Annals of medicine
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Randomized Controlled Trial
A randomized phase-I pharmacokinetic trial comparing the potential biosimilar tocilizumab (QX003S) with the reference product (Actemra®) in Chinese healthy subjects.
QX003S is a biosimilar candidate for the reference tocilizumab, Actemra®. We investigated the tolerance, variability, and pharmacokinetics (PK) of QX003S biosimilar in healthy Chinese male subjects. ⋯ The PK characteristics and immunogenicity exhibited by QX003S were similar to that of the reference product, Actemra®. The safety profile was similar in the two treatment groups with mild-moderate adverse effects.Trial RegistrationThe trial is registered at Chinese Clinical Trial website (http://www.chinadrugtrials.org.cn/index.html#CTR20190002)Key pointsThis was the first clinical report of a new proposed tocilizumab biosimilar, QX003S.This phase-I randomized, controlled study compared pharmacokinetics, variability,immunogenicity, and safety of QX003S vs. the approved tocilizumab product (Actemra@).The results demonstrate bioequivalence between BAT1806 and the reference products (Actemra@), as well as comparable immunogenicity, safety and tolerability profiles.
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This study was performed to compare severe clinical outcome between initially asymptomatic and symptomatic infections and to identify risk factors associated with high patient mortality among initially asymptomatic patients. ⋯ The mortality risk was not determined by the initial presence of symptom among hospitalized COVID-19 patients. The CCIS was the most potent predictors for mortality. The clinicians should predict the risk of death by evaluating age and comorbidities but not the initial presence of symptom. Key messages The mortality rate was not different between initially asymptomatic and symptomatic patients. Symptomatic patients were more likely to admitted to the intensive care unit. Age and comorbidities were the potent risk factors for mortality.
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Multicenter Study
External Validation of a Clinical Risk Score to Predict Hospital Admission and In-Hospital Mortality in COVID-19 Patients.
Identification of patients with novel coronavirus disease 2019 (COVID-19) requiring hospital admission or at high-risk of in-hospital mortality is essential to guide patient triage and to provide timely treatment for higher risk hospitalized patients. ⋯ The COVID-19 Risk of Complications Score predicts the need for hospital admission and in-hospital mortality patients with COVID-19. Key points: Can an electronic health record generated risk score predict the risk of hospital admission and in-hospital mortality in patients diagnosed with coronavirus disease 2019 (COVID-19)? In both validation cohorts of 2,025 and 1,290 COVID-19, the cross-validated C-Statistics showed good discrimination for both hospital admission (C = 0.79 (95% CI: 0.77-0.81)) and in-hospital mortality (C = 0.75 (95% CI: 0.71-0.78)), respectively. The COVID-19 Risk of Complications Score may help predict the need for hospital admission if a patient contracts SARS-CoV-2 infection and in-hospital mortality for a hospitalized patient with COVID-19.
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Meta Analysis
Venous thrombotic events in psoriasis patients: a systematic review with meta-analysis.
Psoriasis is a chronic inflammatory skin disease associated with numerous comorbidities. Psoriasis has been linked to an increased risk of metabolic syndrome and atherosclerotic arterial disease. Inflammatory conditions are known to increase the risk of venous thromboembolism (VTE), a frequent cause of morbidity and mortality. However, the relationship between psoriasis and VTE has received little attention and existing studies have shown conflicting results. ⋯ Published data adjusted for key confounders demonstrate in general a significantly increased prevalence of VTE in psoriasis patients. Both psoriasis severity and number of confounders assessed seem to have an impact on this correlation. In this review, we pooled unadjusted data of the studies and we found a non-significant increased risk for VTE in psoriasis patients compared to healthy controls. This discrepancy suggests that psoriasis severity, age, gender or comorbidities may influence the risk of VTE in subgroups of the psoriasis population. Future research to identify subgroups at risk for VTE is warranted.Key messagesThe included studies reported an increased risk of VTE, DVT, PE and RVO in psoriasis patients.A meta-analysis was performed on five studies that reported raw data and showed that the pooled risk ratio for VTE in psoriasis patients overall was increased, however not significantly, compared to healthy controls.Further research to pinpoint psoriasis subgroups at risk (e.g. severe psoriasis patients, younger age, associated comorbidities) of developing VTE is warranted.
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Meta Analysis
Comprehensive meta-analysis of anti-BCMA chimeric antigen receptor T-cell therapy in relapsed or refractory multiple myeloma.
Chimeric antigen receptor (CAR) T-cell therapy shows impressive results in clinical trials. We conducted a meta-analysis based on the most recent data to systematically describe the efficacy and safety of anti-BCMA CAR T therapy for patients with relapsed or refractory multiple myeloma (R/R MM). ⋯ Anti-BCMA CAR T therapy is effective and safe for patients with R/R MM. It can improve the prognosis of patients with high-risk cytogenetic features while the prognosis of patients with EMD remains poor. Moreover, patients are likely to benefit from an earlier use of CAR T therapy and human-derived CAR T cells have obvious advantages based on the existing data.