Sumary of Studies find mixed results for tocilizumab to treat COVID-19:
- Parr, MD, MPH, assistant professor of medicine in the division of infectious diseases at the University of North Carolina School of Medicine, wrote that the “newly released randomized trials suggest a potential role for tocilizumab in COVID-19 but do not show clear evidence of efficacy, in contrast to observational studies.”.
- The researchers reported that severity of illness and other baseline characteristics were similar between the groups after applying inverse probability weighting..
- He said he hopes the findings “will encourage and help inform the design of future randomized controlled trials to test the efficacy of tocilizumab, specifically among critically ill patients.”.
- Tocilizumab in patients with COVID-19, pneumonia In a prospective, open-label, randomized clinical trial conducted at 24 hospitals in Italy, Carlo Salvarani, MD, of Unità Operativa di Reumatologia, and colleagues randomly assigned 126 patients with COVID-19-related pneumonia and a partial pressure of arterial oxygen to fraction of inspired oxygen ratio of 200 mm Hg to 300 mm Hg to receive either tocilizumab or standard care..
- Salvarani and colleagues found that 28.3% of patients in the tocilizumab group and 27% of those in the standard care group experienced clinical worsening within 2 weeks of randomization (RR = 1.05;.
- Among all participants, two from the tocilizumab group and one from the control group died within 30 days of randomization..
- Additionally, six patients in the tocilizumab group and five in the standard care group were intubated during that time..
- In another study, Olivier Hermine, MD, PhD, of the Universitéde Paris and the Assistance Publique-Hôpitaux de Paris, and colleagues conducted a cohort-embedded, open-label Bayesian randomized control trial in patients with COVID-19 who had moderate or severe pneumonia that required supplemental oxygen but not ventilation or ICU admission..
- In the treatment group, patients received 8 mg/kg of tocilizumab intravenously and usual care on day 1, and then received another 400-mg dose of tocilizumab on day 3 if their required oxygen did not decrease by more than half..
- The researchers evaluated the proportion of patients who died or needed mechanical ventilation by day 4 — indicated by a score greater than five on the WHO 10-point Clinical Progression Scale (WHO-CPS) — and survival at day 14 without the need for noninvasive or mechanical ventilation..
- Hermine and colleagues found that 12 patients in the tocilizumab group had a WHO-CPS score greater than five at day 4 compared with 19 patients who received usual care alone..
- The researchers also found that in the tocilizumab group, 24% of patients required noninvasive ventilation, mechanical ventilation or died compared with 36% of the usual care group (median posterior HR = 0.58;.
- Considerations for tocilizumab trials In his editorial, Parr said all observational studies are subject to residual cofounding, and while the study by Leaf and colleagues can provide physicians with important insights in clinical management, “randomized trials will ultimately determine tocilizumab role in COVID-19.”…