scholarly journals AB0292 EFFICACY AND SAFETY OF TWO BIOSIMILAR ETANERCEPT AFTER THE SWITCH FROM THEIR CORRESPONDING ORIGINATOR IN THE TREATMENT OF PATIENTS WITH AUTOIMMUNE ARTHRITIS; A RETROSPECTIVE ANALYSIS IN A REAL LIFE SETTING

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1445.1-1445
Author(s):  
F. Girelli ◽  
A. Ariani ◽  
M. Bruschi ◽  
A. Becciolini ◽  
L. Gardelli ◽  
...  

Background:The available biosimilars of etanercept are as effective and well tolerated as their bio originator molecule in the naive treatment of chronic autoimmune arthritis. More data about the switching from the bio originator are needed.Objectives:To compare the clinical outcomes of the treatment with etanercept biosimilars (SB4 and GP2015) naïve and after the switch from their corresponding originator in patients affected by autoimmune arthritis in a real life settingMethods:We retrospectively analyzed the baseline characteristics and the retention rate in a cohort of patients who received at least a course of etanercept (originator or biosimilar) in our Rheumatology Units from January 2000 to January 2020. We stratified the study population according to biosimilar use. Descriptive data are presented by medians (interquartile range [IQR]) for continuous data or as numbers (percentages) for categorical data. Drug survival distribution curves were computed by the Kaplan-Meier method and compared by a stratified log-rank test. A Cox proportional hazards regression analysis stratified by indication, drug, age, disease duration, sex, treatment line, biosimilar use and prescription year was performed. P values≤0.05 were considered statistically significant.Results:477 patients (65% female, median age 56 [46-75] years, median disease duration 97 [40.25-178.75] months) treated with etanercept were included in the analysis. 257 (53.9%) were affect by rheumatoid arthritis, 139 (29.1%) by psoriatic arthritis, and 81 (17%) by axial spondylarthritis. 298 (62.5%) were treated with etanercept originator, 97 (20.3%) with SB4, and 82 (17.2%) with GP2015. Among the biosimilars 90/179 (50.3%) patients were naïve to etanercept treatment. Among the 89 switchers we observed 8 treatment discontinuations: one due to surgical infection complication, three due to disease flare, two due to subjective worsening and one due to remission. The overall 6- and 12-month retentions rate were 92.8% and 80.2%. The 6- and 12-month retention rate for etanercept, SB4 and GP2015 were 92.7%, 93.4% and 90.2%, and 82%, 74.5% and 88.1% respectively, without significant differences among the three groups (p=0.374). Patients switching from originator to biosimilars showed and overall higher treatment survival when compared to naive (12-month retention rate 81.2% vs 70.8%, p=0.036). The Cox proportional hazard regression analysis highlighted that the only predictor significantly associated with an overall higher risk of treatment discontinuation was the year of prescription (HR 1.08, 95% CI 1.04 to 1.13; p<0.0001).Conclusion:In our retrospective study etanercept originator and its biosimilars (SB4 and GP2015) showed the same effectiveness. Patients switching from originator to biosimilar showed an significant higher retention rate when compared to naive. The only predictor of treatment discontinuation highlighted by the Cox proportional hazard regression analysis was the year of treatment prescription.Disclosure of Interests:Francesco Girelli: None declared, Alarico Ariani: None declared, Marco Bruschi: None declared, Andrea Becciolini Speakers bureau: Sanofi-Genzyme, UCB and AbbVie, Lucia Gardelli: None declared, Maurizio Nizzoli: None declared

2019 ◽  
Vol 25 (1) ◽  
pp. 57-64
Author(s):  
Susin Park ◽  
Nam Kyung Je

Background: Anticoagulation therapy is recommended for stroke prevention in high-risk patients with atrial fibrillation (AF). This study aimed to estimate the time to switch from warfarin to a direct oral anticoagulant (DOAC) and identify the factors associated with it. Methods: By using claims data, we studied 7111 warfarin-using patients with nonvalvular AF who were aged ≥65 years. The Kaplan-Meier analysis was performed to estimate the time to switch from warfarin to a DOAC, and Cox proportional hazard regression analysis was used to estimate the influencing factors. Results: Approximately one-third of the patients (2403, 33.8%) switched from warfarin to a DOAC during the study period. Female sex, aged between 75 and 79 years, having a Medical Aid or Patriots and Veterans Insurance, hypertension, and history of prior stroke, and transient ischemic attack or thromboembolism (prior stroke/TIA/TE) were associated with a significantly shorter time to switch. The odds of switching to a DOAC were increased by approximately 1.2-fold in the women and 1.4-fold in the patients with prior stroke/TIA/TE. Conclusions: Approximately one-third of the warfarin-using patients switched from warfarin to a DOAC within 6 months after the change in the DOAC reimbursement criteria. In the Cox proportional hazard regression analysis, the factors that affected anticoagulant switching from warfarin to a DOAC were female sex and history of prior stroke/TIA/TE.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jianming Wei ◽  
Ye Zeng ◽  
Xibo Gao ◽  
Tong Liu

Abstract Background Gastric cancer (GC) is a common malignant cancer with a poor prognosis. Ferroptosis has been shown to play crucial roles in GC development. Long non-coding RNAs (lncRNAs) is also associated with tumor progression in GC. This study aimed to screen the prognostic ferroptosis-related lncRNAs and to construct a prognostic risk model for GC. Methods Ferroptosis-related lncRNAs from The Cancer Genome Atlas (TCGA) GC expression data was downloaded. First, single factor Cox proportional hazard regression analysis was used to select seven prognostic ferroptosis-related lncRNAs from TCGA database. And then, the selected lncRNAs were further included in the multivariate Cox proportional hazard regression analysis to establish the prognostic model. A nomogram was constructed to predict individual survival probability. Finally, we performed quantitative reverse transcription polymerase chain reaction (qRT-PCR) to verify the risk model. Results We constructed a prognostic ferroptosis-related lncRNA signature in this study. Kaplan-Meier curve analysis revealed a significantly better prognosis for the low-risk group than for the high-risk group (P = 2.036e-05). Multivariate Cox proportional risk regression analysis demonstrated that risk score was an independent prognostic factor [hazard ratio (HR) = 1.798, 95% confidence interval (CI) =1.410–2.291, P < 0.001]. A nomogram, receiver operating characteristic curve, and principal component analysis were used to predict individual prognosis. Finally, the expression levels of AP003392.1, AC245041.2, AP001271.1, and BOLA3-AS1 in GC cell lines and normal cell lines were tested by qRT-PCR. Conclusions This risk model was shown to be a novel method for predicting prognosis for GC patients.


BMC Urology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jiwon Han ◽  
Young-Tae Jeon ◽  
Jung-Hee Ryu ◽  
Ah-Young Oh ◽  
Hwanik Kim ◽  
...  

Abstract Background Although red blood cells (RBC) transfusion is known to be significantly associated with biochemical recurrence in patients undergoing open prostatectomy, its influence on biochemical recurrence after robot-assisted laparoscopic radical prostatectomy remains unclear. Therefore, this study aimed to validate the effect of RBC transfusion on the 5-year biochemical recurrence in patients undergoing robot-assisted laparoscopic radical prostatectomy. Methods This study retrospectively analyzed the medical records of patients who underwent robot-assisted laparoscopic radical prostatectomy at single tertiary academic hospital between October 2007 and December 2014. Univariate and multivariate Cox proportional hazard regression analysis was performed to identify any potential variables associated with 5-year biochemical recurrence. Results A total of 1311 patients were included in the final analysis. Of these, 30 patients (2.3%) were transfused with RBC either during robot-assisted laparoscopic radical prostatectomy or during their hospital stay, which corresponded to 5-year biochemical recurrence of 15.7%. Multivariate Cox proportional hazard regression analysis showed that RBC transfusion had no influence on the 5-year biochemical recurrence. Variables including pathologic T stage (Hazard ratio [HR] 3.5, 95% confidence interval [CI] 2.4–5.1 p < 0.001), N stage (HR 2.3, 95% CI 1.5–3.7, p < 0.001), Gleason score (HR 2.4, 95% CI 1.8–3.2, p < 0.001), and surgical margin (HR 2.0, 95% CI 1.5–2.8, p < 0.001) were independently associated with the 5-year biochemical recurrence. Conclusions RBC transfusion had no significant influence on the 5-year biochemical recurrence in patients undergoing robot-assisted laparoscopic radical prostatectomy.


2021 ◽  
Author(s):  
Jiwon Han ◽  
Young-Tae Jeon ◽  
Jung-Hee Ryu ◽  
Ah-Young Oh ◽  
Hwanik Kim ◽  
...  

Abstract BackgroundAlthough red blood cells (RBC) transfusion is known to be significantly associated with biochemical recurrence in patients undergoing open prostatectomy, its influence on biochemical recurrence after robot-assisted laparoscopic radical prostatectomy remains unclear. Therefore, this study aimed to validate the effect of RBC transfusion on the 5-year biochemical recurrence in patients undergoing robot-assisted laparoscopic radical prostatectomy. MethodsThis study retrospectively analyzed the medical records of patients who underwent robot-assisted laparoscopic radical prostatectomy at single tertiary academic hospital between October 2007 and December 2014. Univariate and multivariate Cox proportional hazard regression analysis was performed to identify any potential variables associated with 5-year biochemical recurrence. ResultsA total of 1311 patients were included in the final analysis. Of these, 30 patients (2.3%) were transfused with RBC either during robot-assisted laparoscopic radical prostatectomy or during their hospital stay, which corresponded to 5-year biochemical recurrence of 15.7%. Multivariate Cox proportional hazard regression analysis showed that RBC transfusion had no influence on the 5-year biochemical recurrence. Variables including pathologic T stage (Hazard ratio [HR] 3.5, 95% confidence interval [CI] 2.4-5.1 p < 0.001), N stage (HR 2.3, 95% CI 1.5-3.7, p < 0.001), Gleason score (HR 2.4, 95% CI 1.8-3.2, p < 0.001), and surgical margin (HR 2.0, 95% CI 1.5-2.8, p < 0.001) were independently associated with the 5-year biochemical recurrence.ConclusionsRBC transfusion had no significant influence on the 5-year biochemical recurrence in patients undergoing robot-assisted laparoscopic radical prostatectomy.


2021 ◽  
Vol 8 ◽  
Author(s):  
Anmin Huang ◽  
Ting Li ◽  
Xueting Xie ◽  
Jinglin Xia

Long non-coding RNAs (lncRNAs), which were implicated in many pathophysiological processes including cancer, were frequently dysregulated in hepatocellular carcinoma (HCC). Studies have demonstrated that ferroptosis and immunity can regulate the biological behaviors of tumors. Therefore, biomarkers that combined ferroptosis, immunity, and lncRNA can be a promising candidate bioindicator in clinical therapy of cancers. Many bioinformatics methods, including Pearson correlation analysis, univariate Cox proportional hazard regression analysis, least absolute shrinkage and selection operator (LASSO) analysis, and multivariate Cox proportional hazard regression analysis were applied to develop a prognostic risk signature of immune- and ferroptosis-related lncRNA (IFLSig). Finally, eight immune- and ferroptosis-related lncRNAs (IFLncRNA) were identified to develop and IFLSig of HCC patients. We found the prognosis of patients with high IFLSig will be worse, while the prognosis of patients with low IFLSig will be better. The results provide an efficient method of uniting critical clinical information with immunological characteristics, enabling estimation of the overall survival (OS). Such an integrative prognostic model with high predictive power would have a notable impact and utility in prognosis prediction and individualized treatment strategies.


2021 ◽  
pp. 1-7
Author(s):  
Shouliang Hu ◽  
Dan Wang ◽  
Tean Ma ◽  
Fanli Yuan ◽  
Yong Zhang ◽  
...  

<b><i>Background:</i></b> Inflammation appears to be at the biological core of arteriovenous fistula (AVF) dysfunction, and the occurrence of AVF dysfunction is related to high death and disability in hemodialysis (HD) patients. Despite several studies on the correlations between AVF dysfunction and inflammatory indicators, how AVF dysfunction is related to the monocyte-to-lymphocyte ratio (MLR) is much unclear. We hypothesize that preoperative MLR is associated with AVF dysfunction in Chinese HD patients. <b><i>Methods:</i></b> In this single-center retrospective cohort study, totally 769 adult HD patients with a new AVF created between 2011 and 2019 were included. Association of preoperative MLR with AVF dysfunction (thrombosis or decrease of normal vessel diameter by &#x3e;50%, requiring either surgical revision or percutaneous transluminal angioplasty) was assessed by multivariable Cox proportional hazard regression. <b><i>Results:</i></b> The patients were aged 55.8 ± 12.2 years and were mostly males (55%). During the average 32-month follow-up (maximum 119 months), 223 (29.0%) patients had permanent vascular access dysfunction. In adjusted multivariable Cox proportional hazard regression analyses, the risk of AVF dysfunction was 4.32 times higher with 1 unit increase in MLR (hazard ratio [HR]: 5.32; 95% confidence interval [CI]: 3.1–9.11). Compared with patients with MLR &#x3c;0.28, HRs associated with an MLR of 0.28–0.41 and ≥0.41 are 1.54 (95% CI: 1.02–2.32) and 3.17 (2.18–4.62), respectively. <b><i>Conclusions:</i></b> A higher preoperative MLR is independently connected with a severer risk of AVF dysfunction in HD patients. Its clinical value should be determined in the future.


2019 ◽  
Vol 8 (1) ◽  
pp. 93-105
Author(s):  
Eri Setiani ◽  
Sudarno Sudarno ◽  
Rukun Santoso

Cox proportional hazard regression is a regression model that is often used in survival analysis. Survival analysis is phrase used to describe analysis of data in the form of times from a well-defined time origin until occurrence of some particular even or end-point. In analysis survival sometimes ties are found, namely there are two or more individual that have together event. This study aims to apply Cox model on ties event using two methods, Breslow and Efron and determine factors that affect survival of stroke patients in Tugurejo Hospital Semarang. Dependent variable in this study is length of stay, then independent variables are gender, age, type of stroke, history of hypertension, systolic blood pressure, diastolic blood pressure, blood sugar levels, and BMI. The two methods give different result, Breslow has four significant variables there are type of stroke, history of hypertension, systolic blood pressure, and diastolic blood pressure, while Efron contains five significant variables such as type of stroke, history of hypertension, systolic blood pressure, diastolic blood pressure and blood sugar levels. From the smallest AIC criteria obtained the best Cox proportional hazard regression model is Efron method. Keywords: Stroke, Cox Proportional Hazard Regression model, Breslow method, Efron method.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
ZURNILA MARLI KESUMA ◽  
HIZIR SOFYAN ◽  
LATIFAH RAHAYU ◽  
WARDATUL JANNAH

Tuberculosis (TB) is an infectious disease which is one of the biggest health problems in the world, including Indonesia. The government, through the National Tuberculosis Control program, has made various efforts to control tuberculosis. However, this problem was exacerbated by the dramatic increase in the incidence of tuberculosis. This study aimed to determine the Cox proportional hazard regression model and the factors that affect the cure rate of TB patients. We used medical record data for inpatient TB patients for the period July-December 2017 at dr. Zainoel Abidin Hospital. The results showed that with α = 0.1, the factors that influenced the recovery of TB patients were the type of cough, the symptoms of bloody cough and symptoms of sweating at night.  There were 33.93% of patients who did not work. This category included students, domestic helpers, and those who did not work until they suffered from tuberculosis and were treated at dr. Zainoel Abidin Hospital. The hazard ratio (failure ratio) showed that the tendency or cure rate for TB patients who did not experience cough symptoms was 70% greater than patients who experienced phlegm cough symptoms. The cure rate for TB patients who experienced coughing up blood symptoms was 53% greater than patients without these symptoms. The cure rate for TB patients who experienced  symptoms of sweating at night was 54% greater than patients who did not sweat at night.


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