Treatment with mavrilimumab is associated with improved clinical outcomes compared with standard care in non-mechanically ventilated patients with severe coronavirus disease 2019 (COVID-19) pneumonia and systemic hyperinflammation, according to the results of a single-center prospective cohort study published in The Lancet Rheumatology.
Hyperinflammation, with its excessive cytokine production (known as a cytokine storm), has been identified as a key factor of poor prognosis in patients with COVID-19-related severe pneumonia, leading to high frequencies of respiratory failure and mortality. Therefore, researchers investigated whether mavrilimumab, an anti-granulocyte-macrophage colony-stimulating factor (GM-CSF) receptor-α monoclonal antibody, added to standard management, improves clinical outcomes in patients with COVID-19 pneumonia and systemic hyperinflammation.
Between March 17 and April 15, 2020, 39 patients with severe COVID-19 pneumonia, hypoxia, and systemic hyperinflammation were admitted to a hospital in Milan, Italy. A total of 13 non-mechanically ventilated patients received a single intravenous dose (6 mg/kg) of mavrilimumab added to standard care and 26 patients in the control group received standard care.
During the 28-day follow-up, none of the patients in the mavrilimumab group died, and 7 (27%) patients in the control group died (Fisher’s exact test: P =.086). At day 28, all patients in the mavrilimumab group and 17 (65%) patients in the control group showed clinical improvement (P=.030), with earlier improvement in the mavrilimumab than in the control group (P =.0001). Also, 1 (8%) patient in the mavrilimumab group progressed to mechanical ventilation compared with 9 (35%) patients in the control group (P =.14). Fever resolution was faster in mavrilimumab recipients vs controls (P =.0093). Mavrilimumab was well tolerated, with no infusion reactions, whereas 3 (12%) patients in the control group developed infectious complications.
The authors concluded, “These data represent the first evidence of a treatment effect of GM-CSF inhibition in COVID-19 and support further investigation of this biologic in controlled settings.”
Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
De Luca G, Cavalli G, Campochiaro C, et al. GM-CSF blockade with mavrilimumab in severe COVID-19 pneumonia and systemic hyperinflammation: a single-centre, prospective cohort study [published online June 16, 2020]. Lancet Rheumatol. doi:10.1016/S2665-9913(20)30170-3