Combination therapy of Tocilizumab and steroid for management of COVID-19 associated cytokine release syndrome: A single center experience from Pune, Western India

  1. Ameet Dravid
  2. Reema Kashiva
  3. Zafer Khan
  4. Danish Memon
  5. Aparna Kodre
  6. Prashant Potdar
  7. Milind Mane
  8. Rakesh Borse
  9. Vishal Pawar
  10. Dattatraya Patil
  11. Debashis Banerjee
  12. Kailas Bhoite
  13. Reshma Pharande
  14. Suraj Kalyani
  15. Prathamesh Raut
  16. Madhura Bapte
  17. Anshul Mehta
  18. M Sateesh Reddy
  19. Krushnadas Bhayani
  20. S S Laxmi
  21. P D Vishnu
  22. Shipra Srivastava
  23. Shubham Khandelwal
  24. Sailee More
  25. Rohit Shinde
  26. Mohit Pawar
  27. Amol Harshe
  28. Sagar Kadam
  29. Uma Mahajan
  30. Gaurav Joshi
  31. Dilip Mane
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Abstract

Background

Cytokine release syndrome (CRS) or cytokine storm is thought to be the cause of inflammatory lung damage, worsening pneumonia and death in patients with COVID-19. Steroids (Methylprednisolone or Dexamethasone) and Tocilizumab (TCZ), an interleukin-6 receptor antagonist, are approved for the treatment of CRS in India. The aim of this study was to evaluate the efficacy and safety of combination therapy of TCZ and steroids in COVID-19 associated CRS.

Methods

This retrospective cohort study was conducted at a tertiary level private hospital in Pune, India between 2 nd April and 2 nd November 2020. All patients administered TCZ and steroids for treatment of CRS were included. The primary endpoint was incidence of all-cause mortality. Secondary outcomes studied were need for mechanical ventilation and incidence of infectious complications. Baseline and time-dependent risk factors significantly associated with death were identified by Relative risk estimation.

Results

Out of 2831 admitted patients, 515 (24.3% females) were administered TCZ and steroids. Median age of the cohort was 57 (IQR: 46.5, 66) years. Almost 72 % patients had preexisting co-morbidities. Median time to TCZ administration since onset of symptoms was 9 days (IQR: 7, 11). 63% patients needed intensive care unit (ICU) admission. Mechanical ventilation was required in 242 (47%) patients. Of these, 44.2% (107/242) recovered and were weaned off the ventilator. There were 135 deaths (26.2%), while 380 patients (73.8%) had clinical improvement. Infectious complications like hospital acquired pneumonia, bloodstream bacterial and fungal infections were observed in 2.13 %, 2.13 % and 0.06 % patients respectively. Age ≥ 60 years (p=0.014), presence of co-morbidities like hypertension (p = 0.011), IL-6 ≥ 100 pg/ml (p = 0.002), D-dimer ≥ 1000 ng/ml (p < 0.0001), CT severity index ≥ 18 (p < 0.0001) and systemic complications like lung fibrosis (p = 0.019), cardiac arrhythmia (p < 0.0001), hypotension (p < 0.0001) and encephalopathy (p < 0.0001) were associated with increased risk of death.

Conclusions

Combination therapy of TCZ and Steroids is likely to be safe and effective in the management of COVID-19 associated cytokine release syndrome. Efficacy of this anti-inflammatory combination therapy needs to be validated in randomized controlled clinical trials.

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