"Preliminary Guidelines for the Use of Tocilizumab in COVID-19 Pneumonia" "Preliminary Guidelines for the Use of Tocilizumab in COVID-19 Pneumonia"
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Published:
Sep 29, 2021
Keywords:
COVID-19, pneumonia, tocilizumab, mechanical ventilation
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Abstract
We consider it important to make known to the scientific community, the preliminary guidelines for the use of tocilizumab in pneumonia due to COVID-19, it is a recombinant monoclonal antibody directed against the soluble and membrane-bound alpha receptor of IL-6.
Although it has not yet been incorporated into the treatment guidelines of the World Health Organization and has not been approved by the ANMAT in our country for the treatment of COVID-19, due to the additional benefits to the use of dexamethasone that it could have tocilizumab, reducing mortality (particularly in the most serious cases or those with a high risk of progression) and relieving stress on health services (by reducing the time of organic support and hospital stay), we consider it appropriate to make preliminary suggestions for its use in patients hospitalized for COVID-19 in our environment
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cunto eleonora roxana. "Preliminary Guidelines for the Use of Tocilizumab in COVID-19 Pneumonia": "Preliminary Guidelines for the Use of Tocilizumab in COVID-19 Pneumonia". Rev Arg de Ter Int. [Internet]. 2021 Sep. 29 [cited 2024 Nov. 23];38. Available from: https://revista.sati.org.ar/index.php/MI/article/view/781
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References
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4. Giamarellos-Bourboulis EJ, Netea MG, Rovina N, et al. Complex immune dysregulation in COVID-19 patients with severe respiratory failure. Cell Host Microbe 2020; 27(6): 992.e3-1000.e3.DOI: 10.1016 / j.chom.2020.04.009. Epub 2020 21 de abril
5. Aziz M, Fatima R, Assaly R. Elevated interleukin-6 and severe COVID-19: a metaanalysis. J Med Virol 2020; 92: 2283-5. DOI: 10.1002 / jmv.25948
6. Zhu J, Pang J, Ji P, et al. Elevated interleukin- 6 is associated with severity of COVID-19: a meta-analysis. J Med Virol 2020 May 29. DOI: 10.1002 / jmv.26085 (Epub ahead of print).
7. Pairo-Castineira E, Clohisey S, KlaricL, et al. Genetic mechanisms of critical illness in Covid-19. Nature 2020 December 11. DOIhttps://doi.org/10.1038/s41586-020-03065-y (Epub ahead of print).
8. Cellina M, Orsi M, Bombaci F, Sala M, et al. Favorable changes of CT findings in a patient with COVID-19 pneumonia after treatment with tocilizumab. Diagn Interv Imaging 2020; 101: 323-4. doi: 10.1016 / j.diii.2020.03.010
9. Michot J-M, Albiges L, Chaput N, et al. Tocilizumab, an anti-IL-6 receptor antibody, to treat COVID-19-related respiratory failure: a case report. Ann Oncol 2020; 31: 961-4. doi: 10.1016 / j.annonc.2020.03.300.
10. Antwi-Amoabeng D, Kanji Z, Ford B, et al. Clinical outcomes in COVID-19 patients treated with tocilizumab: an individual Patient data systematic review. J Med Virol 2020; 92: 2516-22. doi: 10.1002 / jmv.26038
11. Xu X, Han M, Li T, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A 2020; 117: 10970-5. doi: 10.1073 / pnas.2005615117
12. Kaye A, Siegel R. The efficacy of IL-6 inhibitor tocilizumab in reducing severe COVID-19 mortality: a systematic review. September 3, 2020 (https://www.medrxiv.org/content/10.1101/2020.07.10.20150938v2).preprint.
13. Guaraldi G, Meschiari M, Cozzi-LepriA, et al. Tocilizumab in patients with severe COVID-19: a retrospective cohort study.Lancet Rheumatol 2020; 2(8): e474-e484. doi: 10.1016 / S2665-9913 (20) 30173-9
14. Somers EC, Eschenauer GA, Troost JP,et al. Tocilizumab for treatment of Mechanically ventilated patients with COVID-19. Clin Infect Dis 2020 July 11. DOI: 10.1093 / cid / ciaa954 (Epub ahead of print).
15. Sinha P, Mostaghim A, Catherine G. et al Early administration of Interleukin-6 inhibitors for patients with severe Covid-19 disease is associated with decreased intubation, reduced mortality, and increased discharge. https://doi.org/10.1016/j.ijid.2020.07.023
16. Ramiro S, Remy LM, Magro-Checa C et al. Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated Cytokine storm syndrome: results of the CHIC study. Ann Rheum Dis 2020;0:1–9. doi: 10.1136 / annrheumdis-2020-218479.
17. Price CC, Altice FL, Shyr Y et al. Tocilizumab treatment for Cytokine Release Syndrome in hospitalized COVID-19 patients: survival and clinical outcomes. https://doi.org/10.1016/j.chest.2020.06.006.
18. Stone JH, Frigault MJ, Serling-Boyd NJ, et al. Efficacy of tocilizumab in patients hospitalized withCOVID-19. N Engl J Med. 2020;383(24):2333-2344. DOI: 10.1056 / NEJMoa2028836.
19-Salvarani C, Dolci G, Massari M, et al. Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA Intern Med. 2021;181(1):24-31. doi: 10.1001 / jamainternmed.2020.6615.
20. Hermine O, Mariette X, Tharaux PL, et al. Effect of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Intern Med.2021;181(1):32-40. doi: 10.1001 / jamainternmed.2020.6820.
21. Gupta S, Wang W, Hayek SS, et al.Association between early treatment with tocilizumab and mortality among critically ill patients with COVID-19.JAMA Intern Med. 2021;181(1):41-51. doi: 10.1001 / jamainternmed.2020.6252
22. Rosas I, Bräu N, Waters M, et al. Tocilizumab in hospitalized patients with severe COVID-19 pneumonia. NEJM 2021. DOI: 10.1056/NEJMoa2028700
23. Veiga VC, Prats J, Farias DLC, et al. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial.BMJ. 2021;372:n84. doi: https://doi.org/10.1136/bmj.n84
24. Salama C, Han J, Yau L, et al. Tocilizumab in patients hospitalized with COVID-19 pneumonia. N Engl J Med. 2021;384(1):20-30. DOI: 10.1056 / NEJMoa2030340
25. Gordon AC, Mouncey PR, al-Beidh KM et al (REMAP-CAP Investigators).
Interleukin-6 receptor antagonists in critically ill patients with COVID-19.
N Engl J Med. 2021. Available at: https://www.ncbi.nlm.nih.gov/pubmed/33631065.
26. Horby PW, Pessoa-Amorim G, et al. (RECOVERY Collaborative Group). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platformtrial. medRxiv. 2021;preprint. Available at: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1
27- COVID-19 rapid evidence summary: Tocilizumab for COVID-19 .15 January 2021. www.nice.org.uk/guidance/es33
28- Interim Clinical Commissioning Policy: Tocilizumab for hospitalised patients with Covid-19 pneumonia (adults). Rapid Policy Statement. NHS. 8 January 2021
29- Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults). NHS. 22 February 2021
30- The COVID-19 Treatment Guidelines Panel¨s Statement on teh Use Of Tocilizumab for the Treatment of COVID-19. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. 05/03/2021.NIH.Available at: www.covid19treatmentguidelines.nih.gov
31- Wise J. Covid 19: arthritis drug tocilizumab improve survival in intensive care patients, shows study. BMJ 2021;372:n61. doi: https://doi.org/10.1136/bmj.n61
32-Wise J. Covid 19: arthritis drug tocilizumab reduces deaths in hospitalised patients, study shows. BMJ 2021;372:n433. doi: https://doi.org/10.1136/bmj.n433
33- Bhimraj A, Morgan RL, Shumaker AH et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19March 5, 2021 Version 4.1.0. Available at: www.idsociety.org/COVID19guidelines
34. Lier AJ, Tuan JL, Davis MW, et al. Case report: disseminated strongyloidiasis in a patient with COVID-19. Am J Trop Med Hyg. 2020.
Available at: http://www.ajtmh.org/docserver/fulltext/10.4269/ajtmh.20-0699/tpmd200699.pdf?expires=1598276702&id=id&accname=guest&checksum=D8AA596942F31C34007E0FE 065AF1F5F.
35. Marchese V, Crosato V, Gulletta M, et al. Strongyloides infection manifested during immunosuppressive therapy for SARS-CoV-2 pneumonia. Infection. 2020. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/32910321.
36. Stauffer WM, Alpern JD, Walker PF. COVID-19 and dexamethasone: a potential strategy to avoid steroid related strongyloides hyperinfection. JAMA. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32761166
37-Chalmers JD, Crichton ML, Goeminne PC, et al. Management of
hospitalised adults with coronavirus disease-19 (COVID-19): A European Respiratory Society living guideline. Eur Respir J 2021; in press (https://doi.org/10.1183/13993003.00048-2021).
38-Tocilizumab for COVID-19. Evidence review. NICE (National Institute for Health and Care Excellence). 15 February 2021, last updated 24 February 2021.
39- Ghosn_L, Chaimani_A, Evrenoglou_T, et al. Interleukin-6 blocking agents for treating COVID-19: a living systematic review. Cochrane Database of Systematic Reviews 2021, Issue 3. Art. No.: CD013881.
DOI: 10.1002/14651858.CD013881.
40-Terapeutica para SARS-CoV2. 15 de Marzo de 2021. Sociedad Argentina de Infectologia. Disponible en www,sadi.org.ar
.
1- Guan W-J, Ni Z-Y, Hu Y, et al. Clinical characteristics of coronavirus disease 2019 in China. N Engl J Med 2020; 382: 1708-20. DOI: 10.1056/NEJMoa2002032
2- 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; 8: 475-81. DOI: 10.1016/S2213-2600(20)30079-5
3- Cevik M, Tate M, Lloyd O, et al. SARS-CoV-2, SARSCoV- 1 and MERS-CoV viral load dynamics, duration of viral shedding and infectiousness — a living systematic review and meta-analysis. July 29, 2020 (https:// www .medrxiv .org/ content/10.1101/2020 .07.25.20162107v2).preprint.
4. Giamarellos-Bourboulis EJ, Netea MG, Rovina N, et al. Complex immune dysregulation in COVID-19 patients with severe respiratory failure. Cell Host Microbe 2020; 27(6): 992.e3-1000.e3.DOI: 10.1016 / j.chom.2020.04.009. Epub 2020 21 de abril
5. Aziz M, Fatima R, Assaly R. Elevated interleukin-6 and severe COVID-19: a metaanalysis. J Med Virol 2020; 92: 2283-5. DOI: 10.1002 / jmv.25948
6. Zhu J, Pang J, Ji P, et al. Elevated interleukin- 6 is associated with severity of COVID-19: a meta-analysis. J Med Virol 2020 May 29. DOI: 10.1002 / jmv.26085 (Epub ahead of print).
7. Pairo-Castineira E, Clohisey S, KlaricL, et al. Genetic mechanisms of critical illness in Covid-19. Nature 2020 December 11. DOIhttps://doi.org/10.1038/s41586-020-03065-y (Epub ahead of print).
8. Cellina M, Orsi M, Bombaci F, Sala M, et al. Favorable changes of CT findings in a patient with COVID-19 pneumonia after treatment with tocilizumab. Diagn Interv Imaging 2020; 101: 323-4. doi: 10.1016 / j.diii.2020.03.010
9. Michot J-M, Albiges L, Chaput N, et al. Tocilizumab, an anti-IL-6 receptor antibody, to treat COVID-19-related respiratory failure: a case report. Ann Oncol 2020; 31: 961-4. doi: 10.1016 / j.annonc.2020.03.300.
10. Antwi-Amoabeng D, Kanji Z, Ford B, et al. Clinical outcomes in COVID-19 patients treated with tocilizumab: an individual Patient data systematic review. J Med Virol 2020; 92: 2516-22. doi: 10.1002 / jmv.26038
11. Xu X, Han M, Li T, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci U S A 2020; 117: 10970-5. doi: 10.1073 / pnas.2005615117
12. Kaye A, Siegel R. The efficacy of IL-6 inhibitor tocilizumab in reducing severe COVID-19 mortality: a systematic review. September 3, 2020 (https://www.medrxiv.org/content/10.1101/2020.07.10.20150938v2).preprint.
13. Guaraldi G, Meschiari M, Cozzi-LepriA, et al. Tocilizumab in patients with severe COVID-19: a retrospective cohort study.Lancet Rheumatol 2020; 2(8): e474-e484. doi: 10.1016 / S2665-9913 (20) 30173-9
14. Somers EC, Eschenauer GA, Troost JP,et al. Tocilizumab for treatment of Mechanically ventilated patients with COVID-19. Clin Infect Dis 2020 July 11. DOI: 10.1093 / cid / ciaa954 (Epub ahead of print).
15. Sinha P, Mostaghim A, Catherine G. et al Early administration of Interleukin-6 inhibitors for patients with severe Covid-19 disease is associated with decreased intubation, reduced mortality, and increased discharge. https://doi.org/10.1016/j.ijid.2020.07.023
16. Ramiro S, Remy LM, Magro-Checa C et al. Historically controlled comparison of glucocorticoids with or without tocilizumab versus supportive care only in patients with COVID-19-associated Cytokine storm syndrome: results of the CHIC study. Ann Rheum Dis 2020;0:1–9. doi: 10.1136 / annrheumdis-2020-218479.
17. Price CC, Altice FL, Shyr Y et al. Tocilizumab treatment for Cytokine Release Syndrome in hospitalized COVID-19 patients: survival and clinical outcomes. https://doi.org/10.1016/j.chest.2020.06.006.
18. Stone JH, Frigault MJ, Serling-Boyd NJ, et al. Efficacy of tocilizumab in patients hospitalized withCOVID-19. N Engl J Med. 2020;383(24):2333-2344. DOI: 10.1056 / NEJMoa2028836.
19-Salvarani C, Dolci G, Massari M, et al. Effect of tocilizumab vs standard care on clinical worsening in patients hospitalized with COVID-19 pneumonia: a randomized clinical trial. JAMA Intern Med. 2021;181(1):24-31. doi: 10.1001 / jamainternmed.2020.6615.
20. Hermine O, Mariette X, Tharaux PL, et al. Effect of tocilizumab vs usual care in adults hospitalized with COVID-19 and moderate or severe pneumonia: a randomized clinical trial. JAMA Intern Med.2021;181(1):32-40. doi: 10.1001 / jamainternmed.2020.6820.
21. Gupta S, Wang W, Hayek SS, et al.Association between early treatment with tocilizumab and mortality among critically ill patients with COVID-19.JAMA Intern Med. 2021;181(1):41-51. doi: 10.1001 / jamainternmed.2020.6252
22. Rosas I, Bräu N, Waters M, et al. Tocilizumab in hospitalized patients with severe COVID-19 pneumonia. NEJM 2021. DOI: 10.1056/NEJMoa2028700
23. Veiga VC, Prats J, Farias DLC, et al. Effect of tocilizumab on clinical outcomes at 15 days in patients with severe or critical coronavirus disease 2019: randomised controlled trial.BMJ. 2021;372:n84. doi: https://doi.org/10.1136/bmj.n84
24. Salama C, Han J, Yau L, et al. Tocilizumab in patients hospitalized with COVID-19 pneumonia. N Engl J Med. 2021;384(1):20-30. DOI: 10.1056 / NEJMoa2030340
25. Gordon AC, Mouncey PR, al-Beidh KM et al (REMAP-CAP Investigators).
Interleukin-6 receptor antagonists in critically ill patients with COVID-19.
N Engl J Med. 2021. Available at: https://www.ncbi.nlm.nih.gov/pubmed/33631065.
26. Horby PW, Pessoa-Amorim G, et al. (RECOVERY Collaborative Group). Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): preliminary results of a randomised, controlled, open-label, platformtrial. medRxiv. 2021;preprint. Available at: https://www.medrxiv.org/content/10.1101/2021.02.11.21249258v1
27- COVID-19 rapid evidence summary: Tocilizumab for COVID-19 .15 January 2021. www.nice.org.uk/guidance/es33
28- Interim Clinical Commissioning Policy: Tocilizumab for hospitalised patients with Covid-19 pneumonia (adults). Rapid Policy Statement. NHS. 8 January 2021
29- Interim Position Statement: Interleukin-6 inhibitors (tocilizumab or sarilumab) for patients admitted to ICU with COVID-19 pneumonia (adults). NHS. 22 February 2021
30- The COVID-19 Treatment Guidelines Panel¨s Statement on teh Use Of Tocilizumab for the Treatment of COVID-19. Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. 05/03/2021.NIH.Available at: www.covid19treatmentguidelines.nih.gov
31- Wise J. Covid 19: arthritis drug tocilizumab improve survival in intensive care patients, shows study. BMJ 2021;372:n61. doi: https://doi.org/10.1136/bmj.n61
32-Wise J. Covid 19: arthritis drug tocilizumab reduces deaths in hospitalised patients, study shows. BMJ 2021;372:n433. doi: https://doi.org/10.1136/bmj.n433
33- Bhimraj A, Morgan RL, Shumaker AH et al. Infectious Diseases Society of America Guidelines on the Treatment and Management of Patients with COVID-19March 5, 2021 Version 4.1.0. Available at: www.idsociety.org/COVID19guidelines
34. Lier AJ, Tuan JL, Davis MW, et al. Case report: disseminated strongyloidiasis in a patient with COVID-19. Am J Trop Med Hyg. 2020.
Available at: http://www.ajtmh.org/docserver/fulltext/10.4269/ajtmh.20-0699/tpmd200699.pdf?expires=1598276702&id=id&accname=guest&checksum=D8AA596942F31C34007E0FE 065AF1F5F.
35. Marchese V, Crosato V, Gulletta M, et al. Strongyloides infection manifested during immunosuppressive therapy for SARS-CoV-2 pneumonia. Infection. 2020. Available at:
https://www.ncbi.nlm.nih.gov/pubmed/32910321.
36. Stauffer WM, Alpern JD, Walker PF. COVID-19 and dexamethasone: a potential strategy to avoid steroid related strongyloides hyperinfection. JAMA. 2020. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32761166
37-Chalmers JD, Crichton ML, Goeminne PC, et al. Management of
hospitalised adults with coronavirus disease-19 (COVID-19): A European Respiratory Society living guideline. Eur Respir J 2021; in press (https://doi.org/10.1183/13993003.00048-2021).
38-Tocilizumab for COVID-19. Evidence review. NICE (National Institute for Health and Care Excellence). 15 February 2021, last updated 24 February 2021.
39- Ghosn_L, Chaimani_A, Evrenoglou_T, et al. Interleukin-6 blocking agents for treating COVID-19: a living systematic review. Cochrane Database of Systematic Reviews 2021, Issue 3. Art. No.: CD013881.
DOI: 10.1002/14651858.CD013881.
40-Terapeutica para SARS-CoV2. 15 de Marzo de 2021. Sociedad Argentina de Infectologia. Disponible en www,sadi.org.ar
.