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Tocilizumab and Sarilumab Alone Or in Combination with Corticosteroids For medRxiv preprint doi: https://doi.org/10.1101/2021.07.05.21259867; this version posted July 7, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 1 Tocilizumab and sarilumab alone or in combination with 2 corticosteroids for COVID-19: A systematic review and network meta- 3 analysis 4 Dena Zeraatkar, methodologist 5 Department of Biomedical Informatics, Harvard Medical School 6 Department of Health Research Methods, Evidence, and Impact, McMaster University 7 8 Ellen Cusano, internist 9 Cumming School of Medicine, University of Calgary 10 11 Juan Pablo Díaz Martinez, methodologist 12 Department of Health Research Methods, Evidence, and Impact, McMaster University 13 14 Anila Qasim, methodologist 15 Department of Health Research Methods, Evidence, and Impact, McMaster University 16 17 Sophia O. Mangala, methodologist 18 Department of Health Research Methods, Evidence, and Impact, McMaster University 19 20 Elena Kum, methodologist 21 Department of Health Research Methods, Evidence, and Impact, McMaster University 22 23 Jessica J. Bartoszko, methodologist 24 Department of Health Research Methods, Evidence, and Impact, McMaster University 25 26 Tahira Devji, methodologist 27 Department of Health Research Methods, Evidence, and Impact, McMaster University 28 29 Thomas Agoritsas, internist, methodologist 30 Department of Health Research Methods, Evidence, and Impact, McMaster University 31 Division of General Internal Medicine & Division of Clinical Epidemiology, University Hospitals of 32 Geneva, Geneva 33 MAGIC Evidence Ecosystem Foundation, Oslo 34 35 Francois Lamontagne, critical care physician, methodologist 36 Department of Medicine, University of Sherbooke, Sherbrooke, Quebec 37 Centre de recherche du CHU University of Sherbooke, Sherbrooke, Quebec 38 39 Bram Rochwerg, critical care physician, methodologist 40 Department of Health Research Methods, Evidence, and Impact, McMaster University 41 Department of Medicine, McMaster University 42 43 Per O Vandvik, internist, methodologist 1 NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2021.07.05.21259867; this version posted July 7, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 44 MAGIC Evidence Ecosystem Foundation, Oslo 45 Department of Health Economics and Health Management, Institute for Health and Society, 46 University of Oslo, Oslo 47 48 Romina Brignardello-Petersen, methodologist 49 Department of Health Research Methods, Evidence, and Impact, McMaster University 50 51 Reed Siemieniuk*, internist, methodologist 52 Department of Health Research Methods, Evidence, and Impact, McMaster University 53 54 *Corresponding author: Reed Siemieniuk ([email protected]) 55 Disclaimers: None 56 Funding: This project is supported by two CIHR Operating Grants (VR4- 172738; MM1- 174897). 57 Data: Data is available in the supplementary materials. 58 Authors’ Contributions: DZ, BR, FL, TA, POV, RBP, and RS conceived the study. JB identified studies. DZ, 59 EC, and EK collected the data. AQ and JPDM analyzed the data. TD and RBP assessed the certainty of 60 evidence. DZ drafted the first version of this manuscript. 61 Word count: 2,580 62 63 2 medRxiv preprint doi: https://doi.org/10.1101/2021.07.05.21259867; this version posted July 7, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 64 Abstract 65 66 Objective: To compare the effects of interleukin-6 (IL-6) receptor blockers, with or without 67 corticosteroids, on mortality in patients with COVID-19. 68 Design: Systematic review and network meta-analysis 69 Data sources: WHO COVID-19 database, a comprehensive multilingual source of global covid-19 70 literature, and two prospective meta-analyses 71 Study selection: Trials in which people with suspected, probable, or confirmed COVID-19 were 72 randomized to IL-6 receptor blockers (with or without corticosteroids), corticosteroids, placebo, or 73 standard care. 74 Results: We assessed the risk of bias of included trials using a modification of the Cochrane risk of bias 75 2.0 tool. We performed a Bayesian fixed effect network meta-analysis and assessed the certainty of 76 evidence using the GRADE approach. 77 We identified 45 eligible trials (20,650 patients), 36 (19,350 patients) of which could be included in the 78 network meta-analysis. 27 of 36 trials were rated at high risk of bias, primarily due to lack of blinding. 79 Tocilizumab (20 more per 1000, 15 fewer to 59 more; low certainty) and sarilumab (11 more per 1000, 80 38 fewer to 55 more; low certainty) alone may not reduce the risk of death. Tocilizumab, in combination 81 with corticosteroids, probably reduces the risk of death compared to corticosteroids alone (35 fewer per 82 1000, 52 fewer to 18 more; moderate certainty) and sarilumab, in combination with corticosteroids, 83 may reduce the risk of death compared to corticosteroids alone (43 fewer, 73 fewer to 12 more; low 84 certainty). Tocilizumab and sarilumab, both in combination with corticosteroids, may have similar 85 effects (8 more per 1000, 20 fewer to 35 more; low certainty). 86 Conclusion: IL-6 receptor blockers, when added to standard care that includes corticosteroids, in 87 patients with severe or critical COVID-19, probably reduce mortality. Tocilizumab and sarilumab may 88 have similar effectiveness. 89 Systematic review registration: NA 90 3 medRxiv preprint doi: https://doi.org/10.1101/2021.07.05.21259867; this version posted July 7, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 91 What is already known on this topic? 92 IL-6 receptor blockers have immunosuppressive effects that may be important in COVID-19 93 patients with immune system dysfunction and inflammation 94 Corticosteroids reduce the risk of death in patients with severe or critical COVID-19 95 What this study adds 96 Our systematic review and network meta-analysis provides a comprehensive review of the 97 evidence addressing the effects of IL-6 receptor blockers, alone or in combination with 98 corticosteroids, in COVID-19 99 IL-6 receptor blockers when added to a standard care that includes corticosteroids, in patients 100 with severe or critical COVID-19, probably reduce mortality. 101 Tocilizumab and sarilumab in combination with corticosteroids may have similar effectiveness 102 for reducing mortality. 103 4 medRxiv preprint doi: https://doi.org/10.1101/2021.07.05.21259867; this version posted July 7, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 104 Background 105 As of June 2021, there have been more than 180 million cumulative cases of coronavirus disease 19 106 (COVID-19) worldwide and nearly four million deaths (1). In an attempt to improve outcomes for patients 107 with COVID-19, several drugs have been repurposed with varying results (2). Corticosteroids are the only 108 medication so far to have reduced mortality in patients with severe and critical disease (2). Tocilizumab, 109 an interleukin-6 (IL-6) receptor blocker may also reduce mortality, but whether sarilumab (another IL-6 110 receptor blocker) reduces mortality is uncertain. 111 IL-6 receptor blockers have immunosuppressive effects that may be important in COVID-19 patients with 112 immune system dysfunction and inflammation (3-5). The RECOVERY trial found that tocilizumab reduces 113 mortality and ventilation, particularly among patients receiving corticosteroids (6) and REMAP-CAP 114 showed tocilizumab and sarilumab to reduce mortality and improve organ-support free days (7). Results 115 across other trials, however, have not been consistent (8-10). A prospective meta-analysis also found that 116 tocilizumab reduces mortality (11), but whether sarilumab reduces mortality compared to no IL-6 receptor 117 blocker, and its effect relative to tocilizumab is unclear. 118 Tocilizumab is an expensive drug to which patients with COVID-19 currently have access—in settings 119 where it is available, tocilizumab is often used in only a minority of patients who might benefit from it 120 (12). If sarilumab is a comparable alternative to tocilizumab, it would increase availability for patients with 121 COVID-19 who would not have otherwise have access to IL-6 receptor blocker. 122 Here we report a systematic review and network meta-analysis addressing the effectiveness of IL-6 123 receptor blockers, alone or in combination with corticosteroids, for COVID-19. This review capitalizes on 124 the methods and data of our living systematic review and network meta-analysis of drug therapies for 125 COVID-19
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