EMA Recommends Tocilizumab for Adults With Severe COVID-19

Dawn O'Shea

December 07, 2021

The European Medicines Agency (EMA) has recommended the use of tocilizumab (RoActemra) for the treatment of adults with COVID-19 who are already receiving systemic corticosteroids and who require supplemental oxygen or mechanical ventilation.

The EMA’s decision is based on an evaluation of data from a study of 4116 adults hospitalised with severe COVID-19 who required extra oxygen or mechanical ventilation and who had elevated levels of C-reactive protein.

The study found that the addition of tocilizumab to standard treatment reduced the risk of death by 4% compared with standard treatment alone. Thirty-one percent of patients in the tocilizumab arm died within 28 days of treatment (621 out of 2022) compared with 35% of patients receiving standard treatment alone (729 out of 2094).

The proportion of patients who were discharged from hospital within 28 days was 7% higher in the group receiving tocilizumab plus standard care (57%; 1150 out of 2022) compared with those receiving standard treatment alone (50%; 1044 out of 2094).

The safety profile in patients receiving corticosteroids was favourable, however, the study data suggest an increase in mortality cannot be ruled out when the drug is used in patients who are not receiving systemic corticosteroids.

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