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Impact of interleukin-6 blockade with tocilizumab on SARS-CoV-2 viral kinetics and antibody responses in patients with COVID-19: A prospective cohort study

Masiá et al., EBioMedicine, doi:10.1016/j.ebiom.2020.102999, Oct 2020
https://c19early.org/masia.html
Mortality 80% Improvement Relative Risk ICU admission 8% Hospitalization time -44% Viral clearance -68% Tocilizumab for COVID-19  Masiá et al.  LATE TREATMENT Is late treatment with tocilizumab beneficial for COVID-19? Prospective study of 138 patients in Spain (March - April 2020) Lower mortality (p=0.043) and longer hospitalization (p=0.00038) c19early.org Masiá et al., EBioMedicine, October 2020 Favorstocilizumab Favorscontrol 0 0.5 1 1.5 2+
Prospective cohort study of 138 hospitalized COVID-19 patients showing lower mortality with tocilizumab.
Viral load measured by PCR may not accurately reflect infectious virus measured by viral culture. Porter et al. show that viral load early in infection was correlated with infectious virus, but viral load late in infection could be high even with low or undetectable infectious virus. Assessing viral load later in infection may underestimate reductions in infectious virus with treatment.
risk of death, 79.6% lower, RR 0.20, p = 0.04, treatment 2 of 76 (2.6%), control 8 of 62 (12.9%), NNT 9.7.
risk of ICU admission, 8.2% lower, RR 0.92, p = 1.00, treatment 9 of 76 (11.8%), control 8 of 62 (12.9%), NNT 94.
hospitalization time, 44.4% higher, relative time 1.44, p < 0.001, treatment median 13.0 IQR 9.8 n=76, control median 9.0 IQR 7.0 n=62.
risk of no viral clearance, 68.0% higher, HR 1.68, p = 0.51, treatment 29, control 29, adjusted per study, propensity score matching, multivariable, Cox proportional hazards.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Masiá et al., 31 Oct 2020, prospective, Spain, peer-reviewed, median age 64.0, 10 authors, study period 10 March, 2020 - 17 April, 2020. Contact: marmasia@umh.es, gutierrez_fel@gva.es.
Impact of interleukin-6 blockade with tocilizumab on SARS-CoV-2 viral kinetics and antibody responses in patients with COVID-19: A prospective cohort study
Mar Masiá, Marta Fernández-González, Sergio Padilla, Piedad Ortega, José A García, Vanesa Agulló, Javier García-Abellán, Guillermo Telenti, Lucía Guillén, Félix Gutiérrez
EBioMedicine, doi:10.1016/j.ebiom.2020.102999
Background: The virological and immunological effects of the immunomodulatory drugs used for COVID-19 remain unknown. We evaluated the impact of interleukin (IL)-6 blockade with tocilizumab on SARS-CoV-2 viral kinetics and the antibody response in patients with COVID-19. Methods: Prospective cohort study in patients admitted with COVID-19. Serial nasopharyngeal and plasma samples were measured for SARS-CoV-2 RNA and S-IgG/N-IgG titers, respectively. Findings: 138 patients with confirmed infection were included; 76 (55%) underwent IL-6 blockade. Median initial SOFA (p = 0016) and SARS-CoV-2 viral load (p<0001, Mann-Whitney-Wilcoxon test) were significantly higher among anti-IL-6 users. Patients under IL-6 blockade showed delayed viral clearance in the Kaplan-Meier curves (HR 035 [95%CI] [015À081], log-rank p = 0014), but an adjusted propensity score matching model did not demonstrate a significant relationship of IL-6 blockade with viral clearance (HR 163 [035À77]). Cox regression showed an inverse association between SARS-CoV-2 RNA clearance and the initial viral load (HR 035 [011À089]). Patients under the IL-6 blocker showed shorter median time to seropositivity, higher peak antibody titers, and higher cumulative proportion of seropositivity in the Kaplan Meier curves (HR 31 [19À5] for and HR 30 [19À49] for N-IgG; log-rank p<0001 for both). However, no significant differences between groups were found in either S-IgG (HR 156 [041À60]) nor N-IgG (HR 096 [026À35]) responses in an adjusted propensity score analysis. Interpretation: Our results suggest that in patients infected with SARS-CoV-2, IL-6 blockade does not impair the viral specific antibody responses. Although a delayed viral clearance was observed, it was driven by a higher initial viral load. The study supports the safety of this therapy in patients with COVID-19.
Declaration of Competing Interests Dr. Guti errez reports personal fees from Janssen-Cilag and from ViiV Health Care, outside the submitted work. The other authors have nothing to disclose. Supplementary materials Supplementary material associated with this article can be found, in the online version, at doi:10.1016/j.ebiom.2020.102999.
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Late treatment
is less effective
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