Publications by authors named "Simona Bonavita"

95 Publications

Switch from sequestering to anti-CD20 depleting treatment: disease activity outcomes during wash-out and in the first 6 months of ocrelizumab therapy.

Mult Scler 2021 Apr 15:13524585211005657. Epub 2021 Apr 15.

Department of Health Sciences, University of Genova, Genova, Italy.

Objectives: Switching between treatments is an opportunity for patients with multiple sclerosis (MS) to ameliorate disease control or safety. The aim of this study was to investigate the impact of switching from fingolimod (FTY) or natalizumab (NTZ) to ocrelizumab (OCR) on disease activity.

Methods: We retrospectively enrolled 165 patients treated with OCR from 11 MS centres. We assessed the association of demographic and clinical characteristics on relapse rate (RR) and activity on magnetic resonance imaging (MRI) during wash-out and after 6 months of treatment with OCR through univariable and multivariable negative binomial regression models.

Results: We registered a total of 35 relapses during the wash-out period. Previous treatment with FTY, relapses in the previous year, and relapsing-remitting course were associated with higher RR. In the first 6 months of OCR, 12 patients had clinical or MRI disease activity. Higher Expanded Disability Status Scale (EDSS) and higher lymphocyte count at OCR start were associated with a reduced probability of relapse.

Discussion And Conclusion: This study confirms that withdrawal from sequestering agents as FTY increases the risk of relapses in the wash-out period. Nevertheless, starting OCR before achieving complete immune reconstitution could limit its effectiveness in the first 6 months probably because trapped lymphocytes escape the CD20-mediated depletion.
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http://dx.doi.org/10.1177/13524585211005657DOI Listing
April 2021

Exit Strategies in Natalizumab-Treated RRMS at High Risk of Progressive Multifocal Leukoencephalopathy: a Multicentre Comparison Study.

Neurotherapeutics 2021 Apr 12. Epub 2021 Apr 12.

Department "G.F. Ingrassia", MS Center, Organization University of Catania, Catania, Italy.

The main aim of the study is to evaluate the efficacy and safety profile of ocrelizumab (OCR), rituximab (RTX), and cladribine (CLA), employed as natalizumab (NTZ) exit strategies in relapsing-remitting multiple sclerosis (RRMS) patients at high-risk for progressive multifocal leukoencephalopathy (PML). This is a multicentre, retrospective, real-world study on consecutive RRMS patients from eleven tertiary Italian MS centres, who switched from NTZ to OCR, RTX, and CLA from January 1st, 2019, to December 31st, 2019. The primary study outcomes were the annualized relapse rate (ARR) and magnetic resonance imaging (MRI) outcome. Treatment effects were estimated by the inverse probability treatment weighting (IPTW), based on propensity-score (PS) approach. Additional endpoint included confirmed disability progression (CDP) as measured by Expanded Disability Status Scale and adverse events (AEs). Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX, and 20 to CLA. Patients from the 3 groups did not show differences for baseline characteristics, also after post hoc analysis. The IPTW PS-adjusted models revealed that patients on OCR had a lower risk for ARR than patients on CLA (ExpB 0.485, CI 95% 0.264-0.893, p = 0.020). This result was confirmed also for 12-month MRI activity (ExpB 0.248 CI 95% 0.065-0.948, p = 0.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the 3 groups. Anti-CD20 drugs were revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile.
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http://dx.doi.org/10.1007/s13311-021-01037-2DOI Listing
April 2021

Physical Exercise Moderates the Effects of Disability on Depression in People with Multiple Sclerosis during the COVID-19 Outbreak.

J Clin Med 2021 Mar 16;10(6). Epub 2021 Mar 16.

Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples Federico II, 80131 Naples, Italy.

Physical disability impacts psychosocial wellbeing in people with multiple sclerosis. However, the role of physical activity in this context is still debated. By taking advantage of a previous survey, conducted online from 22 April to 7 May 2020, we performed a post-hoc analysis with the aim to assess the associations between disability, physical exercise, and mental health in multiple sclerosis. We retrieved the following data: (i) sociodemographic information, (ii) changes in lifestyle (including exercise), (iii) physical disability, as measured with the Patient-Determined Disease Steps scale, and (iv) anxiety feelings and depressive symptoms assessed via the items included in the Quality of Life in Neurological Disorders measurement system. Examination of the interaction plot showed that the effect of disability on depression, but not on anxious symptoms, was significant for all levels of physical exercise (low: b = 1.22, 95% C.I. 0.85, 1.58, < 0.001; moderate: b = 0.95, 95% C.I. 0.66, 1.24, < 0.001; and high: b = 0.68, 95% C.I. 0.24, 1.13, = 0.003). Based on these data, we can conclude that disability significantly impacted depression during the COVID-19 pandemic, with physical activity playing a moderating role. Our results suggest that favoring exercise in multiple sclerosis (MS) would ameliorate psychological wellbeing regardless of the level of physical disability.
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http://dx.doi.org/10.3390/jcm10061234DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002261PMC
March 2021

Assessment of Multiple Sclerosis Disability Progression Using a Wearable Biosensor: A Pilot Study.

J Clin Med 2021 Mar 10;10(6). Epub 2021 Mar 10.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.

Background: The evaluation of walking activity of people with multiple sclerosis (pwMS) is desirable. We evaluate the power of the correlation of motor parameters detected by the accelerometer in the Samsung Gear S2 smartwatch with multiple sclerosis (MS) disability measures and patient reported outcomes (PROs).

Methods: We enrolled 25 relapsing remitting MS patients. We assessed disability with the expanded disability status scale, two-minute walking test (2MWT), timed 25-foot walk test (T25FWT), and nine-hole peg test. We collected PROs measuring fatigue, ambulatory ability, depression, quality of life, and bladder/bowel function. Participants were asked to wear the accelerometer for a period of 30 days.

Results: The Spearman's rank correlation coefficient showed a moderate negative correlation between the patient-determined disease steps (PDDS) score with the mean steps/day, a strong negative correlation between the PDDS score with the maximum number of daily steps (MNDS) and a moderate negative correlation between the fatigue severity scale score and MNDS. A moderate negative correlation between MNDS and the 2MWT and a moderate negative correlation between MNDS and the T25FW was found.

Conclusion: Our results suggest that motor parameters derived from the accelerometer could be a reliable measure of motor disability in pwMS.
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http://dx.doi.org/10.3390/jcm10061160DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001885PMC
March 2021

Public Engagement and Neurology: An Update.

Brain Sci 2021 Mar 28;11(4). Epub 2021 Mar 28.

Division of Neurology, Department of Advanced Medical and Surgical Sciences, AOU-University of Campania "Luigi Vanvitelli", P.zza Miraglia 2, 80138 Naples, Italy.

Background: Public engagement (PE) is defined as the involvement of "specialists who listen, develop their understanding, and interact with non-specialists in non-profit activities of educational, cultural, and social nature to engage the public in science-related matters". The public health relevance of PE consists in building up a scientifically literate society, able to participate in and support scientific and technological developments and their implications for educational settings. Neurological disorders account for 35% of all diseases. PE could have a positive impact on the lives of people affected by neurological diseases.

Method: This review evaluates the role of PE in dementia, stroke, epilepsy, multiple sclerosis, Parkinson's disease, migraine, neurogenetics, and amyotrophic lateral sclerosis.

Results And Conclusions: PE can provide accessible information, support research activities and prevention through appropriate lifestyles, and increase knowledge and awareness of neurological disorders, improving their diagnosis and treatment.
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http://dx.doi.org/10.3390/brainsci11040429DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8065487PMC
March 2021

MRI activity and extended interval of Natalizumab dosing regimen: a multicentre Italian study.

J Neurol Sci 2021 May 6;424:117385. Epub 2021 Mar 6.

Clinical and Biological Sciences Department, Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano, Torino, Italy.

Background: To minimize the risk of Progressive Multifocal Leukoencephalopathy and rebound in JCV-positive multiple sclerosis (MS) patients after 24 natalizumab doses, it has been proposed to extend the administrations interval. The objective is to evaluate the EID efficacy on MRI activity compared with the standard interval dosing (SID).

Methods: Observational, multicentre, retrospective cohort study, starting from the 24th natalizumab infusion to the loss of follow-up or 2 years after baseline. Three hundred and sixteen patients were enrolled. The median dose interval (MDI) following the 24th infusion was 5 weeks, with a bimodal distribution (modes at 4 and 6 weeks). Patients were grouped into 2 categories according to the mean number of weeks between doses: <5 weeks, SID; ≥5 weeks, EID.

Results: One hundred and eighty-seven patients were in the SID group (MDI = 4.5 weeks) and 129 in the EID group (MDI 6.1 weeks). The risk to develop active lesions on MRI is similar in SID and EID groups during the 6 and 12 months after the 24th natalizumab infusion, respectively 4.27% (95% CI:0.84-7.70) vs 4.71% (95% CI:0.16-9.25%) [p = 0.89] and 8.50% (95% CI:4.05-12.95) vs 6.55% (95% CI:2.11-11.00%) [p = 0.56]. The EID regimen does not appear to increase the occurrence of MRI activity during follow-up.

Conclusion: There is no evidence of the reduced efficacy of natalizumab in an EID setting regarding the MRI activity. This observation supports the need for a bigger randomized study to assess the need to change the standard of the natalizumab dosing schedule, to better manage JCV-positive patients.
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http://dx.doi.org/10.1016/j.jns.2021.117385DOI Listing
May 2021

Editorial: Digital Technology in Neurology: From Clinical Assessment to Neurorehabilitation.

Front Neurol 2020 21;11:614074. Epub 2021 Jan 21.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

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http://dx.doi.org/10.3389/fneur.2020.614074DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7858643PMC
January 2021

Stroke and digital technology: a wake-up call from COVID-19 pandemic.

Neurol Sci 2021 Mar 12;42(3):805-809. Epub 2021 Jan 12.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

Introduction: The pandemic has implemented the need for new digital technologies as useful tools during the emergency and the long recovery phase that will follow. SARS-CoV-2 has strongly impacted stroke care with significant contraction in a number of patients treated.

Methods: This mini-review is an initiative of the "Digital Technologies, Web and Social Media Study Group" of the Italian Society of Neurology and briefly discusses digital tools for managing the acute phase and the rehabilitation after stroke, even considering the new apps that will improve the process of remote monitoring of patients after discharge at home.

Results: Telemedicine and digital technologies could play a role in each of the three stroke-belt stages: hyperacute treatment and reperfusion, acute care, etiological classification and secondary prevention and rehabilitation.

Conclusion: The global emergency represented by the COVID-19 pandemic can be the stimulus to accelerate the digitalization process in the field of stroke for the use of new methods on a large scale.
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http://dx.doi.org/10.1007/s10072-020-04993-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801773PMC
March 2021

Perceived stress and social support in a large population of people with multiple sclerosis recruited online through the COVID-19 pandemic.

Eur J Neurol 2020 Dec 23. Epub 2020 Dec 23.

Department of Advanced Medical and Surgical Sciences, University of Campania 'Luigi Vanvitelli', Naples, Italy.

Background And Purpose: The COVID-19 emergency may cause post-traumatic stress disorder (PTSD), and with regard to people with MS (pwMS) chronic exposure to a wide range of challenging life events has been shown to be correlated with worsening of neurological symptoms, increased lesion burden on brain magnetic resonance imaging and relapses. The aim was to investigate perceived stress, depression, perceived social support, habits and behaviour changes in pwMS through COVID-19 in comparison to a control group.

Methods: A web-based survey was posted on SMsocialnetwork.com to investigate perceived stress (using the Perceived Stress Scale), depression (with Patient Health Questionnaire 2) and perceived social support (using Social Provision Scale 10 item) in pwMS and a control group through the COVID-19 pandemic. A secondary group of people with migraine was investigated.

Results: In all, 1286 answers from 612 pwMS and 674 control people were included in the final analysis. The answers from 318 people with migraine were included for a secondary analysis. A higher proportion of pwMS were depressed (43.1% vs. 23.1%; p < 0.001), had a high level of perceived stress (58% vs. 39.8%; p < 0.001) and felt significantly less social support (median 33 vs. 35; Q1-Q3 28-36 vs. 32-37; p < 0.001) compared to the control group. A higher percentage of people with migraine were depressed (50% vs. 43%, p = 0.04) compared to pwMS.

Conclusions: Considering the negative impact that prolonged stress may have on clinical and radiological disease activity of pwMS, and bearing in mind that a beneficial effect has been demonstrated and achieved with stress management, it is suggested to promote stress control in these patients during the COVID-19 pandemic.
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http://dx.doi.org/10.1111/ene.14697DOI Listing
December 2020

The role of sex hormones in women with multiple sclerosis: From puberty to assisted reproductive techniques.

Front Neuroendocrinol 2021 Jan 12;60:100889. Epub 2020 Nov 12.

Department of Advanced Medical and Surgical Sciences, University of Campania Luigi Vanvitelli, Piazza Miraglia, 2, 80138 Naples, Italy. Electronic address:

Background: Multiple Sclerosis is a multifactorial chronic autoimmune disease, affecting predominantly females in the fertile age. Sex hormones changes during a woman's life, from puberty to menopause, including pregnancy and puerperium, may influence the onset and course of Multiple Sclerosis. The effect of estrogen levels on immune, clinical and radiological aspects of Multiple Sclerosis, also stimulated investigation on the effect of sexual hormones therapies, such as oral contraceptives and assisted reproductive technique, on the Multiple Sclerosis course.

Search Strategy And Selection Criteria: A literature search for original articles and reviews was conducted in the databases, including PubMed, Scopus, and ClinicalTrials.gov of the U.S. National Library of Medicine site from 1988 to 2020.

Results And Conclusion: This review reports the effects of the physiological and iatrogenic hormonal changes either on immune or clinical or paraclinical features in the different life stages of women affected by Multiple Sclerosis.
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http://dx.doi.org/10.1016/j.yfrne.2020.100889DOI Listing
January 2021

Unilateral polymicrogyria, hemispheric atrophy and spastic hemiparesis: rare etiologies for a common condition.

Acta Neurol Belg 2020 Nov 5. Epub 2020 Nov 5.

I Division of Neurology and Neurophysiopathology, University of Campania "Luigi Vanvitelli", P.za Miraglia 2, 80138, Naples, Italy.

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http://dx.doi.org/10.1007/s13760-020-01537-6DOI Listing
November 2020

Hippocampal connectivity in Amyotrophic Lateral Sclerosis (ALS): more than Papez circuit impairment.

Brain Imaging Behav 2020 Oct 23. Epub 2020 Oct 23.

Department of Advanced Medical and Surgical Sciences, MRI Research Center SUN-FISM, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy.

Emerging evidence suggests that memory deficit in amyotrophic lateral sclerosis (ALS), a neurodegenerative disease with varying impairment of motor abilities and cognitive profile, may be independent from executive dysfunction. Our multimodal magnetic resonance imaging (MRI) approach, including resting state functional MRI (RS-fMRI), diffusion tensor imaging (DTI) and voxel-based morphometry (VBM), aimed to investigate structural and functional changes within and beyond the Papez circuit in non-demented ALS patients (n = 32) compared with healthy controls (HCs, n = 21), and whether these changes correlated with neuropsychological measures of verbal and non-verbal memory. We revealed a decreased functional connectivity between bilateral hippocampus, bilateral parahippocampal gyri and cerebellum in ALS patients compared with HCs. Between-group comparisons revealed white matter abnormalities in the genu and body of the corpus callosum and bilateral cortico-spinal tracts, superior longitudinal and uncinate fasciculi in ALS patients (p < .05, family-wise error corrected). Interestingly, changes of Digit Span forward performance were inversely related to RS-fMRI signal fluctuations in the cerebellum, while changes of both episodic and visual memory scores were inversely related to mean and radial diffusivity abnormalities in several WM fiber tracts, including middle cerebellar peduncles. Our findings revealed that ALS patients showed significant functional and structural connectivity changes across the regions comprising the Papez circuit, as well as more extended areas including cerebellum and frontal, temporal and parietal areas, supporting the theory of a multi-system pathology in ALS that spreads from cortical to subcortical structures.
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http://dx.doi.org/10.1007/s11682-020-00408-1DOI Listing
October 2020

Clinical effectiveness of different natalizumab interval dosing schedules in a large Italian population of patients with multiple sclerosis.

J Neurol Neurosurg Psychiatry 2020 12 14;91(12):1297-1303. Epub 2020 Oct 14.

Department of Surgical and Medical Sciences Advanced Technologies GF Ingrassia, University of Catania, Catania, Italy

Introduction: Natalizumab (NTZ) is one of the most effective treatment options for multiple sclerosis (MS) treatment. Our study aimed to evaluate the effectiveness of NTZ when administered according to the extended dosing strategy compared with standard 4-weekly administration in a large Italian MS population.

Materials And Methods: This retrospective multicentre study included patients with relapsing-remitting MS (RR-MS) who received NTZ administrations between the 1 June 2012 and the 15 May 2018 and were followed by the 'Italian MS Register'. All patients with MS were stratified into two groups based on NTZ administration schedule: standard interval dosing (SID) patients who received infusions on average from 28 to 32 days (median 30) and extended interval dosing (EID) including patients who have been infused with interval between 33 and 49 days (median 43). Clinical data were assessed at baseline (before starting NTZ), after 12 (T1) and 24 months (T2) of treatment.

Results: Out of 5231 patients with RR-MS screened, 2092 (mean age 43.2±12.0, 60.6% women) were enrolled. A total of 1254 (59.9%) received NTZ according to SID, and 838 (40.1%) according to EID. At 12 and 24 months, no differences in terms of annualised relapse rate and disability status were found between the two groups. Progression index and confirmed disability worsening were similar between the two groups.

Discussion: The use of NTZ with an extended interval schedule showed similar effectiveness compared with SID. Unchanged clinical efficacy of EID schedule may raise the question of a possible advantage in terms of tolerability and safety.
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http://dx.doi.org/10.1136/jnnp-2020-323472DOI Listing
December 2020

Telemedicine for management of patients with amyotrophic lateral sclerosis through COVID-19 tail.

Neurol Sci 2021 Jan 6;42(1):9-13. Epub 2020 Oct 6.

Department of Advanced Medical and Surgical Sciences, I Clinic of Neurology, University of Campania "Luigi Vanvitelli", Naples, Italy.

Over the last months, due to coronavirus disease (COVID-19) pandemic, containment measures have led to important social restriction. Healthcare systems have faced a complete rearrangement of resources and spaces, with the creation of wards devoted to COVID-19 patients. In this context, patients affected by chronic neurological diseases, such as amyotrophic lateral sclerosis (ALS), are at risk to be lost at follow-up, leading to a higher risk of morbidity and mortality. Telemedicine may allow meet the needs of these patients. In this commentary, we briefly discuss the digital tools to remotely monitor and manage ALS patients. Focusing on detecting disease progression and preventing life-threatening conditions, we propose a toolset able to improve ALS management during this unprecedented situation.
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http://dx.doi.org/10.1007/s10072-020-04783-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538170PMC
January 2021

The Rise of the GRN C157KfsX97 Mutation in Southern Italy: Going Back to the Fall of the Western Roman Empire.

J Alzheimers Dis 2020 ;78(1):387-394

Division of Neurology V - Neuropathology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Background: Frontotemporal lobar degeneration (FTLD) designates a group of neurodegenerative diseases with remarkable clinical, pathological, and genetic heterogeneity. Mutations in progranulin gene (GRN) are among the most common causes of familial FTLD. The GRN C157KfsX97 mutation is the most frequent mutation occurring in Southern Italy and has been already described in a previous work.

Objective: In this study, we reported on additional cases carrying the same mutation and performed a genetic study on the whole cohort, aiming at demonstrating the existence of a founder effect and estimating the age of this mutation.

Methods/results: Based on the haplotype sharing analysis, a founder effect was highly probable, while the age of the mutation, estimated by means of DMLE+ software, resulted in a range between 52 and 82 generations, with the highest frequency at about 62 generations, 1,550 years ago.

Conclusion: This is the first study that reports the age estimation of the most recent common ancestor for the GRN C157KfsX97 mutation recurring in Southern Italy. Mutation dating in a geographically restricted population may be useful in order to plan genetic counseling and screening programs in the field of public health.
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http://dx.doi.org/10.3233/JAD-200924DOI Listing
January 2020

Severe disease activity in MS patients treated with cladribine after fingolimod withdrawal.

J Neurol Sci 2020 11 30;418:117156. Epub 2020 Sep 30.

Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DINOGMI), University of Genoa, Genoa, Italy.

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http://dx.doi.org/10.1016/j.jns.2020.117156DOI Listing
November 2020

Singular cases of Alzheimer's disease disclose new and old genetic "acquaintances".

Neurol Sci 2021 May 2;42(5):2021-2029. Epub 2020 Oct 2.

Division of Neurology V - Neuropathology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.

Background: Alzheimer's disease (AD) is the most common age-related dementia. Besides its typical presentation with amnestic syndrome at onset, atypical AD cases are being increasingly recognized, often in presenile age.

Objectives: To provide an extensive clinical and genetic characterization of six AD patients carrying one or more singular features, including age of onset, atypical phenotype and disease progression rate. By reviewing the pertinent literature and accessing publicly available databases, we aimed to assess the frequency and the significance of the identified genetic variants.

Methods: Biomarkers of amyloid-β deposition and neurodegeneration were used to establish the in vivo diagnosis of probable AD, in addition to neurological and neuropsychological evaluation, extensive laboratory assays and neuroradiological data. Considering the presenile onset of the majority of the cases, we hypothesized genetically determined AD and performed extensive genetic analyses by both Sanger sequencing and next generation sequencing (NGS).

Results: We disclosed two known missense variants, one in PSEN1 and the other in PSEN2, and a novel silent variant in PSEN2. Most notably, we identified several additional variants in other dementia-related genes by NGS. Some of them have never been reported in any control or disease databases, representing variants unique to our cases.

Conclusions: This work underlines the difficulties in reaching a confident in vivo diagnosis in cases of atypical dementia. Moreover, a wider genetic analysis by NGS approach may prove to be useful in specific cases, especially when the study of the so-far known AD causative genes produces negative or conflicting results.
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http://dx.doi.org/10.1007/s10072-020-04774-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043869PMC
May 2021

Screening neuromyelitis optica patients for COVID-19 infection.

Autoimmun Rev 2020 11 14;19(11):102669. Epub 2020 Sep 14.

Universal Council of Epidemiology (UCE), Universal Scientific Education and Research Network (USERN), Tehran University of Medical Sciences, Tehran, Iran. Electronic address:

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http://dx.doi.org/10.1016/j.autrev.2020.102669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489250PMC
November 2020

Resting state functional MRI brain signatures of fast disease progression in amyotrophic lateral sclerosis: a retrospective study.

Amyotroph Lateral Scler Frontotemporal Degener 2021 02 4;22(1-2):117-126. Epub 2020 Sep 4.

Department of Advanced Medical and Surgical Sciences; MRI Research Center SUN-FISM, Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy.

Objective: Advanced neuroimaging techniques may offer the potential to monitor disease spreading in amyotrophic lateral sclerosis (ALS). We aim to investigate brain functional and structural magnetic resonance imaging (MRI) changes in a cohort of ALS patients, examined at diagnosis and clinically monitored over 18 months, in order to early discriminate fast progressors (FPs) from slow progressors (SPs). Resting state functional MRI (RS-fMRI), diffusion tensor imaging (DTI) and voxel-based morphometry (VBM) analyses were performed at baseline in 54 patients with ALS and 22 HCs. ALS patients were classified into FPs ( = 25) and SPs ( = 29) based on changes in Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised score from baseline to the 18-month assessment (ΔALSFRS-R), applying a k-means clustering algorithm. At diagnosis, when compared to HCs, ALS patients showed reduced functional connectivity in both motor and extra-motor networks. When compared to SPs, at baseline, FPs showed decreased function connectivity in paracentral lobule (sensorimotor network), precuneus (in the default mode network), middle frontal gyri (frontoparietal networks) and increased functional connectivity in insular cortices (salience network). Structural analyses did not reveal significant differences in gray and white matter damage by comparing FPs to SPs. Receiver operating characteristic (ROC) curve analysis showed that functional connectivity increase in the left insula at baseline best discriminated FPs and SPs (area under the curve 78%). Impairment of extra-motor networks may appear early in ALS patients with faster disease progression, suggesting that a more widespread functional connectivity damage may be an indicator of poorer prognosis.
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http://dx.doi.org/10.1080/21678421.2020.1813306DOI Listing
February 2021

Cladribine vs other drugs in MS: Merging randomized trial with real-life data.

Neurol Neuroimmunol Neuroinflamm 2020 11 14;7(6). Epub 2020 Aug 14.

From the Department of Health Sciences (A. Signori, M.P.S.), Section of Biostatistics, University of Genoa; Department of Neurosciences (F.S., R.L., C.V.R.), Reproductive Sciences and Odontostomatology, Multiple Sclerosis Center, Federico II University, Naples; Neurological Clinic and Multiple Sclerosis Center of "AORN A.Cardarelli" (G.T.M.), Naples; Centro di Sclerosi Multipla (E.S.), II Clinica Neurologica, Università della Campania "Luigi Vanvitelli," Napoli; 2nd Neurology Unit and CRRSM (Regional Referral Multiple Sclerosis Center) (A.M.R.), Careggi University Hospital, University of Florence; Multiple Sclerosis Study Center (P.A., D.B.), ASST Valle Olona, PO di Gallarate (VA); Clinical and Biological Sciences Department (M.C.), Neurology Unit, University of Torino, San Luigi Gonzaga Hospital, Orbassano; Centro SM (E.B.), Dipartimento di Neuroscienze, Ospedale Universitario Città della Salute e della Scienza di Torino; Neurological Clinic (R.C.), Department of Experimental and Clinical Medicine, Marche Polytechnic University, Ancona; Policlinic Tor Vergata (G.M., D.L.), Rome; The Multiple Sclerosis Center of the Veneto Region (P.P.), Department of Neurosciences, University of Padua; Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences (S. Bonavita, L.L., S.E., D.I.), University of Campania Luigi Vanvitelli, Naples; Department of Clinical and Experimental Medicine (I.R.Z.), University of Sassari; Department Neuroscience, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (A.L.), Center of Excellence for Biomedical Research (CEBR), University of Genova; Neuroimmunology and Neuromuscular Diseases Unit (L.P.-G., V.T.C.), IRCCS Foundation Carlo Besta Neurological Institute, Milan; Centro Sclerosi Multipla ASST Papa Giovanni XXIII di Bergamo (S.L.G., B.F., V.B.); Department of Medical Science and Public Health (J.F., E.C., G.F.), University of Cagliari; Neurology Clinic (A. Sartori), Department of Medical, Surgical, and Health Sciences, University of Trieste; Multiple Sclerosis Center (S.R., C.C.), ASST Spedali Civili, PO di Montichiari (BS); Department of Medicine, Surgery and Neuroscience (M.L.S.), University of Siena; 2nd Neurology Unit and CReSM (Regional Referral Multiple Sclerosis Center) (A.D.S.), AOU San Luigi Gonzaga, Orbassano, Torino; Regina Montis Regalis Hospital (A.D.S.), Mondovì; Department of Neurology and Psychiatry (S.P.), Sapienza University, Rome; Neurologia Universitaria OORR (R.G.), Foggia; Institute of Neurology (S. Barone), University Magna Graecia of Catanzaro; Department of Neurology (C.B.), Valduce Hospital, Como; Merck Serono S.p.A. (A.V.), Rome; and IRCCS Ospedale Policlinico San Martino (A.L., M.P.S.), Genova, Italy.

Objective: Cladribine tablets were tested against placebo in randomized controlled trials (RCTs). In this study, the effectiveness of cladribine vs other approved drugs in patients with relapsing-remitting MS (RRMS) was compared by matching RCT to observational data.

Methods: Data from the pivotal trial assessing cladribine tablets vs placebo (CLARITY) were propensity score matched to data from the Italian multicenter database i-MuST. This database included 3,150 patients diagnosed between 2010 and 2018 at 24 Italian MS centers who started a disease-modifying drug. The annualized relapse rate (ARR) over 2 years from treatment start and the 24-week confirmed disability progression were compared between patients treated with cladribine and other approved drugs (interferon, glatiramer acetate, fingolimod, natalizumab, and dimethyl fumarate), with comparisons with placebo as a reference. Treatment effects were estimated by the inverse probability weighting negative binomial regression model for ARR and Cox model for disability progression. The treatment effect has also been evaluated according to baseline disease activity.

Results: All weighted baseline characteristics were well balanced between groups. All drugs tested had an effect vs placebo close to that detected in the RCT. Patients treated with cladribine had a significantly lower ARR compared with interferon (relapse ratio [RR] = 0.48; < 0.001), glatiramer acetate (RR = 0.49; < 0.001), and dimethyl fumarate (RR = 0.6; = 0.001); a similar ARR to that with fingolimod (RR = 0.74; = 0.24); and a significantly higher ARR than natalizumab (RR = 2.13; = 0.014), confirming results obtained by indirect treatment comparisons from RCTs (network meta-analyses). The relative effect of cladribine tablets 10 mg (cumulative dose 3.5 mg/kg over 2 years) was higher in patients with high disease activity vs all treatments except fingolimod and natalizumab. Effects on disability progression were largely nonsignificant, probably due to lack of power for such analysis.

Conclusion: In patients with RRMS, cladribine tablets showed lower ARR compared with matched patients who started interferon, glatiramer acetate, or dimethyl fumarate; was similar to fingolimod; and was higher than natalizumab. The beneficial effect of cladribine tablets was generally amplified in the subgroup of patients with high disease activity.

Classification Of Evidence: This study provides Class III evidence that for patients with RRMS, cladribine-treated patients had lower ARR compared with interferon, glatiramer acetate, or dimethyl fumarate; similar ARR compared with fingolimod; and higher ARR compared with natalizumab.
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http://dx.doi.org/10.1212/NXI.0000000000000878DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7641098PMC
November 2020

MicroRNA Expression Signature in Mild Cognitive Impairment Due to Alzheimer's Disease.

Mol Neurobiol 2020 Nov 31;57(11):4408-4416. Epub 2020 Jul 31.

Department of Advanced Medical and Surgical Sciences, University of Campania "L. Vanvitelli", Naples, Italy.

Mild cognitive impairment (MCI) defines an intermediate state between normal ageing and dementia, including Alzheimer's disease (AD). Identification of MCI subjects who will progress to AD (MCI-AD) is today of crucial importance, especially in light of the possible development of new pathogenic therapies. Several evidences suggest that miRNAs could play relevant roles in the biogenesis of AD, and the links between selected miRNAs and specific pathogenic aspects have been partly explored. In this study, we analysed the composition of microRNA transcriptome in blood, serum and cerebrospinal fluid samples from MCI-AD subjects, from an enriched small RNA library. Real-time qPCR from MCI-AD and AD patients and normal controls was performed to profile miRNA expression. In particular, four microRNAs, hsa-mir-5588-5p, hsa-mir-3658, hsa-mir-567 and hsa-mir-3908, among all selected microRNAs, are dysregulated. Hsa-mir-567 was found to be differentially expressed in cerebrospinal fluid samples, blood and serum from MCI-AD patients, showing the highest fold change and statistical significance. Target prediction analysis have been performed to evaluate mRNAs whose expression was controlled by miRNAs found to be dysregulated here, showing that hsa-mir-567 target genes are functionally active in neuronal cells. We propose that miRNA profiles found in samples from MCI-AD patients might be relevant for a better understanding of AD-related cognitive decline and could lead to set up suitable and potential biomarkers for MCI-AD progression to AD.
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http://dx.doi.org/10.1007/s12035-020-02029-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7515963PMC
November 2020

In Amyotrophic Lateral Sclerosis Blood Cytokines Are Altered, but Do Not Correlate with Changes in Brain Topology.

Brain Connect 2020 10 8;10(8):411-421. Epub 2020 Oct 8.

Institute of Applied Sciences and Intelligent Systems of National Research Council, Pozzuoli, Italy.

The present study aims at investigating the possible correlation between peripheral markers of inflammation and brain networks. Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease dominated by progressive motor impairment. Among the complex mechanisms contributing to the pathogenesis of the disease, neuroinflammation, which is associated with altered circulating cytokine levels, is suggested to play a prominent role. Based on magnetoencephalography data, we estimated topological properties of the brain networks in ALS patients and healthy controls. Subsequently, the blood levels of a subset of cytokines were assayed. Finally, we modeled the brain topological features in the function of the cytokine levels. Significant differences were found in the levels of the cytokines interleukin (IL)-4, IL-1β, and interferon-gamma (IFN-γ) between patients and controls. In particular, IL-4 and IL-1β levels increased in ALS patients, while the IFN-γ level was higher in healthy controls. We also detected modifications in brain global topological parameters in terms of hyperconnectedness. Despite both blood cytokines and brain topology being altered in ALS patients, such changes do not appear to be in a direct relationship. Our results would be in line with the idea that topological changes relate to neurodegenerative processes. However, the absence of correlation between blood cytokines and topological parameters of brain networks does not preclude that inflammatory processes contribute to the alterations of the brain networks. Impact statement The progression of amyotrophic lateral sclerosis entails both neurodegenerative and inflammatory processes. Furthermore, disease progression induces global modifications of the brain networks, with advanced stages showing a more compact, hyperconnected network topology. The pathophysiological processes underlying topological changes are unknown. In this article, we hypothesized that the global inflammatory profile would relate to the topological alterations. Our results showed that this is not the case, as modeling the topological properties as a function of the inflammatory state did not yield good predictions. Hence, our results suggest that topological changes might directly relate to neurodegenerative processes instead.
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http://dx.doi.org/10.1089/brain.2020.0741DOI Listing
October 2020

Telemedicine in Parkinson's Disease: How to Ensure Patient Needs and Continuity of Care at the Time of COVID-19 Pandemic.

Telemed J E Health 2020 12 13;26(12):1533-1536. Epub 2020 Jul 13.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli," Naples, Italy.

With the spread of the SARS-CoV2 pandemic, telemedicine has become the safest way to guarantee care continuity, especially for chronic disabling diseases requiring frequent medical consultations and therapeutic adjustments, such as Parkinson's disease (PD). The age-related prevalence of PD, combined with increased vulnerability due to age-related comorbidities, makes PD patients protection a priority. We reviewed potentials and limitations of teleneurology in PD and suggested a specific battery of tests, including patient-reported outcomes, smartphone applications, and neurological examination through telemedicine. These tools can provide full neurological consultations, with the engagement of both patients and caregivers, and can support clinicians in defining whether patients need to access diagnostic and therapeutic procedures. Telemedicine will also carry a value in the future, within conventional health care, to support clinicians in decision making, enabling more efficacious follow-up, reducing burden for caregivers, and delivering neurological expertise to local realities. These advantages are very important when there is physical distance between patients and neurologists, and when patients are not recommended to attend in-person consultations.
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http://dx.doi.org/10.1089/tmj.2020.0184DOI Listing
December 2020

Nabiximols discontinuation rate in a large population of patients with multiple sclerosis: a 18-month multicentre study.

J Neurol Neurosurg Psychiatry 2020 09 13;91(9):914-920. Epub 2020 Jul 13.

Department of Medical Sciences, Università degli Studi di Cagliari, Cagliari, Sardegna, Italy.

Introduction: Delta-δ-tetrahydrocannabinol and cannabidiol (THC:CBD) oromucosal spray is used as an add-on therapy option for moderate to severe multiple sclerosis (MS) spasticity resistant to other medications. Aims of this study were to provide real-life data on long-term clinical outcomes in a large population of Italian patients treated with THC:CBD and to evaluate predictors of THC:CBD therapy continuation.

Materials And Methods: This prospective observational multicentre Italian study screened all patients with MS consecutively included in the Agenzia Italiana del Farmaco e-registry at the start of THC:CBD treatment (baseline), after 4 weeks (T1), 12±3 weeks (T2), 24±3 weeks (T3), 48±3 weeks (T4) and 72±3 weeks (T5) from baseline.

Results: A total of 1845 patients were recruited from 32 MS Italian centres. At T1, 1502 (81.4%) of patients reached a Numerical Rating Scale (NRS) improvement of ≥20%, with an NRS reduction of 26.9% at T1 and of 34.4% at T5. At T5, 725 patients (48.3% of 1502) discontinued treatment with highest discontinuation rate at T2 and T3. Daily number of puffs was generally stable through the observation period. The multivariate analysis showed that higher NRS scores at baseline (OR 2.28, 95% CI 1.15 to 6.36, p<0.01) and higher differences of NRS between T0 and T1 (OR 2.11, 95% CI 1.08 to 8.26, p<0.05) were associated with an increased probability to continue therapy after 18 months.

Discussion: THC:CBD effects were sustained for 18 months with a relatively stable number of puffs per day. About 50% of patients abandoned THC:CBD therapy for loss of efficacy or adverse events.
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http://dx.doi.org/10.1136/jnnp-2019-322480DOI Listing
September 2020

Sex effects across the lifespan in women with multiple sclerosis.

Ther Adv Neurol Disord 2020 1;13:1756286420936166. Epub 2020 Jul 1.

Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Bochum, Germany.

Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating central nervous system disorder that is more common in women, with onset often during reproductive years. The female:male sex ratio of MS rose in several regions over the last century, suggesting a possible sex by environmental interaction increasing MS risk in women. Since many with MS are in their childbearing years, family planning, including contraceptive and disease-modifying therapy (DMT) counselling, are important aspects of MS care in women. While some DMTs are likely harmful to the developing fetus, others can be used shortly before or until pregnancy is confirmed. Overall, pregnancy decreases risk of MS relapses, whereas relapse risk may increase postpartum, although pregnancy does not appear to be harmful for long-term prognosis of MS. However, ovarian aging may contribute to disability progression in women with MS. Here, we review sex effects across the lifespan in women with MS, including the effect of sex on MS susceptibility, effects of pregnancy on MS disease activity, and management strategies around pregnancy, including risks associated with DMT use before and during pregnancy, and while breastfeeding. We also review reproductive aging and sexual dysfunction in women with MS.
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http://dx.doi.org/10.1177/1756286420936166DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7331774PMC
July 2020

Are patients with multiple sclerosis (MS) at higher risk of COVID-19 infection?

Neurol Sci 2020 09 7;41(9):2315-2316. Epub 2020 Jul 7.

Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Piazza Miraglia, 2, 80138, Naples, Italy.

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http://dx.doi.org/10.1007/s10072-020-04570-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7340752PMC
September 2020

The Use of Social Media and Digital Devices Among Italian Neurologists.

Front Neurol 2020 16;11:583. Epub 2020 Jun 16.

Second Division of Neurology, Department of Advanced Medical and Surgical Sciences, MRI Research Center SUN-FISM, AOU - University of Campania "Luigi Vanvitelli", Naples, Italy.

Digital devices and online social networks are changing clinical practice. In this study, we explored attitudes, awareness, opinions, and experiences of neurologists toward social media and digital devices. Each member of the Italian Society of Neurology (SIN) participated in an online survey (January to May 2018) to collect information on their attitude toward digital health. Four hundred and five neurologists participated in the study. At work, 95% of responders use the personal computer, 87% the smartphone, and 43.5% the tablet. These devices are used to obtain health information (91%), maintain contact with colleagues (71%), provide clinical information (59%), and receive updates (67%). Most participants (56%) use social media to communicate with patients, although 65% are against a friendship with them on social media. Most participants interact with patients on social media outside working hours (65.2%) and think that social media have improved (38.0%) or greatly improved (25.4%) the relationship with patients. Most responders (66.7%) have no wearable devices available in clinical practice. Italian neurologists have different practices and views regarding the doctor-patient relationship in social media. The availability of digital devices in daily practice is limited. The use of social networks and digital devices will increasingly permeate into everyday life, bringing a new dimension to health care. The danger is that advancement will not go hand in hand with a legal and cultural adaptation, thus creating ambiguity and risks for clinicians and patients. Neurologists will need to be able to face the opportunities and challenges of this new scenario.
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http://dx.doi.org/10.3389/fneur.2020.00583DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7308485PMC
June 2020

Dementia care and COVID-19 pandemic: a necessary digital revolution.

Neurol Sci 2020 Aug 17;41(8):1977-1979. Epub 2020 Jun 17.

Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, II Clinic of Neurology, University of Campania "Luigi Vanvitelli", Naples, Italy.

Due to the COVID-19 pandemic, most memory clinics have had to suspend their activities. On the other hand, international dementia experts have recommended to provide urgently worldwide support for people living with dementia. This situation urges to play out new strategies to guarantee adequate care. Telemedicine and digital technology (DT) devices, such as smartphones, can be very helpful in remote monitoring and care. Technological devices such as videoconference or smartphone apps might be used for follow-up visits and support to patients and caregivers and to acquire digital markers of clinical progression. Hopefully, this dramatic situation would facilitate the process of progressive familiarization of neurologists with telemedicine and DT approach.
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http://dx.doi.org/10.1007/s10072-020-04512-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7298162PMC
August 2020

Multidimensional assessment of the effects of erenumab in chronic migraine patients with previous unsuccessful preventive treatments: a comprehensive real-world experience.

J Headache Pain 2020 Jun 9;21(1):69. Epub 2020 Jun 9.

Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, Headache Center, University of Campania "Luigi Vanvitelli", Piazza Miraglia 2 - I, 80138, Naples, Italy.

Background: erenumab was safe and effective in clinical trials for the prevention of migraine. However, real-life data are still lacking. Here we report the clinical experience from an Italian real-world setting using erenumab in patients with chronic migraine experiencing previous unsuccessful preventive treatments.

Methods: Seventy patients with chronic migraine and failure to ≥4 migraine preventive medication classes initially received monthly erenumab 70 mg s.c. Patients without a clinically meaningful improvement, considered as a > 30% reduction in headache days per month, after ≥3 months of therapy switched to monthly erenumab 140 mg. At the first administration and after 3 and 6 months, patients underwent extensive interviews to assess clinical parameters of disease severity and migraine-related disability and impact, and validated questionnaires to explore depression/anxiety, sleep, and quality of life (QoL). Finally, the Pain Catastrophizing Scale, Allodynia Symptom Checklist-12 and MIGraine attacks-Subjective COGnitive impairments scale (MIG-SCOG) were administered.

Results: 70% of patients were "responders" after the third administration of erenumab 70 mg, whereas 30% switched to erenumab 140 mg; 29% (6 pts) responded after the sixth administration. The headache-day frequency was reduced from 21.1 ± 0.7 to 11.4 ± 0.9 days after the third administration (p < 0.001) and to 8.9 ± 0.7 days after the sixth administration (p < 0.001). 53% and 70% of patients, respectively, showed a reduction of ≥50% of headache days/month after the third and the sixth administrations. Also improved were headache pain severity, migraine-related disability, and impact on daily living, QoL, pain catastrophizing and allodynia (all p < 0.001), quality of sleep, symptoms of depression or anxiety (p < 0.05) but not MIG-SCOG. There were no new adverse event signals.

Conclusion: These real-world data support monthly erenumab 70 or 140 mg s.c. as a safe and effective preventive treatment to reduce headache frequency and severity in chronic migraine patients experiencing previous unsuccessful preventive treatments.
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http://dx.doi.org/10.1186/s10194-020-01143-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7282180PMC
June 2020

Dimethyl fumarate vs Teriflunomide: an Italian time-to-event data analysis.

J Neurol 2020 Oct 6;267(10):3008-3020. Epub 2020 Jun 6.

Department "G.F. Ingrassia", MS Center University of Catania, Policlinico G. Rodolico, V. Santa Sofia 78, 95123, Catania, Italy.

Background: The introduction of oral disease-modifying therapies (DMTs) for relapsing-remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment.

Objectives: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients.

Materials And Methods: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were "time-to-first-relapse", "time-to-Magnetic-Resonance-Imaging (MRI)-activity" and "time-to-disability-progression".

Results: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p < .05) at baseline. Time-varying Cox-model for the event "time-to-first relapse" revealed that no differences were found between the two groups in the first 38 months of treatment (HR = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HR = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression.

Conclusions: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months on therapy.
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http://dx.doi.org/10.1007/s00415-020-09959-1DOI Listing
October 2020