PubMed | Hospital Universitario La Paz, University of Newcastle, Francicus Ziekenhuis, Brain and Mind Research Institute and 27 more.
Type: Journal Article | Journal: PloS one | Year: 2015
Multiple Sclerosis is more common in women than men and females have more relapses than men. In a large international cohort we have evaluated the effect of gender on disability accumulation and disease progression to determine if male MS patients have a worse clinical outcome than females.Using the MSBase Registry, data from 15,826 MS patients from 25 countries was analysed. Changes in the severity of MS (EDSS) were compared between sexes using a repeated measures analysis in generalised linear mixed models. Kaplan-Meier analysis was used to test for sex difference in the time to reach EDSS milestones 3 and 6 and the secondary progressive MS.In relapse onset MS patients (n = 14,453), males progressed significantly faster in their EDSS than females (0.133 vs 0.112 per year, P<0.001,). Females had a reduced risk of secondary progressive MS (HR (95% CI) = 0.77 (0.67 to 0.90) P = 0.001). In primary progressive MS (n = 1,373), there was a significant increase in EDSS over time in males and females (P<0.001) but there was no significant sex effect on the annualized rate of EDSS change.Among registrants of MSBase, male relapse-onset patients accumulate disability faster than female patients. In contrast, the rate of disability accumulation between male and female patients with primary progressive MS is similar.
PubMed | Ospedali Riuniti, AORN San Giuseppe Moscati, Ospedale Caldarelli, Azienda Ospedaliera San Camillo Forlanini and 9 more.
Type: Journal Article | Journal: International journal of immunopathology and pharmacology | Year: 2014
We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68%; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93%; the proportion of patients free from combined clinical activity was 65%; the proportion of patients free from MRI activity was 77%; and the proportion of patients free from any disease activity was 53%. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time.
PubMed | Hospital Italiano, Hunter Medical Research Institute, C Mondino National Neurological Institute, Liverpool Hospital and 26 more.
Type: | Journal: Journal of neurology, neurosurgery, and psychiatry | Year: 2016
To evaluate variability and predictability of disability trajectories in moderately advanced and advanced multiple sclerosis (MS), and their modifiability with immunomodulatory therapy.The epochs between Expanded Disability Status Scale (EDSS) steps 3-6, 4-6 and 6-6.5 were analysed. Patients with relapse-onset MS and having reached 6-month confirmed baseline EDSS step (3/4/6) were identified in MSBase, a global observational MS cohort study. We used multivariable survival models to examine the impact of disease-modifying therapy, clinical and demographic factors on progression to the outcome EDSS step (6/6.5). Sensitivity analyses with varying outcome definitions and inclusion criteria were conducted.For the EDSS 3-6, 4-6 and 6-6.5 epochs, 1560, 1504 and 1231 patients were identified, respectively. Disability trajectories showed large coefficients of variance prebaseline (0.92-1.11) and postbaseline (2.15-2.50), with no significant correlations. The probability of reaching the outcome step was not associated with prebaseline variables, but was increased by higher relapse rates during each epoch (HRs 1.58-3.07; p<0.001). A greater proportion of each epoch treated with higher efficacy therapies was associated with lower risk of reaching the outcome disability step (HRs 0.72-0.91 per 25%; p0.02). 3 sensitivity analyses confirmed these results.Disease progression during moderately advanced and advanced MS is highly variable and amnesic to prior disease activity. Lower relapse rates and greater time on higher efficacy immunomodulatory therapy after reaching EDSS steps 3, 4 and 6 are associated with a decreased risk of accumulating further disability. Highly effective immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced relapse-onset MS.
Kalincik T.,Royal Melbourne Hospital |
Kalincik T.,University of Melbourne |
Buzzard K.,Royal Melbourne Hospital |
Jokubaitis V.,University of Melbourne |
And 17 more authors.
Multiple Sclerosis Journal | Year: 2014
Objectives: The aim was to analyse risk of relapse phenotype recurrence in multiple sclerosis and to characterise the effect of demographic and clinical features on this phenotype. Methods: Information about relapses was collected using MSBase, an international observational registry. Associations between relapse phenotypes and history of similar relapses or patient characteristics were tested with multivariable logistic regression models. Tendency of relapse phenotypes to recur sequentially was assessed with principal component analysis. Results: Among 14,969 eligible patients (89,949 patient-years), 49,279 phenotypically characterised relapses were recorded. Visual and brainstem relapses occurred more frequently in early disease and in younger patients. Sensory relapses were more frequent in early or non-progressive disease. Pyramidal, sphincter and cerebellar relapses were more common in older patients and in progressive disease. Women presented more often with sensory or visual symptoms. Men were more prone to pyramidal, brainstem and cerebellar relapses. Importantly, relapse phenotype was predicted by the phenotypes of previous relapses. (OR = 1.8-5, p = 10-14). Sensory, visual and brainstem relapses showed better recovery than other relapse phenotypes. Relapse severity increased and the ability to recover decreased with age or more advanced disease. Conclusion: Relapse phenotype was associated with demographic and clinical characteristics, with phenotypic recurrence significantly more common than expected by chance. © The Author(s) 2014.
Jokubaitis V.G.,University of Melbourne |
Jokubaitis V.G.,Royal Melbourne Hospital |
Li V.,Royal Melbourne Hospital |
Kalincik T.,University of Melbourne |
And 24 more authors.
Neurology | Year: 2014
Objective: To determine early risk of relapse after switch from natalizumab to fingolimod; to compare the switch experience to that in patients switching from interferon-β/glatiramer acetate (IFN-β/GA) and those previously treatment naive; and to determine predictors of time to first relapse on fingolimod. Methods: Data were obtained from the MSBase Registry. Relapse rates (RRs) for each patient group were compared using adjusted negative binomial regression. Survival analyses coupled with adjusted Cox regression were used to model predictors of time to first relapse on fingolimod. Results: A total of 536 patients (natalizumab-fingolimod [n 5 89]; IFN-β/GA-fingolimod [n 5 350]; naive-fingolimod [n 5 97]) were followed up for a median 10 months. In the natalizumab-fingolimod group, there was a small increase in RR on fingolimod (annualized RR [ARR] 0.38) relative to natalizumab (ARR 0.26; p 5 0.002). RRs were generally low across all patient groups in the first 9 months on fingolimod (RR 0.001-0.13). However, 30% of patients with disease activity on natalizumab relapsed within the first 6 months on fingolimod. Independent predictors of time to first relapse on fingolimod were the number of relapses in the prior 6 months (hazard ratio [HR] 1.59 per relapse; p 5 0.002) and a gap in treatment of 2-4 months compared to no gap (HR 2.10; p 5 0.041). Conclusions: RRs after switch to fingolimod were lowin all patient groups. The strongest predictor of relapse on fingolimod was prior relapse activity. Based on our data, we recommend a maximum 2-month treatment gap for switches to fingolimod to decrease the hazard of relapse. Classification of evidence: This study provides Class IV evidence that RRs are not higher in patients with multiple sclerosis switching to fingolimod from natalizumab compared to those patients switching to fingolimod from other therapies. © 2014 American Academy of Neurology.
Vargas N.,Aorn San Giuseppe Moscati Hospital |
Vargas M.,University of Naples Federico II |
Galluccio V.,AORN San Giuseppe Moscati' |
Carifi S.,Aorn San Giuseppe Moscati Hospital |
And 5 more authors.
Aging Clinical and Experimental Research | Year: 2014
Introduction: A leading role for non-invasive ventilation (NIV), as comfort treatment or palliative care, is actually recognized for very old patients suffering from ARF. NIV was frequently used in both ICU and respiratory ICU (RICUs) for very old patients and it is associated with a reduced rate of endotracheal intubations and mortality. This study aims to evaluate the effects of NIV, performed in a setting of half-open geriatric ward with family support, in a cohort of very old patients with ARF and DNI decision.Methods: A consecutive cohort of 20 very old patients with DNI decision was admitted in our 26-bed geriatric ward during a 6 months’ period. DNI decision was obtained in emergency room with an intensive care physician supported by a psychologist. Pressure support ventilation was the first choice of NIV. NIV has been performed by three adequately trained geriatricians, with one of them experienced in ICU, and in close collaboration with intensive care physicians. Arterial blood gases, to assess the response to ventilation, were obtained after 1, 6 and 12 h. NIV settings were modified according to arterial blood gas analyses or respiratory fatigue, if needed.Results: Therefore, 75 % of patients were discharged home and 12 out of 20 patients had home respiratory support. PaO2/FiO2 ratio and pH increased while PaCO2 decreased during the 12 h of NIV with statistical significance. At the admission, alive patients had PaCO2 significantly lower than dead patients. After 12 h, alive patients had a better pH than dead patients. Dead patients experienced more complication than survivors.Conclusion: Very old DNI patients with ARF could be treated with NIV in half-open geriatric ward with trained physicians and nurses. The presence of family members may improve patients’ comfort and reduce anxiety level even at the end of life. Further studies are needed to address the effective role of NIV in very old patients with DNI decisions. © Springer International Publishing Switzerland 2014.
PubMed | Neuro Rive Sud, AORN San Giuseppe Moscati, Orbis Medical Center, University of Bari and 12 more.
Type: Journal Article | Journal: Multiple sclerosis (Houndmills, Basingstoke, England) | Year: 2014
The aim was to analyse risk of relapse phenotype recurrence in multiple sclerosis and to characterise the effect of demographic and clinical features on this phenotype.Information about relapses was collected using MSBase, an international observational registry. Associations between relapse phenotypes and history of similar relapses or patient characteristics were tested with multivariable logistic regression models. Tendency of relapse phenotypes to recur sequentially was assessed with principal component analysis.Among 14,969 eligible patients (89,949 patient-years), 49,279 phenotypically characterised relapses were recorded. Visual and brainstem relapses occurred more frequently in early disease and in younger patients. Sensory relapses were more frequent in early or non-progressive disease. Pyramidal, sphincter and cerebellar relapses were more common in older patients and in progressive disease. Women presented more often with sensory or visual symptoms. Men were more prone to pyramidal, brainstem and cerebellar relapses. Importantly, relapse phenotype was predicted by the phenotypes of previous relapses. (OR = 1.8-5, p = 10(-14)). Sensory, visual and brainstem relapses showed better recovery than other relapse phenotypes. Relapse severity increased and the ability to recover decreased with age or more advanced disease.Relapse phenotype was associated with demographic and clinical characteristics, with phenotypic recurrence significantly more common than expected by chance.
PubMed | EORTC Headquarters, Data Center, CHU Sart Tilman, Lyon University Hospital Center and 13 more.
Type: Journal Article | Journal: Bone marrow transplantation | Year: 2015
The faster hematopoietic recovery after autologous peripheral blood SCT (APBSCT) in patients with AML may be offset by an increased relapse risk as compared with autologous BMT (ABMT). The EORTC and GIMEMA Leukemia Groups conducted a trial (AML-10) in which they compared, as second randomization, APBSCT and ABMT in first CR patients without an HLA compatible donor. A total of 292 patients were randomized. The 5-year DFS rate was 41% in the APBSCT arm and 46% in the ABMT arm with a hazard ratio (HR) of 1.17; 95% confidence interval=0.85-1.59; P=0.34. The 5-year cumulative relapse incidence was 56% vs 49% (P=0.26), and the 5-year OS 50% and 55% (P=0.6) in the APBSCT and ABMT groups, respectively. APBSCT was associated with significantly faster recovery of neutrophils and platelets, shorter duration of hospitalization, reduced need of transfusion packed RBC and less days of intravenous antibiotics. In both treatment groups, higher numbers of mobilized CD34+ cells were associated with a significantly higher relapse risk irrespective of the treatment given after the mobilization. Randomization between APBSCT and ABMT did not result in significantly different outcomes in terms of DFS, OS and relapse incidence.
Gridelli C.,A.O.R.N. San Giuseppe Moscati
Journal of cancer research and clinical oncology | Year: 2014
LIFE (non-small cell Lung cancer management In patients progressing after First-linE of treatment in the metastatic setting) is a multicentre Italian observational study, including a cross-sectional and a longitudinal phase, with the aim of describing the therapeutic approach in clinical practice for advanced non-small cell lung cancer (NSCLC) patients, progressing after first-line treatment. In this paper, the cross-sectional phase is outlined, with the primary endpoint of describing the proportion of patients receiving second-line treatment among those progressed during or after first-line treatment according to clinical practice. From July 2011 to January 2012, 603 patients were enrolled and 541 (90 %) were evaluable. A total of 464 (86 %) patients received a second-line therapy outside clinical trials. Chemotherapy and targeted therapies were administered to 65 and 34 % of patients, respectively (1 % both). No tissue collection was required within the observational trial, and biomarkers analysis was performed at diagnosis or later in 314 patients (58 %). In details, activating epidermal growth factor receptor mutations were detected in 21 % of 311 evaluable patients, Kirsten rat sarcoma 2 viral oncogene homolog mutation in 22 % of the 77 evaluable patients and anaplastic lymphoma kinase translocations analysis was performed in 74 patients and resulted positive in 23 % of cases. These high proportions were probably due to enriched patient population tested. These results showed a pattern of care for NSCLC second-line therapy which reflects international guidelines recommendations and current expected clinical practice. Interestingly, biomarkers analyses were performed in a higher percentage than expected.
Masiello A.,A.O.R.N. San Giuseppe Moscati |
Pacifico P.,A.O.R.N. San Giuseppe Moscati |
Giglio S.,A.O.R.N. San Giuseppe Moscati |
Maio P.,A.O.R.N. San Giuseppe Moscati |
And 3 more authors.
Infezioni in Medicina | Year: 2012
In developing countries, tuberculosis (TBC) is commonly associated with inadequate socio-economic and sanitary conditions. Currently, in Western countries, TBC is often linked with HIV infection, an ageing population or trans-global migration. Approximately two out of ten TB cases worldwide are extra-pulmonary, of which abdominal tuberculosis accounts for 11%-16%. The Mycobacterium tuberculosis complex involves the abdomen as primary or secondary localization (hematogenous spread or from pulmonary foci or infected neighbouring organs). Abdominal TBC can infect the gastrointestinal tract, peritoneum, mesentery, abdominal lymph nodes, liver, spleen, and pancreas. Diagnosis of abdominal tuberculosis is difficult because of vague and non-specific clinical features and due to the differential diagnosis with other granulomatous diseases such as Crohn's Disease. It is of great importance for clinicians to pay great attention to tubercular aetiology as a possible cause of gastrointestinal symptoms. Here we describe the clinical case of a young immigrant patient with intestinal TB for whom the wrong initial diagnosis led to a delay in the correct diagnosis and a worsening of the already serious general conditions.