Abstract
Objectives: This study was designed to compare the efficacy and safety of methylprednisolone and tocilizumab in the treatment of patients with severe COVID-19.
Methods: During a prospective cohort study, hospitalized patients with severe COVID-19 received intravenous methylprednisolone (250-500 mg daily up to three doses), weight-based tocilizumab (maximum 800 mg, one or two doses as daily interval) or dexamethasone (8 mg daily). The primary outcome was time to onset of clinical response. Secondary outcomes were improvement rate of oxygen saturation and CRP, need for ICU admission, duration of hospitalization and 28-day mortality. During study, adverse events of the treatments were recorded.
Results: Although the difference was not statistically significant (p = 0.090), clinical response occurred faster in the tocilizumab group than other groups (10 vs. 16 days). Clinical response was detected in 74.19%, 81.25%, and 60% of patients in the methylprednisolone, tocilizumab, and dexamethasone groups respectively (p = 0.238). Based on the Cox regression analysis and considering dexamethasone as the reference group, HR (95% CI) of clinical response was 1.08 (0.65-1.79) and 1.46 (0.89-2.39) in the methylprednisolone and tocilizumab groups respectively. Improvement rate of oxygen saturation and CRP was not significantly different between the groups (p = 0.791 and p = 0.372 respectively). Also need for ICU admission and 28-day mortality was comparable between the groups (p = 0.176 and p = 0.143 respectively). Compared with methylprednisolone, tocilizumab caused more sleep disturbances (p = 0.019). Other adverse events were comparable among patients in the groups.
Conclusion: When or where access to tocilizumab is a problem, methylprednisolone may be considered as an alternative for the treatment of patients with severe COVID-19.
Keywords: COVID; Dexamethasone; Methylprednisolone; Tocilizumab.
【저자키워드】 Dexamethasone, Methylprednisolone, Tocilizumab, COVID, 【초록키워드】 Dexamethasone, Methylprednisolone, Treatment, severe COVID-19, Tocilizumab, 28-day mortality, CRP, oxygen, outcome, hospitalized patients, prospective cohort study, adverse events, improvement, oxygen saturation, clinical, adverse event, Patient, ICU admission, Sleep disturbances, Efficacy and safety, group, Other, dose, Sleep disturbance, Primary outcome, clinical response, 95% CI, alternative, Secondary outcomes, Cox regression analysis, problem, doses, intravenous methylprednisolone, duration of hospitalization, secondary, occurred, caused, hospitalized patient, faster, comparable, groups, statistically significant, were recorded, not significantly different, 【제목키워드】 Methylprednisolone, Treatment, Patient, Efficacy and safety,