Tocilizumab

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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 retrospective case series of 8 patients who were diagnosed with COVID-19 and posterior reversible encephalopathy syndrome (PRES) from March 2020 to July 2020, four patients (three women and one man) aged 36−66 years were described, who developed PRES following off-label treatment with tocilizumab for COVID-19 [routes and dosages not stated; duration of treatments to reaction onsets not clearly stated].

A 49-year-old woman (Patient 1 from table 1 of the article) was admitted to the ICU with severe pneumonia. A SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR) test was found to be positive. She started receiving off-label treatment with tocilizumab, lopinavir/ritonavir, chloroquine and unspecified corticosteroids for COVID-19. However, 17 days after COVID-19 development, she developed PRES as complication. PRES symptoms included focal signs (paresis) and visual disturbance. Her renal function was normal. At the time of PRES diagnosis, SARS-CoV-2 RT-PCR test was positive. Radiological investigation revealed vasogenic oedema in parieto-occipital region with asymmetric lesions. Vasoconstriction associated with the vasogenic oedema was also noted. Off-label treatment with tocilizumab was suspected to have contributed in the development of PRES. She also developed septic shock and bacterial superinfection secondary to COVID-19 which was treated with unspecified empiric antibiotic therapy. She was treated with nimodipine for PRES. Repeat MRI revealed resolution of vasogenic oedema. She was discharged after 38 days of hospitalisation. At the time of discharge, she had persistent focal sequel in the form of paresis.

A 36-year-old woman (Patient 2 from table 1 of the article) was admitted to the ICU with severe pneumonia. A SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR) test was found to be positive. She started receiving off-label treatment with tocilizumab, lopinavir/ritonavir, chloroquine and unspecified corticosteroids for COVID-19. However, 9 days after COVID-19 development, she developed PRES as complication. PRES symptoms included seizures, impaired consciousness and focal signs (paresis). Her renal function was normal. At the time of PRES diagnosis, SARS-CoV-2 RT-PCR test was positive. Radiological investigation revealed hemispheric involvement of the vasogenic oedema with asymmetric lesions. Intracranial haemorrhage was also noted. Off-label treatment with tocilizumab was suspected to have contributed in the development of PRES. She also developed fungal superinfection secondary to COVID-19 which was treated with unspecified empiric antibiotic therapy. She was treated with unspecified antiepileptic drugs for PRES. She was discharged after 60 days of hospitalisation. At the time of discharge, she had persistent focal sequel in the form of paresis.

A 53-year-old man (Patient 4 from table 1 of the article) was admitted to the ICU with severe pneumonia. A SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR) test was found to be positive. He started receiving off-label treatment with tocilizumab, lopinavir/ritonavir, chloroquine and convalescent-anti-SARS-COV-2-plasma [convalescent plasma] for COVID-19. However, 44 days after COVID-19 development, he developed PRES as complication. PRES symptoms included seizures and impaired consciousness. He had concurrent acute kidney injury. At the time of PRES diagnosis, SARS-CoV-2 RT-PCR test was positive. Radiological investigation revealed vasogenic oedema in parieto-occipital region with symmetric lesions. Off-label treatment with tocilizumab was suspected to have contributed in the development of PRES. He also developed septic shock and bacterial superinfection secondary to COVID-19 which was treated with unspecified empiric antibiotic therapy. He was treated with unspecified antiepileptic drugs for PRES. He was discharged into a subacute nursing facility after 35 days of hospitalisation. At the time of discharge, he was neurologically asymptomatic.

A 66-year-old woman (Patient 7 from table 1 of the article) was admitted to the ICU with severe pneumonia. A SARS-CoV-2 reverse-transcription polymerase chain reaction (RT-PCR) test was found to be positive. Her medical history was significant for high blood pressure, dyslipidaemia, diabetes mellitus and deep vein thrombosis. She started receiving off-label treatment with tocilizumab, lopinavir/ritonavir, chloroquine, convalescent-anti-SARS-COV-2-plasma [convalescent plasma] and unspecified corticosteroids for COVID-19. However, 48 days after COVID-19 development, she developed PRES as complication. PRES symptoms included seizures and impaired consciousness. She had concurrent acute kidney injury and acute hypertension. At the time of PRES diagnosis, SARS-CoV-2 RT-PCR test was positive. Radiological investigation revealed vasogenic oedema in parieto-occipital region with symmetric lesions. Off-label treatment with tocilizumab was suspected to have contributed in the development of PRES. She also developed bacterial superinfection secondary to COVID-19 which was treated with unspecified empiric antibiotic therapy. She was treated with unspecified antiepileptic drugs for PRES. Subsequently, she was discharged. At the time of discharge, she was neurologically asymptomatic.