Mavrilimumab outperforms placebo in severe COVID-19

In patients with severe COVID-19 pneumonia and hyper-inflammation, mavrilimumab was associated with decreased mechanical ventilation and death compared with placebo.

AEs were less common in mavrilimumab-treated patients

In patients with severe COVID-19 pneumonia and hyper-inflammation, mavrilimumab was associated with decreased mechanical ventilation and death compared with placebo. Moreover, this global randomised double-blind phase 2 trial demonstrated a beneficial safety profile of mavrilimumab over placebo.

The need for treatment alternatives in COVID-19 pneumonia is largely unmet. Mavrilimumab, a human monoclonal antibody blocking GM-CSF signalling, has shown clinical benefits in previous phase 2 trials investigating this population. In the current phase 2 trial, non-mechanically-ventilated severe COVID-19 patients with pneumonia and hyper-inflammation (n=114, mean age 57.1) were randomised to 1 of the 3 treatment arms: 6 mg/kg intravenous mavrilimumab (first week qd, thereafter qw), 10 mg/kg mavrilimumab, or placebo. The primary efficacy endpoint was the proportion of patients alive and without mechanical ventilation at day 29.

Median return to room air was 7 days for mavrilimumab, 9 days for placebo

Dr Lara Pupim (Kiniksa Pharmaceutical Corp., USA) presented the results. On day 29, 86.7% of the patients in the mavrilimumab treatment arms were alive and without mechanical ventilation versus 74.4% of the patients in the placebo arm. The risk of death was 61% lower in mavrilimumab recipients and the risk of death or mechanical ventilation was reduced by 65%. In addition, the median time to a 2-point clinical improvement on the National Institute of Allergy and Infectious Diseases COVID-19 ordinal scale was respectively 7 days for mavrilimumab recipients and 11 days for the placebo group. The median time to return to room air was 7 days (mavrilimumab) versus 9 days (placebo).

No drug-related serious adverse events (AEs) occurred in the mavrilimumab arms. AEs were less common in mavrilimumab-treated patients and infections were more likely to occur in the placebo group (mavrilimumab 9.8–11.4% vs placebo 22.5%). Thrombotic events were only observed in the placebo arm. Finally, no apparent differences in efficacy or safety were registered between the 2 mavrilimumab treatment arms. 

Source:
Pupim L, et al. Mavrilimumab Improves Outcomes in Phase 2 Trial in Non-Mechanically Ventilated Patients with Severe COVID-19 Pneumonia and Systemic Hyperinflammation. LB0001, EULAR 2021 Virtual Congress, 2-5 June.

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