Background: Elevated proinflammatory cytokines, including IL-6, are associated with significant morbidity and mortality in COVID-19, and it is hypothesized that blocking the inflammatory pathway may prevent disease progression[1]. IL 6 inhibitors were proposed as a treatment option for hospitalized patients to improve patient-centered outcomes[1]. Few studies that investigated the safety of tocilizumab showed heterogeneous results[2,3]. We proposed a retrospective cohort study to evaluate the hospital length of stay, intubation rates, and mortality rates in hospitalized patients receiving tocilizumab and steroid combination as a part of the therapy compared to only steroid therapy for COVID-19.
Methods: After receiving IRB approval, a multicenter retrospective observational cohort study involving four hospitals was performed across our enterprise between January 2020 and September 2020. A total of 204 patients were identified and included in our study based on our inclusion criteria after screening our institutional medical records for patients hospitalized with COVID-19. The patients were divided into an intervention group that received both tocilizumab and steroids and a control group that only received steroids for COVID-19. All patients were treated with the standard of care considered appropriate at that time. The extracted data were analyzed using a t-test, Fisher exact test, and Mann Whitney U test based on the data distribution.
Results: The intervention group had 55 patients, and the control group had 149 patients. Both groups had similar demographics of age, sex, race, underlying comorbidities (COPD, CAD, and BMI), and laboratory data (WBC count, D-dimer, ferritin, LDH on admission). The intervention group had a higher incidence of diabetes mellitus (52.7% vs 34%, P-value 0.02) and a higher level of CRP (249 vs 151 mg/L, P-value 0.0001) on admission. On analysis of patient-related outcomes, patients who received tocilizumab had a statistically significant higher hospital length of stay (16 vs 10 days, P-value 0.002), intubation rates (43.6% vs 28.2%, P-value 0.044), and mortality (43.6% vs 24%, P-value 0.009). The patients in the intervention group received a significantly higher dose of steroids (reported as dexamethasone equivalents) compared to the control group (165 mg vs 71 mg, P-value < 0.0001).
Conclusions: In our study patients, tocilizumab as an adjuvant therapy along with steroids is associated with increased hospital length of stay, intubation rates, and mortality rates. Caution must be exercised using Tocilizumab as adjuvant therapy in the treatment of hospitalized COVID 19 patients. More randomized control trials are required to support the use of Tocilizumab in COVID 19 patients.