Abstract: PO1977
Adverse Events Following Rituximab Infusion in Children with Nephrotic Syndrome: A Systematic Review
Session Information
- Pediatric Nephrology: AKI, Dialysis, Transplant, CKD, and Nephrotic Syndrome
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: Pediatric Nephrology
- 1700 Pediatric Nephrology
Authors
- 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
Background
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).
Methods
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.
Results
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.
Conclusion
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/SE | Description of AE/SE | Proportion of Patients Affected (n=1143) | CTCAE Severity Grading | |||||
| 1 | 2 | 3 | 4 | 5 | Unclear | |||
| Infusion-related reaction | respiratory 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 reaction | 22.05% | 146 | 43 | 1 | 0 | 0 | 62 |
| General | fever, chronic cough, chest discomfort, severe obesity | 1.05% | 1 | 6 | 1 | 0 | 0 | 4 |
| Cardiovascular | hypertension, transient electrocardiographic change | 0.35% | 3 | 0 | 1 | 0 | 0 | 0 |
| Respiratory | respiratory distress/disturbance, RTX-associated lung injury, respiratory tract infection | 1.92% | 0 | 7 | 6 | 0 | 2 | 7 |
| Dermatological | skin rash/dermatitis, urticaria, cellulitis, purulent folliculitis, hyperpigmentation, hypertrichosis, alopecia | 2.19% | 1 | 6 | 3 | 0 | 0 | 15 |
| Renal | gross hematuria, acute kidney injury, hemorrhagic cystitis, renal tract infection | 0.52% | 0 | 0 | 2 | 0 | 0 | 4 |
| Gastrointestinal | diarrhea, abdominal pain, irritable colon, gastrointestinal infection | 1.57% | 2 | 2 | 5 | 0 | 0 | 9 |
| Hepatic | deranged liver enzymes | 0.35% | 0 | 0 | 1 | 0 | 0 | 3 |
| Musculoskeletal and Connective | acute arthritis, osteopenia | 1.14% | 0 | 6 | 0 | 0 | 0 | 7 |
| Metabolic | hyperuricemia, adrenal insufficiency | 0.17% | 0 | 0 | 1 | 1 | 0 | 0 |
| Hematological | erythrocythemia, eosinophilia, leukopenia, lymphocytopenia, neutropenia, thrombocytopenia, thrombosis, reduced granulocyte count | 5.16% | 5 | 2 | 10 | 14 | 0 | 28 |
| Infection, Immunologic, or Oncologic | hypogammaglobulinemia, axillary abscess, Kikuchi disease, lymphadenopathy, fibroadenoma, other non-specific infections | 14.44% | 7 | 61 | 3 | 0 | 0 | 94 |
| HEENT (Head, Eye, Ear, Nose, and Throat) | gingivitis/gum infection, oral candidiasis, otitis | 0.35% | 1 | 0 | 2 | 0 | 0 | 1 |