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Abstract: PO1977

Adverse Events Following Rituximab Infusion in Children with Nephrotic Syndrome: A Systematic Review

Session Information

Category: Pediatric Nephrology

  • 1700 Pediatric Nephrology


  • Xue, Yuanxin, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  • Robinson, Cal, Division of Nephrology, Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada
  • Bamhraz, Abdulaziz Ahmed, Division of Pediatric Nephrology, Department of Pediatrics, McMaster Children's Hospital, Hamilton, Ontario, Canada
  • Lee, James, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  • Chung, Jason, University of Toronto Temerty Faculty of Medicine, Toronto, Ontario, Canada
  • Thabane, Lehana, McMaster University Department of Health Research Methods Evidence and Impact, Hamilton, Ontario, Canada
  • Ewusie, Joycelyne Efua, Biostatistics Unit, The Research Institute of St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
  • Sinha, Rajiv, Department of Pediatric Medicine and Pediatric Nephrology, Institute of Child Health, Kolkata, India
  • Chanchlani, Rahul, Division of Pediatric Nephrology, Department of Pediatrics, McMaster Children's Hospital, Hamilton, Ontario, Canada

Rituximab (RTX) is often used off-label in children with various kidney diseases. However, there are limited data on the frequency and severity of adverse events and side effects (AE/SE) observed in children following RTX administration. The aim of this systematic review is to evaluate the AE/SE of RTX in children with nephrotic syndrome (NS).


Six databases were searched to include literature from 1991-2019 that provided AE/SE data on children (≤18 yrs) receiving RTX. Article screening, data extraction, and quality assessment were independently completed and verified by two reviewers. Primary outcome was the cumulative incidence of AE/SE. Secondary outcomes included the severity (evaluated by the Common Terminology Criteria for Adverse Events), timing, and affected body systems of each AE/SE.


Out of 3364 citations, 40 articles were included and 13% were randomized controlled trials (Table). Most reported AE/SE were infusion-related reactions (22.0%), infections (13.9%), granulocytopenia (3.9%), and hypogammaglobulinemia (2.7%). Reporting of the timing or duration of AE/SE was heterogenous and frequently incomplete. Out of all patients experiencing AE/SE (n=455), 12.7% were severe (grade 3-5), 50.8% were mild (grade 1-2), and the severity in the rest were indeterminable. Overall, 53/1143 (4.6%) children experienced severe AE/SE.


The majority of children receiving RTX for NS do not experience serious AE/SE and RTX is generally well-tolerated. However, standardized reporting of AE/SE including timing, duration, and severity grade is warranted in future studies.

Type of AE/SEDescription of AE/SEProportion of Patients Affected (n=1143)CTCAE Severity Grading
Infusion-related reactionrespiratory distress, bronchospasm, epistaxis, cough/itchy throat, hypotension, hypertension, tachycardia, bradycardia, arrhythmia, nausea, vomiting, chest discomfort, skin rash, itching, facial flushing, abdominal/ankle/pelvic pain, dyspnea, polypnea, pruritus, myalgia, chills, fever, allergic reaction22.05%1464310062
Generalfever, chronic cough, chest discomfort, severe obesity1.05%161004
Cardiovascularhypertension, transient electrocardiographic change0.35%301000
Respiratoryrespiratory distress/disturbance, RTX-associated lung injury, respiratory tract infection1.92%076027
Dermatologicalskin rash/dermatitis, urticaria, cellulitis, purulent folliculitis, hyperpigmentation, hypertrichosis, alopecia2.19%1630015
Renalgross hematuria, acute kidney injury, hemorrhagic cystitis, renal tract infection0.52%002004
Gastrointestinaldiarrhea, abdominal pain, irritable colon, gastrointestinal infection1.57%225009
Hepaticderanged liver enzymes0.35%001003
Musculoskeletal and Connectiveacute arthritis, osteopenia1.14%060007
Metabolichyperuricemia, adrenal insufficiency0.17%001100
Hematologicalerythrocythemia, eosinophilia, leukopenia, lymphocytopenia, neutropenia, thrombocytopenia, thrombosis, reduced granulocyte count5.16%521014028
Infection, Immunologic, or Oncologichypogammaglobulinemia, axillary abscess, Kikuchi disease, lymphadenopathy, fibroadenoma, other non-specific infections14.44%76130094
HEENT (Head, Eye, Ear, Nose, and Throat)gingivitis/gum infection, oral candidiasis, otitis0.35%102001