Tocilizumab and steroid treatment in patients with COVID-19 pneumonia

  1. Malgorzata Mikulska
  2. Laura Ambra Nicolini
  3. Alessio Signori
  4. Antonio Di Biagio
  5. Chiara Sepulcri
  6. Chiara Russo
  7. Silvia Dettori
  8. arco Berruti
  9. Maria Pia Sormani
  10. Daniele Roberto Giacobbe
  11. Antonio Vena
  12. Andrea De Maria
  13. Chiara Dentone
  14. Lucia Taramasso
  15. Michele Mirabella
  16. Laura Magnasco
  17. Sara Mora
  18. Emanuele Delfino
  19. Federica Toscanini
  20. Elisa Balletto
  21. Anna Ida Alessandrini
  22. Federico Baldi
  23. Federica Briano
  24. Marco Camera
  25. Ferdinando Dodi
  26. Antonio Ferrazin
  27. Laura Labate
  28. Giovanni Mazzarello
  29. Rachele Pincino
  30. Federica Portunato
  31. Stefania Tutino
  32. Emanuela Barisione
  33. Bianca Bruzzone
  34. Andrea Orsi
  35. Eva Schenone
  36. Nirmala Rosseti
  37. Elisabetta Sasso
  38. Giorgio Da Rin
  39. Paolo Pelosi
  40. Sabrina Beltramini
  41. Mauro Giacomini
  42. Giancarlo Icardi
  43. Angelo Gratarola
  44. Matteo Bassetti
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Abstract

Introduction

Coronavirus disease 2019 (COVID-19) can lead to respiratory failure due to severe immune response. Treatment targeting this immune response might be beneficial but there is limited evidence on its efficacy.

The aim of this study was to determine if early treatment of patients with COVID-19 pneumonia with tocilizumab and/or steroids was associated with better outcome.

Methods

This observational single-center study included patients with COVID-19 pneumonia who were not intubated and received either standard of care (SOC, controls) or SOC plus early (within 3 days from hospital admission) anti-inflammatory treatment. SOC consisted of hydroxychloroquine 400mg bid plus, in those admitted before March 24th, also darunavir/ritonavir. Anti-inflammatory treatment consisted of either tocilizumab (8mg/kg intravenously or 162mg subcutaneously) or methylprednisolone 1 mg/kg for 5 days or both. Failure was defined as intubation or death, and the endpoints were failure-free survival (primary endpoint) and overall survival (secondary) at day 30. Difference between the groups was estimated as Hazard Ratio by a propensity score weighted Cox regression analysis (HROW).

Results

Overall, 196 adults were included in the analyses. They were mainly male (67.4%), with comorbidities (78.1%) and severe COVID-19 pneumonia (83.7%). Median age was 67.9 years (range, 30-100) and median PaO2/FiO2200 mmHg (IQR 133-289). Among them, 130 received early anti-inflammatory treatment with: tocilizumab (n=29, 22.3%), methylprednisolone (n=45, 34.6%), or both (n=56, 43.1%). The adjusted failure-free survival among tocilizumab/methylprednisolone/SOC treated patients vs. SOC was 80.8% (95%CI, 72.8-86.7) vs. 64.1% (95%CI, 51.3-74.0), HROW0.48, 95%CI, 0.23-0.99; p=0.049. The overall survival among tocilizumab/methylprednisolone/SOC patients vs. SOC was 85.9% (95%CI, 80.7-92.6) vs. 71.9% (95%CI, 46-73), HROW0.41, 95%CI: 0.19-0.89, p=0.025.

Conclusion

Early adjunctive treatment with tocilizumab, methylprednisolone or both may improve outcomes in non-intubated patients with COVID-19 pneumonia.

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