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Influence of anti-Spike protein antibody levels on tocilizumab efficacy in hospitalized patients with severe COVID-19 pneumonia: a post-hoc analysis of the COVACTA trial.

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  • معلومة اضافية
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 100968551 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2334 (Electronic) Linking ISSN: 14712334 NLM ISO Abbreviation: BMC Infect Dis Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: London : BioMed Central, [2001-
    • الموضوع:
      Antibodies, Monoclonal, Humanized*/therapeutic use ; COVID-19 Drug Treatment* ; SARS-CoV-2*/immunology ; Spike Glycoprotein, Coronavirus*/immunology ; Antibodies, Viral*/blood; Humans ; Male ; Female ; Middle Aged ; COVID-19/mortality ; COVID-19/immunology ; Double-Blind Method ; Aged ; Antibodies, Neutralizing/blood ; Hospitalization ; Treatment Outcome ; Interleukin-6/antagonists & inhibitors
    • نبذة مختصرة :
      Competing Interests: Declarations. Ethics approval and consent to participate: Ethical approval was not required as the work consists of a post hoc analysis of published data. Consent for publication: Not applicable. Competing interests: José Aguareles received meeting grant from PharmaMar SA and served as a scientific consultant. Carles Forné (Heorfy Consulting) has received fees from Hospital Universitario Quirónsalud Madrid for statistical analysis. Pablo Guisado-Vasco received speaker fees from FLS Science, PharmaMar SA (Madrid, Spain) and GlaxoSmithKline (Spain); consulting fees from Angelini Pharma and PharmaMar SA; served as an advisory board member for Berlin Cures GmbH and PharmaMar SA; and meeting grants from GlaxoSmithKline and PharmaMar SA. All remaining authors have declared no conflicts of interest.
      Background: Our aim in this work is to find biomarkers to optimize therapy with IL-6 inhibitors, as not all clinical trials have shown clear benefits on mortality or mechanical ventilation progression. Given the link between delayed seroconversion and higher complication risks, we aim to test if evaluating SARS-CoV-2 spike protein antibody status before treatment could enhance IL-6 inhibitor therapy effectiveness in COVID-19 patients.
      Methods: We conducted a post hoc analysis of the COVACTA study, a phase 3, randomized, double-blind, placebo-controlled trial of the efficacy and safety of tocilizumab in hospitalized patients with severe COVID-19. Cox and logistic regression analysis were used to assess the tocilizumab's efficacy in severe COVID-19 patients on survival and ICU stay at day 28, based on SARS-CoV-2 S-spike and neutralizing antibody levels.
      Results: Tocilizumab reduced 28-day mortality over placebo in patients with low S-spike antibody titers (20% vs. 29%). No benefit was observed for higher antibody levels. Patients with low S-spike antibody levels treated with tocilizumab exhibited a lower probability of ICU stay at day 28 compared to those treated with placebo (63% vs. 82%). No significant differences were noted in mortality and ICU stay based on whole neutralizing antibody titers.
      Conclusions: Our findings suggest that using IL-6 inhibitors in severe COVID-19 patients with low S-spike antibody titers may improve clinical outcomes.
      Clinical Trial: Not applicable.
      (© 2025. The Author(s).)
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    • Contributed Indexing:
      Keywords: Antibodies; COVID-19; IL-6 inhibitors; SARS-CoV-2; Serostatus; Tocilizumab
    • الرقم المعرف:
      0 (Antibodies, Monoclonal, Humanized)
      I031V2H011 (tocilizumab)
      0 (Spike Glycoprotein, Coronavirus)
      0 (Antibodies, Neutralizing)
      0 (spike protein, SARS-CoV-2)
      0 (Antibodies, Viral)
      0 (Interleukin-6)
    • الموضوع:
      Date Created: 20250509 Date Completed: 20250509 Latest Revision: 20250523
    • الموضوع:
      20250523
    • الرقم المعرف:
      PMC12063319
    • الرقم المعرف:
      10.1186/s12879-025-11001-6
    • الرقم المعرف:
      40340657