Tocilizumab in Patients Hospitalized with Covid-19 Pneumonia
| Autor: | Lavannya Pandit, Julia Garcia-Diaz, Gerard J. Criner, Benjamin Kramer, Jamie Freedman, Maria F. González-Lara, Rachel Baden, Linda Yau, Jian Han, Shalini V. Mohan, Miriam L Cameron, Reena Shah, Carlos Salama, Victoria Chávez, Martha Mekebeb-Reuter, Ferdinando Lima de Menezes, Jeffrey D. Neidhart, Emma Kaplan-Lewis, W. Reiss, Beverly Assman |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Intention-to-treat analysis Coronavirus disease 2019 (COVID-19) business.industry Incidence (epidemiology) General Medicine 030204 cardiovascular system & hematology medicine.disease law.invention 03 medical and health sciences Pneumonia chemistry.chemical_compound 0302 clinical medicine Pharmacotherapy Tocilizumab Randomized controlled trial chemistry law Internal medicine Medicine Original Article 030212 general & internal medicine business Survival rate |
| Zdroj: | New England Journal of Medicine The New England Journal of Medicine |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | 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 ClinicalTrials.gov number, NCT04372186.) |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|