Efficacy and Drug Survival after Switching from Etanercept to the Biosimilar SB4: A Real-Life Long-Term Study.

We evaluated the 3-year drug survival and efficacy of the biosimilar SB4/Benepali in rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) patients, previously treated with etanercept (ETA). Drug survival rate was calculated using the Kaplan-Meier method and Cox proportional hazard models were developed to examine predictors of SB4 discontinuation. 236 patients (120 RA, 80 PsA and 36 AS), aged 60.

Intensive Postural and Motor Activity Program Reduces Scoliosis Progression in People with Rett Syndrome.

Background: A scoliosis prevalence of 94% was reported in the population with Rett syndrome (RTT), with an annual progression rate of 14 to 21° Cobb which may result in pain, loss of sitting balance, deterioration of motor skills, and lung disfunction. This paper describes the efficacy of an intensive conservative individualized physical and postural activity program in preventing scoliosis curvature progression in patients with RTT.

Methods: Twenty subjects diagnosed with RTT and scoliosis were recruited, and an individualized intensive daily physical activity program was developed for each participant.

Treatment with Idelalisib in Patients with Relapsed or Refractory Follicular Lymphoma: The Observational Italian Multicenter FolIdela Study.

Follicular lymphoma (FL) is an indolent hematological disease, often responsive to the first line of treatment, but characterized by repeated relapses. The therapeutic algorithm for relapsed/refractory FL patients comprises phosphatidylinositol 3-kinase inhibitors. Idelalisib showed anticancer activity, while inducing a significant rate of toxicities.

Echocardiographically defined haemodynamic categorization predicts prognosis in ambulatory heart failure patients treated with sacubitril/valsartan.

Aim: Echo-derived haemodynamic classification, based on forward-flow and left ventricular (LV) filling pressure (LVFP) correlates, has been proposed to phenotype patients with heart failure and reduced ejection fraction (HFrEF). To assess the prognostic relevance of baseline echocardiographically defined haemodynamic profile in ambulatory HFrEF patients before starting sacubitril/valsartan.

Methods And Results: In our multicentre, open-label study, HFrEF outpatients were classified into 4 groups according to the combination of forward flow (cardiac index; CI:< or ≥2.

Preventing heart failure: a position paper of the Heart Failure Association in collaboration with the European Association of Preventive Cardiology.

The heart failure epidemic is growing and its prevention, in order to reduce associated hospital readmission rates and its clinical and economic burden, is a key issue in modern cardiovascular medicine. The present position paper aims to provide practical evidence-based information to support the implementation of effective preventive measures. After reviewing the most common risk factors, an overview of the population attributable risks in different continents is presented, to identify potentially effective opportunities for prevention and to inform preventive strategies.

Preventing heart failure: a position paper of the Heart Failure Association in collaboration with the European Association of Preventive Cardiology.

The heart failure epidemic is growing and its prevention, in order to reduce associated hospital readmission rates and its clinical and economic burden, is a key issue in modern cardiovascular medicine. The present consensus document aims to provide practical evidence-based information to support the implementation of effective preventive measures. After reviewing the most common risk factors, an overview of the population attributable risks in different continents is presented, to identify potentially effective opportunities for prevention and to inform preventive strategies.

Cochlear Implant in Patients with Intralabyrinthine Schwannoma without Tumor Removal.

(1) Background: Schwannomas of the vestibulocochlear nerve are benign, slow-growing tumors, arising from the Schwann cells. When they originate from neural elements within the vestibule or cochlea, they are defined as intralabyrinthine schwannomas (ILSs). Cochlear implant (CI) has been reported as a feasible solution for hearing restoration in these patients.

Interdisciplinary Approaches to the Study of Listening Effort in Young Children with Cochlear Implants.

Very early bilateral implantation is thought to significantly reduce the attentional effort required to acquire spoken language, and consequently offer a profound improvement in quality of life. Despite the early intervention, however, auditory and communicative outcomes in children with cochlear implants remain poorer than in hearing children. The distorted auditory input via the cochlear implants requires more auditory attention resulting in increased listening effort and fatigue.

Coexistence of homologous-type carcinosarcoma of the cervix with undifferentiated carcinoma of the endometrium: A case report with Immunohistochemical analysis and literature review.

We report a case of undifferentiated carcinoma of the endometrium associated with malignant mixed Müllerian tumour of the uterine cervix. Immunohistochemical analysis with multiple markers was performed to demonstrate the coexistence of highly two aggressive components in the same uterus. Clinical data were collected and followed up, and a careful literature review was performed to establish the occurence of these components in a uterine malignancy.

Melflufen or pomalidomide plus dexamethasone for patients with multiple myeloma refractory to lenalidomide (OCEAN): a randomised, head-to-head, open-label, phase 3 study.

Background: Melphalan flufenamide (melflufen), an alkylating peptide-drug conjugate, plus dexamethasone showed clinical activity and manageable safety in the phase 2 HORIZON study. We aimed to determine whether melflufen plus dexamethasone would provide a progression-free survival benefit compared with pomalidomide plus dexamethasone in patients with previously treated multiple myeloma.

Methods: In this randomised, open-label, head-to-head, phase 3 study (OCEAN), adult patients (aged ≥18 years) were recruited from 108 university hospitals, specialist hospitals, and community-based centres in 21 countries across Europe, North America, and Asia.

A comparative study on the incidence of type 1 diabetes mellitus between children of North African migrants and Italian children in Emilia-Romagna region, Italy.

Unlabelled: In the last few decades, many studies have reported an increasing global incidence of type 1 diabetes. Studies on migrant populations have underlined the importance of both environmental and genetic factors.

Aims: Evaluate the incidence of type 1 diabetes in North African vs Italian children aged 0-14 years from 1 January 2015, to 31st December 2018, in Emilia-Romagna region, Italy.

Listening comprehension in profoundly deaf children with cochlear implants: the role of auditory perception and foundational linguistic and cognitive skills.

Purpose: The aim of the study was to investigate the listening comprehension (LC) skills in deaf and hard of hearing children (DHH) using cochlear implants (CI). Besides, personal and audiological variables that could influence the levels of competence reached were analyzed.

Methods: Thirty-four children using CI were enrolled.

Quantified mitral regurgitation and left atrial function in heart failure with reduced ejection fraction: interplay and outcome implications.

Aims: The clinical and prognostic importance of functional mitral regurgitation (FMR) in heart failure patients with reduced ejection fraction (HFrEF) has been highly debated. This study aims to define FMR linkage to cardiovascular (CV) outcomes and the interplay with left atrial (LA) function in a prospective cohort of consecutive HFrEF outpatients.

Methods And Results: Overall, 286 consecutive outpatients with chronic HFrEF were prospectively enrolled.

A Clinical Prognostic Model Based on Machine Learning from the Fondazione Italiana Linfomi (FIL) MCL0208 Phase III Trial.

Background: Multicenter clinical trials are producing growing amounts of clinical data. Machine Learning (ML) might facilitate the discovery of novel tools for prognostication and disease-stratification. Taking advantage of a systematic collection of multiple variables, we developed a model derived from data collected on 300 patients with mantle cell lymphoma (MCL) from the Fondazione Italiana Linfomi-MCL0208 phase III trial (NCT02354313).

Benefit from sacubitril/valsartan is associated with hemodynamic improvement in heart failure with reduced ejection fraction: An echocardiographic study.

Background: Sacubitril/valsartan improves outcome in patients with heart failure (HF) with reduced left ventricular (LV) ejection fraction (EF, HFrEF). However, little is known about possible mechanisms underlying this favourable effect.

Purpose: To assess changes in echocardiographically-derived hemodynamic profiles induced by sacubitril/valsartan and their impact on outcome.

EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis.

Background And Aims: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP.

Methods: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success.

Predictors of the multiwire technique use in carotid artery stenting.

Objectives: The multiwire technique (MWT) in carotid artery stenting (CAS), characterized by the use of more than one guidewire to support guiding catheter in patients with hostile neck anatomy, increases procedural time, enhancing the risk of periprocedural stroke. The aim of the present study was to identify which factors are predictors of the MWT use in CAS, in order to stratify patients with longer procedure at potential higher risk of periprocedural stroke.

Methods: The study retrospectively included patients who underwent CAS for stenotic plaque between January 2015 and December 2019.

Analysis of the humoral and cellular immune response after a full course of BNT162b2 anti-SARS-CoV-2 vaccine in cancer patients treated with PD-1/PD-L1 inhibitors with or without chemotherapy: an update after 6 months of follow-up.

Background: The durability of immunogenicity of SARS-CoV-2 vaccination in cancer patients remains to be elucidated. We prospectively evaluated the immunogenicity of the vaccine in triggering both the humoral and the cell-mediated immune response in cancer patients treated with anti-programmed cell death protein 1/programmed death-ligand 1 with or without chemotherapy 6 months after BNT162b2 vaccine.

Patients And Methods: In the previous study, 88 patients were enrolled, whereas the analyses below refer to the 60 patients still on immunotherapy at the time of the follow-up.

Biomarkers Predict In-Hospital Major Adverse Cardiac Events in COVID-19 Patients: A Multicenter International Study.

Background: The COVID-19 pandemic carries a high burden of morbidity and mortality worldwide. We aimed to identify possible predictors of in-hospital major cardiovascular (CV) events in COVID-19.

Methods: We retrospectively included patients hospitalized for COVID-19 from 10 centers.

Computed Tomography Texture Analysis of Carotid Plaque as Predictor of Unfavorable Outcome after Carotid Artery Stenting: A Preliminary Study.

Novel biomarkers are advocated to manage carotid plaques. Therefore, we aimed to test the association between textural features of carotid plaque at computed tomography angiography (CTA) and unfavorable outcome after carotid artery stenting (CAS). Between January 2010 and January 2021, were selected 172 patients (median age, 77 years; 112/172, 65% men) who underwent CAS with CTA of the supra-aortic vessels performed within prior 6 months.

The Use of Low-Profile Angular-Stability Plates in a "Nutcracker" Tarsal Navicular Fracture Combined with a Cuboid Fracture: ORIF Experience.

Clear recommendations about the optimal treatment of traumatic tarsal navicular fractures are still very debated in the literature, and this is due to several factors: navicular fractures are rare and often misdiagnosed injuries, they are frequently associated with other fractures or a dislocation of the midfoot, and the current knowledge is based on few papers mainly considering a limited number of cases and dealing with different therapeutic approaches. The treatment of navicular body fractures is controversial and burdened by a high incidence of complications; in particular, Sangeorzan type III comminuted fractures represent a real challenge for the orthopedic surgeon. An accurate preoperative planning, a scrupulous surgical technique aimed at restoring volume and bony anatomy, and the use of low-profile angular-stability plates can lead to optimal clinical and functional results, decreasing the chances of arthritic evolution of mid-foot joints.

Comparison of performances of infliximab biosimilars CT-P13 versus SB2 in the treatment of inflammatory bowel diseases: a real-life multicenter, observational study in Italy.

Background: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy.

Research Design And Methods: Three hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint.

Management of Children with Acute Asthma Attack: A RAND/UCLA Appropriateness Approach.

Bronchial asthma is the most frequent chronic disease in children and affects up to 20% of the pediatric population, depending on the geographical area. Asthma symptoms vary over time and in intensity, and acute asthma attack can resolve spontaneously or in response to therapy. The aim of this project was to define the care pathway for pediatric patients who come to the primary care pediatrician or Emergency Room with acute asthmatic access.