Tocilizumab not associated with increased infection risk after CAR T-cell therapy: implications for COVID-19?
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ABSTRACT:
SUBMITTER: Frigault MJ
PROVIDER: S-EPMC7332891 | biostudies-literature | 2020 Jul
REPOSITORIES: biostudies-literature
Publications
Tocilizumab not associated with increased infection risk after CAR T-cell therapy: implications for COVID-19?
Frigault Matthew J MJ Nikiforow Sarah S Mansour Michael K MK Hu Zhen-Huan ZH Horowitz Mary M MM Riches Marcie L ML Hematti Peiman P Turtle Cameron J CJ Zhang Mei-Jie MJ Perales Miguel-Angel MA Pasquini Marcelo C MC
Blood 20200701 1
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Project description:IntroductionThe impact of COVID-19 infection on surgical patients is largely described by small-cohort studies. This study characterized the risk factors for postoperative mortality among patients with preoperative COVID-19 infection.MethodsData were abstracted from the electronic medical record for patients who tested positive for COVID-19 before surgery, excluding procedures related to extracorporeal membrane oxygenation (case, March 2020-April 2021). Mortality was compared with that for patients from the American College of Surgeons National Surgical Quality Improvement Program database (control, January 2018‒February 2020) with chi-square, t test, and multivariable regression.ResultsThere were 5,209 patients in the control cohort. Among 1,072 patients with positive COVID-19 testing before surgery, 589 had surgeries with specialties tracked by the American College of Surgeons National Surgical Quality Improvement Program (General Surgery, Gynecology, Neurosurgery, Orthopedics, Thoracic, Vascular). Patients with previous COVID-19 infection were younger (age 48 vs 59 years, p<0.001), were more likely to be Black (42% vs 28%, p<0.001), and underwent fewer elective surgeries (55% vs 83%, p<0.001). Postoperative mortality was greater among the case cohort (4.4% vs 1%, p<0.001). On multivariable logistic regression, postoperative mortality increased with age (OR=1.02), emergent surgeries (OR=2.6), and previous COVID-19 infection (OR=3.8). Among patients with previous COVID-19 infection, postoperative mortality was associated with male sex (OR=2.7), higher American Society of Anesthesiologists Physical Status Classification Score (OR=4.8), and smoking history (OR=3.7).ConclusionsAlthough data abstraction was limited by the electronic medical record, postoperative mortality is nearly 6 times higher for patients infected with COVID-19 within 2 weeks before surgery when adjusting for patient- and procedure-level factors. Among those with previous COVID-19 infection, postoperative mortality is associated with male sex, American Society of Anesthesiologists Physical Status Classification Score, and smoking history.
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Project description:We sought to assess if COVID-19 infection recovery is associated with increased rates of newly diagnosed erectile dysfunction. Using IBM MarketScan, a commercial claims database, men with prior COVID-19 infection were identified using ICD-10 diagnosis codes. Using this cohort along with an age-matched cohort of men without prior COVID-19 infection, we assessed the incidence of newly diagnosed erectile dysfunction. Covariates were assessed using a multivariable model to determine association of prior COVID-19 infection with newly diagnosed erectile dysfunction. 42,406 men experienced a COVID-19 infection between January 2020 and January 2021 of which 601 (1.42%) developed new onset erectile dysfunction within 6.5 months follow up. On multivariable analysis while controlling for diabetes, cardiovascular disease, smoking, obesity, hypogonadism, thromboembolism, and malignancy, prior COVID-19 infection was associated with increased risk of new onset erectile dysfunction (HR 1.27; 95% CI 1.1-1.5; P = 0.002). Prior to the widespread implementation of the COVID-19 vaccine, the incidence of newly diagnosed erectile dysfunction is higher in men with prior COVID-19 infection compared to age-matched controls. Prior COVID-19 infection was associated with a 27% increased likelihood of developing new-onset erectile dysfunction when compared to those without prior infection.
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Project description:BackgroundSevere hypoxic respiratory failure from COVID-19 pneumonia carries a high mortality risk. There is uncertainty surrounding which patients benefit from corticosteroids in combination with tocilizumab and the dosage and timing of these agents. The balance of controlling inflammation without increasing the risk of secondary infection is difficult. At present, dexamethasone 6 mg is the standard of care in COVID-19 hypoxia; whether this is the ideal choice of steroid or dosage remains to be proven.ObjectivesThe primary objective was to assess the impact on mortality of tocilizumab only, corticosteroids only, and combination therapy in patients with COVID-19 respiratory failure.MethodsA multihospital, retrospective study of adult patients with severe respiratory failure from COVID-19 who received supportive therapy, corticosteroids, tocilizumab, or combination therapy were assessed for 28-day mortality, biomarker improvement, and relative risk of infection. Propensity-matched analysis was performed between corticosteroid alone and combination therapies to further assess mortality benefit.ResultsThe steroid-only, tocilizumab-only, and combination groups showed hazard reduction in mortality at 28 days when compared with supportive therapy. In a propensity-matched analysis, the combination group (daily equivalent dexamethasone 10 mg and tocilizumab 400 mg) had an improved 28-day mortality compared with the steroid-only group (daily equivalent dexamethasone 10 mg; hazard ratio (95% CI) = 0.56 (0.38-0.84), P = 0.005] without increasing the risk of infection.Conclusion and relevanceCombination of tocilizumab and corticosteroids was associated with improved 28-day survival when compared with corticosteroids alone. Modification of steroid dosing strategy as well as steroid type may further optimize therapeutic effect of the COVID-19 treatment.
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Project description:Some risk factors for severe coronavirus disease 2019 (COVID-19) have been identified, including age, race, and obesity. However, 20%-50% of severe cases occur in the absence of these factors. Cytomegalovirus (CMV) is a herpesvirus that infects about 50% of all individuals worldwide and is among the most significant nongenetic determinants of immune system. We hypothesized that latent CMV infection might influence the severity of COVID-19. Our analyses demonstrate that CMV seropositivity is associated with more than twice the risk of hospitalization due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Immune profiling of blood and CMV DNA quantitative polymerase chain reaction in a subset of patients for whom respiratory tract samples were available revealed altered T-cell activation profiles in absence of extensive CMV replication in the upper respiratory tract. These data suggest a potential role for CMV-driven immune perturbations in affecting the outcome of SARS-CoV-2 infection and may have implications for the discrepancies in COVID-19 severity between different human populations.
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Project description:COVID-19 inequities have been well-documented. We evaluated whether higher rates of severe COVID-19 in racial and ethnic minority groups were driven by higher infection rates by evaluating if disparities remained when analyses were restricted to people with infection. We conducted a retrospective cohort study of adults insured through Kaiser Permanente (Colorado, Northwest, Washington), follow-up in March-September 2020. Laboratory results and hospitalization diagnosis codes identified individuals with COVID-19. Severe COVID-19 was defined as invasive mechanical ventilation or mortality. Self-reported race and ethnicity, demographics, and medical comorbidities were extracted from health records. Modified Poisson regression estimated adjusted relative risks (aRRs) of severe COVID-19 in full cohort and among individuals with infection. Our cohort included 1,052,774 individuals, representing diverse racial and ethnic minority groups (e.g., 68,887 Asian, 41,243 Black/African American, 93,580 Hispanic or Latino/a individuals). Among 7,399 infections, 442 individuals experienced severe COVID-19. In the full cohort, severe COVID-19 aRRs for Asian, Black/African American, and Hispanic individuals were 2.09 (95% CI: 1.36, 3.21), 2.02 (1.39, 2.93), and 2.09 (1.57, 2.78), respectively, compared to non-Hispanic Whites. In analyses restricted to individuals with COVID-19, all aRRs were near 1, except among Asian Americans (aRR 1.82 [1.23, 2.68]). These results indicate increased incidence of severe COVID-19 among Black/African American and Hispanic individuals is due to higher infection rates, not increased susceptibility to progression. COVID-19 disparities most likely result from social, not biological, factors. Future work should explore reasons for increased severe COVID-19 risk among Asian Americans. Our findings highlight the importance of equity in vaccine distribution.
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Project description:Hydroxychloroquine has been touted as a potential COVID-19 treatment. Tocilizumab, an inhibitor of IL-6, has also been proposed as a treatment of critically ill patients. In this retrospective observational cohort study drawn from electronic health records we sought to describe the association between mortality and hydroxychloroquine or tocilizumab therapy among hospitalized COVID-19 patients. Patients were hospitalized at a 13-hospital network spanning New Jersey USA between March 1, 2020 and April 22, 2020 with positive polymerase chain reaction results for SARS-CoV-2. Follow up was through May 5, 2020. Among 2512 hospitalized patients with COVID-19 there have been 547 deaths (22%), 1539 (61%) discharges and 426 (17%) remain hospitalized. 1914 (76%) received at least one dose of hydroxychloroquine and 1473 (59%) received hydroxychloroquine with azithromycin. After adjusting for imbalances via propensity modeling, compared to receiving neither drug, there were no significant differences in associated mortality for patients receiving any hydroxychloroquine during the hospitalization (HR, 0.99 [95% CI, 0.80-1.22]), hydroxychloroquine alone (HR, 1.02 [95% CI, 0.83-1.27]), or hydroxychloroquine with azithromycin (HR, 0.98 [95% CI, 0.75-1.28]). The 30-day unadjusted mortality for patients receiving hydroxychloroquine alone, azithromycin alone, the combination or neither drug was 25%, 20%, 18%, and 20%, respectively. Among 547 evaluable ICU patients, including 134 receiving tocilizumab in the ICU, an exploratory analysis found a trend towards an improved survival association with tocilizumab treatment (adjusted HR, 0.76 [95% CI, 0.57-1.00]), with 30 day unadjusted mortality with and without tocilizumab of 46% versus 56%. This observational cohort study suggests hydroxychloroquine, either alone or in combination with azithromycin, was not associated with a survival benefit among hospitalized COVID-19 patients. Tocilizumab demonstrated a trend association towards reduced mortality among ICU patients. Our findings are limited to hospitalized patients and must be interpreted with caution while awaiting results of randomized trials. Trial Registration: Clinicaltrials.gov Identifier: NCT04347993.
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