Respiratory symptoms were most common (66% of all events). Ninety-five percent of the IR was observed within 3 h after rituximab infusion initiation. Sixty-eight percent of the events were classified as grade 1 and others classified as grade 2. Only 18% required medical intervention. CD20 cell count in patients with IR was significantly higher than in patients without IR. Incidence of IR was similar in subsequent rituximab treatment after B-cell recovery. Patients who experienced IR at first rituximab treatment were more likely to experience recurrent IR with subsequent treatments compared to those not having IR at initial treatment (odds ratio 3.64; p < 0.001).
In patients with complicated nephrotic syndrome, respiratory symptoms were the major type of IR, mostly observed within 3 h of infusion. Incidence of IR was lower and its severity milder in patients with complicated nephrotic syndrome than those with lymphoma.
KeywordsRituximab Infusion reaction Complicated nephrotic syndrome B-cell Respiratory symptoms
Compliance with ethical standards
Conflict of interest
KK has received lecture fees from the Chugai Pharmaceutical Co., Ltd. SI has received lecture fees and/or grants from the Chugai Pharmaceutical Co., Ltd.; Zenyaku Kogyo Co., Ltd.; Asahi Kasei Pharma; Novartis Pharma K.K.; and Astellas Pharma Inc. KI has received lecture fees from the Asahi Kasei Pharma; Chugai Pharmaceutical Co., Ltd.; Zenyaku Kogyo Co., Ltd.; and Novartis Pharma K.K. and a consultant fee from Ono Pharmaceutical Co., Ltd.
The design and execution of this study were in accordance with the ethical standards of the Declaration of Helsinki. The protocol was approved by the Ethics Committee of the National Center for Child Health and Development (no. 1505).
For this type of study, formal informed consent is not required.
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