ABSTRACT
Background. Tocilizumab (TOCI) and baricitinib (BARI) have been shown to improve mortality in patients with severe COVID-19. However, there is limited comparative data between the two agents head to head. The purpose of this study was to evaluate patient characteristics and efficacy of BARI versus TOCI for the treatment of severe COVID-19. Methods. A retrospective, observational chart review was conducted during September 2020 to November 2021 in a three hospital health system in New Jersey. Hospitalized patients were included if they were >= 18 years old, requiring supplemental oxygenation and being treated for severe COVID-19 with TOCI. These patients were then matched based on BMI, age, and severity of hypoxemia with patients who received BARI. Patients were excluded if they required invasive mechanical ventilation (IMV) at the start of therapy. The primary outcome of the study was to assess incidence of all cause inpatient mortality (ACIM) in patients receiving TOCI or BARI. A subgroup analysis was performed that assessed clinical improvement and progression to IMV between both treatment groups. Secondary endpoints included analysis of independent variables associated with ACIM. Results. Total of 194 patients were screened for eligibility and of these 87 patients in the TOCI group were matched with 87 patients in the BARI group. Overall, there was no difference seen in ACIM between TOCI compared to BARI (22% vs 33% OR 1.11 (0.49-2.71, P=0.18). For subgroup analysis, more patients in TOCI group experienced clinical improvement compared to BARI group (44% vs 22%, P=0.004). Additionally, patients in TOCI group were less likely to progress to require IMV (10% vs 26%, P=0.02). When logistic regression model was used to assess mortality predicting factors, patients receiving BARI who required ICU level of care (OR 2.10, CI 0.91-0.08, p=0.00055) and IMV (OR 2.40, CI 1.16-3.64, p=0.00015) had higher odds of ACIM compared to TOCI. Mortality predicting factors among patients receiving tocilizumab or baricitinib Conclusion. There was no difference seen in ACIM between TOCI and BARI. At the end of hospitalization patients receiving TOCI were more likely to experience clinical improvement compared to BARI. TOCI should be preferred in patients requiring ICU level of care and IMV.
ABSTRACT
Background. Tocilizumab (TCZ) and remdesivir (RDV) have both shown benefit for patients with SARS-CoV-2. However, there have been no head to head studies comparing the efficacy of the two therapies. The purpose of this study is to compare clinical outcomes of patients who have received corticosteroids (CS) along with TCZ or RDV. Methods. This is an IRB approved retrospective observational study completed in a three hospital health system in New Jersey. Patients were included if age was ≥ 18, admitted with SARS-CoV2 infection requiring oxygen. Patients were stratified into two treatment arms;CS + TCZ and CS + RDV. The primary objective was to compare all-cause inpatient mortality (ACIM) based on oxygenation status;nasal cannula (NC), high-flow nasal cannula (HFNC), and invasive mechanical intubation (IMV). Secondary objectives was a snapshot analysis with a focus on clinical improvement (CI) defined as improvement in clinical ordinal scale by 2 or more at end of stay. Additional endpoint included progression to IMV after therapy initiation. Results. There were total of 1053 patients included (123 in the CS+TCZ arm, 930 in the CS+RDV arm). Oxygen requirements were as follows: In the CS+TCZ arm (NC n=57, HFNC n=26, IMV n=40), and the RD+CS arm (NC n=669, HFN n=159, and IMV n=102). Results from the primary endpoints can be found in Table 1. No statistically significant differences were observed between the two treatment arms. For the secondary objective there were 214 patients included (70 in the CS+TCZ arm and 105 in the CS+RDV arm). For patients receiving NC, no difference seen in CI between two treatment arms (81.4% CS+RDV vs. 81.5% CS+TCZ). In HFNC group more patients in the CS+TCZ group observed CI compared to CS+RDV (68.8% vs. 40%). Less patients requiring HFNC progressed to IMV in CS+TCZ group (25%) compared to CS+RDV (40%). Conclusion. No statistical difference in ACIM was detected between the two treatment arms regardless of baseline oxygenation requirements. There was a trend towards lower ACIM for IMV patients in the CS+TCZ arm compared to the CS+RDV arm. More patients experienced CI in CS+TCZ group compared to CS+RDV in HFNC group. Less HFNC patients also required new IMV in the CS+TCZ arm. Larger studies need to be performed to evaluate a true statistical difference between the two treatment arms.
ABSTRACT
Background: Tocilizumab (TCZ) is a monoclonal antibody against the interleuikin- 6 receptor which is potentially beneficial in COVID-19 induced cytokine release syndrome (CRS). However, there are limited studies showing anti-inflammatory effect and clinical benefit of TCZ in COVID-19 patients. This retrospective study examines treatment responses of criteria based TCZ therapy for SARS-CoV-2 respiratory infection for ICU vs. non-ICU patients. Methods: We established institutional criteria to identify patients at risk of CRS from COVID-19. Patients were included if they received at least 1 dose of TCZ and were admitted for at least 72 hours. Primary endpoint was to assess clinical improvement (CI) at the end of admission. CI was defined by extubation, downgrade from ICU, discharged or improvement in Clinical Ordinal Scale by 2. Secondary endpoint of the study was to assess inpatient mortality (IM) and risk factors associated with IM. Subgroup analysis included impact of early (< 96 hours) vs late (≥ 96 hours) TCZ therapy on IM. Results: Between March 25 to May 6, 2020, 170 patients met criteria and received TCZ. There were 83 non-ICU patients and 87 in the ICU. Forty five patients needed invasive mechanical ventilation (IMV). ICU patients tended to be obese, receive 2 doses of TCZ and have longer length of stay. Overall CI was seen in 71% of patients. CI was higher in non-ICU vs ICU patients (85.5% vs 57.5%, P=0.002). Overall IM was 18.8%;however, IM was lower in non-ICU vs ICU patients (8.4% vs 28.7%, P=0.0014). IM was higher in patients on IMV vs. non-IMV (30% vs 15.4%, P=0.03). Risk factors of ICU admission, BMI ≥ 30 kg/m2 and AKI were associated with higher risk of IM. Many IM patients were made comfort care. No differences were observed in early vs late TCZ therapy on inpatient mortality, but there was a trend toward lower mortality with early TCZ. COS Review of Tocilizumab Patients Conclusion: TCZ is an effective treatment option in patients with SARS-CoV-2 patients at risk of CRS. Patients receiving TCZ in non-ICU setting had a better response to treatment compared to ICU patients. Obesity and AKI were associated with higher risk of mortality, but there was no statistical difference in early vs late therapy. Further studies with control group and larger sample size are warranted.