Tocilizumab effectiveness in mechanically ventilated COVID-19 patients (T-MVC-19 Study): a multicenter real-world evidence

References

• Guan W, Ni Z, and Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med. 2020 Feb 28;382(18):1708–1720.* A good article on the clinical presentation of COVID-19 patients.
   PubMed Web of Science ®Google Scholar
• World Health Organization: Coronavirus Disease 2019 (COVID-19) situation report - 66 [Internet]. World Health Organization; 2020 [cited 2021 Aug 06]. Available from: https://www.who.int/docs/default-source/coronaviruse/situation-reports/20200326-sitrep-66-covid-19.pdf?sfvrsn=81b94e61_2
   Google Scholar
• World Health Organization: WHO coronavirus disease (COVID-19) dashboard [Internet]. World Health Organization; 2020 [updated 2021 Dec 10; cited 2021 Aug 06]. Available from: https://covid19.who.int/
   Google Scholar
• Macedo A, Gonçalves N, Febra C. COVID-19 fatality rates in hospitalized patients: systematic review and meta-analysis. Ann Epidemiol. 2021 May 1;57:14–21.
   PubMed Web of Science ®Google Scholar
• Yang X, Yu Y, Xu J, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May 1;8(5):475–481.
   PubMed Web of Science ®Google Scholar
• Chen C, Hu F, Wei J, et al. Systematic review and meta-analysis of tocilizumab in persons with coronavirus disease-2019 (COVID-19). Leuk. 2021 [2021 May 17];35(6):1661–1670.
   PubMed Web of Science ®Google Scholar
• Wang D, Hu B, Hu C, et al. Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus–infected pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061–1069.
   PubMed Web of Science ®Google Scholar
• Al-Dadah O, Novel Coronavirus HC. (COVID-19): a global pandemic. Knee. 2020 Mar 1;27(2):279.
   PubMed Web of Science ®Google Scholar
• Channappanavar R, Perlman S. Pathogenic human coronavirus infections: causes and consequences of cytokine storm and immunopathology. Semin Immunopathol. 2017 2017 May 2;39(5):529–539.
   PubMed Web of Science ®Google Scholar
• Giamarellos-Bourboulis EJ, Netea MG, Rovina N, et al. Complex immune dysregulation in COVID-19 patients with severe respiratory failure. Cell Host Microbe. 2020 Jun 10;27(6):992–1000.e3.
   PubMed Web of Science ®Google Scholar
• Vardhana SA, Wolchok JD. The many faces of the anti-COVID immune response. J Exp Med. 2020;217:6.
   Web of Science ®Google Scholar
• Xiao-Shan W, Xiao-Rong W, Jian-Chu Z, et al. A cluster of health care workers with COVID-19 pneumonia caused by SARS-CoV-2. J Microbiol Immunol Infect. 2021 Feb 1;54(1):54–60.
   PubMedGoogle Scholar
• Xiaoling X, Mingfeng H, Tiantian L, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A. 2020 May 19;117(20):10970–10975.
   PubMed Web of Science ®Google Scholar
• Shao-Huan L, Chih-Cheng L, and Hui-Ting H, et al. Tocilizumab for severe COVID-19: a systematic review and meta-analysis. Int J Antimicrob Agents. 2020 Sep 1;56(3 106103).
   PubMed Web of Science ®Google Scholar
• Tleyjeh IM, Kashour Z, Damlaj M, et al. Efficacy and safety of tocilizumab in COVID-19 patients: a living systematic review and meta-analysis. Clin Microbiol Infect. 2021 Feb 1;27(2):215–227.
   PubMed Web of Science ®Google Scholar
• Aziz M, Haghbin H, Sitta EA, et al. Efficacy of tocilizumab in COVID-19: a systematic review and meta-analysis. J Med Virol. 2021 Mar 1;93(3):1620–1630.
   PubMed Web of Science ®Google Scholar
• Malgie J, Schoones JW, Pijls BG. Decreased mortality in coronavirus disease 2019 patients treated with Tocilizumab: a rapid systematic review and meta-analysis of observational studies. Clin Infect Dis. 2021 Jun 1;72(11):E742–9.
   PubMed Web of Science ®Google Scholar
• Abani O, Abbas A, Abbas F, et al. Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial. Lancet. 2021 May 1;397(10285):1637–1645.
   PubMed Web of Science ®Google Scholar
• Qiu W, Hua L, Rong-Guo W, et al. Tocilizumab treatment for COVID-19 patients: a systematic review and meta-analysis. Infect Dis Poverty. 2021 [2021 May 18];10(1):1–17.
   PubMed Web of Science ®Google Scholar
• von Elm E, Altman DG, Egger M, et al. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. In Equator network. 2020.
   Google Scholar
• Vassar M, Holzmann M. The retrospective chart review: important methodological considerations. J Educ Eval Health Prof. 2013 Nov;30(10):12.
   Google Scholar
• Saudi Minestry of Health: Saudi MoH Protocol for supportive care and antiviral treatment of suspected or confirmed COVID-19 infection (Version 3.1) [Internet]. Saudi Arabia: Saudi Minestry of Health; 2021 [ cited 2021 Aug 26]. Available from: https://www.moh.gov.sa/Ministry/MediaCenter/Publications/Documents/MOH-therapeutic-protocol-for-COVID-19.pdf
   Google Scholar
• Harris PA, Taylor R, Minor BL, et al. The REDCap consortium: building an international community of software platform partners. J Biomed Inform. 2019 Jul 1;95:103208.
   PubMed Web of Science ®Google Scholar
• Springer Link: Modeling Survival Data: Extending the Cox Model. [Internet]. New York: Springer Nature; 2000 [ cited 2021 Aug 26]. Available from: https://link.springer.com/book/10.1007/978-1-4757-3294-8
   Google Scholar
• Springer link: ggplot2: elegant graphics for data analysis [Internet]. New York: Springer Nature; 2016 [ cited 2021 Aug 26]. Available from: http://link.springer.com/10.1007/978-3-319-24277-4
   Google Scholar
• Survminer: drawing Survival Curves using ‘ggplot2’ [Version 0.4.9] [Internet]. 2021 [cited 2021 Aug 26]. Available from: https://cran.r-project.org/web/packages/survminer/index.html
   Google Scholar
• Wiley online library: complex surveys: a guide to analysis using R. biostatistics [Internet]. John Wiley & Sons; 2010 [cited 2021 Aug 26]. Available from: https://onlinelibrary.wiley.com/doi/book/10.1002/9780470580066
   Google Scholar
• Buuren SV, Groothuis-Oudshoorn K. mice: multivariate imputation by chained equations in R. J Stat Softw. 2011 Dec 12;45(1):1–67.
   Google Scholar
• MatchThem: matching and weighting multiply imputed datasets [R package matchthem version 1.0.0] [Internet]. 2021 [cited 2021 Aug 26]. Available from: https://cran.r-project.org/package=MatchThem
   Google Scholar
• Cobalt: covariate balance tables and plots [R package cobalt version 4.3.1] [Internet]. 2021 [cited 2021 Aug 26]. Available from: https://ngreifer.github.io/cobalt/
   Google Scholar
• CrrSC: competing risks regression for stratified and clustered data [Version 1.1]. [Internet]. 2015 [cited 2021 Aug 26]. Available from: https://cran.r-project.org/web/packages/crrSC/index.html
   Google Scholar
• Sterne JA, White IR, Carlin JB, et al. Multiple imputation for missing data in epidemiological and clinical research: potential and pitfalls. BMJ. 2009 Jul 18;338(7713):157–160.
   Google Scholar
• Desai RJ, Franklin JM. Alternative approaches for confounding adjustment in observational studies using weighting based on the propensity score: a primer for practitioners. BMJ. 2019 Oct 23; 367. DOI:https://doi.org/10.1136/bmj.l5657.
   Google Scholar
• Austina PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015 Dec 10;34(28):3661–3679.
   PubMed Web of Science ®Google Scholar
• Wiley online library: multiple imputation for nonresponse in surveys [Internet]. John Wiley & Sons; 1987 [cited 2021 Aug 26]. Available from: http://doi.wiley.com/10.1002/9780470316696
   Google Scholar
• Austina PC. Optimal caliper widths for propensity-score matching when estimating differences in means and differences in proportions in observational studies. Pharm Stat. 2011 Mar;10(2):150–161.
   PubMed Web of Science ®Google Scholar
• Klein JP, Moeschberger ML. Survival analysis: techniques for censored and truncated data. Journal of the Neurological Sciences. 1997;149(2):95.
   PubMedGoogle Scholar
• PC A, DS L, JP F. Introduction to the analysis of survival data in the presence of competing risks. Circulation. 2016 Feb 9;133(6):601–609.
   PubMed Web of Science ®Google Scholar
• PC A, JP F. Propensity-score matching with competing risks in survival analysis. Stat Med. 2019 Feb 28;38(5):751–777.
   PubMed Web of Science ®Google Scholar
• Latouche A, Allignol A, Beyersmann J, et al. A competing risks analysis should report results on all cause-specific hazards and cumulative incidence functions. J Clin Epidemiol. 2013 Jun 1;66(6):648–653.
   PubMed Web of Science ®Google Scholar
• WHO Solidarity Trial Consortium. Repurposed antiviral drugs for Covid-19 — interim WHO solidarity trial results. N Engl J Med. 2020 Dec 2;384(6): 497–511.
   PubMed Web of Science ®Google Scholar
• The RECOVERY Collaborative Group. Dexamethasone in hospitalized patients with Covid-19. N Engl J Med. 2020 Jul 17;384(8): 693–704.
   PubMed Web of Science ®Google Scholar
• Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 [Internet]. Food and Drug Administration; 2020 [updated 2020 Nov 21; cited 2021 Aug 17]. Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19
   Google Scholar
• Fusina F, Albani F, Granato E, et al. Effect of corticosteroids on mortality in hospitalized COVID-19 patients not receiving invasive mechanical ventilation. Clin Pharmacol Ther. 2021 Jun 1;109(6):1660–1667.
   PubMed Web of Science ®Google Scholar
• Salama C, Han J, Yau L, et al. Tocilizumab in patients hospitalized with Covid-19 Pneumonia. N Engl J Med. 2020 Dec 17;384(1):20–30.
   PubMed Web of Science ®Google Scholar
• Rosas IO, Bräu N, Waters M, et al. Tocilizumab in hospitalized patients with severe Covid-19 Pneumonia. N Engl J Med. 2021 Feb 25;384(16):1503–1516.
   PubMed Web of Science ®Google Scholar
• COVID-19 treatment guidelines: interleukin-6 inhibitors [Internet] National Institutes of Health; 2021 [updated 2021 Oct 19; cited 2021 Aug 15]. Available from: https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/interleukin-6-inhibitors/
   Google Scholar
• Moore JB, June CH. Cytokine release syndrome in severe COVID-19. Science (80). 2020;368(6490):473–474.
   PubMed Web of Science ®Google Scholar
• FDA briefing document arthritis advisory committee meeting August 2, 2017 [Internet]. Food and Drug Administration; 2017 [cited 2021 Aug 27]. Available from: https://www.fda.gov/media/106325/download
   Google Scholar
• Tsai A, Diawara O, Nahass RG, et al. Impact of tocilizumab administration on mortality in severe COVID-19. Sci Rep. 2020 [2020 Nov 5];10(1):1–7.
   PubMed Web of Science ®Google Scholar
• Soin AS, Kumar K, Choudhary NS, et al. Tocilizumab plus standard care versus standard care in patients in India with moderate to severe COVID-19-associated cytokine release syndrome (COVINTOC): an open-label, multicentre, randomised, controlled, phase 3 trial. Lancet Respir Med. 2021 May 1;9(5):511–521.
   PubMed Web of Science ®Google Scholar
• Fisher MJ, Marcos Raymundo LA, Monteforte M, et al. Tocilizumab in the treatment of critical COVID-19 pneumonia: a retrospective cohort study of mechanically ventilated patients. Int J Infect Dis. 2021 Feb 1;103:536–539.
   PubMed Web of Science ®Google Scholar
• Somers EC, Eschenauer GA, Troost JP, et al. Tocilizumab for treatment of mechanically ventilated patients with COVID-19. medRxiv. 2020 Jun 3. DOI:https://doi.org/10.1101/2020.05.29.20117358.
   Google Scholar
• Lévesque LE, Hanley JA, Kezouh A, et al. Problem of immortal time bias in cohort studies: example using statins for preventing progression of diabetes. BMJ. 2010 Mar 12;340(7752):907–911.
   Google Scholar
• Biran N, Ip A, Ahn J, et al. Tocilizumab among patients with COVID-19 in the intensive care unit: a multicentre observational study. Lancet Rheumatol. 2020 Oct 1;2(10):e603.
   PubMedGoogle Scholar
• Fernández-Ruiz M, López-Medrano F, Carretero O, et al. Tocilizumab therapy in SARS-CoV-2 pneumonia: a matched retrospective cohort analysis. Med Clin (Barc). 2021. DOI:https://doi.org/10.1016/j.medcli.2021.06.014.
   Google Scholar
• Group TWREA for C-19 T (REACT) W, Domingo P, Mur I, Mateo GM, et al. Association between administration of IL-6 antagonists and mortality among patients hospitalized for COVID-19: a meta-analysis. JAMA. 2021;326(6):499–518.
   PubMed Web of Science ®Google Scholar
• Rossi B, Nguyen LS, Zimmermann P, et al. Effect of Tocilizumab in hospitalized patients with severe COVID-19 Pneumonia: a case-control cohort study. Pharm. 2020 [2020 Oct 17];13(10):317.
   Google Scholar
• Capra R, Rossi ND, Mattioli F, et al. Impact of low dose tocilizumab on mortality rate in patients with COVID-19 related pneumonia. Eur J Intern Med. 2020 Jun 1;76:31.
   PubMed Web of Science ®Google Scholar
• Guaraldi G, Meschiari M, Cozzi-Lepri A, et al. Tocilizumab in patients with severe COVID-19: a retrospective cohort study. Lancet Rheumatol. 2020 Aug 1;2(8):e474.
   PubMedGoogle Scholar
• Menzella F, Fontana M, Salvarani C, et al. Efficacy of tocilizumab in patients with COVID-19 ARDS undergoing noninvasive ventilation. Crit Care. 2020 [2020 Sep 29];24(1):1–9.
   PubMed Web of Science ®Google Scholar
• Petrak RM, Van Hise NW, Skorodin NC, et al. Early Tocilizumab dosing is associated with improved survival in critically Ill patients infected with severe acute respiratory syndrome coronavirus-2. Crit Care Explor. 2021;3(4):e0395.
   PubMedGoogle Scholar
• Ellis AG, Trikalinos TA, Wessler BS, et al. Propensity score–based methods in comparative effectiveness research on coronary artery disease. Am J Epidemiol. 2018 May 1;187(5):1064–1078.
   PubMed Web of Science ®Google Scholar
• Brookhart MA, Schneeweiss S, Rothman KJ, et al. Variable selection for propensity score models. Am J Epidemiol. 2006 Jun;163(12):1149.
   PubMed Web of Science ®Google Scholar
• Walraven CV, Davis D, Forster AJ, et al. Time-dependent bias was common in survival analyses published in leading clinical journals. J Clin Epidemiol. 2004 Jul;57(7):672–682.
   PubMed Web of Science ®Google Scholar
• Koller MT, Raatz H, Steyerberg EW, et al. Competing risks and the clinical community: irrelevance or ignorance? Stat Med. 2012 May 20;31(11–12):1089–1097.
   PubMed Web of Science ®Google Scholar
• Zhang Z, Navas T, Herrick WG. Survival analysis in the presence of competing risks. Ann Transl Med. 2017 Feb 1;5:3.
   PubMed Web of Science ®Google Scholar
• Poguntke I, Schumacher M, Beyersmann J, et al. Simulation shows undesirable results for competing risks analysis with time-dependent covariates for clinical outcomes. BMC Med Res Methodol. 2018 [2018 Jul 16];18(1):1–10.
   PubMedGoogle Scholar
• Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983 Apr 1;70(1):41–55.
   Web of Science ®Google Scholar
• Flisiak R, Jaroszewicz J, Rogalska M, et al. Tocilizumab improves the prognosis of COVID-19 in patients with high IL-6. J Clin Med. 2021;10(8):1583.
   PubMed Web of Science ®Google Scholar
• Salvati L, Occhipinti M, Gori L, et al. Pulmonary vascular improvement in severe COVID-19 patients treated with tocilizumab. Immunol Lett. 2020;228:122–128.
   PubMed Web of Science ®Google Scholar
• Liu F, Li L, and Da XM, et al. Prognostic value of interleukin-6, C-reactive protein, and procalcitonin in patients with COVID-19. J Clin Virol. 2020;127:104370.
   PubMed Web of Science ®Google Scholar
• Herold T, Jurinovic V, Arnreich C, et al. Elevated levels of IL-6 and CRP predict the need for mechanical ventilation in COVID-19. J Allergy Clin Immunol. 2020;146(1):128–136.e4.
   PubMed Web of Science ®Google Scholar
• Saudi Minestry of Health: Saudi MoH protocol for patients suspected of/confirmed with COVID-19; supportive care and antiviral treatment of suspected or confirmed COVID-19 infection (Version 3.4) [Internet]. Saudi Arabia: Saudi Minestry of Health; 2022 [cited 2022 Jan 08]. Available from: https://www.moh.gov.sa/Ministry/MediaCenter/Publications/Documents/MOH-therapeutic-protocol-for-COVID-19.pdf
   Google Scholar