Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia

Carlos Salama, Jian Han, Linda Yau, William G Reiss, Benjamin Kramer, Jeffrey D Neidhart, Gerard J Criner, Emma Kaplan-Lewis, Rachel Baden, Lavannya Pandit, Miriam L Cameron, Julia Garcia-Diaz, Victoria Chávez, Martha Mekebeb-Reuter, Ferdinando Lima de Menezes, Reena Shah, Maria F González-Lara, Beverly Assman, Jamie Freedman, Shalini V Mohan
New England Journal of Medicine 2020 December 17

BACKGROUND: Coronavirus disease 2019 (Covid-19) pneumonia is often associated with hyperinflammation. Despite the disproportionate incidence of Covid-19 among underserved and racial and ethnic minority populations, the safety and efficacy of the anti-interleukin-6 receptor antibody tocilizumab in patients from these populations who are hospitalized with Covid-19 pneumonia are unclear.

METHODS: We randomly assigned (in a 2:1 ratio) patients hospitalized with Covid-19 pneumonia who were not receiving mechanical ventilation to receive standard care plus one or two doses of either tocilizumab (8 mg per kilogram of body weight intravenously) or placebo. Site selection was focused on the inclusion of sites enrolling high-risk and minority populations. The primary outcome was mechanical ventilation or death by day 28.

RESULTS: A total of 389 patients underwent randomization, and the modified intention-to-treat population included 249 patients in the tocilizumab group and 128 patients in the placebo group; 56.0% were Hispanic or Latino, 14.9% were Black, 12.7% were American Indian or Alaska Native, 12.7% were non-Hispanic White, and 3.7% were of other or unknown race or ethnic group. The cumulative percentage of patients who had received mechanical ventilation or who had died by day 28 was 12.0% (95% confidence interval [CI], 8.5 to 16.9) in the tocilizumab group and 19.3% (95% CI, 13.3 to 27.4) in the placebo group (hazard ratio for mechanical ventilation or death, 0.56; 95% CI, 0.33 to 0.97; P = 0.04 by the log-rank test). Clinical failure as assessed in a time-to-event analysis favored tocilizumab over placebo (hazard ratio, 0.55; 95% CI, 0.33 to 0.93). Death from any cause by day 28 occurred in 10.4% of the patients in the tocilizumab group and 8.6% of those in the placebo group (weighted difference, 2.0 percentage points; 95% CI, -5.2 to 7.8). In the safety population, serious adverse events occurred in 38 of 250 patients (15.2%) in the tocilizumab group and 25 of 127 patients (19.7%) in the placebo group.

CONCLUSIONS: In hospitalized patients with Covid-19 pneumonia who were not receiving mechanical ventilation, tocilizumab reduced the likelihood of progression to the composite outcome of mechanical ventilation or death, but it did not improve survival. No new safety signals were identified. (Funded by Genentech; EMPACTA number, NCT04372186.).

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Mansoor Keen

obviously IL-6 blocking pathway is a double edged sword for inflammatory drive and prevention of cytokine storm,the studies and worldwide trials have not been encouraging its use in isolation for such situations.
TCZ is indeed a risk for more bacterial infections but there has not been any conclusive evidence of statistically significant fungal infections procluding it as absolute contra indication for use.
We need more evidence and trials where use of IL-6 with steroids and antibiotics can be compared.
I hope development of vaccines and short term herd immunity will limit further use of IL-6 blocking pathway for now.


Muhammad Shaikh

Tocilizumab is an absolute contraindication for this condition. As it has no role in whatever that has been proposed to prevent the so-called "cytokine release syndrome" etc. It is associated with increased mortality and excessive immunosuppression with development of deadly fungal infections.


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