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Efficacy of Tocilizumab in Patients Hospitalized with Covid-19 #MMPMID33085857
Stone JH; Frigault MJ; Serling-Boyd NJ; Fernandes AD; Harvey L; Foulkes AS; Horick NK; Healy BC; Shah R; Bensaci AM; Woolley AE; Nikiforow S; Lin N; Sagar M; Schrager H; Huckins DS; Axelrod M; Pincus MD; Fleisher J; Sacks CA; Dougan M; North CM; Halvorsen YD; Thurber TK; Dagher Z; Scherer A; Wallwork RS; Kim AY; Schoenfeld S; Sen P; Neilan TG; Perugino CA; Unizony SH; Collier DS; Matza MA; Yinh JM; Bowman KA; Meyerowitz E; Zafar A; Drobni ZD; Bolster MB; Kohler M; D'Silva KM; Dau J; Lockwood MM; Cubbison C; Weber BN; Mansour MK
N Engl J Med 2020[Dec]; 383 (24): 2333-2344 PMID33085857show ga
BACKGROUND: The efficacy of interleukin-6 receptor blockade in hospitalized patients with coronavirus disease 2019 (Covid-19) who are not receiving mechanical ventilation is unclear. METHODS: We performed a randomized, double-blind, placebo-controlled trial involving patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, hyperinflammatory states, and at least two of the following signs: fever (body temperature >38 degrees C), pulmonary infiltrates, or the need for supplemental oxygen in order to maintain an oxygen saturation greater than 92%. Patients were randomly assigned in a 2:1 ratio to receive standard care plus a single dose of either tocilizumab (8 mg per kilogram of body weight) or placebo. The primary outcome was intubation or death, assessed in a time-to-event analysis. The secondary efficacy outcomes were clinical worsening and discontinuation of supplemental oxygen among patients who had been receiving it at baseline, both assessed in time-to-event analyses. RESULTS: We enrolled 243 patients; 141 (58%) were men, and 102 (42%) were women. The median age was 59.8 years (range, 21.7 to 85.4), and 45% of the patients were Hispanic or Latino. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% confidence interval [CI], 0.38 to 1.81; P = 0.64), and the hazard ratio for disease worsening was 1.11 (95% CI, 0.59 to 2.10; P = 0.73). At 14 days, 18.0% of the patients in the tocilizumab group and 14.9% of the patients in the placebo group had had worsening of disease. The median time to discontinuation of supplemental oxygen was 5.0 days (95% CI, 3.8 to 7.6) in the tocilizumab group and 4.9 days (95% CI, 3.8 to 7.8) in the placebo group (P = 0.69). At 14 days, 24.6% of the patients in the tocilizumab group and 21.2% of the patients in the placebo group were still receiving supplemental oxygen. Patients who received tocilizumab had fewer serious infections than patients who received placebo. CONCLUSIONS: Tocilizumab was not effective for preventing intubation or death in moderately ill hospitalized patients with Covid-19. Some benefit or harm cannot be ruled out, however, because the confidence intervals for efficacy comparisons were wide. (Funded by Genentech; ClinicalTrials.gov number, NCT04356937.).
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N+Engl+J+Med 2020 ; 383 (24): 2333-2344
