Publications by authors named "Iaffaldano P"

Objective: Cognitive impairment affects approximately 30% of pediatric onset Multiple Sclerosis (POMS) patients with a negative impact on everyday life. The aim of this study was to evaluate the feasibility and effectiveness of a home-based, computer-assisted training of attention in patients with POMS.

Methods: This was a randomized double-blind study.

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'Active' and 'non-active' secondary progressive MS (SPMS) have distinct pathophysiological mechanisms and clinical characteristics, but there is still no consensus regarding the frequency of these MS forms in the real-world setting. We aimed to evaluate the frequency of 'active' and 'non-active' SPMS in a large cohort of Italian MS patients and the differences in terms of clinical and MRI characteristics and disease progression. This multicenter study collected data about MS patients who have transitioned to the SP form in the period between 1st January 2014 and 31st December 2019 and followed by the MS centers contributing to the Italian MS Registry.

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Article Synopsis
  • The study compares disability progression in Multiple Sclerosis (MS) patients based on age of onset: pediatric (POMS), adult (AOMS), and late-onset (LOMS), as well as those with and without progression independent of relapse activity (PIRA).
  • Data from 3,777 MS patients revealed that AOMS showed significant disability increases compared to POMS starting in the second year, with POMS having a less steep disability trajectory over time.
  • The findings underscore that younger patients with MS experience different disability progression patterns than older patients, highlighting the importance of age in MS disease management.
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Introduction: The transition from fingolimod (FIN) to siponimod (SIP) for Multiple Sclerosis (MS) treatment in the occurrence of Secondary Progressive Multiple Sclerosis (SPMS) diagnosis has increasingly attracted considerable interest in the recent literature.

Methods: We evaluated the efficacy and safety of a direct switch from FIN to SIP in nine MS patients who had switched directly from FIN to SIP due to SPMS diagnosis at the Multiple Sclerosis Center of the University Hospital Policlinico of Bari.

Results And Conclusion: Real-world results from our cohort demonstrated that the direct switch from FIN to SIP in patients transitioning in SP course is associated with clinical and disability progression stability, with a favorable safety profile.

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Objective: No direct comparisons of the effect of natalizumab and ocrelizumab on progression independent of relapse activity (PIRA) and relapse-associated worsening (RAW) events are currently available. We aimed to compare the risk of achieving first 6 months confirmed PIRA and RAW events and irreversible Expanded Disability Status Scale (EDSS) 4.0 and 6.

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Objectives: Cladribine tablets (CLAD) for adult patients with highly active relapsing multiple sclerosis (RMS) have been available in Italy since 2018. We aimed to assess predictors of no-evidence-of-disease-activity-3 (NEDA-3) status after 24 months of the last dose of CLAD.

Results: We included 88 patients (70.

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Objectives: We investigated the occurrence and relative contribution of relapse-associated worsening (RAW) and progression independent of relapse activity (PIRA) to confirmed disability accrual (CDA) and transition to secondary progression (SP) in relapsing multiple sclerosis (MS).

Methods: Relapsing-onset MS patients with follow-up > / = 5 years (16,130) were extracted from the Italian MS Registry. CDA was a 6-month confirmed increase in Expanded Disability Status Scale (EDSS) score.

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Background: The Big Multiple Sclerosis Data (BMSD) network ( https://bigmsdata.org ) was initiated in 2014 and includes the national multiple sclerosis (MS) registries of the Czech Republic, Denmark, France, Italy, and Sweden as well as the international MSBase registry. BMSD has addressed the ethical, legal, technical, and governance-related challenges for data sharing and so far, published three scientific papers on pooled datasets as proof of concept for its collaborative design.

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Background: High-efficacy disease-modifying therapies have been proven to slow disability accrual in adults with relapsing-remitting multiple sclerosis. However, their impact on disability worsening in paediatric-onset multiple sclerosis, particularly during the early phases, is not well understood. We evaluated how high-efficacy therapies influence transitions across five disability states, ranging from minimal disability to gait impairment and secondary progressive multiple sclerosis, in people with paediatric-onset multiple sclerosis.

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Background: Predicting disease progression in patients with the first clinical episode suggestive of multiple sclerosis (MS) is crucial for personalized therapeutic approaches. This study aimed to develop the EUMUS score for accurately estimating the risk of early evidence of disease activity and progression (EDA).

Methods: Retrospective analysis was conducted on data from 221 patients with a first clinical MS episode collected from four Italian MS centers.

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Article Synopsis
  • The study aims to identify predictors of treatment switching in patients with relapsing-remitting MS using data from multiple national registries.
  • A total of 269,822 treatment episodes from 110,326 patients were analyzed, focusing on those who started disease-modifying treatments during their RRMS phase.
  • Key findings indicate that higher disability scores (EDSS), being female, and older age increase the likelihood of treatment switching, with certain DMTs initiated between 2007 and 2012 showing even higher rates of switching.
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Background: Generally infrequent, multiple sclerosis (MS) with late onset (LOMS) is characterized by an onset over the age of 50 and a mainly progressive course, while relapsing-remitting (RR) forms are less frequently observed and explored. This study aimed to characterize a large cohort of MS patients with RRMS at onset to assess the baseline factors related to the worst disability trajectories and explore the role of LOMS.

Methods: The data were extracted from the Italian MS Register (IMSR).

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Article Synopsis
  • - As of September 2022, a lack of standardized core data elements for multiple sclerosis (MS) hindered effective data sharing and collaboration in healthcare and research.
  • - A global task force of 20 experts developed a core dataset of 44 variables in eight categories to improve data consistency from real-world data sources, which includes demographic information, disease history, MRI results, and treatment details.
  • - The resulting MS Data Alliance Core Dataset aims to assist newly formed and existing registries, promoting data harmonisation and improving research outcomes in the field of MS.
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  • - The study analyzed the factors behind treatment changes in 4,739 patients with active relapsing-remitting and secondary progressive multiple sclerosis from the Italian MS Register, focusing on those who experienced relapses within the past two years.
  • - Results revealed that over half of the patients switched their disease-modifying therapy (DMT) due to clinical relapses, with those who switched being typically younger and less disabled than non-switchers.
  • - The use of high-efficacy DMTs, particularly anti-CD20 drugs like Alemtuzumab and Ocrelizumab, was shown to significantly lower the risk of needing to switch treatments due to disease activity.
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  • The study explored how pediatric-onset multiple sclerosis (POMS) compares to adult-onset (AOMS) and late-onset MS (LOMS) in terms of progression without relapse and disability levels, suggesting POMS patients may have better outcomes due to their ability to recover more effectively.* -
  • Data from over 16,000 MS patients indicated that while POMS patients showed less disability, they had higher disease activity and longer exposure to disease-modifying therapy (DMT) compared to AOMS and LOMS patients.* -
  • Key findings revealed that older age at onset and longer disease duration increased the risk of progression, while shorter DMT exposure correlated with better outcomes for POMS patients, highlighting the importance of
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Background: This research aimed to investigate the experience of Neuromyelitis Optica Spectrum Disorders (NMOSD) by integrating the perspectives of patients, caregivers and clinicians through narrative-based medicine to provide new insights to improve care relationships.

Methods: The research was conducted in the second half of 2022 and involved six Italian centres treating NMOSD and targeted adult patients, their caregivers and healthcare providers to collect the three points of view of living with or caring for this rare disease, still difficult to treat despite the pharmacological options. Narratives followed a structured outline according to the time: yesterday-today-tomorrow, to capture all disease phases.

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Ocrelizumab is a recombinant humanized monoclonal antibody selectively targeting CD20-expressing B cells. The effect of ocrelizumab on primary progressive multiple sclerosis (PPMS) has been evaluated during phase 3 trials that enrolled patients under 55 years with a maximum Expanded Disability Status Scale (EDSS) of 6.5.

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Background: Information processing speed is commonly impaired in people with multiple sclerosis (PwMS). However, depression and fatigue can affect the cognitive profile of patients: fatigue has a negative impact from the disease's earliest stage and a reduced information processing speed is often associated with higher levels of depression. Therefore, the aim of this study was to investigate the correlations between information processing speed and physical fatigue in a cohort of Italian PwMS from a single center, considering the effect of depression.

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Background: The decision of initiating treatment for multiple sclerosis (MS) with a high-efficacy DMT (HE DMT) or non-high-efficacy DMT (non-HE DMT) is influenced by several factors, including risk perception of patients and physicians.

Objective: Investigate the influence of physicians' risk perception on decision-making when switching treatments for MS and the reasons for switching.

Methods: Data were drawn from the Adelphi Real-World MS Disease-Specific Program (a retrospective survey) and analysis included people with RMS identified between 2017- 2021.

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Background: To assign a course of secondary progressive multiple sclerosis (MS) (SPMS) may be difficult and the proportion of persons with SPMS varies between reports. An objective method for disease course classification may give a better estimation of the relative proportions of relapsing-remitting MS (RRMS) and SPMS and may identify situations where SPMS is under reported.

Materials And Methods: Data were obtained for 61,900 MS patients from MS registries in the Czech Republic, Denmark, Germany, Sweden, and the United Kingdom (UK), including date of birth, sex, SP conversion year, visits with an Expanded Disability Status Scale (EDSS) score, MS onset and diagnosis date, relapses, and disease-modifying treatment (DMT) use.

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Although cladribine induces sustained reductions in peripheral T and B lymphocytes, little is known about its effect on axonal damage reduction in multiple sclerosis (MS), which could be demonstrated by assessing the serum neurofilament light chain (sNfL) levels. We investigated the reduction/reconstitution of different lymphocyte subsets (LS) by verifying the correlation with no evidence of disease activity (NEDA) and the variation in sNfL levels during cladribine treatment. We analysed 33 highly active relapsing MS patients and followed them up for 12 ± 3.

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Background And Objectives: Uncontrolled evidence suggests that autologous hematopoietic stem cell transplantation (AHSCT) can be effective in people with active secondary progressive multiple sclerosis (SPMS). In this study, we compared the effect of AHSCT with that of other anti-inflammatory disease-modifying therapies (DMTs) on long-term disability worsening in active SPMS.

Methods: We collected data from the Italian Bone Marrow Transplantation Study Group and the Italian Multiple Sclerosis Register.

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Background: Over the decades, several natural history studies on patients with primary (PPMS) or secondary progressive multiple sclerosis (SPMS) were reported from international registries. In PPMS, a consistent heterogeneity on long-term disability trajectories was demonstrated. The aim of this study was to identify subgroups of patients with SPMS with similar longitudinal trajectories of disability over time.

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