Comparative study of tocilizumab versus itolizumab in coronavirus disease 2019-infected patients: a randomized controlled trial

Abstract

Objective We aimed to compare the effect of tocilizumab and itolizumab in terms of PaO2/FiO2 ratio (P/F ratio), interleukin 6 (IL-6) level, serum ferritin, C-reactive protein, and a reduction in mortality. Our primary objective was to compare P/F ratio at various time intervals: baseline (before administering the drug), 12 h after drug administration, once a day for the next 7 days, and on the 14th day. Our secondary objective was to evaluate serum level of biomarkers like IL-6, ferritin, and C-reactive protein before start of drug infusion and following drug infusion at 72 h and on 7th day. Patients and methods A total of 50 patients, age between 18 and 60 years, having moderate Acute Respiratory distress syndrome (ARDS) following coronavirus disease 2019 infection were recruited. Patients of group I received a single dose of injection of tocilizumab 8 mg/kg intravenously (i.v.) via infusion over 1–2 h. Group II patients received premedication with hydrocortisone 100 mg and pheniramine 30 mg and a single dose of injection itolizumab 1.6 mg/kg dissolved in 250 ml of 0.9% normal saline infusion over 5–6 h. Results We observed significantly higher P/F ratio in the itolizumab group (239.18±97.31) than in the tocilizumab group (104.87±75.25) on the 3rd day following drug administration (P<0.001). Similarly, the IL-6 level was lower in the itolizumab group (72±100) in comparison with the tocilizumab group (682±1360), and the differences were statistically significant (P<0.05). We identified adverse effects of the drugs in 10 patients who have received itolizumab. Conclusion We observed an increasing trend in P/F ratio on the 3rd day following itolizumab administration in comparison with tocilizumab, and the difference was statistically significant (P<0.001).