Through COTA’s ongoing work with the Real world Evidence COVid-19 RegistrY (RE-COV-RY), researchers found that off-label use of tocilizumab was associated with a decreased mortality risk among patients with severe COVID-19. The findings were published in The Lancet Rheumatology, and represent part of a growing body of evidence supporting the use of this therapy among the most severe COVID-19 cases.
According to study co-author Shivam Mathura, Director of Product & Strategy at COTA, Inc., “Many treatment options are receiving attention, but there is limited scientific evidence to guide frontline teams on the best option for their patients. Real world data is significantly informing us of the clinical factors and therapies having an impact, and here we are able to characterize the use of tocilizumab for the most critical patients with COVID-19. While these results need to be further validated through clinical trials, we are thrilled to provide early insights to those in the field as we continue to fight this pandemic.”
Normally used in rheumatoid arthritis and cancer treatments, tocilizumab improved hospital survival in critically-ill patients admitted to the intensive care unit (ICU). The study included 630 patients who were admitted to the ICUs of 13 Hackensack Meridian Health hospitals from March 1 to April 22 – the height of the pandemic in New Jersey. In the observational study 210 patients received tocilizumab, and the other 420 did not.
The later phases of COVID-19 – the pulmonary and inflammatory phases – cause the immune system to secrete cytokines into the blood, including interleukin (IL)-6 that induces inflammation. Tocilizumab is a monoclonal antibody, which binds and blocks the interleukin (IL)-6 receptor and helps damper the inflammatory response. This provided enough evidence for researchers to consider the therapy as a potential treatment.
Through the observational study, there was a roughly 36% decrease in hospital-related mortality among ICU patients who received the drug compared to ICU patients who did not. Additional studies have also shown the interleukin (IL)-6 receptor inhibitor tocilizumab may be associated with a reduction in time on mechanical ventilation and shorter hospital stays.
As no treatment has been identified as the gold standard of care for patients with COVID-19, these findings support continued evaluation of tocilizumab for patients with severe cases. Learn more about COTA’s work with the RE-COV-RY database and how real-world data can support an early understanding of COVID-19 here.
The prospective observational database is registered on ClinicalTrials.gov, NCT04347993.