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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
A retrospective observational chart review study of 38 patients admitted to The Brooklyn Hospital Center, USA, with COVID-19 and treated with tocilizumab along with other COVID-19 therapies between 1 February 2020 and 22 May 2020 described 15patients [6 men and 9 women] aged 38−90 years, who showed elevated AST, ALT, total bilirubin or developed thrombocytopenia, pneumonia due to methicillin-resistant Staphylococcus aureus (MRSA), multidrug resistant Acinetobacter baumannii infection, multidrug resistant Pseudomonas aeruginosa infection, extended spectrum β-lactamase (ESBL)-producing Klebsiella pneumoniae or ESBL-producing Klebsiella oxytoca, bacteraemia due to vancomycin-resistant Enterococcus, MRSA or Klebsiella pneumoniae, urinary tract infection (UTI) due to ESBL-producing Klebsiella pneumoniae, Candida albicans or Acinetobacter baumannii, wound infections due to multidrug resistant Stenotrophomonas maltophilia or MRSA, or fungaemia due to Candida auris during treatment with tocilizumab for COVID-19.
The patients, who were admitted to The Brooklyn Hospital Center, USA, with COVID-19 and acute respiratory distress syndrome, received off-label treatment with tocilizumab 324mg−1200mg [routes not stated]. Additionally, the patients received off-label treatment with unspecified corticosteroids, hydroxychloroquine, azithromycin, lopinavir/ritonavir [Kaletra], convalescent-anti-SARS-CoV-2-plasma [convalescent plasma] or IV immune globulin. Ten of these 15 patients had co-morbidities including hyperlipidaemia, dementia, diabetes mellitus, osteoarthritis, asthma, deep venous thrombosis, obstructive sleep apnoea, gastroesophageal reflux disease, hypertension, hyperlipidaemia, obesity, cardiovascular disease, collagen vascular disease (on hydroxychloroquine), rheumatoid arthritis, gout, HIV, pulmonary embolism, end-stage renal disease (on haemodialysis), osteomyelitis, heart failure with preserved ejection fraction, schizophrenia, atrial fibrillation or aortic mechanical valve. Subsequently, the patients showed elevated AST (n=1), pneumonia due to ESBL-producing Klebsiella pneumoniae, elevated AST and elevated ALT (n=1), elevated AST, elevated ALT and thrombocytopenia (n=1), pneumonia due to multidrug resistant Pseudomonas aeruginosa, fungaemia due to Candida auris and bacteraemia due to vancomycin-resistant Enterococcus, elevated total bilirubin, elevated AST and elevated ALT (n=1), pneumonia due to MRSA (n=1), pneumonia due to multidrug resistant Pseudomonas aeruginosa and thrombocytopenia (n=1), pneumonia due to multidrug resistant Acinetobacter baumannii and UTI due to ESBL-producing Klebsiella pneumoniae (n=1), wound infections due to multidrug resistant Stenotrophomonas maltophilia (n=1), pneumonia due to ESBL-producing Klebsiella oxytoca (n=1), pneumonia and bacteraemia due to MRSA and UTI due to Candida albicans (n=1) thrombocytopenia (n=1), elevated AST, elevated ALT, and pneumonia, UTI and bacteraemia due to Acinetobacter baumannii and Klebsiella pneumoniae (n=1), pneumonia due to Klebsiella pneumoniae (n=1), MRSA wound infection (n=1) and elevated ALT (n=1). These episodes of elevated liver enzyme levels, superinfections and thrombocytopenia were attributed to tocilizumab treatment [durations of treatments to reactions onsets not stated].
Liver function of two patients recovered to the normal range within 1 and 3 months after tocilizumab treatment. Four patients were discharged home. At the time of this report writing, one patient was still in the hospital, one was in the acute rehabilitation and one was back to nursing home, while six patients had died [causes of deaths not stated; not all outcomes stated].