bluuebunny/crossref_metadata_2025_split huggingface dataset:
PFO closure with only fluoroscopic guidance: 7 years real‐world single centre experience
Authors: Mangieri Antonio , Godino Cosmo , Montorfano Matteo , Arioli Francesco , Rosa Isabella , Ajello Silvia , Piraino Daniela , Monello Alberto , Pavon Anna Giulia , Viani Giacomo , Magni Valeria , Cappelletti Alberto , Margonato Alberto , Colombo Antonio 
Published: November 2014

AimsTo evaluate the safety and the efficacy of fluoroscopy‐guided only (Fluo‐G) and of echocardiography‐guided (Echo‐G; trans‐esophageal echocardiography—TEE—or intracardiac echocardiography‐ICE) percutaneous closure of patent foramen ovale (PFO).Methods and ResultsSingle center retrospective registry enrolling 368 consecutive patients (mean age 50.5 years) who underwent PFO closure between June 2004 and December 2011. Most patients had prior cryptogenic stroke (n = 126; 34.2%), TIA (n = 218; 51.1%); some of these had recurrent neurological events [multiple strokes n = 28 (7.8%); multiple TIAs n = 72 (18.6%)]. All the patients underwent a preprocedure TEE. PFO closure was performed with Echo‐G in 187 patients (50.8%) (TEE n = 69, 36.8% and ICE n = 124, 66.3%). In Fluo‐G cases, PFO with atrial septal aneurysm (ASA) was significantly less present (P < 0.005) and smaller devices (<25 mm) were implanted more frequently (P < 0.001). Both fluoroscopy and total procedural time were lower in the Fluo‐G group (P < 0.0001). No differences were found in terms of successful device deployment (98.3% Fluo‐G vs. 98.3% Echo‐G) and RtL‐shunt at follow‐up (11.7% Fluo‐G vs. 7.6% Echo‐G). The rate of conversion from Fluoro‐G to Echo‐G procedure was 4.4% (n = 8). At a median follow‐up of 4 years, freedom from recurrent embolic events rate was similar between the two groups (Echo‐G 94.5 vs. Fluo‐G 95.7%).ConclusionsIn our experience Fluoro‐G PFO closure was performed mainly in cases of simple anatomy, with similar results in terms of safety and efficacy compared to Echo‐G cases. Both fluoroscopy and total procedural times were lower in the Fluo‐G cases. © 2015 Wiley Periodicals, Inc.
A smoothed finite element method for analysis of anisotropic large deformation of passive rabbit ventricles in diastole
Authors: Jiang Chen , Liu Gui‐Rong , Han Xu , Zhang Zhi‐Qian , Zeng Wei 
Published: November 2014

SummaryThe smoothed FEM (S‐FEM) is firstly extended to explore the behavior of 3D anisotropic large deformation of rabbit ventricles during the passive filling process in diastole. Because of the incompressibility of myocardium, a special method called selective face‐based/node‐based S‐FEM using four‐node tetrahedral elements (FS/NS‐FEM‐TET4) is adopted in order to avoid volumetric locking. To validate the proposed algorithms of FS/NS‐FEM‐TET4, the 3D Lame problem is implemented. The performance contest results show that our FS/NS‐FEM‐TET4 is accurate, volumetric locking‐free and insensitive to mesh distortion than standard linear FEM because of absence of isoparametric mapping. Actually, the efficiency of FS/NS‐FEM‐TET4 is comparable with higher‐order FEM, such as 10‐node tetrahedral elements. The proposed method for Holzapfel myocardium hyperelastic strain energy is also validated by simple shear tests through the comparison outcomes reported in available references. Finally, the FS/NS‐FEM‐TET4 is applied in the example of the passive filling of MRI‐based rabbit ventricles with fiber architecture derived from rule‐based algorithm to demonstrate its efficiency. Hence, we conclude that FS/NS‐FEM‐TET4 is a promising alternative other than FEM in passive cardiac mechanics. Copyright © 2015 John Wiley & Sons, Ltd.
Assays and Strategies for Immunogenicity Assessment of Biological Agents
Authors: Nencini Francesca , Pratesi Sara , Petroni Giulia , Matucci Andrea , Maggi Enrico , Vultaggio Alessandra 
Published: November 2014

Abstract

Enabling Technology, Genomics, Proteomics
Preclinical Development Toxicology, Formulation Drug Delivery, Pharmacokinetics

Some patients with chronic inflammatory diseases either do not respond to or lose their initial responsiveness to Tumor Necrosis Factor (TNF) inhibitor therapy. In these patients, the clinical response after switching to another anti‐TNF drug suggests that lack of response is not related to the therapeutic target itself but immunogenicity. All biologics are potentially immunogenic and can induce the development of antidrug antibodies (ADAs). ADA formation is associated with lower serum drug levels, infusion reactions, and loss of response. Analytical methods for ADA detection include enzyme‐linked immunosorbent assay (ELISA), radioimmunoassay (RIA), surface plasmon resonance, and electrochemiluminescence. Currently, RIA and ELISA are the preferred methods due to a combination of reproducibility, sensitivity, and cost but have some limitations. There is no single available assay that has all pros and no cons, and therefore the use of more methods for the assessment of samples is a high priority.
Pharmacogenetics and Future Therapeutic Scenarios: What Affects the Prediction of Response to Treatment with Etanercept?
Authors: Murdaca Giuseppe , Gulli Rossella , Spanò Francesca , Mandich Paola , Puppo Francesco 
Published: November 2014

Abstract

Enabling Technology, Genomics, Proteomics
Clinical Development Phases I‐III Regulatory, Quality, Manufacturing

There are five tumor necrosis factor alpha (TNF‐α) inhibitors available for clinical use that have demonstrated efficacy as monotherapy or in combination with other anti‐inflammatory or disease‐modifying anti‐rheumatic drugs (DMARDs) in the treatment of immune‐mediated diseases. These include the anti‐TNF‐α monoclonal antibodies infliximab, adalimumab, golimumab, and certolizumab pegol, and the fusion protein, etanercept. The use of pharmacogenetic testing has the potential to increase drug efficiency by identifying genetic factors responsible for a lack of response to, or toxicities from, TNF‐α inhibitors, and could be used to individualize therapy. Several studies have reported associations between genetic polymorphisms and the response to etanercept, but most are small and insufficiently powered to detect effect, and markers tend to be more prognostic than predictive of therapeutic response. Limitations of pharmacogenetic studies include the use of single nucleotide polymorphisms (SNPs), genes in linkage with other loci, interaction of environmental factors, and cohort heterogeneity, all of which can complicate the relationship between genetic polymorphisms and treatment response. Further studies are needed for pharmacogenetics to become a routine part of daily clinical therapeutic practice.
Detection of Adalimumab and Anti‐Adalimumab Levels by ELISA: Clinical Considerations
Authors: Marinari Barbara , Botti Elisabetta , Bavetta Mauro , Spallone Giulia , Zangrilli Arianna , Talamonti Marina , Richetta Antonio , Chimenti Sergio , Costanzo Antonio 
Published: November 2014

Abstract

Enabling Technology, Genomics, Proteomics
Clinical Development Phases I‐III Regulatory, Quality, Manufacturing

Psoriasis (Ps) is a common and stigmatizing chronic inflammatory skin disease that may cause other chronic inflammatory conditions with overlapping pathology, such as rheumatoid arthritis (RA). Tumor necrosis factor (TNF) is a proinflammatory cytokine that plays a pivotal role in chronic inflammatory and autoimmune diseases such as uveitis, multiple sclerosis, systemic lupus, arthritis, Ps, and Crohn's disease. The TNF superfamily and receptors represent active targets for drug development. Anti‐TNF biological therapies, such as infliximab, adalimumab (ADL), and etanercept, are effective in treating RA, spondyloarthritis, Ps, and inflammatory bowel diseases, but long‐term treatment can induce anti‐drug antibody (ADA) formation associated with lower drug levels and clinical nonresponse. An investigation of the relationship between serum ADL/anti‐adalimumab antibody (AAA) concentration, and clinical response in moderate to severe Ps, confirmed an association between ADL and AAA levels and response. Although the detection of ADAs can be used to determine the cause of nonresponse and aid therapy decisions, the contrary observation of long‐term responders with low drug levels and detectable ADA suggests that another mechanism is also involved.
Killer‐Cell Immunoglobulin‐Like Receptors (KIR) and HLA‐Class I Heavy Chains in Ankylosing Spondylitis
Authors: Cauli Alberto , Piga Matteo , Dessole Grazia , Porru Giovanni , Floris Alberto , Vacca Alessandra , Desogus Elisabetta , La Nasa Giorgio , Mathieu Alessandro 
Published: November 2014

Abstract

Postmarketing Phase IV

HLA‐B27 (B27) interactions with the killer‐cell immunoglobulin‐like receptors (KIR) have been implicated in the pathogenesis of ankylosing spondylitis (AS), with consistent differences among populations. KIR3DL1 and possibly KIR3DS1 interact with classical B27, whereas KIR3DL2 binds B27 heavy chain dimers. The aim of this review is to summarize data from recent studies performed in our laboratory and from the literature, which provide support for a possible role of KIR3DL2/B27 dimer interactions in the pathogenesis of AS. Recent studies in cells from AS patients and from health controls carrying the predisposing B*2705 and the nonpredisposing B*2709 haplotypes, have shown a higher percentage of positive cells and a higher surface expression of KIR3DL2 receptors on natural killer (NK) and CD4+ T cells in B*2705 AS patients compared with B*2705, B*2709 and B27‐negative healthy controls. Increased expression of HC10‐reactive molecules on AS monocytes was seen, supporting the possible role of the KIR3DL2/B272 pair in the pathogenesis of AS. These results underline the importance of NK cells and innate immunity, and of CD4+ T cells in the inflammatory pathogenesis of AS.
Thalassemic Trait Prevalence in Patients Affected by Psoriatic Arthritis in Anti‐TNF Treatment
Authors: Atteno Mariangela , Costa Luisa , Vitiello Maria , Caso Francesco , Sarnelli Giovanni , Del Puente Antonio , Scarpa Raffaele 
Published: November 2014

Abstract

Clinical Development Phases I‐III Regulatory, Quality, Manufacturing
Postmarketing Phase IV

Thalassemic trait (Thal) is associated with rheumatic disease, particularly a mild form of seronegative polyarthritis resembling rheumatoid arthritis (RA), but not with other rheumatic diseases. The aim of this study was to estimate the frequency of Thal in patients with psoriatic arthritis (PsA) and to evaluate the efficacy of anti‐tumor necrosis factor alpha (TNF‐α) therapy in patients with PsA and Thal. We performed a retrospective study in 321 patients with PsA who started therapy with TNF‐α blockers. For all patients included in the study, at baseline and every 3 months for the 1 year of follow up, data concerning PsA activity and ferritin levels were registered. In our group of PsA patients, a total of 27 (8%) with concomitant Thal were identified and included in the study. In patients without Thal, all variables improved significantly after 6 months of therapy, while in patients with Thal, the same variables showed a significant decrease after 12 months.: Our study shows that PsA is significantly associated with Thal, but further studies are needed to address this issue. The presence of Thal could be a negative predictor of achieving remission during treatment with TNF‐α‐blockers.
Treatment Adherence to Different Etanercept Regimens, Continuous vs. Intermittent, in Patients Affected by Plaque‐Type Psoriasis
Authors: Esposito Maria , Gisondi Paolo , Cassano Nicoletta , Babino Graziella , Cannizzaro Maria Vittoria , Ferrucci Giuliano , Chimenti Sergio , Giunta Alessandro 
Published: November 2014

Abstract

Postmarketing Phase IV

Treatment adherence to anti‐tumor necrosis factor alpha (anti‐TNF‐α) agents is marker of treatment success, but overall efficacy of anti‐TNF‐α therapy decreases over time leading to a progressive loss of adherence. The present observational study was conducted in order to estimate the long‐term adherence to etanercept in patients affected by plaque‐type psoriasis, evaluating differences among intermittent and continuous treatment regimen. Our findings reflect routine clinical practice in three academic referral centers and show high treatment adherence with etanercept in psoriatic patients. Treatment survival was consistently high in the short/medium term. The univariate analysis showed longer treatment duration in patients undergoing intermittent treatment regimen (mean 1,706 days) compared with continuous regimen (mean 1,249 days). Results showed that a flexible pulsed treatment with etanercept can be optimal in terms of clinical success and adherence.
Monoclonal Gammopathy of Undetermined Significance in Patients with Psoriasis: Is it Really a Side Effect of Biological Therapy?
Authors: Conti Andrea , Esposito Ilaria , Lasagni Claudia , Miglietta Roberta , Padalino Claudia , Fabiano Antonella , Pellacani Giovanni 
Published: November 2014

Abstract

Postmarketing Phase IV

Moderate‐to‐severe psoriasis is treated using biological drugs targeting cytokines involved in the pathogenesis of the disease, such as tumor necrosis factor alpha (TNF‐α) (adalimumab, infliximab, etanercept) and interleukin 12/23 (IL 12/23) (ustekinumab). There is a slight risk of developing hematological malignancies, such as monoclonal gammopathy of undetermined significance (MGUS) with anti TNF‐α agents. There are no data available on anti‐IL12/23 drugs. This retrospective study of data from 191 patients describes the appearance and follow‐up of MGUS in three patients with psoriasis receiving long‐term biological therapy. Since the appearance of MGUS occurred after about 6 years of anti‐TNFα treatment in only three subjects, it was deemed unlikely to be due to the biological treatment. The decision not to suspend biological therapy after the appearance of MGUS was taken after careful assessment of the possible risks and benefits.
Use of Anti‐Tumor Necrosis Factor Alpha Therapy in Patients with Concurrent Rheumatoid Arthritis and Hepatitis B or Hepatitis C: A Retrospective Analysis of 32 Patients
Authors: Ballanti Eleonora , Conigliaro Paola , Chimenti Maria Sole , Kroegler Barbara , Di Muzio Gioia , Guarino Maria Domenica , Triggianese Paola , Gigliucci Gianfranco , Novelli Lucia , Barbato Carmen , Perricone Roberto 
Published: November 2014

Abstract

Postmarketing Phase IV

The safety of tumor necrosis factor‐alpha (TNF‐α) inhibitors in the setting of hepatitis B virus (HBV) and hepatitis C virus (HCV) infections is controversial. The use of anti‐TNF‐α in rheumatoid arthritis (RA) is associated with an increased risk of hepatitis re‐activation. This paper reports experience of using etanercept and adalimumab in 32 patients with RA and previous HBV or HCV infection. No cases of HBV or HCV reactivation were seen. In just over a fifth of patients, increased transaminases levels were seen, which were associated with concomitant use of disease‐modifying antirheumatic drugs, isoniazid prophylaxis, or alcohol abuse. In our experience, anti‐TNF‐α therapy appears to be safe in RA patients with previous HBV or HCV infection, but monitoring remains necessary in these patients.
Periodontal Disease: An Oral Manifestation of Psoriasis or an Occasional Finding?
Authors: Ganzetti Giulia , Campanati Anna , Santarelli Andrea , Pozzi Valentina , Molinelli Elisa , Minnetti Ilaria , Brisigotti Valerio , Procaccini Maurizio , Emanuelli Monica , Offidani Annamaria 
Published: November 2014

AbstractPostmarketing Phase IVEven if the existence of oral psoriasis has been suggested, it is still a debated issue. Indeed, oral inflammatory diseases may histologically resemble psoriasis‐related oral lesions. However, an increased prevalence of fissured tongue and geographic tongue has been associated with psoriatic patients, being a transitory and permanent lesion, respectively. Recently, it was hypothesized that gingivitis and periodontitis share the same underlying inflammatory pathogenetic process of psoriasis. Thus, in the present study, psoriatic patients were investigated for oral mucosa lesions prevalence as well as gum disease. Results displayed an increased association between gingivitis/periodontitis and psoriasis, which may suggest common underlying pathogenic risk factors. However, large‐scale studies are needed to evaluate the real prevalence of gingivitis and periodontitis in these patients, to consider them a comorbidity of psoriasis.
The Use of an Interferon‐Gamma Release Assay as a Biomarker of Response to Anti‐TNF‐Alpha Treatment
Authors: Cacciapaglia Fabio , Buzzulini Francesca , Arcarese Luisa , Ferraro Elisabetta , Afeltra Antonella 
Published: November 2014

Abstract

Postmarketing Phase IV

Tumor necrosis factor alpha (TNF‐α) is a pleiotropic cytokine that plays a central role in the immune system functioning and in the pathogenesis of rheumatoid arthritis (RA). TNF‐α inhibition has been demonstrated effective to treat RA; however, response to anti‐TNF‐α therapies is heterogeneous, with roughly one‐third of patients not achieving disease control. Identification of a biological marker to assess the effectiveness of TNF‐α inhibition may help to discriminate patients with a reduced response to anti‐TNF‐α agents. The aim of this study was to assess whether anti‐TNF‐α treatment was able to modify the cytokine network interfering with interferon gamma (INFγ) release after phytohemagglutinin (PHA) stimulation of peripheral blood mononuclear cells (PBMCs) from RA patients, according to disease activity. We found that RA patients with active disease had low release of INFγ after PHA stimulation, but anti‐TNF‐α agents were able to modify INFγ production. In anti‐TNF‐α responders, we observed a higher release of INFγ, achieving levels comparable with those seen in healthy subjects. The ability of PBMCs from RA patients to release INFγ may serve as a biomarker of disease activity and response to anti‐TNF‐α. Larger studies are needed to validate these data.
Insights on the Role of Physical Activity in Patients with Rheumatoid Arthritis
Authors: Conigliaro Paola , Triggianese Paola , Ippolito Francesco , Lucchetti Ramona , Chimenti Maria Sole , Perricone Roberto 
Published: November 2014

Abstract

Postmarketing Phase IV

Patients with rheumatoid arthritis (RA) are physically inactive, and trials have been undertaken to examine the effect of physical activity on pain, disease activity, functional ability and quality of life (QoL) in RA. The aim of this study was to explore the relationship between physical activity and disease‐activity in RA and in healthy controls. Our findings showed that fewer RA patients had a professional occupation compared with controls, but patients and controls were similar with respect to the sedentary extent of their job. Physical exercise was inversely associated with disease activity (DAS‐28), stiffness visual analog scale (VAS), patient global VAS and SF‐36, but not associated with Health Assessment Questionnaire (HAQ), pain VAS, fatigue VAS, global health and the Arthritis Ipact Measurement Scale (AIMS), suggesting that pain and fatigue are important barriers to physical activity. Our findings suggest that this is more pronounced in RA patients who do not participate in regular physical activity, and so physical exercise should be recommended as part of comprehensive RA care.
Self‐Reported Adherence to a Home‐Based Exercise Program Among Patients Affected by Psoriatic Arthritis with Minimal Disease Activity
Authors: Chimenti Maria Sole , Triggianese Paola , Conigliaro Paola , Santoro Matteo , Lucchetti Ramona , Perricone Roberto 
Published: November 2014

Abstract

Postmarketing Phase IV

More than half of all patients with psoriatic arthritis (PsA) exhibit progressive erosive arthritis, associated with severe functional impairment and psychosocial disability. Biologics have been suggested to be more effective in inducing minimal disease activity” (MDA) than disease‐modifying antirheumatic drugs (DMARDs). Behavioral patient education appears to be more effective in encouraging patients to increase their physical activity (PA) levels. The aim of the study was to evaluate the benefits of home‐based exercises program on disease activity and quality of life in MDA‐PsA patients treated with an anti‐tumor necrosis factor (TNF) and DMARD therapy. We observed a self‐reported adherence rate to home‐based exercise of 76.6% and data showed the impact of the exercise program on self‐reported health and mental assessment. A positive relationship between patient and therapist is crucial, influencing the quality of the performance, the emotional support, and increasing motivation in PsA patients.
Emergence of Antinuclear Antibodies in Psoriatic Patients Treated with Infliximab: Personal Experience and Literature Review
Authors: Chimenti Maria Sole , Spinelli Francesca Romana , Giunta Alessandro , Martinelli Francesco , Saraceno Rosita , Conti Fabrizio , Perricone Roberto , Valesini Guido 
Published: November 2014

Abstract

Postmarketing Phase IV

Psoriasis is a chronic inflammatory skin disease affecting up to 2.5% of the population, with joint involvement in approximately 30% of patients. Given the role of tumor necrosis factor (TNF) in the pathogenesis of psoriasis, anti‐TNF therapies have been developed; several studies have demonstrated the efficacy of infliximab (IFX) as induction and maintenance therapy in the treatment of moderate to severe plaque psoriasis. The development of antinuclear antibodies (ANA) in anti‐TNF‐treated patients has been frequently reported. The aim of this study was to investigate the incidence of ANA and anti‐double stranded DNA (anti‐dsDNA) antibodies in psoriatic patients receiving IFX. Incidence of new ANA and anti‐ds‐DNA was 16.2% and 8.1% respectively. No case of anti‐TNF induced Lupus was observed during the follow‐up.
A Possible Role of Polycystic Ovary Syndrome for Pregnancy Complications in Women with Psoriasis
Authors: De Simone Clara , Caldarola Giacomo , Corbeddu Marialuisa , Moro Francesca , Tropea Anna , Moretta Gaia , Apa Rosanna 
Published: November 2014

Abstract

Postmarketing Phase IV

Psoriasis is a common, chronic, relapsing immune‐mediated inflammatory disease (IMID) of the skin. IMIDs are multifactorial diseases characterized by common molecular pathways leading to a systemic inflammation. Patients with an IMID are also at higher risk of developing co‐morbidities, such as adverse pregnancy outcomes, than the general population. A higher rate of pregnancy complications have been seen in inflammatory bowel disease and rheumatoid arthritis. The data for psoriasis are inconsistent but it appears that women with moderate‐to‐severe psoriasis may also have an increased risk of poor pregnancy outcomes. The cause of this association is unknown, although it may be related to elevated proinflammatory cytokines such as IL‐6 and TNF‐α, the high prevalence of comorbidities and other unhealthy behaviours, or the high prevalence of polycystic ovary syndrome (PCOS). In a recent study, PCOS prevalence in a psoriatic cohort (n = 51) was higher than in non‐psoriatic women (n = 102) (47% versus 11%), and women with PCOS and psoriasis had a greater probability of insulin resistance, hyperinsulinaemia, and dyslipidaemia as well as a more severe skin condition, than those with psoriasis alone. Further studies are necessary to clarify the impact of psoriasis on pregnancy and in particular if these effects are mediated by concomitant PCOS.