Publications by authors named "Daniele Spitaleri"
Background And Objectives: Women with multiple sclerosis (MS) are at risk of disease reactivation in the early postpartum period. Ocrelizumab (OCR) is an anti-CD20 therapy highly effective at reducing MS disease activity. Data remain limited regarding use of disease-modifying therapies (DMTs), including OCR, and disease activity during peripregnancy periods.
View Article and Find Full Text PDFArticle Synopsis
- - The study examines the effectiveness of high-efficacy disease-modifying treatments (hDMTs) versus low-efficacy treatments (lDMTs) in reducing spinal cord lesions in multiple sclerosis (MS) patients, noting the limited previous data on this specific outcome.
- - Researchers analyzed data from patients with relapse-onset MS who underwent MRI scans before and after starting treatment, comparing new lesions in both cord and brain areas.
- - Results indicate that while hDMTs significantly reduced new brain lesions and MS relapses compared to lDMTs, they did not show a significant benefit in preventing new spinal cord lesions.
Background: Comparisons between cladribine and other potent immunotherapies for multiple sclerosis (MS) are lacking.
Objectives: To compare the effectiveness of cladribine against fingolimod, natalizumab, ocrelizumab and alemtuzumab in relapsing-remitting MS.
Methods: Patients with relapsing-remitting MS treated with cladribine, fingolimod, natalizumab, ocrelizumab or alemtuzumab were identified in the global MSBase cohort and two additional UK centres.
Article Synopsis
- * Machine learning models were applied to predict confirmed disability progression after two years, achieving a ROC-AUC score of 0.71, indicating moderate accuracy, while historical disability was found to be a stronger predictor than treatment or relapse history.
- * The research followed strict guidelines and made its coding accessible for others to facilitate future benchmarking in predicting disability progression in MS patients.
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.
View Article and Find Full Text PDFBackground: The COVID-19 pandemic raised concern amongst clinicians that disease-modifying therapies (DMT), particularly anti-CD20 monoclonal antibodies (mAb) and fingolimod, could worsen COVID-19 in people with multiple sclerosis (pwMS). This study aimed to examine DMT prescribing trends pre- and post-pandemic onset.
Methods: A multi-centre longitudinal study with 8,771 participants from MSBase was conducted.
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.
Background: It remains unclear whether routine cerebrospinal fluid (CSF) parameters can serve as predictors of multiple sclerosis (MS) disease course.
Methods: This large-scale cohort study included persons with MS with CSF data documented in the MSBase registry. CSF parameters to predict time to reach confirmed Expanded Disability Status Scale (EDSS) scores 4, 6 and 7 and annualised relapse rate in the first 2 years after diagnosis (ARR2) were assessed using (cox) regression analysis.
Article Synopsis
- - 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.
Article Synopsis
- 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
Importance: Autologous hematopoietic stem cell transplant (AHSCT) is available for treatment of highly active multiple sclerosis (MS).
Objective: To compare the effectiveness of AHSCT vs fingolimod, natalizumab, and ocrelizumab in relapsing-remitting MS by emulating pairwise trials.
Design, Setting, And Participants: This comparative treatment effectiveness study included 6 specialist MS centers with AHSCT programs and international MSBase registry between 2006 and 2021.
Background And Objectives: A variety of neurologic disorders have been reported as presentations or complications of coronavirus disease 2019 (COVID-19) infection. The objective of this study was to determine their incidence dynamics and long-term functional outcome.
Methods: The Neuro-COVID Italy study was a multicenter, observational, cohort study with ambispective recruitment and prospective follow-up.
Risk of secondary progressive multiple sclerosis after early worsening of disability.
J Neurol Neurosurg Psychiatry
December 2023
Background: Whether progression independent of relapse activity (PIRA) heralds earlier onset of secondary progressive multiple sclerosis (SPMS) and more rapid accumulation of disability during SPMS remains to be determined. We investigated the association between early PIRA, relapse-associated worsening (RAW) of disability and time to SPMS, subsequent disability progression and their response to therapy.
Methods: This observational cohort study included patients with relapsing-remitting multiple sclerosis (RRMS) from the MSBase international registry across 146 centres and 39 countries.
Article Synopsis
- The study investigates geographical differences in the risk of secondary progressive multiple sclerosis (SPMS) and how these may be influenced by factors like latitude and treatment types.
- It utilizes data from a global patient registry, focusing on relapsing-remitting multiple sclerosis patients and factors such as age, sex, and treatment efficacy.
- The research analyzes data from over 51,000 patients across 27 countries to establish patterns in the progression from relapsing-remitting to secondary progressive phases of the disease.
What Is This Summary About?: Patient registries contain anonymous data from people who share the same medical condition. The MSBase registry contains information from over 80,000 people living with multiple sclerosis (MS) across 41 countries. Using information from the MSBase registry, the GLIMPSE (Generating Learnings In MultiPle SclErosis) study looked at real-life outcomes in 3475 people living with MS who were treated with cladribine tablets (Mavenclad) compared with other oral treatments.
View Article and Find Full Text PDFDisability accrual in primary and secondary progressive multiple sclerosis.
J Neurol Neurosurg Psychiatry
September 2023
Article Synopsis
- The study compares disability progression in primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS), revealing that SPMS has a later onset and slower disability accrual compared to PPMS.* -
- Analysis utilized data from the MSBase cohort, adjusting for factors like age, sex, and drug therapies, and included 1,872 PPMS patients and 2,575 SPMS patients.* -
- Findings suggest that although SPMS patients start with greater baseline disability, their slower progression may lead to similar disability levels over time, indicating the need for careful consideration when combining these groups in clinical trials.*
Background: Apathy is relatively frequent and significantly associated with clinical and cognitive outcomes in Multiple Sclerosis (MS), even if previous research has produced mixed results. This varied picture could be due to most studies treating apathy as a unitary construct, despite the evidence showing that apathy is a multifaceted syndrome including three different sub-domains (i.e.
View Article and Find Full Text PDFBackground: The prognostic significance of non-disabling relapses in people with relapsing-remitting multiple sclerosis (RRMS) is unclear.
Objective: To determine whether early non-disabling relapses predict disability accumulation in RRMS.
Methods: We redefined mild relapses in MSBase as 'non-disabling', and moderate or severe relapses as 'disabling'.
Background: In the absence of evidence from randomised controlled trials, observational data can be used to emulate clinical trials and guide clinical decisions. Observational studies are, however, susceptible to confounding and bias. Among the used techniques to reduce indication bias are propensity score matching and marginal structural models.
View Article and Find Full Text PDFBackground And Purpose: This study assessed the effect of patient characteristics on the response to disease-modifying therapy (DMT) in multiple sclerosis (MS).
Methods: We extracted data from 61,810 patients from 135 centers across 35 countries from the MSBase registry. The selection criteria were: clinically isolated syndrome or definite MS, follow-up ≥ 1 year, and Expanded Disability Status Scale (EDSS) score ≥ 3, with ≥1 score recorded per year.
Background: Cognitive impairment (CI) is common in Multiple Sclerosis (MS), and its prevalence rate ranges between 22% and 70%. Because CI significantly impacts vocational status, caregiver burden, and quality of life, an accurate neuropsychological assessment is required. Three widely used and validated batteries for MS-associated CI are the Brief Repeatable Neuropsychological Battery (BRN-B), the Minimal Assessment of Cognitive Function (MACFIMS), and the Brief International Cognitive Assessment (BICAMS).
View Article and Find Full Text PDFBackground: Effectiveness of cladribine tablets, an oral disease-modifying treatment (DMT) for multiple sclerosis (MS), was established in clinical trials and confirmed with real-world experience.
Objectives: Use real-world data to compare treatment patterns and clinical outcomes in people with MS (pwMS) treated with cladribine tablets versus other oral DMTs.
Methods: Retrospective treatment comparisons were based on data from the international MSBase registry.
Early predictors of disability in paediatric multiple sclerosis: evidence from a multi-national registry.
J Neurol Neurosurg Psychiatry
September 2022
Background: Early recognition of markers of faster disability worsening in paediatric-onset multiple sclerosis (MS) is a key requisite of personalised therapy for children with MS at the earliest possible time.
Objective: To identify early predictors of rapid disability accrual in patients with paediatric-onset MS.
Methods: Using the global MSBase registry, we identified patients who were <18 years old at the onset of MS symptoms.
Article Synopsis
- The study focuses on the state of stroke care in Campania, Italy, revealing that only a small percentage of patients received important treatments for acute ischemic strokes in previous years.
- Between 2019 and 2020, while the number of AIS admissions decreased, the rates of intravenous thrombolysis (IVT) and mechanical thrombectomies (MT) showed improvement, with more patients receiving these treatments.
- Despite this progress, a significant number of stroke patients were still not admitted to neurology units or given necessary acute treatments, indicating ongoing challenges in stroke care in the region.