Assessing causality by means of the Naranjo scale in a paediatric patient with life threatening respiratory failure after alemtuzumab administration: a case report

• Published in: BMC pediatrics Vol. 21; no. 1; p. 229
• Main Authors: Smeets, Nori J L, Eijk, Ruud J R, de Wildt, Saskia N, Bootsma-Robroeks, Charlotte M H H T
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 12-05-2021; BioMed Central; BMC
• Subjects: Alemtuzumab; Antibodies; Biopsy; Case Report; Case reports; Case studies; Causality; Causes of; Complications and side effects; Creatinine; Diagnosis; Diffuse alveolar oedema; Dosage and administration; Drug dosages; Drug therapy; Edema; Hemodialysis; Immunosuppressive agents; Kidney transplants; Kidneys; Monoclonal antibodies; Naranjo scale; Organ transplant recipients; Patients; Pediatric research; Pediatrics; Peptides; Respiratory distress syndrome; Respiratory failure; Respiratory insufficiency; Side effects; Thrombocytopenia; Transplantation; Ventilators; Netherlands; Case report; Alemtuzumab; Respiratory failure; Diffuse alveolar oedema; Naranjo scale
• ISSN: 1471-2431; 1471-2431
• DOI: 10.1186/s12887-021-02698-w

Alemtuzumab is a T cell depleting antibody agent used as induction immunosuppressant therapy in solid organ transplant recipients. In addition, it is being increasingly used to treat severe or glucocorticoid-resistant graft rejection. Despite the effectiveness of the treatment, severe adverse events have been reported related to alemtuzumab administration. We present a similar event illustrating the severity of this adverse drug reaction (ADR) and we highlight the structure causality assessment provides in approaching such a case.
We report a case of life-threatening respiratory failure after alemtuzumab administration in a 17 year old paediatric kidney transplant recipient. He developed near fatal severe respiratory and circulatory failure based on acute respiratory distress syndrome (ARDS) with diffuse alveolar oedema and haemoptysis hours after his second alemtuzumab administration. As it was questionable whether alemtuzumab could be regarded as the origin of his reaction and in order to assess the causality of this reaction as well as to structure clinical reasoning, we applied a widely used ADR probability scale to systematically review our case.
Our case shows a severe ADR after alemtuzumab administration. It illustrates the importance of proper causality assessment, the structure it provides and the benefit of a clinical pharmacology consultation when a severe reaction is suspected to be an ADR. By taking our case as an example, we demonstrate the added value of structured causality assessment to clinical reasoning and in generating differential diagnoses.