scholarly journals The impact of certolizumab pegol treatment on the incidence of anterior uveitis flares in patients with axial spondyloarthritis: 48-week interim results from C-VIEW

RMD Open ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e001161 ◽  
Author(s):  
Irene van der Horst-Bruinsma ◽  
Rianne van Bentum ◽  
Frank D Verbraak ◽  
Thomas Rath ◽  
James T Rosenbaum ◽  
...  
Keyword(s):  
Incidence Rate ◽  
Anterior Uveitis ◽  
Poisson Regression ◽  
Axial Spondyloarthritis ◽  
Certolizumab Pegol ◽  
Tnf Inhibitor ◽  
Open Label ◽  
Before And After ◽  
History Of ◽  
The Impact

BackgroundAcute anterior uveitis (AAU) is the most common extra-articular manifestation in patients with axial spondyloarthritis (axSpA). C-VIEW investigates the impact of the Fc-free TNF inhibitor certolizumab pegol (CZP) on AAU flares in patients with active axSpA at high risk of recurrent AAU.MethodsC-VIEW (NCT03020992) is a 96-week ongoing, multicentre, open-label, phase 4 study. Included patients had an axSpA diagnosis, a history of recurrent AAU (≥2 AAU flares, ≥1 flare in the year prior to study entry), HLA-B27 positivity, active disease, and failure of ≥2 non-steroidal anti-inflammatory drugs. Patients received CZP 400 mg at Weeks 0/2/4, then 200 mg every 2 weeks up to 96 weeks. This 48-week pre-planned interim analysis compares AAU flare incidence in the 48 weeks before and after initiation of CZP treatment, using Poisson regression to account for possible within-patient correlations.ResultsIn total, 89 patients were included (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean axSpA disease duration: 8.6 years). During 48 weeks’ CZP treatment, 13 (15%) patients experienced 15 AAU flares, representing an 87% reduction in AAU incidence rate (146.6 per 100 patient-years (PY) in the 48 weeks pre-baseline to 18.7 per 100 PY during CZP treatment). Poisson regression analysis showed that the incidence rate of AAU per patient reduced from 1.5 to 0.2 (p<0.001). No new safety signals were identified.ConclusionsThere was a significant reduction in the AAU flare rate during 48 weeks of CZP treatment, indicating that CZP is a suitable treatment option for patients with active axSpA and a history of recurrent AAU.

scholarly journals Reduction of anterior uveitis flares in patients with axial spondyloarthritis on certolizumab pegol treatment: final 2-year results from the multicenter phase IV C-VIEW study

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110038
Author(s):  
Irene E. van der Horst-Bruinsma ◽  
Rianne E. van Bentum ◽  
Frank D. Verbraak ◽  
Atul Deodhar ◽  
Thomas Rath ◽  
...  
Keyword(s):  
Anterior Uveitis ◽  
Axial Spondyloarthritis ◽  
Event Rate ◽  
Certolizumab Pegol ◽  
Human Leukocyte ◽  
Primary Analysis ◽  
Open Label ◽  
Flare Event ◽  
Patients At Risk ◽  
History Of

Introduction: Acute anterior uveitis (AAU), affecting up to 40% of patients with axial spondyloarthritis (axSpA), risks permanent visual deficits if not adequately treated. We report 2-year results from C-VIEW, the first study to prospectively investigate certolizumab pegol (CZP) on AAU in patients with active axSpA at high risk of recurrent AAU. Patients and methods: C-VIEW (NCT03020992) was a 104-week (96 weeks plus 8-week safety follow-up), open-label, multicenter study. Eligible patients had active axSpA, human leukocyte antigen-B27 (HLA-B27) positivity and a history of recurrent AAU (⩾2 AAU flares in total; ⩾1 in the year prior to baseline). Patients received CZP 400 mg at weeks 0, 2 and 4, then 200 mg every 2 weeks to week 96. The primary efficacy endpoint was the AAU flare event rate during 96 weeks’ CZP versus 2 years pre-baseline. Results: Of 115 enrolled patients, 89 initiated CZP (male: 63%; radiographic/non-radiographic axSpA: 85%/15%; mean disease duration: 9.1 years); 83 completed week 96. There was a significant 82% reduction in AAU flare event rate during CZP versus pre-baseline [rate ratio (95% confidence interval): 0.18 (0.12–0.28), p < 0.001]. One hundred percent and 59.6% of patients experienced ⩾1 and ⩾2 AAU flares pre-baseline, respectively, compared to 20.2% and 11.2% during treatment. Age, sex and axSpA population subgroup analyses were consistent with the primary analysis. There were substantial improvements in axSpA disease activity with no new safety signal identified. Conclusion: CZP treatment significantly reduced AAU flare event rate in patients with axSpA and a history of AAU, indicating CZP is a suitable treatment option for patients at risk of recurrent AAU. Trial Registration ClinicalTrials.gov: NCT03020992, URL: https://clinicaltrials.gov/ct2/show/NCT03020992

Glucose Levels and Outcome After Primary Intraventricular Hemorrhage

2019 ◽  
Vol 16 (1) ◽  
pp. 40-46
Author(s):  
Rui Guo ◽  
Ruiqi Chen ◽  
Chao You ◽  
Lu Ma ◽  
Hao Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Blood Glucose ◽  
Blood Glucose Level ◽  
Incidence Rate ◽  
Glucose Level ◽  
Intraventricular Hemorrhage ◽  
Laboratory Data ◽  
History Of ◽  
Poor Outcomes ◽  
The Impact

Background and Purpose: Hyperglycemia is reported to be associated with poor outcome in patients with spontaneous Intracerebral Hemorrhage (ICH), but the association between blood glucose level and outcomes in Primary Intraventricular Hemorrhage (PIVH) remains unclear. We sought to identify the parameters associated with admission hyperglycemia and analyze the impact of hyperglycemia on clinical outcome in patients with PIVH. Methods: Patients admitted to Department of Neurosurgery, West China Hospital with PIVH between 2010 and 2016 were retrospectively included in our study. Clinical, radiographic, and laboratory data were collected. Univariate and multivariate logistic regression analyses were used to identify independent predictors of poor outcomes. Results: One hundred and seventy patients were included in the analysis. Mean admission blood glucose level was 7.78±2.73 mmol/L and 10 patients (5.9%) had a history of diabetes mellitus. History of diabetes mellitus (P = 0.01; Odds Ratio [OR], 9.10; 95% Confidence Interval [CI], 1.64 to 50.54) was independent predictor of admission critical hyperglycemia defined at 8.17 mmol/L. Patients with admission critical hyperglycemia poorer outcome at discharge (P < 0.001) and 90 days (P < 0.001). After adjustment, admission blood glucose was significantly associated with discharge (P = 0.01; OR, 1.30; 95% CI, 1.06 to 1.59) and 90-day poor outcomes (P = 0.03; OR, 1.27; 95% CI, 1.03 to 1.58), as well as mortality at 90 days (P = 0.005; OR, 1.41; 95% CI, 1.11 to 1.78). In addition, admission critical hyperglycemia showed significantly increased the incidence rate of pneumonia in PIVH (P = 0.02; OR, 6.04; 95% CI 1.27 to 28.80) even after adjusting for the confounders. Conclusion: Admission blood glucose after PIVH is associated with discharge and 90-day poor outcomes, as well as mortality at 90 days. Admission hyperglycemia significantly increases the incidence rate of pneumonia in PIVH.

scholarly journals THU0378 DO COMORBIDITIES DECREASE THE FIRST TNF-INHIBITOR RETENTION AND TREATMENT RESPONSE IN AXIAL SPONDYLOARTHRITIS PATIENTS? DATA FROM TURKBIO

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 422-423
Author(s):  
Y. Erez ◽  
A. Karakas ◽  
S. B. Kocaer ◽  
T. Yüce İnel ◽  
S. Gulle ◽  
...  
Keyword(s):  
Disease Activity ◽  
Treatment Response ◽  
Axial Spondyloarthritis ◽  
Cerebrovascular Event ◽  
Tnf Inhibitor ◽  
Drug Survival ◽  
Drug Retention ◽  
Significant Difference ◽  
Baseline Characteristics ◽  
The Impact

Background:The frequency of comorbidities has increased in spondyloarthritis patients compared to the general population. The effect of comorbidities on tumour necrosis factor alpha inhibitor (TNFi) drug retention and treatment response has not been well evaluated.Objectives:The purpose of this study to assess the impact of comorbidities on the first TNFi drug survival and treatment response in patients with axial spondyloarthritis (axSpA) registered in theTURKBIOdatabase.Methods:In this study, the frequency of comorbidities, disease activity scores at baseline and month 6 and drug retention were recorded in AxSpA patients iniating first TNFi treatment between 2011 and 2019. Kaplan Meier plot and log rank tests were used for drug survival analysis. Cox regression analysis with HR was performed to evaluate the correlation between comorbidities and drug survival.Results:There were 2428 patients with AxSpA (39.3% female) who used their first TNFi during the study period. Among them, a total of 770 (31%) had at least one comorbid disease. Hypertension was the most common comorbidity (9.7%), followed by the affective disorders (8%) and chronic lung disease (5.8%). The baseline characteristics of patients are shown in Table 1.The presence of any comorbidity did not impact the first TNFi retention (Figure 1). When comorbidities were analysed seperately, we found that only history of cerebrovascular event was negatively associated with drug retention rate (HR: 6.9, p:0.008). There was no statistically significant difference in Bath AS Disease Activity Index 50% (BASDAI50) response between patients with and without comorbidity at 6 months. Less axSpA patients with comorbidity achieved a ASDAS score ≤ 2.1 compared to patients without comorbidity at 6 months.Table 1.Baseline Characteristics of PatientsRadiographic Spondyloarthritis, n (%)2318 (95.5)Female, n(%)954 (39.3)Age, year42.2±11.8Age at diagnosis, years32.5± 11.3Age at initial TNFi, years39.4 ± 11.1Symptom duration, years9.7± 7.5Time to initial TNFi, years7±6.8HLA-B27- positivity, n (%)1144 (47.1)Smokers, n (%)1068 (44)Baseline BASDAI35.5±22.2Baseline ASDAS-CRP2.8±1.1Baseline CRP (mg/L)15.7±24.4VAS global patient46.6±28.7-Quantitative variables are presented as mean ± SD, and qualitative variables are presented as frequency and percentage-ASDAS-CRP, Ankylosing Spondylitis Disease Activity Score using C-reactive protein VAS, visual analogue scaleConclusion:The results of this study demonstrated that the presence of previous cerebrovascular event decreased the first TNFi survival in patients with axSpA. It also suggested that comorbidities might decrease TNFi treatment response.Disclosure of Interests:None declared

Tracheobronchial Foreign Bodies: The Impact of a Postgraduate Educational Program on Diagnosis, Morbidity, and Treatment

PEDIATRICS ◽  
1982 ◽  
Vol 70 (1) ◽  
pp. 96-98
Author(s):  
Marc Puterman ◽  
Rafael Gorodischer ◽  
Alberto Leiberman
Keyword(s):  
Educational Program ◽  
Foreign Bodies ◽  
Final Diagnosis ◽  
Physician Performance ◽  
Postgraduate Educational ◽  
Before And After ◽  
History Of ◽  
The Mean ◽  
Hospital Days ◽  
The Impact

Aspirated foreign bodies (FBs) may remain undetected and cause serious complications. As part of a postgraduate educational program, results of a local survey were presented to the local medical staff in order to increase its awareness of this diagnostic possibility. The present study was carried out in order to evaluate the management of children with tracheobronchial FBs during two 2-year periods, before and after teaching sessions held in December 1976. In comparison with the previous two years during the 1977-1978 period, the percentage of cases in which a positive history of aspiration was obtained increased from 47.6% to 84.0%; the mean number of hospitalizations due to tracheobronchial FBs decreased from 1.9 to 1.04 per infant, and the mean number of hospital days required for final diagnosis decreased from 17.6 to 5.3. The postgraduate educational program had a positive effect on physician performance and patient care.

scholarly journals Is a positive family history of spondyloarthritis relevant for diagnosing axial spondyloarthritis once HLA-B27 status is known?

Rheumatology ◽  
2019 ◽  
Vol 58 (9) ◽  
pp. 1649-1654 ◽  
Author(s):  
Miranda van Lunteren ◽  
Désirée van der Heijde ◽  
Alexandre Sepriano ◽  
Inger J Berg ◽  
Maxime Dougados ◽  
...  
Keyword(s):  
Back Pain ◽  
Family History ◽  
Anterior Uveitis ◽  
Chronic Back Pain ◽  
Axial Spondyloarthritis ◽  
Positive Family History ◽  
Hla B27 ◽  
Acute Anterior Uveitis ◽  
Negative Results ◽  
History Of

Abstract Objectives A positive family history (PFH) of spondyloarthritis, in particular a PFH of AS or acute anterior uveitis, is associated with HLA-B27 carriership in chronic back pain patients. As it is unknown, the study aimed to investigate if a PFH contributes to diagnosing axial spondyloarthritis (axSpA) once HLA-B27 status is known. Methods In axSpA-suspected patients from the Assessment of SpondyloArthritis international Society (ASAS), DEvenir des Spondyloarthropathies Indifférenciéés Récentes (DESIR) and SPondyloArthritis Caught Early (SPACE) cohorts, logistic regression analyses were performed with HLA-B27 status and PFH according to the ASAS definition (ASAS-PFH) as determinants and clinical axSpA diagnosis as outcome at baseline. Analyses were repeated with a PFH of AS or acute anterior uveitis. Results In total, 1818 patients suspected of axSpA were analysed (ASAS n = 594, DESIR n = 647, and SPACE n = 577). In patients from the ASAS, DESIR and SPACE cohorts, respectively 23%, 39% and 38% had an ASAS-PFH, 52%, 58% and 43% were HLA-B27 positive, and 62%, 47% and 54% were diagnosed with axSpA. HLA-B27 was independently associated with an axSpA diagnosis in each cohort but an ASAS-PFH was not [ASAS cohort: HLA-B27 odds ratio (OR): 6.9 (95% CI: 4.7, 10.2), ASAS-PFH OR: 0.9 (95% CI: 0.6, 1.4); DESIR: HLA-B27 OR: 2.1 (95% CI: 1.5, 2.9), ASAS-PFH OR: 1.0 (95% CI 0.7, 1.3); SPACE: HLA-B27 OR: 10.4 (95% CI: 6.9, 15.7), ASAS-PFH OR: 1.0 (95% CI: 0.7, 1.5)]. Similar negative results were found for PFH of AS and acute anterior uveitis. Conclusion In three independent cohorts with different ethnical backgrounds, ASAS, DESIR and SPACE, a PFH was not associated independently of HLA-B27 with a diagnosis of axSpA. This indicates that in the vast majority of patients presenting with back pain, a PFH does not contribute to the likelihood of an axSpA diagnosis if HLA-B27 status is known.

scholarly journals A Unique Personalized Nutrition Program Facilitates Lifestyle Behavior Changes: Novel Insights from HABIT's Personalized Approach to Health (PATH) Study (P15-020-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Barbara Winters ◽  
Tanja Krone ◽  
Kristin Nieman ◽  
Suzan Wopereis ◽  
Sabina Bijlsma ◽  
...  
Keyword(s):  
Health Outcomes ◽  
Activity Levels ◽  
Personalized Nutrition ◽  
Dietary Recommendations ◽  
Open Label ◽  
Lifestyle Behavior ◽  
Before And After ◽  
Personalized Approach ◽  
And Behavior ◽  
The Impact

Abstract Objectives A key to a successful personalized nutrition (PN) strategy is tailoring the behavior intervention to achieve sustained behavior change consistent with desired health outcomes. The objective of this study was to evaluate the impact of a digitally-delivered, systems biology-based PN program (Habit, LLC, Oakland, CA), that included nutrition and behavior advice, and meals. Methods In this single-arm, multi-phase, open-label study (clinicaltrials.gov: NCT03424395), participants (n = 107; 67% female), 30–59 years of age, were provided a Fitbit® Activity Tracker and instructions to complete an at-home kit that included collection of DNA and capillary blood before and after (30 and 120 min) consuming a mixed macronutrient challenge beverage. Lifestyle behavior data and activity levels were collected at baseline. Participants completed a 10-week control phase and a 10-week PN program intervention phase that included tailored nutrition and behavior advice, and meals (2 meals/day, 5 days/week). Validated quality of life, perceived stress, diet self-efficacy, and eating behavior questionnaires were administered to assess behavior before and after the intervention. Data from 73 compliant participants (66% female) were included in the analysis. Anthropometric and biological results were used to categorize participants into subgroups including Protein Seekers (PS) and Range Seekers (RS). Results Participants reported feeling fuller faster after the intervention, relative to before (P = 0.002), which could be linked to the dietary recommendations and behavior advice. Analysis by gender showed men reported more control over their eating patterns during negative events at baseline, compared to women (P = 0.005). This difference was not evident at the end of the intervention with women reporting slightly more, and men slightly less control. PS entered the study with a higher weight and BMI (P < 0.001 for both) and reported eating more quickly than RS (P = 0.003). This difference diminished, and by the end of the intervention PS did not differ from RS which could reflect the tailored advice provided. Conclusions These and other data provide novel insights on how a tailored personalized intervention that targeted food behavior may help drive positive changes in health outcomes. Funding Sources Habit, LLC.

scholarly journals Impact of a structured, group-based running programme on clinical, cognitive and social function in youth and adults with complex mood disorders: a 12-week pilot study

2019 ◽  
Vol 5 (1) ◽  
pp. e000521
Author(s):  
Laura E Keating ◽  
Suzanna Becker ◽  
Katie McCabe ◽  
Jeff Whattam ◽  
Laura Garrick ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mood Disorders ◽  
Exercise Intervention ◽  
Bodily Pain ◽  
Cognitive Outcomes ◽  
Open Label ◽  
Mood Symptoms ◽  
Before And After ◽  
The Impact

BackgroundIndividuals with mood disorders often report lingering health-related quality of life (HRQOL) and social and cognitive impairments even after mood symptoms have improved. Exercise programmes improve mood symptoms in patients, but whether exercise improves functional outcomes in patients with difficult-to-treat mood disorders remains unknown.DesignWe evaluated the impact of a 12-week structured running programme on cognitive, social and quality-of-life outcomes in participants with difficult-to-treat mood disorders.MethodsIn a prospective, open-label study, patients referred to the St Joseph’s Healthcare HamiltonTeam Unbreakablerunning programme for youth and adults with mood disorders completed a comprehensive assessment battery before and after the 12-week exercise intervention.ResultsWe collected preintervention and postintervention data from 18 participants who improved on the general health, vitality, role of emotions, social functioning and mental health (all p≤0.01) HRQOL subscales. Performance improved on cognitive tests that assessed working memory and processing speed (p≤0.04); there were no improvements in complex executive functioning tasks. Regression analyses indicated that younger age, shorter illness duration and reduced bodily pain predicted social and cognitive outcomes.ConclusionParticipation in a group-based, structured running programme was associated with improved HRQOL and social and cognitive function.

scholarly journals UTICAJ KURSEVA IZ ETIKE NA MORALNE INTUICIJE STUDENATA FILOZOFIJE

2021 ◽  
Vol 3 (1) ◽  
pp. 55-65
Author(s):  
Bojan Blagojević
Keyword(s):  
Moral Intuitions ◽  
History Of Ethics ◽  
Before And After ◽  
History Of ◽  
Second Year ◽  
Significant Change ◽  
Students Attitudes ◽  
Ethics Courses ◽  
The Impact

In this paper, we analyze part of the research conducted within the project “The impact of philosophy courses on students’ attitudes” which concerns the impact of History of Ethics courses on the moral intuitions of second-year philosophy students at the Faculty of Philosophy in Nis. Students evaluated the statements given in a specially designed questionnaire on two occasions (before and after listening to the courses). By analyzing possible changes in the answers given by the students, we try to determine whether the courses they have attended in the meantime have led to a significant change in their moral intuitions.

Fifty years of the UK Misuse of Drugs Act 1971: the legislative contexts

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Blaine Stothard
Keyword(s):  
Design Methodology ◽  
Evidence Base ◽  
People Who Use Drugs ◽  
Content Type ◽  
Before And After ◽  
History Of ◽  
The Government ◽  
The Uk ◽  
The Impact ◽  
Practical Implications

Purpose The purpose of this paper is to illustrate the history of relevant legislation before and after the 1971 Misuse of Drugs Act (MDA). Design/methodology/approach A chronological narrative of laws and reports with concluding discussion. Findings That UK legislators have not made use of the evidence base available to them and have favoured enforcement rather than treatment approaches. That current UK practice has exacerbated not contain the use of and harms caused by illegal drugs. Research limitations/implications The paper does not cover all relevant documents, especially those from non-governmental sources. Practical implications The practical implications centre on the failure of consecutive governments to reflect on and review the impact of current legislation, especially on people who use drugs. Social implications That the situations of people who use drugs are currently ignored by the government and those proven responses which save lives and reduce harm are rejected. Originality/value The paper attempts to show the historical contexts of control and dangerousness of which the MDA is one instrument.

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