Early use of canakinumab to prevent mechanical ventilation in select COVID-19 patients: A retrospective, observational analysis

Abstract

Introduction The fully-human monoclonal anti-interleukin (IL)-1β antibody canakinumab may inhibit the production of inflammatory mediators in patients with coronavirus disease 2019 (COVID-19) and the hyperinflammatory response potentially leading to acute respiratory distress syndrome. Objectives The goal of our retrospective, observational analysis was to evaluate the safety and efficacy of subcutaneous (s.c.) canakinumab in combination with our standard of care (SOC) treatment of selected patients with COVID-19 with respiratory failure and elevated reactive pro-inflammatory markers. Methods Eight participants received two doses of s.c. canakinumab 150 mg (or 2 mg/kg for participants weighing ≤40 kg) in addition to SOC. 12 patients received only SOC treatment. Results Canakinumab treatment reduced the need for mechanical ventilation and reduced proinflammatory markers, resulting in an amelioration of the final outcome, with respect to the control group who received SOC alone. The treatment was safe and well tolerated; no adverse events were reported. Conclusion The use of canakinumab (300 mg, s.c.) in the early stage of COVID-19 with mild-to-moderate respiratory failure was superior to SOC at preventing clinical deterioration and may warrant further investigation as a treatment option for patients with COVID-19 who experience a hyperinflammatory response in the early stage of the disease.

Passive Immunotherapy Against SARS-CoV-2: From Plasma-Based Therapy to Single Potent Antibodies in the Race to Stay Ahead of the Variants

“…Based on clinical data, the US-CDC recommends against the use of canakinumab for treatment of COVID-19 [ 519 ]. Nevertheless, similar to tocilizumab and antibodies targeting SARS-CoV-2, early use of canakinumab was shown to provide superior efficacy over standard of care [ 536 ]. Similarly, clinical studies on antibodies targeting IL-33R, IL-22, P-selectin, IFN-γ, CTGF, and CD73 to improve COVID-19 outcomes all have been discontinued due to lack of clinical efficacy (Table 10 ).…”

Cell deaths: Involvement in the pathogenesis and intervention therapy of COVID-19

“…Canakinumab showed positive effects on inflammatory markers, oxygen improvement, and final outcomes of COVID-19 patients according to the results of several retrospective studies. 180 – 183 However, a randomized, double-blind, placebo-controlled phase III study indicated that canakinumab exhibited no benefit on mechanical ventilation requirement and mortality in hospitalized patients with severe COVID-19 (NCT04362813). 184 In addition, Canakinumab has been evaluated in the COVID-19 patients concurrently with cardiac injury or type 2 diabetes, whose results have not been published (NCT04365153, NCT04510493).…”

The effect of canakinumab on clinical outcomes in patients with COVID-19: A meta-analysis

“…After literature search, a total of 6 studies 4 , 5 , 6 , 7 , 8 , 9 comprising of 1121 adult patients with COVID-19, including 379 in the canakinumab (administered alone) and 742 in the control group arm, were included in this meta-analysis. The study characteristics of the included studies are listed in Table 1 .…”