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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
In a study of 43 patients with severe Coronavirus disease (COVID-19) pneumonia were treated with tocilizumab between 10 March 2020 to 18 March 2020 in Italy, 3 men aged 58-78 years were described, who developed candidaemia during off-label treatment with tocilizumab for COVID-19 pneumonia [route not stated; duration of treatment to reaction onset and outcomes not stated].
Patient 1: A 67-year-old man developed candidaemia during off-label treatment with tocilizumab for COVID-19 pneumonia: The man, who had cerebral ischemia, was hospitalised on 14 March 2020 due to COVID-19 pneumonia. He had been receiving aspirin concomitantly. Initially, his interleukin-6 (IL-6) level was found to be 325 ng/L. Subsequently, he started receiving off label treatment with tocilizumab 8 mg/kg (560mg) on 15 March 2020. He received a repeated dose of tocilizumab after 12 hours. Additionally, he received parenteral nutrition for 8 days and unspecified antibacterials for 2 days during the hospitalisation. Also, he had undergone central venous catheterization. Subsequently, he had an increase in the WBC count; hence, he underwent a blood culture on 27 March 2020 that showed positive results for Candida albicans. He had infections as an eye and aortic valve and diagnosed with endophthalmitis, endocarditis and candidaemia. His candidaemia was attributed to tocilizumab treatment. A CRP level was found to be 10 mg/dL. Therefore, he was treated with caspofungin and fluconazole. Despite the treatment with caspofungin and fluconazole, he remained hospitalised.
Patient 2: A 58-year-old man developed candidaemia during off-label treatment with tocilizumab for COVID-19 pneumonia: The man, who had hypertension, was hospitalised on 9 March 2020 due to COVID-19 pneumonia. He had been receiving ramipril concomitantly. Initially, his IL-6 level was found to be 116 ng/L. Subsequently, he started receiving off label treatment with tocilizumab 8 mg/kg (600mg) on 13 March 2020. He received a repeated dose of tocilizumab after 12 hours. Additionally, he received parenteral nutrition for 13 days during the hospitalisation. Subsequently, he had an increase in the WBC count; hence, he underwent a blood culture on 26 March 2020 that showed positive results for Candida tropicalis and he was diagnosed with candidaemia, which was attributed to tocilizumab treatment. His CRP level was found to be 43 mg/dL. Therefore, he was treated with caspofungin. Despite the treatment with caspofungin, he remained hospitalised.
Patient 3: A 78-year-old man developed candidaemia during off-label treatment with tocilizumab for COVID-19 pneumonia: The man, who had diabetes and obesity, was hospitalised on 18 March 2020 due to COVID-19 pneumonia. He had been receiving metformin. Initially, his IL-6 level was found to be 105 ng/L. Subsequently, he started receiving off label treatment with tocilizumab 8 mg/kg (800mg) on 18 March 2020. He received a repeated dose of tocilizumab after 12 hours. Additionally, he received parenteral nutrition for 13 days, unspecified antibacterial and steroid during the hospitalisation. Also, he had undergone central venous catheterisation. Subsequently, he had an increase in the WBC count; hence, he underwent a blood culture on 01 April 2020 that showed positive results for Candida parapsilosi and he was diagnosed with candidaemia, which was attributed to tocilizumab treatment. His CRP level was found to be 0.8 mg/dL. Therefore, he was treated with caspofungin and fluconazole. Despite the treatment with caspofungin and fluconazole, he remained hospitalised.
Reference
- Antinori S, et al. Tocilizumab for cytokine storm syndrome in COVID-19 pneumonia: an increased risk for candidemia?. Autoimmunity Reviews 19: 102564, No. 7, Jul 2020. Available from: URL: 10.1016/j.autrev.2020.102564 [DOI] [PMC free article] [PubMed]