scholarly journals Persistence of biologic treatments in psoriatic arthritis: a population-based study in Sweden

2020 ◽  
Vol 4 (2) ◽  
Author(s):  
Kirk Geale ◽  
Ingrid Lindberg ◽  
Emma C Paulsson ◽  
E Christina M Wennerström ◽  
Anna Tjärnlund ◽  
...  

Abstract Objectives TNF inhibitors (TNFis) and IL inhibitors are effective treatments for PsA. Treatment non-persistence (drug survival, discontinuation) is a measure of effectiveness, tolerability and patient satisfaction or preferences in real-world clinical practice. Persistence on these treatments is not well understood in European PsA populations. The aim of this study was to compare time to non-persistence for either ustekinumab (IL-12/23 inhibitor) or secukinumab (IL-17 inhibitor) to a reference group of adalimumab (TNFi) treatment exposures in PsA patients and identify risk factors for non-persistence. Methods A total of 4649 exposures of adalimumab, ustekinumab, and secukinumab in 3918 PsA patients were identified in Swedish longitudinal population-based registry data. Kaplan–Meier curves were constructed to measure treatment-specific real-world risk of non-persistence and adjusted Cox proportional hazards models were estimated to identify risk factors associated with non-persistence. Results Ustekinumab was associated with a lower risk of non-persistence relative to adalimumab in biologic-naïve [hazard ratio (HR) 0.48 (95% CI 0.33, 0.69)] and biologic-experienced patients [HR 0.65 (95% CI 0.56, 0.76)], while secukinumab was associated with a lower risk in biologic-naïve patients [HR 0.65 (95% CI 0.49, 0.86)] but a higher risk of non-persistence in biologic-experienced patients [HR 1.20 (95% CI 1.03, 1.40)]. Biologic non-persistence was also associated with female sex, axial involvement, recent disease onset, biologic treatment experience and no psoriasis. Conclusion Ustekinumab exhibits a favourable treatment persistency profile relative to adalimumab overall and across lines of treatment. The performance of secukinumab is dependent on biologic experience. Persistence and risk factors for non-persistence should be accounted for when determining an optimal treatment plan for patients.

Circulation ◽  
2016 ◽  
Vol 133 (suppl_1) ◽  
Author(s):  
Faye L Norby ◽  
Lindsay G Bengtson ◽  
Lin Y Chen ◽  
Richard F MacLehose ◽  
Pamela L Lutsey ◽  
...  

Background: Rivaroxaban is a novel oral anticoagulant approved in the US in 2011 for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). Information on risks and benefits among rivaroxaban users in real-world populations is limited. Methods: We used data from the US MarketScan Commercial and Medicare Supplemental databases between 2010 and 2013. We selected patients with a history of NVAF and initiating rivaroxaban or warfarin. Rivaroxaban users were matched with up to 5 warfarin users by age, sex, database enrollment date and drug initiation date. Ischemic stroke, intracranial bleeding (ICB), myocardial infarction (MI), and gastrointestinal (GI) bleeding outcomes were defined by ICD-9-CM codes in an inpatient claim after drug initiation date. Cox proportional hazards models were used to assess the association between rivaroxaban vs. warfarin use and outcomes adjusting for age, sex, and CHA2DS2-VASc score. Separate models were used to compare a) new rivaroxaban users with new warfarin users, and b) switchers from warfarin to rivaroxaban to continuous warfarin users. Results: Our analysis included 34,998 rivaroxaban users matched to 102,480 warfarin users with NVAF (39% female, mean age 71), in which 487 ischemic strokes, 179 ICB, 647 MI, and 1353 GI bleeds were identified during a mean follow-up of 9 months. Associations of rivaroxaban vs warfarin were similar in new users and switchers; therefore we pooled both analyses. Rivaroxaban users had lower rates of ICB (hazard ratio (HR) (95% confidence interval (CI)) = 0.72 (0.46, 1.12))) and ischemic stroke (HR (95% CI) = 0.88 (0.68, 1.13)), but higher rates of GI bleeding (HR (95% CI) = 1.15 (1.01, 1.33)) when compared to warfarin users (table). Conclusion: In this large population-based study of NVAF patients, rivaroxaban users had a non-significant lower risk of ICB and ischemic stroke than warfarin users, but a higher risk of GI bleeding. These real-world findings are comparable to results reported in published clinical trials.


2018 ◽  
Vol 14 (1) ◽  
pp. 61-68 ◽  
Author(s):  
Maria Carlsson ◽  
Tom Wilsgaard ◽  
Stein Harald Johnsen ◽  
Liv-Hege Johnsen ◽  
Maja-Lisa Løchen ◽  
...  

Background Studies on the relationship between temporal trends in risk factors and incidence rates of intracerebral hemorrhage are scarce. Aims To analyze temporal trends in risk factors and incidence rates of intracerebral hemorrhage using individual data from a population-based study. Methods We included 28,167 participants of the Tromsø Study enrolled between 1994 and 2008. First-ever intracerebral hemorrhages were registered through 31 December 2013. Hazard ratios (HRs) for intracerebral hemorrhage were analyzed by Cox proportional hazards models, risk factor levels over time by generalized estimating equations, and incidence rate ratios (IRR) by Poisson regression. Results We registered 219 intracerebral hemorrhages. Age, male sex, systolic blood pressure (BP), diastolic BP, and hypertension were associated with intracerebral hemorrhage. Hypertension was more strongly associated with non-lobar intracerebral hemorrhage (HR 5.08, 95% CI 2.86–9.01) than lobar intracerebral hemorrhage (HR 1.91, 95% CI 1.12–3.25). In women, incidence decreased significantly (IRR 0.46, 95% CI 0.23–0.90), driven by a decrease in non-lobar intracerebral hemorrhage. Incidence rates in men remained stable (IRR 1.27, 95% CI 0.69–2.31). BP levels were lower and decreased more steeply in women than in men. The majority with hypertension were untreated, and a high proportion of those treated did not reach treatment goals. Conclusions We observed a significant decrease in intracerebral hemorrhage incidence in women, but not in men. A steeper BP decrease in women may have contributed to the diverging trends. The high proportion of untreated and sub-optimally treated hypertension calls for improved strategies for prevention of intracerebral hemorrhage.


2016 ◽  
Vol 2 (3_suppl) ◽  
pp. 76s-76s ◽  
Author(s):  
Elysia Alvarez ◽  
Midori Seppa ◽  
Kevin Messacar ◽  
John Kurap ◽  
E. Alejandro Sweet-Cordero ◽  
...  

Abstract 59 Background: Abandonment of therapy is a major cause of therapeutic failure in the treatment of childhood cancer in Low and Middle Income Countries (LMIC). This study examines factors associated with increased risk of therapy abandonment in Guatemalan children with cancer and the rates of therapy abandonment before and after implementation of a multidisciplinary psychosocial intervention program. Methods: A retrospective population-based study was performed to identify risk factors for abandonment of therapy in Guatemalan children, ages 0-18, with cancer who were seen at UNOP from 2001-2008. Patient data was collected from the Pediatric Oncology Networked Database (POND4Kids). Abandonment was defined as a lapse of 4 weeks in planned treatment or failure to begin treatment for a potentially curable cancer. Cox proportional hazards analysis identified the effect of age, sex, year of diagnosis, distance travelled to UNOP, ethnicity, and principal diagnosis on abandonment of therapy. Kaplan Meier analysis was used to evaluate survival. Results: A retrospective analysis of 1,789 charts was performed and 367 patients abandoned therapy. The rate of abandonment decreased from 27% in 2001 to 7% in 2008 following a multidisciplinary psychosocial intervention program. Greater distance to UNOP (p = 0.00), younger age (p = 0.02) and earlier year of diagnosis (p = 0.00) were associated with increased risk of abandonment. Abandonment of therapy correlated with decreased survival. The cumulative survival at 8.3 years was 0.57 ± 0.02 (survival±SE) for those who completed therapy vs 0.06 ± 0.02 for those who abandoned and refused therapy (p=0.000) in an abandonment sensitive analysis. Conclusion: This study identified distance, age, and year of diagnosis as risk factors for abandonment of therapy for pediatric cancer in Guatemala. This study highlights risk factors for abandonment of therapy and the role of targeted interventions in altering rates of abandonment that could be replicated in other LMIC countries. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: No COIs from the authors.


2021 ◽  
Vol 8 ◽  
Author(s):  
Wei Jiang ◽  
Fu-Rong Li ◽  
Huan-Huan Yang ◽  
Guo-Chong Chen ◽  
Yong-Fei Hua

Background: N-3 long-chain polyunsaturated fatty acids (LCPUFAs) prevented non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC) in studies of mouse models. We examined prospective relationships between fish oil use and risk of primary liver cancer and the major histological subtypes, such as HCC and intrahepatic cholangiocarcinoma (ICC).Methods: We included 434,584 middle-aged and older men and women who were free of cancer at recruitment of the UK Biobank (2006–2010). Information on fish oil use and other dietary habits was collected via questionnaires. Cox proportional hazards models were used to compute the hazard ratio (HR) and 95% CI of liver cancer associated with fish oil use, with adjustment for socio-demographic, lifestyle, dietary, and other clinical risk factors.Results: At baseline, 31.4% of participants reported regular use of fish oil supplements. During a median of 7.8 years of follow-up, 262 incident liver cancer cases were identified, among which 127 were HCC and 110 were ICC cases. As compared with non-users, fish oil users had a significantly 44% (95% CI: 25–59%) lower risk of total liver cancer, and 52% (95% CI: 24–70%) and 40% (95% CI: 7–61%) lower risk of HCC and ICC, respectively. Higher intake of oily fish also was associated with a lower risk of HCC (≥2 vs. <1 serving/week: HR = 0.46; 95% CI: 0.23–0.96; P-trend = 0.027) but not ICC (P-trend = 0.96).Conclusion: Habitual use of fish oil supplements was associated lower risk of primary liver cancer regardless of cancer histological subtypes, potentially supporting a beneficial role of dietary n-3 LCPUFAs in liver cancer prevention.


2016 ◽  
Vol 116 (11) ◽  
pp. 975-986 ◽  
Author(s):  
Allison Keshishian ◽  
Shital Kamble ◽  
Xianying Pan ◽  
Jack Mardekian ◽  
Ruslan Horblyuk ◽  
...  

SummaryIn addition to warfarin, there are four non-vitamin K antagonist oral anticoagulants (NOACs) available for stroke prevention in non valvular atrial fibrillation (NVAF). There are limited data on the comparative risks of major bleeding among newly anticoagulated NVAF patients who initiate warfarin, apixaban, dabigatran, or rivaroxaban, when used in ‘real world’ clinical practice. The study used the Truven MarketScan® Commercial & Medicare supplemental US claims database. NVAF patients aged ≥18 years newly prescribed an oral anticoagulant 01JAN2013–31DEC2014, with a ≥1-year baseline period, were included (study period: 01JAN2012–31DEC2014). Major bleeding was defined as bleeding requiring hospitalisation. Propensity score matching (PSM) was used to balance age, sex, region, baseline comorbidities, and comedications. Cox proportional hazards models were used to estimate the PSM hazard ratio (HR) of major bleeding. Among 45,361 newly anticoagulated NVAF patients, 15,461 (34.1 %) initiated warfarin, 7,438 (16.4 %) initiated apixaban, 17,801 (39.2 %) initiated rivaroxaban, and 4,661 (10.3 %) initiated dabigatran. Compared to matched warfarin initiators, apixaban (HR: 0.53; 95 % CI: 0.39–0.71) and dabigatran (HR: 0.69; 95 % CI: 0.50–0.96) initiators had a significantly lower risk of major bleeding. Patients initiating rivaroxaban (HR: 0.98; 95 % CI: 0.83–1.17) had a non-significant difference in major bleeding risk compared to matched warfarin patients. When comparisons were made between NOACs, matched rivaroxaban patients had a significantly higher risk of major bleeding (HR: 1.82; 95 % CI: 1.36–2.43) compared to apixaban patients. The differences for apixaban-dabigatran and dabigatran-rivaroxaban matched cohorts were not statistically significant. Among newly anticoagulated NVAF patients in the real-world setting, apixaban and dabigatran initiation was associated with significantly lower risk of major bleeding compared to warfarin initiation. When compared to apixaban, rivaroxaban initiation was associated with significantly higher risk of major bleeding.Note: The review process for this paper was fully handled by Christian Weber, Editor in Chief.Supplementary Material to this article is available online at www.thrombosis-online.com.


2021 ◽  
pp. 1-12
Author(s):  
Jagan A. Pillai ◽  
Kou Lei ◽  
James Bena ◽  
Lisa Penn ◽  
James B. Leverenz

Background: There is significant interest in understanding the role of modifiable vascular risk factors contributing to dementia risk across age groups. Objective: Risk of dementia onset was assessed in relation to vascular risk factors of hypertension and hypercholesterolemia among cognitively normal APOE ɛ4 carriers and non-carriers. Methods: In a sample of prospectively characterized longitudinal cohort from the National Alzheimer’s Coordinating Center database, 9,349 participants met criteria for normal cognition at baseline, had a CDR-Global (CDR-G) score of zero, and had concomitant data on APOE ɛ4 status and medical co-morbidities including histories of hypertension and hypercholesterolemia. Multivariable Cox proportional hazards models adjusted for well-known potential confounders were used to compare dementia onset among APOE ɛ4 carriers and non-carriers by young (≤65 years) and old (>  65 year) age groups. Results: 519 participants converted to dementia within an average follow up of 5.97 years. Among older APOE ɛ4 carriers, hypercholesterolemia was related to lower risk of dementia (HR (95% CI), 0.68 (0.49–0.94), p = 0.02). Among older APOE ɛ4 non-carriers, hypertension was related to higher risk of dementia (HR (95% CI), 1.44 (1.13–1.82), p = 0.003). These results were corroborated among a subset with autopsy data characterizing underlying neuropathology. Among younger participants, vascular risk factors did not impact dementia risk, likely from a lower frequency of vascular and Alzheimer’s as etiologies of dementia among this cohort. Conclusion: A history of hypercholesterolemia related to a lower risk of dementia among older APOE ɛ4 carriers, while hypertension related to a higher risk of dementia among older APOE ɛ4 non-carriers.


2019 ◽  
Author(s):  
Zahra Maleki ◽  
Haleh Ghaem ◽  
Mozhgan Seif ◽  
Sedigheh Foruhari

Abstract Background: For parents, stillbirth is a disappointing phenomenon; thus, identifying the associated risk factors can be beneficial in order to prevent this event. This study aimed to investigate the incidence and risk factors associated with stillbirth.Methods: In this historical cohort study, a total of 18129 birth records were investigated. For each case of stillbirth, three live birth infants on the same day and same hospital were selected as the controls, which were matched for gestational age. The data was collected using a researcher-made checklist. Finally, data were analyzed using STATA, 13.0 with Cox proportional hazards regression model at the significance level of 0.05.Results: The cumulative incidence of still birth was 9.48 per 1000 live births. Based on multivariate Cox regression model, five risk factors for stillbirth were identified, including male gender, fetal diseases, gestational hypertension, gestational diabetes, and hypothyroidism, (all hazard ratios > 1 and p<0.05).Conclusion: For the first time, maternal hypothyroidism, oligohydramnios and polyhydramnios were shown as risk factors for stillbirth, which were not evaluated in any previous study. The findings of this study suggest that some maternal and fetal risk factors can be recognized as predictors of stillbirth, which might help to prevent and detect high-risk parents at early stages in order to avoid adverse health consequences in the mother and her neonate.


Author(s):  
Ziv Harel ◽  
Eric McArthur ◽  
Nivethika Jeyakumar ◽  
Manish Sood ◽  
Amit Garg ◽  
...  

Background: Anticoagulation with either with a vitamin K antagonist or a direct oral anticoagulant (DOAC) may be associated with acute kidney injury (AKI). Our objective was to assess the risk of AKI among elderly individuals with atrial fibrillation (AF) newly prescribed a DOAC (dabigatran, rivaroxaban, or apixaban) versus warfarin. Methods: A population-based cohort study of 20,683 outpatients in Ontario, Canada, ≥66 years, with atrial fibrillation who were prescribed warfarin, dabigatran, rivaroxaban or apixaban between 2009- 2017. Inverse probability of treatment weighting based on derived propensity scores for the treatment with each DOAC was used to balance baseline characteristics among patients receiving each of the three DOACs, compared to warfarin. Cox proportional hazards regression was performed in the weighted population to compare the association between the prescribed anticoagulant and the outcomes of interest. The exposure was an outpatient prescription of warfarin, or one of the DOACs. The primary outcome was a hospital encounter with AKI, defined using KDIGO thresholds. Prespecified subgroup analyses were conducted by estimated glomerular filtration rate (eGFR) category, and by the percentage of international normalized ratio measurements in range, a validated marker of anticoagulation control. Results: : Each DOAC was associated with a significantly lower risk of AKI compared to warfarin (weighted HR 0.65; 95% CI 0.53 to 0.80 for dabigatran, weighted HR 0.85; 95% CI 0.73 to 0.98 for rivaroxaban; and weighted HR 0.81; 95% CI 0.72 to 0.93 for apixaban). In subgroup analysis, the lower risk of AKI associated with each DOAC was consistent across each eGFR strata. The risk of AKI was significantly lower among users of each of the DOACs compared to warfarin users who had a percentage of international normalized ratio measurements ≤56.1%. Conclusions: DOACs were associated with a lower risk of AKI compared to warfarin.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 11-11
Author(s):  
Anuj K. Patel ◽  
Victoria Barghout ◽  
Mihran Ara Yenikomshian ◽  
Guillaume Germain ◽  
Philippe Jacques ◽  
...  

11 Background: Adherence to oral chemotherapies is a critical but difficult to measure factor in the care of patients with advanced cancer. FTD/TPI and REG have both demonstrated prolonged survival in patients with refractory mCRC, but with notably different side effect profiles. This study utilizes real-world data to assess adherence and discontinuation of patients treated with FTD/TPI or REG and explore the effect of sequencing on adherence. Methods: Adults diagnosed with mCRC were identified using the nationally representative IQVIA Real-World Data Adjudicated Claims – US database (10/2014–07/2017). The first dispensing date of FTD/TPI or REG (if after FTD/TPI approval [10/2015]) was defined as the index date and the 3 months before as the baseline period. The observation period spanned from the index to the earliest date of a switch to another mCRC agent, end of continuous enrollment, or end of data availability. Medication possession ratio (MPR), proportion of days covered (PDC) at 3 months, and discontinuation (i.e., allowable gap≥45 days) were compared. Logistic (odds ratio [OR]) and Cox proportional hazards (hazard ratio [HR]) regressions, adjusting for baseline characteristics, were used to compare adherence and discontinuation, respectively. A subgroup analysis was conducted among switchers (FTD/TPI to REG vs REG to FTD/TPI). Results: A total of 469 FTD/TPI and 311 REG users were identified. FTD/TPI users had higher compliance with an MPR ≥ 80% (OR = 2.47; p < 0.001) and PDC ≥ 80% (OR = 2.77; p < 0.001). FTD/TPI users had lower risk of discontinuation (HR = 0.76; p = 0.006). Among switchers (96 FTD/TPI to REG; 83 REG to FTD/TPI), those switching from FTD/TPI to REG were more likely to have an MPR ≥ 80% (OR = 2.91; p < 0.001) and PDC ≥ 80% (OR = 4.60; p < 0.001) compared to REG to FTD/TPI switchers. Additionally, FTD/TPI to REG switchers had a lower risk of first treatment discontinuation (HR = 0.66; p = 0.009). Conclusions: In this study, FTD/TPI users had significantly higher compliance, lower discontinuation rate, and switchers treated first with FTD/TPI had better compliance, demonstrating that claims data can provide insight into oral chemotherapy adherence patterns in mCRC.


2021 ◽  
Author(s):  
Huei-Kai Huang ◽  
Jen-Hung Wang ◽  
Sheng-Lun Kao

Abstract Background Hypothyroidism has a detrimental effect on the immune system, which may predispose patients to infection. However, evidence about the risk of developing either community- or hospital-acquired pneumonia in patients with hypothyroidism is scarce. Objective To evaluate the association between hypothyroidism and the risk of developing pneumonia. Methods This was a retrospective population-based cohort study from Taiwan’s National Health Insurance Research Database. After 1:1 propensity score matching, 9749 patients (age ≥20 years) newly diagnosed with hypothyroidism between 2001 and 2014 and 9749 patients without hypothyroidism or other thyroid diseases were included in the hypothyroidism and non-hypothyroidism cohorts, respectively, and followed up until 2015. The development of pneumonia was defined as the primary outcome. Cox proportional hazards regression models were used to calculate the hazard ratios (HRs) of developing pneumonia between hypothyroidism and non-hypothyroidism cohorts after adjusting for age, sex and baseline comorbidities. To evaluate whether thyroxine replacement therapy (TRT) modified the risk for pneumonia, we divided patients with hypothyroidism into subgroups: patients who received TRT and those who did not. Results Hypothyroidism was associated with a higher risk of pneumonia [adjusted HR (aHR) 1.38, 95% confidence interval (CI) 1.29–1.49, P &lt; 0.001]. Patients with hypothyroidism who received TRT had a lower risk of pneumonia than patients who did not (aHR 0.85, 95% CI 0.76–0.93, P = 0.001). Similar results were obtained in the age- and sex-stratified analyses. Conclusions Clinically diagnosed hypothyroidism was independently associated with the risk of pneumonia. In patients with hypothyroidism, TRT was associated with a lower risk of pneumonia.


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