scholarly journals Evolution of Drug Survival with Biological Agents and Apremilast Between 2012 and 2018 in Psoriasis Patients from the PsoBioTeq Cohort

Author(s):  
Thomas Bettuzzi ◽  
Hervé Bachelez ◽  
Marie Beylot-Barry ◽  
Hugo Arlégui ◽  
Carle Paul ◽  
...  

Drug survival reflects treatment effectiveness and safety in real life. There is limited data on the variation of drug survival with the availability of additional biological (bDMARDs) or synthetic (sDMARDs) systemic treatments. We aimed to determine whether the increasing number of available systemic treatment in psoriasis over time affects drug survival. We used the Psobioteq cohort, a French prospective observational cohort enrolling patients with moderate to severe psoriasis. All patients initiating a first bDMARD or sDMARD were included. The primary outcome was the comparison of the drug survival over time. A multivariate cox proportional hazard ratio model was computed. There were 1,866 patients included, 739 females (39%) with a median age of 47 years. In multivariate Cox model, no association was found between the calendar year of initiation and drug survival (HR overlapping from 0.80 (0.42-1.52) to 1.17 (0.64-2.17), p=0.633). In conclusion, drug survival in psoriasis is not affected by the year of initiation.

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 3 (Supplement_1) ◽  
pp. S682-S682
Author(s):  
Joanna M Blodgett ◽  
Kenneth Rockwood ◽  
Olga Theou

Abstract Positive advances in life expectancy, healthcare access and medical technology have been accompanied by an increased prevalence of chronic diseases and substantial population ageing. How this impacts changes in both frailty level and subsequent mortality in recent decades are not well understood. We aimed to investigate how these factors changed over an 18-year period. Nine waves of the National Health and Nutrition Examination Survey (1999-2016) were harmonized to create a 46-item frailty index (FI) using self-reported and laboratory-based health deficits. Individuals aged 20+ were included in analyses (n=44086). Mortality was ascertained in December 2015. Weighted multilevel models estimated the effect of cohort on FI score in 10-year age-stratified groups. Cox proportional hazard models estimated if two or four-year mortality risk of frailty changed across the 1999-2012 cohorts. Mean FI score was 0.11±0.10. In the five older age groups (&gt;40 years), later cohorts had higher frailty levels than did earlier cohorts. For example, in people aged 80+, each subsequent cohort had an estimated 0.007 (95%CI: 0.005, 0.009) higher FI score. However, in those aged 20-29, later cohorts had lower frailty [β=-0.0009 (-0.0013, -0.0005)]. Hazard ratios and cohort-frailty interactions indicated that there was no change in two or four-year lethality of FI score over time (i.e. two-year mortality: HR of 1.069 (1.055, 1.084) in 1999-2000 vs 1.061 (1.044, 1.077) in 2011-2012). Higher frailty levels in the most recent years in middle and older aged adults combined with unchanged frailty lethality suggests that the degree of frailty may continue to increase.


2020 ◽  
Author(s):  
Sudhir Bhandari ◽  
Amit Tak ◽  
Sanjay Singhal ◽  
Jyotsna Shukla ◽  
Bhoopendra Patel ◽  
...  

Abstract Objectives: The present study is aimed at estimating patient flow dynamical parameters and requirement of hospital beds. Secondly, the effects of age and gender on parameters were evaluated. Patients and Methods: In this retrospective cohort study, 987 COVID-19 patients were enrolled from SMS Medical College, Jaipur (Rajasthan, India). The survival analysis was carried out from 29 Feb to 19 May 2020 for two hazards – ‘Hazard 1’ was hospital discharge and ‘Hazard 2’ was hospital death. The starting point for survival analysis of the two hazards was considered to be hospital admission . The survival curves were estimated and additional effects of age and gender were evaluated using Cox proportional hazard regression analysis. Results: The Kaplan Meier estimates of lengths of hospital stay (Median =10 days, IQR =10 days) and median survival rate ( more than 60 days due to large amount of censored data) were obtained. The Cox Model for ‘Hazard 1’ showed no significant effect of age and gender on duration of hospital stay. Similarly, the Cox Model 2 showed no significant difference of gender on survival rate. The case fatality rate 8.1 % , recovery rate 78.8% , mortality rate 0.10 per 100 person--days and hospital admission rate 0.35 per 105 person-days were estimated.Conclusion : The study estimates hospital bed requirement based on patient flow dynamic parameters. Furthermore, study concludes that average length of hospital stay were similar for patients of both genders and all age groups.


2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 585-585
Author(s):  
Dylan J Martini ◽  
Julie M. Shabto ◽  
Yuan Liu ◽  
Bradley Curtis Carthon ◽  
Alexandra Speak ◽  
...  

585 Background: Cabo is approved for the treatment for mRCC. We investigated the association of sites of mets and clinical outcomes (CO) in mRCC pts treated with cabo. Methods: We performed a retrospective analysis of 65 mRCC pts treated with cabo at Winship Cancer Institute from 2016 to 2018. Overall survival (OS) and progression-free survival (PFS) were measured from first dose of cabo to date of death and clinical or radiographic progression, respectively. Objective response was defined as a complete response (CR) or partial response (PR). Sites of mets were obtained from radiology and clinic notes and included bone, lymph node, brain, lung, and liver. Univariate analysis (UVA) and multivariate analysis (MVA) was performed using Cox proportional hazard or logistic regression model. Results: The median age was 63 years and most (68%) were males. The majority of pts (79%) had ccRCC and 48% received at least 2 prior systemic treatments. The distribution of mets were: bone (42%), lymph node (69%), brain (6%), lung (83%), and liver (40%). The UVA and MVA of association between sites of mets and CO are presented in Table. Pts with bone mets had significantly longer OS in UVA and trended towards longer OS and PFS in MVA compared to pts without bone mets. Conclusions: Bone mets may be a prognostic factor for improved CO in mRCC pts treated with cabo. Larger studies are needed to validate the results of this study. UVA and MVA† of bone metastases and CO. [Table: see text]


2021 ◽  
Vol 8 (1) ◽  
pp. e000899
Author(s):  
Andrew Achaiah ◽  
Amila Rathnapala ◽  
Andrea Pereira ◽  
Harriet Bothwell ◽  
Kritica Dwivedi ◽  
...  

RationaleIdiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with poor prognosis. Identifying patients early may allow intervention which could limit progression. The ‘indeterminate for usual interstitial pneumonia’ (iUIP) CT pattern, defined in the 2018 IPF guidelines, could be a precursor to IPF but there is limited data on how patients with iUIP progress over time.ObjectiveTo evaluate the radiological progression of iUIP and explore factors linked to progression to IPF.MethodsWe performed a retrospective analysis of a lung fibrosis clinic cohort (n=230) seen between 2013 and 2017. Cases with iUIP were identified; first ever CTs for each patient found and categorised as 'non-progressor' or 'progressors' (the latter defined as increase in extent of disease or to 'definite' or 'probable' UIP CT pattern) during their follow-up. Lung function trends, haematological data and patient demographics were examined to explore disease evolution and potential contribution to progression.Results48 cases with iUIP CT pattern were identified. Of these, 32 had follow-up CT scans, of which 23 demonstrated progression. 17 patients in this cohort were diagnosed with IPF over a mean (SD) period of 3.9 (±1.9) years. Monocyte (HR: 23, 95% CI: 1.6 to 340, p=0.03) and neutrophil levels (HR: 1.8, 95% CI: 1.3 to 2.3, p<0.001), obtained around the time of initial CT, were associated with progression to IPF using Cox proportional hazard modelling.Conclusion53% of our evaluable patients with iUIP progressed to IPF over a mean of 4 years. Monocyte and neutrophil levels at initial CT were significantly associated with progression in disease. These data provide a single-centre analysis of the evolution of patients with iUIP CT pattern, and first signal for potential factors associated with progression to IPF.


2021 ◽  
Vol 184 (3) ◽  
pp. 413-422
Author(s):  
Cihan Atila ◽  
Clara O Sailer ◽  
Stefano Bassetti ◽  
Sarah Tschudin-Sutter ◽  
Roland Bingisser ◽  
...  

Objective The pandemic of coronavirus disease (COVID-19) has rapidly spread globally and infected millions of people. The prevalence and prognostic impact of dysnatremia in COVID-19 is inconclusive. Therefore, we investigated the prevalence and outcome of dysnatremia in COVID-19. Design The prospective, observational, cohort study included consecutive patients with clinical suspicion of COVID-19 triaged to a Swiss Emergency Department between March and July 2020. Methods Collected data included clinical, laboratory and disease severity scoring parameters on admission. COVID-19 cases were identified based on a positive nasopharyngeal swab test for SARS-CoV-2, patients with a negative swab test served as controls. The primary analysis was to assess the prognostic impact of dysnatremia on 30-day mortality using a cox proportional hazard model. Results 172 (17%) cases with COVID-19 and 849 (83%) controls were included. Patients with COVID-19 showed a higher prevalence of hyponatremia compared to controls (28.1% vs 17.5%, P < 0.001); while comparable for hypernatremia (2.9% vs 2.1%, P = 0.34). In COVID-19 but not in controls, hyponatremia was associated with a higher 30-day mortality (HR: 1.4, 95% CI: 1.10–16.62, P = 0.05). In both groups, hypernatremia on admission was associated with higher 30-day mortality (COVID-19 - HR: 11.5, 95% CI: 5.00–26.43, P < 0.001; controls - HR: 5.3, 95% CI: 1.60–17.64, P = 0.006). In both groups, hyponatremia and hypernatremia were significantly associated with adverse outcome, for example, intensive care unit admission, longer hospitalization and mechanical ventilation. Conclusion Our results underline the importance of dysnatremia as predictive marker in COVID-19. Treating physicians should be aware of appropriate treatment measures to be taken for patients with COVID-19 and dysnatremia.


2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii14-ii14
Author(s):  
P B van der Meer ◽  
L Dirven ◽  
M Fiocco ◽  
M Vos ◽  
M C M Kouwenhoven ◽  
...  

Abstract BACKGROUND About 30% of glioma patients need an add-on antiepileptic drug (AED) due to uncontrolled seizures on AED monotherapy. This study aimed to determine whether levetiracetam combined with valproic acid (LEV+VPA), a commonly prescribed duotherapy, is more effective than other duotherapy combinations including either LEV or VPA in glioma patients. MATERIAL AND METHODS In this multicenter retrospective observational cohort study, treatment failure (i.e. replacement by or addition of a new AED, or withdrawal of an AED) for any reason was the primary outcome. Secondary outcomes included: 1) treatment failure due to uncontrolled seizures; and 2) treatment failure due to adverse effects. Time to treatment failure was defined as the time from the start of AED duotherapy until the time of treatment failure. Multivariable Cox proportional hazard models were estimated to study the association between risk factors and treatment failure. The maximum duration of follow-up was 36 months. RESULTS A total of 1435 patients were treated with first-line monotherapy LEV or VPA, of which 355 patients received AED duotherapy after they had treatment failure due to uncontrolled seizures on monotherapy. LEV+VPA was prescribed in 66% (236/355) and other AED duotherapy combinations including LEV or VPA in 34% (119/355) of patients. Patients using other duotherapy versus LEV+VPA had higher risk of treatment failure for any reason (cause-specific hazard ratio [csHR]=1.50 [95%CI=1.07–2.12], p=0.020), treatment failure due to uncontrolled seizures (csHR=1.73 [95%CI=1.10–2.73], p=0.018). There were no differences in failure due to adverse effects (csHR=0.88 [95%CI=0.47–1.67]), p=0.703) between the two groups. CONCLUSION This observational cohort study suggests that LEV+VPA has better efficacy than other AED combinations. Similar toxicities were experienced in the two groups.


2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  

This paper investigates the duration of overqualification in Canada, the time-varying probability of leaving overqualification, and the wage consequences associated with the transition. The paper also applies a survival analysis approach to examine the impact of key driving factors on the probability of transitioning from overqualification to a job match using a proportional hazard (Cox) model. The analysis shows that within a 5-year period, an overqualified worker has a 22 percent probability of transitioning to an occupation that matches the education level. The probability of transition also decreases quickly over time, thus lowering the chances of finding a job match after 12 months. Regression analyses also provide evidence that overqualified workers with short tenure are more likely to transition than workers with medium to long tenure. Finally, job-related training nearly doubles the chance of transitioning out of overqualification.


BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e025666 ◽  
Author(s):  
Ruihua Kang ◽  
Liuhong Luo ◽  
Huanhuan Chen ◽  
Qiuying Zhu ◽  
Lingjie Liao ◽  
...  

ObjectivesChina has continued to expand antiretroviral therapy (ART) services and optimise ART guidelines in an effort to significantly reduce and prevent mortality and transmission rates among HIV patients. However, no study to date has compared treatment outcomes of initial differential antiretroviral regimens among HIV patients in a real-world setting in China. This study aimed to compare the effects of different ART regimens on treatment outcomes among adults.DesignObservational retrospective cohort study.SettingData from 2011 to 2013 in Guangxi, China.ParticipantsPatients aged ≥18 years (n=25 732) were selected.ResultsA total of 25 732 patients were included in this study. The average mortality and attrition rate were 2.64 and 4.98, respectively, per 100 person-years. Using Cox proportional hazard models, zidovudine-based (AZT-based) regimen versus stavudine-based (D4T-based) regimen had an adjusted HR (AHR) for death of 0.65 (95% CI 0.58 to 0.73); the AHR of tenofovir-based (TDF-based) versus D4T-based regimens was 0.81 (95% CI 0.71 to 0.92), and of lopinavir–ritonavir-based (LPV/r-based) versus D4T-based regimens, 1.19 (95% CI 1.04 to 1.37). AZT-based versus D4T-based regimens had an AHR for dropout of 0.89 (95% CI 0.81 to 0.97); this ratio for TDF-based versus D4T-based regimens was 0.88 (95% CI 0.80 to 0.98), and for LPV/r-based versus D4T-based regimens, 1.42 (95% CI 1.27 to 1.58). AZT-based and TDF-based regimens had a lower risk compared with D4T-based regimens, while LPV/r-based regimens had a higher risk. High gastrointestinal reactions and poor adherence were observed among HIV patients whose initial ART regimen was LPV/r-based.ConclusionsOur study found that the treatment outcomes of initial ART regimens that were AZT-based or TDF-based were significantly better than D4T-based or LPV/r-based regimens. This finding could be related to the higher rates of gastrointestinal reactions and poorer adherence associated with the LPV/r-based regimens compared with other initial ART regimens.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3691-3691 ◽  
Author(s):  
Emily Rimmer ◽  
Steve Doucette ◽  
Donald S. Houston ◽  
Brett L. Houston ◽  
Chantalle Menard ◽  
...  

Abstract Background: Septic shock is among the most common causes of admission to medical intensive care units (ICU) and is associated with mortality of 20-40%. The white blood cell count (WBC) at time of admission correlates with prognosis in septic shock but it is not known if the change in WBC over time (i.e. the WBC trajectory) impacts survival. Hypothesis: We hypothesized that the trajectory of the WBC count in septic shock can identify distinct clinical groups and be an independent predictor of 30-day mortality. Objectives: 1) To identify groups of patients with different WBC trajectories using group-based trajectory analysis; 2) To evaluate patient and illness factors associated with WBC count trajectories; and 3) To estimate the association of WBC trajectory with mortality in septic shock. Methods: We completed a retrospective cohort study of adult patients with septic shock admitted to an ICU in Winnipeg, Canada between 2006-2014. We used group-based trajectory analysis to analyze the trend of WBC over the first 7 days of ICU admission to group patients according to stastically similar trajectories. Group-based trajectory analysis is a statistical method that can be used to describe the pattern of a variable over time. Rather than pre-specifying groups within a population, or using methods to measure an average trajectory for the entire population, group-based trajectory analysis allows for different groups with different trajectories to emerge. We used the Bayesian Information Criterion (BIC) and clinical validity characteristics to select the optimal trajectory model. We developed a multinomial logistic regression model to evaluate the association of patient and illness factors with WBC trajectories. We constructed a multivariable Cox proportional hazard models adjusted for age, Acute Physiology and Chronic Health Evaluation (APACHE) II score, comorbidities, infection type and antibiotics to evaluate the association of WBC trajectory on 30-day mortality. Results: Our final study cohort comprised 917 patients with septic shock. The favoured model identified 7 distinct trajectories of WBC (Figure 1). We found that only baseline platelet count and sex were associated with WBC trajectory. The 30-day mortality of the entire cohort was 26.3%, and ranged from 23.1% in group 4 to 63% in group 5 (rising WBC trajectory). In a multivariable Cox proportional hazard model, group 5 was independently associated with an increased hazard of death (Hazard Ratio 3.48, 95% CI 1.92 to 6.35, p<0.01). Conclusions: We found seven unique and clinically relevant groups of patients with septic shock using trajectory analysis of the WBC count. Routine baseline characteristics are poor predictors of trajectory group assignment. The rising WBC trajectory is associated with an increased risk of death in septic shock. Further studies are required to fully describe the clinical characteristics and prognosis associated with distinct WBC trajectories and whether this information can inform level of care decisions and anticipated response to treatments. In the era of Big Data, trajectory analysis will be broadly applicable to the field of hematology where trends in blood counts or biomarkers of disease may provide valuable clinical or prognostic information. Examples could include analysis of the M-protein trajectory in Multiple Myeloma, and the trajectory of platelet counts in immune thrombocytopenia. Figure 1. Figure 1. Disclosures No relevant conflicts of interest to declare.


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