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377 result(s) for "Francesco Patti"
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Optimizing the benefit of multiple sclerosis therapy: the importance of treatment adherence
Poor treatment adherence is problematic in many therapy areas, including multiple sclerosis (MS). Several immunomodulatory drugs are available for the treatment of MS, all of which require frequent parenteral administration. Current first-line therapies are two formulations of interferon (IFN) beta-1a, one of IFN beta-1b, and one of glatiramer acetate. Discontinuation of treatment is common, particularly in the first few months after initiation. Although the true effect of poor adherence to MS therapy is not known, it is likely to lead to a fall in treatment efficacy. Many factors influence a patient's adherence to treatment, including the patient's MS subtype and disability level, cognitive impairment resulting from MS, perceived lack of efficacy of the prescribed medication, and adverse events associated with MS therapy. This article summarizes the barriers to adherence to MS therapies, and discusses patient management strategies that can be employed to encourage adherence. Future advances in the field of MS treatment will be explored, including the development of orally administered drugs, which may enhance adherence.
Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder
Relapse of neuromyelitis optica spectrum disorder occurred in 20% of patients who received satralizumab, a subcutaneous anti–interleukin-6 antibody, as compared with 43% of those in the placebo group. The drug may have been more effective in patients with anti–aquaporin-4 IgG antibody than in those without the antibody.
An update on idiopathic intracranial hypertension in adults: a look at pathophysiology, diagnostic approach and management
Idiopathic intracranial hypertension is a neurological syndrome determined by a rise in intracranial pressure without a detectable cause. Course and prognosis may be changeable, requiring a multidisciplinary approach for its diagnosis and management. Although its precise pathogenesis is still unknown, many studies have been carried out to define the possible causal and associated factors, such as retinoids, steroid hormones, body mass index and recent weight gains, cytokines and adipokines levels. The clinical presentation can be variable including chronic headache, disturbance of vision, diplopia and tinnitus. Even if papilloedema is considered the most specific sign, it could not be observed in more than 5% of patients during the evaluation of the fundus oculi. Neuroradiological signs acquire greater importance in patients who do not present papilloedema and may suggest the diagnosis of idiopathic intracranial hypertension. Other assessments can be useful in the diagnostic process, such as optical coherence tomography, visual evoked potentials, ocular ultrasonography and fundus fluorescein angiography and autofluorescence. Nonetheless, cerebrospinal fluid pressure measurement is required to establish a definite diagnosis. Management may be different, since surgical procedures or lumbar punctures are often required when symptoms develop rapidly leading to a loss of visual function. Apart from these cases, patients can be treated with a pharmacological approach and low-calorie diet, but they also need to be monitored over time since relapses years later are not uncommon.
Alexithymia and illness perceptions in persons with multiple sclerosis and their partners
Illness perceptions (IPs) encompass opinions regarding the nature, severity and curability of a disease. The aim of this cross-sectional study was to investigate the association between alexithymia and IPs among persons with multiple sclerosis (PwMS) and their partners, as well as within the dyads composed of PwMS and partners. PwMS referred to the Multiple Sclerosis Center of the University Hospital “Policlinico-San Marco” from 11th August 2021 to 7th January 2022 and their partners completed a battery of questionnaires, including the Toronto Alexithymia Scale-20 and the Illness Perception Questionnaire Revised. A dyadic data analysis (Actor-Partner Interdependence Model) was performed to test the effect of alexithymic traits both on a person’s own illness perceptions (actor effect) and on the partner’s illness perceptions (partner effect). 100 PwMS (71 women; mean age 47.6 ± 10.4 years) and 100 partners (29 women; mean age 49.1 ± 10.8 years), with a mean partnership duration of 20.1 ± 11.7 years, were enrolled. At the dyadic analysis, statistically significant small-to-moderate actor and partner effects were found considering alexithymia (total score and alexithymic facets) and IPs, whereby higher alexithymic traits related to higher negative perceptions (i.e. consequences, emotional representations) and lower positive ones (i.e. coherence, treatment control). Our findings support the relationship between alexithymia and negative illness appraisals. This data may inform therapeutic interventions aimed at reducing alexithymic traits, which in turn may reduce negative, and potentially dysfunctional, illness perceptions.
Incidence of late onset multiple sclerosis in Italy: a population-based study
Late onset multiple sclerosis (LOMS) represents between 0.6 and 12% of all MS patients. However, little is known on the incidence of LOMS in the general population. Therefore, we aimed to study the annual incidence of LOMS in a population-based cohort. The study was conducted in the province of Catania, Italy. Case ascertainment was conducted retrospectively including all patients aged ≥ 50 years at onset and with the onset between 2005 and 2020. Incidence rates (IR) have been calculated for all the study period, according to sex, age classes and for subperiods. Incidence rate ratios (IRR) have been computed to compare incidence rates. During the study period, 183 patients with LOMS were identified (113 women; 61.8%). The mean age at onset was 55.8 ± 5.4 years and the main phenotype was Relapsing Remitting MS ( n  = 123; 67.2%). The average annual crude IR was 2.87/100,000 person-years (95% Confidence Intervals, CI 2.31–3.13). IR increased from 2.54/100,000 in 2005–2010 to 3.32/100,000 in 2016–2020, especially in in the age group 60–69 (IRR 3.48; 95%CI 1.41–9.76; p-value 0.002). In conclusion, an increased IR over the time was observed in the age-group 60–69, possibly reflecting an increased age at onset of MS.
Environmental and Occupational Risk Factors of Amyotrophic Lateral Sclerosis: A Population-Based Case-Control Study
Objectives: Amyotrophic lateral sclerosis (ALS) is a progressive and fatal neurodegenerative disease with still unknown etiology. We aimed at investigating the association between environmental and occupational factors with ALS risk. Methods: We performed a population-based case-control study in four Italian provinces (Catania, Modena, Novara, and Reggio Emilia) by administration of tailored questionnaires to ALS cases (n = 95) and randomly selected population referents (n = 135). We estimated ALS risk by calculating the odds ratio (OR) with its 95% confidence interval (CI) using an unconditional logistic regression model. Results: We found a positive association with disease risk for history of occupation in the agricultural sector (OR = 2.09, 95% CI 0.79–7.54), especially for longer than 10 years (OR = 2.72, 95% 1.02–7.20). Overall occupational exposure to solvents also suggested a positive association, especially for thinners (OR = 2.27, 95% CI 1.14–4.54) and paint removers (OR = 2.01, 95% CI 0.90–4.48). Both occupational and environmental exposure to electromagnetic fields show a slightly increased risk with OR = 1.69 (95% CI 0.70–4.09) and 2.41 (95% CI 1.13–5.12), respectively. Occupational but not environmental exposure to pesticides (OR = 1.22, 95% CI 0.63–2.37), particularly fungicides, and exposure to metals (OR = 4.20, 95% CI 1.88–9.38), particularly lead, mercury, and selenium, showed an imprecise but positive association. Finally, there was an indication of increased risk for living in proximity to water bodies. Conclusions: Despite the caution that needs to be used due to some study limitations, such as the low number of exposed subjects and the possibility of recall bias, these results suggest the potential role of some environmental and occupational factors in ALS etiology.
Personalized Unfair Terms Control: EU Law Meets Innovative US Doctrines
According to part of the US scholarship, the use of big data and prediction algorithms could entail a paradigmatic change in contract law: No longer would one have general and abstract legal norms, but rather granular and personalized ones, customized on the needs and features of the contracting parties. This shift to a law tailored to specific individuals could affect both default and mandatory rules and provide for a more efficient and just legal system. The argument goes that such a flexible and technology-driven regulation is also capable of addressing the issue of unfair personalized pricing schemes applied by businesses in online transactions. The present contribution adopts a futuristic approach and investigates whether these doctrinal proposals could possibly pave the way for an amendment of the Directive 93/13 on unfair terms in consumer contracts. In doing so, the main elements of the unfair terms control are highlighted, together with their link with national default rules, which serve both as a benchmark for the assessment of the unfair character of the clause and as gap-fillers. Based on a comparison with the findings of US scholars, it then explores how the unfair terms control may change in order to reduce cross-subsidies to a minimum and tackle discriminatory pricing schemes. Finally, this article elaborates further on how the modifications could be implemented within a new enforcement mechanism, using a technology that would also cover so-called smart contracts.
Advance care planning in multiple sclerosis (ConCure-SM): A multicenter single-arm pilot and feasibility study
Advance care planning (ACP) practice in people with progressive multiple sclerosis (PwPMS) remains limited. ConCure-SM project aims to assess the effectiveness of a structured ACP intervention (clinician's training programme and use of a booklet during ACP conversations) using a multi-phased design. Single-arm pilot/feasibility trial involving PwPMS, their significant others (SOs), and clinicians from six Italian centers. Primary study outcome was completion of an advance care plan document (ACP-Doc). Other outcomes included safety, feasibility of enrollment and assessment, and (analyzed using mixed-methods approach) Hospital Anxiety and Depression Scale (HADS), quality of communication, quality of life (MSQOL-29), and caregiver burden. Participants were interviewed to identify factors influencing the ACP implementation process. Seventy-five PwPMS were eligible out of 164 screened; 56/75 (75%) refused participation and 19 were included. Of these, 11 (58% vs 30% hypothesized) completed the ACP-Doc. A total of 25 adverse events (increase in anxiety) occurred, three possibly related to the intervention, and we found a worsening of HADS-Anxiety score (p = 0.02) and MSQOL-29 mental health composite score (p = 0.04) during follow-up. PwPMS/SO interviews revealed four themes: significance of the ACP process (on the individual, on relation with clinicians), its impact (on emotions, on family relations), preparedness as key, and challenges (practicability, SO commitment). Barriers and facilitators for ACP were identified in two clinician focus groups. The intervention supported neurologists in guiding PwPMS in their ACP. However, trial findings and the high proportion of refusals point to the need to enrich the intervention with a new component targeting PwPMS and SOs. ISRCTN48527663.
Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study
Background Despite trends towards the increased age of patients living with multiple sclerosis (MS), little is known about the response of older adults with MS to disease-modifying therapies (DMTs). Thus, a post-hoc analysis was undertaken using data from a 2-year, international, non-interventional, prospective cohort study (NCT00787657; BEACON: BEtaferon prospective study on Adherence, COping and Nurse support) of patients above the age of 40 years with MS and starting interferon beta-1b (IFNB-1b) treatment within 6 months before study entry. Methods Middle-aged and older patients with MS were divided into two sub-groups: 41–50 years and > 50 years. Treatment with IFNB-1b started within 6 months before study entry. Patients were followed-up for a 2-year observation period. Assessments included disease history and course, annualised relapse rate (ARR), Expanded Disability Scale Score (EDSS), treatment adherence, Hospital Anxiety and Depression Scale (HADS), and adverse events (AE). Results At baseline, the intention-to-treat (ITT) population ( n  = 481) aged 41–50 years ( n  = 327) and > 50 years ( n  = 154), had mean (standard deviation [SD]) ages of 45.1 (2.8) and 56.2 (4.2) years, maximum age of 72 years, and duration of MS since onset of symptoms of 3.9 (5.2) and 5.9 (7.1) years, respectively. At baseline, the proportion of patients with relapsing–remitting MS (RRMS) was 96.3 and 94.9 %, and secondary progressive MS (SPMS) was 3.7 and 5.1 %, in the 41–50 and > 50 years sub-groups, respectively. The ARR in the 2 years before study start was 0.93 (0.48) and 0.86 (0.54) for the 41–50 and > 50 years groups, respectively, and decreased since study start to 0.20 (1.09) and 0.07 (0.37), respectively. The percentage of patients with anxiety and depression, as measured by HADS, were stable over the study period. Polypharmacy (five or more medications) was seen in 32.3 and 41.2 % of patients aged 41–50 and > 50 years. No unexpected AEs were reported. Conclusions This study provides observational data on patients between 40 and 72 years of age, suggesting that IFNB-1b can be an effective and well-tolerated treatment option in MS patients of advanced age. Trial registration ClinicalTrials.gov, NCT00787657.
Intelligent non-colorimetric indicators for the perishable supply chain by non-wovens with photo-programmed thermal response
Spoiled perishable products, such as food and drugs exposed to inappropriate temperature, cause million illnesses every year. Risks range from intoxication due to pathogen-contaminated edibles, to suboptimal potency of temperature-sensitive vaccines. High-performance and low-cost indicators are needed, based on conformable materials whose properties change continuously and irreversibly depending on the experienced time-temperature profile. However, these systems can be limited by unclear reading, especially for colour-blind people, and are often difficult to be encoded with a tailored response to detect excess temperature over varying temporal profiles. Here we report on optically-programmed, non-colorimetric indicators based on nano-textured non-wovens encoded by their cross-linking degree. This combination allows a desired time-temperature response to be achieved, to address different perishable products. The devices operate by visual contrast with ambient light, which is explained by backscattering calculations for the complex fibrous material. Optical nanomaterials with photo-encoded thermal properties might establish new design rules for intelligent labels. High-performance and low-cost indicators are important in food and cosmetics industry but market uptake is low due to several challenges such as toxicity, cost and unclear reading. Here, the authors report on optically-programmed, non-colorimetric indicators based on nanotextured organic non-wovens, encoded by controlling their cross-linking degree.