In patients hospitalized for COVID-19 pneumonia, treatment with usual care plus namilumab, but not infliximab, was associated with greatly decreased C-reactive protein levels as well as improved outcomes, according to results in a recent study in the Lancet Respiratory Medicine published study.
Namilumab is an anti-granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody that has been studied in inflammatory diseases such as rheumatoid arthritis and has a good safety profile. Infliximab is a widely distributed anti-tumor necrosis factor (TNF) monoclonal antibody and as such an important pro-inflammatory cytokine. The study researchers sought to determine whether the efficacy and safety of these drugs warranted further testing in larger clinical trials. The investigation was based on the hypothesis that recruitment and activation of inflammatory monocytes and macrophages is important in the pathogenesis of severe COVID-19.
This Phase 2, randomised, multicentre, open-label, proof-of-concept study enrolled patients hospitalized for COVID-19 pneumonia in 9 UK hospitals. Participants were randomized to groups receiving either usual care (control group) or usual care plus a single intravenous dose of either 150 mg namilumab or 5 mg/kg infliximab (namilumab or infliximab treatment groups). Of the 299 recruited patients who underwent screening for study inclusion, 146 met the inclusion and exclusion criteria and were enrolled in the study. These 146 patients were then randomized in a 1:1:1 ratio to receive normal care (n=54) and groups receiving either namilumab (n=57) or infliximab (n=35). After administration of namilumab or infliximab, all patients were followed up for 28 days. The primary endpoint was improvement in inflammation as measured by C-reactive protein levels over time.
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The researchers found that the likelihood that interventions were superior to usual care alone in reducing C-reactive protein levels over time was 97% for namilumab and 15% for infliximab. Death occurred in 11% of patients in the namilumab group compared with 19% in the usual care group, while 14% of patients in the infliximab group died compared with 15% in the usual care group . Notably, the infliximab trial “was halted due to futility,” investigators said.
The researchers concluded, “Our study showed that the addition of namilumab, but not infliximab, to usual care reduced inflammation, as measured by CRP concentration, in hospitalized patients with COVID-19 compared to usual care alone.” They added that “targeted GM-CSF inhibitors such as namilumab should be further investigated in hospitalized patients with COVID-19.”
Disclosure: Several study authors declared their affiliation with the pharmaceutical industry. For a full list of authors’ disclosures, see the original reference.
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Fisher BA, Veenith T, Slade D, et al. Namilumab or infliximab versus standard of care in hospitalized patients with COVID-19 (CATALYST): a randomized, multi-center, multi-arm, multi-stage, open-label, adaptive, phase 2 proof-of-concept study. Lancet Respir Med. Published online December 16, 2021. doi:10.1016/S2213-2600(21)00460-4
This article originally appeared on Pulmonology Advisor
