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1. Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies

Author

Sormani M. P., Schiavetti I., Carmisciano L., Inglese M., Laroni A., Lapucci C., Uccelli A., Da Rin G., Serrati C., Gandoglia I., Tassinari T., Perego G., Brichetto G., Gazzola P., Mannironi A., Stromillo M. L., Cordioli C., Landi D., Clerico M., Signoriello E., Frau J., Ferro M. T., Di Sapio A., Pasquali L., Ulivelli M., Marinelli F., Callari G., Iodice R., Liberatore G., Caleri F., Repice A. M., Cordera S., Battaglia M. A., Salvetti M., Franciotta D., Maglione A., Signori A., Iovino A., Nicoletti C. G., Mancinelli C. R., Bezzini D., Carmagnini D., Brogi D., Orazio E. N., Cocco E., Nako E., Assandri E., Baldi F., Ansaldi F., Bovis F., Siciliano G., Cola G., Lus G., Icardi G., bellucci G., Rin G. D., Marfia G. A., Vazzoler G., Trivelli G., Maietta I., Sticchi L., Lorefice L., Ruggiero L., Manzino M., Bragadin M. M., Buscarinu M. C., Gagliardi M., Rilla M. T., Ponzano M., Fronza M., Sette M. D., Scialabba M., Bedognetti M., De Rossi N., De Stefano N., Bigi R., Dubbioso R., Renie R., Fabbri S., Rasia S., Rolla S., Platzgummer S., Carlini V., Sormani, M. P., Schiavetti, I., Carmisciano, L., Inglese, M., Laroni, A., Lapucci, C., Uccelli, A., Da Rin, G., Serrati, C., Gandoglia, I., Tassinari, T., Perego, G., Brichetto, G., Gazzola, P., Mannironi, A., Stromillo, M. L., Cordioli, C., Landi, D., Clerico, M., Signoriello, E., Frau, J., Ferro, M. T., Di Sapio, A., Pasquali, L., Ulivelli, M., Marinelli, F., Callari, G., Iodice, R., Liberatore, G., Caleri, F., Repice, A. M., Cordera, S., Battaglia, M. A., Salvetti, M., Franciotta, D., Maglione, A., Signori, A., Iovino, A., Nicoletti, C. G., Mancinelli, C. R., Bezzini, D., Carmagnini, D., Brogi, D., Orazio, E. N., Cocco, E., Nako, E., Assandri, E., Baldi, F., Ansaldi, F., Bovis, F., Siciliano, G., Cola, G., Lus, G., Icardi, G., Bellucci, G., Rin, G. D., Marfia, G. A., Vazzoler, G., Trivelli, G., Maietta, I., Sticchi, L., Lorefice, L., Ruggiero, L., Manzino, M., Bragadin, M. M., Buscarinu, M. C., Gagliardi, M., Rilla, M. T., Ponzano, M., Fronza, M., Sette, M. D., Scialabba, M., Bedognetti, M., De Rossi, N., De Stefano, N., Bigi, R., Dubbioso, R., Renie, R., Fabbri, S., Rasia, S., Rolla, S., Platzgummer, S., and Carlini, V.

Subjects
Oncology, Male, Medicine (General), COVID-19 Vaccine, Immunosuppressive Agent, Multiple Sclerosi, Monoclonal, Prospective Studies, Humanized, biology, Coronavirus, Immunomodulatory therapies, Multiple sclerosis, General Medicine, Middle Aged, 2019-nCoV Vaccine mRNA-1273, Adult, Antibodies, Monoclonal, Humanized, Antibody Formation, BNT162 Vaccine, COVID-19, COVID-19 Vaccines, Cladribine, Female, Fingolimod Hydrochloride, Humans, Immunosuppressive Agents, Italy, Multiple Sclerosis, Rituximab, Treatment Outcome, Fingolimod, Vaccination, Immunomodulatory therapie, Medicine, Antibody, medicine.drug, Human, medicine.medical_specialty, Coronaviru, Context (language use), Settore MED/26, Article, General Biochemistry, Genetics and Molecular Biology, Antibodies, R5-920, Antigen, Internal medicine, medicine, business.industry, medicine.disease, Prospective Studie, biology.protein, Ocrelizumab, business
Abstract

Background: In patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) affects immune response to antigens. Therefore, post-vaccination serological assessments are needed to evaluate the effect of the vaccine on SARS-CoV-2 antibody response. Methods: We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination with mRNA vaccines (BNT162b2, Pfizer/BioNTech,Inc or mRNA-1273, Moderna Tx,Inc). A blood collection before the first vaccine dose and 4 weeks after the second dose was planned, with a centralized serological assessment (electrochemiluminescence immunoassay, ECLIA, Roche-Diagnostics). The log-transform of the antibody levels was analyzed by multivariable linear regression. Findings: 780 pwMS (76% BNT162b2 and 24% mRNA-1273) had pre- and 4-week post-vaccination blood assessments. 87 (11·2%) were untreated, 154 (19·7%) on ocrelizumab, 25 (3·2%) on rituximab, 85 (10·9%) on fingolimod, 25 (3·2%) on cladribine and 404 (51·7%) on other DMTs. 677 patients (86·8%) had detectable post-vaccination SARS-CoV-2 antibodies. At multivariable analysis, the antibody levels of patients on ocrelizumab (201-fold decrease (95%CI=128–317), p < 0·001), fingolimod (26-fold decrease (95%CI=16–42), p < 0·001) and rituximab (20-fold decrease (95%CI=10–43), p < 0·001) were significantly reduced as compared to untreated patients. Vaccination with mRNA-1273 resulted in a systematically 3·25-fold higher antibody level (95%CI=2·46–4·27) than with the BNT162b2 vaccine (p < 0·001). The antibody levels on anti-CD20 therapies correlated to the time since last infusion, and rituximab had longer intervals (mean=386 days) than ocrelizumab patients (mean=129 days). Interpretation: In pwMS, anti-CD20 treatment and fingolimod led to a reduced humoral response to mRNA-based SARS-CoV-2 vaccines. As mRNA-1273 elicits 3·25-higher antibody levels than BNT162b2, this vaccine may be preferentially considered for patients under anti-CD20 treatment or fingolimod. Combining our data with those on the cellular immune response to vaccines, and including clinical follow-up, will contribute to better define the most appropriate SARS-CoV-2 vaccine strategies in the context of DMTs and MS. Funding: FISM[2021/Special-Multi/001]; Italian Ministry of Health‘Progetto Z844A 5 × 1000′.

Published
2021

2. MRI quality control for the Italian Neuroimaging Network Initiative: moving towards big data in multiple sclerosis

Author

Storelli, L., Rocca, M. A., Pantano, P., Pagani, E., De Stefano, N., Tedeschi, G., Zaratin, P., Filippi, M., Valsasina, P., Sibilia, M., Preziosa, P., Gallo, A., Bisecco, A., Docimo, R., Petsas, N., Ruggieri, S., Tommasin, S., Stromillo, M. L., Brocci, R. T., Storelli, L, Rocca, Ma, Pantano, P, Pagani, E, De Stefano, N, Tedeschi, G, Zaratin, P, Filippi, M, on behalf of the INNI, Network, Storelli, L., Rocca, M. A., Pantano, P., Pagani, E., De Stefano, N., Tedeschi, G., Zaratin, P., Filippi, M., Valsasina, P., Sibilia, M., Preziosa, P., Gallo, A., Bisecco, A., Docimo, R., Petsas, N., Ruggieri, S., Tommasin, S., Stromillo, M. L., and Brocci, R. T.

Subjects
Adult, Big Data, Male, Quality Control, Multiple Sclerosis, Datasets as Topic, Neuroimaging, Fluid-attenuated inversion recovery, White matter, Big data, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Magnetic resonance imaging (MRI), 030212 general & internal medicine, Neuroradiology, business.industry, Multiple sclerosis, Isocenter, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Multiple sclerosis (MS), Image contrast, Italian Neuroimaging Network Initiative (INNI), Female, Italy, medicine.anatomical_structure, Neurology, Neurology (clinical), Nuclear medicine, business, 030217 neurology & neurosurgery
Abstract

The Italian Neuroimaging Network Initiative (INNI) supports the creation of a repository, where MRI, clinical, and neuropsychological data from multiple sclerosis (MS) patients and healthy controls are collected from Italian Research Centers with internationally recognized expertise in MRI applied to MS. However, multicenter MRI data integration needs standardization and quality control (QC). This study aimed to implement quantitative measures for characterizing the standardization and quality of MRI collected within INNI. MRI scans of 423 MS patients, including 3D T1- and T2-weighted, were obtained from INNI repository (from Centers A, B, C, and D). QC measures were implemented to characterize: (1) head positioning relative to the magnet isocenter; (2) intensity inhomogeneity; (3) relative image contrast between brain tissues; and (4) image artefacts. Centers A and D showed the most accurate subject positioning within the MR scanner (median z-offsets = − 2.6 ± 1.7cm and − 1.1 ± 2cm). A low, but significantly different, intensity inhomogeneity on 3D T1-weighted MRI was found between all centers (p < 0.05), except for Centers A and C that showed comparable image bias fields. Center D showed the highest relative contrast between gray and normal appearing white matter (NAWM) on 3D T1-weighed MRI (0.63 ± 0.04), while Center B showed the highest relative contrast between NAWM and MS lesions on FLAIR (0.21 ± 0.06). Image artefacts were mainly due to brain movement (60%) and ghosting (35%). The implemented QC procedure ensured systematic data quality assessment within INNI, thus making available a huge amount of high-quality MRI to better investigate pathophysiological substrates and validate novel MRI biomarkers in MS.

Published
2019

3. Deep Gray Matter Volume Loss

Author

Eshaghi, Arman, Prados, Ferran, Brownlee, Wallace J., Altmann, Daniel R., Tur, Carmen, Cardoso, M. Jorge, De Angelis, Floriana, van de Pavert, Steven H., Cawley, Niamh, De Stefano, Nicola, Stromillo, M. Laura, Battaglini, Marco, Ruggieri, Serena, Gasperini, Claudio, Filippi, Massimo, Rocca, Maria A., Rovira, Alex, Sastre‐Garriga, Jaume, Vrenken, Hugo, Leurs, Cyra E., Killestein, Joep, Pirpamer, Lukas, Enzinger, Christian, Ourselin, Sebastien, Wheeler‐Kingshott, Claudia A.M. Gandini, Chard, Declan, Thompson, Alan J., Alexander, Daniel C., Barkhof, Frederik, Ciccarelli, Olga, Eshaghi, Arman, Prados, Ferran, Brownlee, Wallace J., Altmann, Daniel R., Tur, Carmen, Cardoso, M. Jorge, De Angelis, Floriana, van de Pavert, Steven H., Cawley, Niamh, De Stefano, Nicola, Stromillo, M. Laura, Battaglini, Marco, Ruggieri, Serena, Gasperini, Claudio, Filippi, Massimo, Rocca, Maria A., Rovira, Alex, Sastre-Garriga, Jaume, Vrenken, Hugo, Leurs, Cyra E., Killestein, Joep, Pirpamer, Luka, Enzinger, Christian, Ourselin, Sebastien, Wheeler-Kingshott, Claudia A. M. Gandini, Chard, Declan, Thompson, Alan J., Alexander, Daniel C., Barkhof, Frederik, Ciccarelli, Olga, Radiology and nuclear medicine, Amsterdam Neuroscience - Neuroinfection & -inflammation, Neurology, AII - Inflammatory diseases, and NCA - Neuroinflamation

Subjects
Adult, Male, Brain, grey matter, Neuroimaging, Middle Aged, Neurology, Neurology (clinical), multiple sclerosis, Magnetic Resonance Imaging, Disability Evaluation, disability, Image Interpretation, Computer-Assisted, Disease Progression, Humans, Female, Longitudinal Studies, Atrophy, Gray Matter, Research Articles, brain atrophy, Research Article, Retrospective Studies
Abstract

Objective: Gray matter (GM) atrophy occurs in all multiple sclerosis (MS) phenotypes. We investigated whether there is a spatiotemporal pattern of GM atrophy that is associated with faster disability accumulation in MS. Methods: We analyzed 3,604 brain high-resolution T1-weighted magnetic resonance imaging scans from 1,417 participants: 1,214 MS patients (253 clinically isolated syndrome [CIS], 708 relapsing-remitting [RRMS], 128 secondary-progressive [SPMS], and 125 primary-progressive [PPMS]), over an average follow-up of 2.41 years (standard deviation [SD] = 1.97), and 203 healthy controls (HCs; average follow-up = 1.83 year; SD = 1.77), attending seven European centers. Disability was assessed with the Expanded Disability Status Scale (EDSS). We obtained volumes of the deep GM (DGM), temporal, frontal, parietal, occipital and cerebellar GM, brainstem, and cerebral white matter. Hierarchical mixed models assessed annual percentage rate of regional tissue loss and identified regional volumes associated with time-to-EDSS progression. Results: SPMS showed the lowest baseline volumes of cortical GM and DGM. Of all baseline regional volumes, only that of the DGM predicted time-to-EDSS progression (hazard ratio = 0.73; 95% confidence interval, 0.65, 0.82; p < 0.001): for every standard deviation decrease in baseline DGM volume, the risk of presenting a shorter time to EDSS worsening during follow-up increased by 27%. Of all longitudinal measures, DGM showed the fastest annual rate of atrophy, which was faster in SPMS (–1.45%), PPMS (–1.66%), and RRMS (–1.34%) than CIS (–0.88%) and HCs (–0.94%; p < 0.01). The rate of temporal GM atrophy in SPMS (–1.21%) was significantly faster than RRMS (–0.76%), CIS (–0.75%), and HCs (–0.51%). Similarly, the rate of parietal GM atrophy in SPMS (–1.24-%) was faster than CIS (–0.63%) and HCs (–0.23%; all p values

Published
2018
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4. Efficacy and Safety of Intravenous Immunoglobulin Treatment in Refractory Behcet's Disease with Different Organ Involvement: A Case Series

Author

Cantarini, L., Stromillo, M. L., Vitale, A., Lopalco, G., Emmi, G., Silvestri, E., Federico, A., Galeazzi, M., Iannone, F., and Nicola De Stefano

Subjects
Adult, Male, Behcet Syndrome, Drug Resistance, Immunoglobulins, Intravenous, Middle Aged, Severity of Illness Index, Treatment Outcome, Antirheumatic Agents, HLA-B51 Antigen, Secondary Prevention, Humans, Administration, Intravenous, Female, Symptom Assessment
Abstract

Behçet's disease (BD) is a multi-systemic disorder of unknown etiology characterized by relapsing oral-genital ulcers, uveitis, and involvement of the articular, gastrointestinal, neurologic, and vascular systems. The choice of treatment is based on the severity of systemic involvement, clinical presentation and the site affected, and includes corticosteroids, azathioprine, interferon, cyclophosphamide, methotrexate or tumor necrosis factor-alpha and interleukin-1 blockers. We present a case series of four refractory BD patients successfully treated with intravenous immunoglobulins (IVIG). All patients fulfilled International Study Group criteria. The patients' mean age was 38.75 ± 12.09 years and mean disease duration 10.25 ± 8.5 years. Human leukocyte antigen B51 was positive in two of four patients. In addition to oral aphthosis, all patients suffered from genital ulcers and cutaneous BD-related manifestations; central nervous system involvement and arthralgia were found in two patients. Peripheral nervous system, gastrointestinal and eye involvement occurred in 25% of cases. In all patients, previously treated according to EULAR recommendations without reaching satisfactory results, IVIG induced immediate and sustained response over time without incurring any side effects. We propose IVIG administration as an additional effective and safe treatment option in patients with severe and resistant BD.

Published
2016

5. The Italian multicenter observational study on post-stroke depression (DESTRO)

Author

Paolucci, S. T., Gandolfo, C., Provinciali, L., Torta, R., TOSO AND ON THE BEHALF OF THE DESTRO STUDY GROUP, V., Lagalla, THE DESTRO STUDY GROUP INCLUDES G., Manicone, M. G., Del, M., Gobbo, Paolini, S., Ancona, Bottacchi, E., Corso, G., Aosta, Federico, F., Martino, D, Bari, Salsa, F., Turinese, E., BASSANO DEL GRAPPA VI, Gentile, M., Bogo, S., Belluno, Crisci, M., Sacquegna, T., Bologna, Santamato, V., Pietrarossa, G., Carbonara, Ba, Coppola, G., Toni, V., Trianni, G., Casarano, Le, Pennisi, Giovanni, Bella, Rita, Catania, Ricci, S., Amantini, K., Città, DELLA PIEVE PG, Buzzelli, S., DI FRANCESCO, L., ANGELO PE, CITTÀ S., Antonelli, B, Pelliccia, G., Fermo, Ap, Paolino, E., Iezzi, E., Ferrara, P, Nencini, Sarti, C., Florence, Neri, W., Galletti, G., Forli, Pretta, S., Sette, Genoa, Giaccaglini, E., Sconocchini, C., Iesi, An, Carolei, A., Capannolo, C, Laquila, Musolino, R., Gangemi, S., Vita, G., DI LEO, R., Messina, Comola, M., Mammi, S., Zamperetti, M. A., Defanti, C. A., Milan, DE FALCO, F. A., Santangelo, R., Scarano, V., Naples, M. T, Giordana, Sciolla, R., Orbassano, To, Meneghetti, G., Ottina, M., Padua, Ponari, A., Castiglia, R., Palermo, Mancia, D., Zanferrari, C., Parma, Micieli, G., Zambrelli, E., Pavia, Cardaioli, G., Gallai, V., Perugia, Badino, R., Tassinari, T., PIETRA LIGURE SV, Orlandi, G., Fanucchi, S., Pisa, Ciucci, G., Padoan, G., Ravenna, Gasparini, F., Guidetti, D., Reggio, Emilia, DE ANGELIS, D., Amabile, G. A., Fiermonte, G., Rome, Roberti, C., Foti, A., Roma, Cainelli, L., Chiusole, M., Rovereto, Tn, Pasqualino, S., Intiso, D., GIOVANNI ROTONDO FG, S., Tonizzo, M., Basile, A., VITO AL, S., Tagliamento, Pn, Viviani, P., SANT ARSENIO SA, Stromillo, M. L., Federico, A, Siena, Liboni, W., Pavanelli, E., Bergamasco, B., Cerrato, P., Boghi, A, Cicolin, A., Berra, C., Turin, Zorzon, M., Tommasi, M. A., Chiodo, F., Grandi, Koscica, N., Trieste, Micoli, B., Lorio, R., Venice, Bovi, P., Trabucco, G., Verona, Consoli, D., Galati, F., and Vibo, Valentia

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Time Factors, Adolescent, Personality Inventory, Physical examination, Observation, Disability Evaluation, Quality of life, medicine, History of depression, Post-stroke depression, Humans, Psychiatry, Stroke, Depression (differential diagnoses), Aged, Retrospective Studies, Aged, 80 and over, Psychiatric Status Rating Scales, Chi-Square Distribution, medicine.diagnostic_test, Depression, Beck Depression Inventory, Retrospective cohort study, Middle Aged, medicine.disease, Neurology, Italy, Female, Neurology (clinical), Psychology
Abstract

Despite growing information, questions still surround various aspects of post-stroke depression (PSD). The Italian multicenter observational study Destro was designed to help clarify in a large sample the frequency and clinical impact of PSD. A total of 53 centers consecutively admitted 1064 patients with ischemic or hemorrhagic stroke, assessing them periodically in the first 9 months after the event. Patients with depression were followed for two years. Depression was diagnosed on clinical examination, verbal (Beck Depression Inventory) and non-verbal rating systems (Visual Analog Mood Scale), identifying the nosographic condition attributable to the mental state. The patient's clinical history, residual independence, and post-ictus quality of life were also taken into account. PSD was detected in 383 patients (36 %), most of whom had minor depression (80.17 %), with dysthymia, rather than major depression and adaptation disorder. About 80% developed depression within three months of the stroke. Cases with later onset tended to have less severe symptoms. Risk factors were a history of depression, severe disability, previous stroke and female sex, but not the type and site of the vascular lesion. PSD was not correlated with any increase in mortality or cerebrovascular recurrences, but these patients had lower autonomy and quality of life ratings. In conclusion, patients should be close observed in the first few weeks after a stroke in order to check for depression,which is more likely in those with clear risk factors and may spoil their quality of life.

Published
2006

6. Quantification of the risk of post stroke depression : the Italian multicenter observational study DESTRO

Author

Paolucci, S., Gandolfo, C., Provinciali, L., Torta, R., SOMMACAL ON BEHALF OF, S., DESTRO STUDY GROUP AND, Lagalla, V. TOSOPARTICIPANTS IN THE DESTRO STUDY INCLUDE G., M. G, Manicone, DEL GOBBO, M., Paolini, S., Ancona, Bottacchi, E., Corso, G., Aosta, Federico, F., Martino, D., Bari, Salsa, F., Turinese, E, BASSANO DEL GRAPPA VI, Gentile, M., Bogo, S., Belluno, Crisci, M., Sacquegna, T., Bologna, Santamato, V., Pietrarossa, G, Carbonara, Ba, Coppola, G., Toni, V., Trianni, G, Casarano, Le, Pennisi, Giovanni, Bella, Rita, Catania, S, Ricci, Amantini, K., CITTA DELLA PIEVE PG, Buzzelli, S., Di, L., Francesco, ANGELO PE, CITTA S., Antonelli, B., Pelliccia, G., Fermo, Ap, Paolino, E., Iezzi, E., Ferrara, Nencini, P., Sarti, C., Florence, Neri, W., Galletti, G., Forli, Pretta, S., DEL SETTE, M., Genoa, Giaccaglini, E., Sconocchini, C., Iesi, An, Carolei, A., Capannolo, C., Laquila, Musolino, R., Gangemi, S., Vita, G., DI LEO, R., Messina, Comola, M., Mammi, S., Zamperetti, M. A., Defanti, C. A., Grassivaro, N., Rudelli, G., Milan, F. A., De, Falco, Santangelo, R., Scarano, V., Naples, M. T, Giordana, Sciolla, R., Orbassano, To, Meneghetti, G., Ottina, M, Padua, Ponari, A., Castiglia, R., Palermo, Mancia, D., Zanferrari, C, Parma, Micieli, G., Zambrelli, E., Pavia, Cardaioli, G., Gallai, V., Perugia, Badino, R., Tassinari, T., Pietra, Ligure, Orlandi, G., Fanucchi, S., Pisa, Ciucci, G., Padoan, G., Ravenna, Gasparini, F., Guidetti, D., Reggio, Emilia, De, D., Angelis, Amabile, G. A., FIERMONTE ROME, G., Roberti, C., Foti, A, Roma, Cainelli, L., Chiusole, M., Rovereto, Tn, Pasqualino, S, Intiso, D., GIOVANNI ROTONDO FG, S., Tonizzo, M., Basile, A., VITO AL TAGLIAMENTO PN, S., Viviani, P., Santarsenio, Sa, Stromillo, M. L., Federico, A., Siena, W, Liboni, Pavanelli, E., Bergamasco, B., Cerrato, P., Boghi, A., Cicolin, A, Berra, C., Turin, Zorzon, M., Tommasi, M. A., F, Chiodo, Grandi, Koscica, N., Trieste, Micoli, B., Lorio, R., Venice, Bovi, P., Trabucco, G., Verona, Consoli, D., Galati, F., Vibo, Valentia, Bortolon, F., Morra, M., Vicenza, and Crespi, V.

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Multivariate analysis, Adolescent, Sex Factors, Risk Factors, mental disorders, medicine, Humans, Disabled Persons, Risk factor, Stroke, Depression (differential diagnoses), Aged, Aged, 80 and over, Psychiatric Status Rating Scales, Depression, business.industry, Beck Depression Inventory, Middle Aged, medicine.disease, Psychiatry and Mental health, Mood, Italy, Relative risk, Physical therapy, Female, Observational study, business, Follow-Up Studies
Abstract

Objective: The Italian multicenter observational study depression in stroke (DESTRO) aimed to identify risk factors for poststroke depression (PSD) and quantify the likelihood of it arising in various categories of patients. Method: Mood evaluation was performed in 1064 consecutive stroke patients by means of Beck Depression Inventory and Visual Analog Mood Scale. Depressive symptoms were classified using the DSM-IV and revised WHO criteria for depression in the course of a neurological disorder. Results: Poststroke depression was seen in 36% of the survivors, with dysthymia by far the predominant form (80.7%). Female sex, disability, previous cerebrovascular or depressive episodes were significantly associated with an increased risk of depression. Combinations of these factors raised the risk of PSD exponentially, from 24.3 to 89.1%. The site of the stroke did not come into the uni- or multivariate analysis. Conclusion.: At admission, it is possible to predict the likelihood of PSD and quantify the relative risk.

Published
2005

7. Validation of the DYMUS questionnaire for the assessment of dysphagia in multiple sclerosis

Author

Bergamaschi, R., Rezzani, C., Minguzzi, S., Amato, M. P., Patti, F., Marrosu, M. G., Bonavita, S., Grasso, M. G., Ghezzi, A., Rottoli, M., Gasperini, C., Restivo, D., Maimone, D., Rossi, P., Stromillo, M. L., Cristina Montomoli, Solaro, C., Romani, A., Bargiggia, V., Crivelli, P., Tavazzi, E., Zipoli, V., Giannini, M., Portaccio, E., Hakiki, B., D Amico, E., Cocco, E., Frau, J., Lorefice, L., Della Corte, M., Finamore, L., Annovazzi, P., Galgani, S., Judica, E., and Stefano, N.

Subjects
Adult, Male, Multiple Sclerosis, Adolescent, Reproducibility of Results, Middle Aged, Severity of Illness Index, Disability Evaluation, Young Adult, Surveys and Questionnaires, Humans, Female, Child, Deglutition Disorders, Factor Analysis, Statistical, Aged
Abstract

Swallowing problems can complicate the course of multiple sclerosis (MS). However, no validated questionnaire for the assessment of dysphagia in MS is currently available. We previously developed a 10-item DYsphagia in Multiple Sclerosis questionnaire (DYMUS). In the present study, this questionnaire was submitted to a validation process. Thirteen Italian MS centres took part in this research in which DYMUS was administered to 1734 consecutive MS patients during routine checkups outside relapse. The questionnaire showed very good internal consistency (Cronbach's alpha = 0.914). It was then subdivided into two subscales, both of which also showed very good internal consistency: Cronbach's alpha was 0.885 for the 'dysphagia for solids' subscale and 0.864 for the 'dysphagia for liquids' subscale. The DYMUS questionnaire was found to be an easy and reliable tool for detecting dysphagia and also for the preliminary selection of patients requiring more specific instrumental analyses, and those suitable for aspiration prevention programmes.

8. Clinical activity after fingolimod cessation: Disease reactivation or rebound?

Author

S La Gioia, B Forci, Sabrina Realmuto, Pietro Annovazzi, Arianna Sartori, Roberta Grasso, Cinzia Cordioli, M. L. Stromillo, R Lanzillo, B. Frigeni, Eleonora Cocco, Elisabetta Signoriello, Alessio Signori, Sandro Rossi, Giuseppe Fenu, M. P. Sormani, Damiano Baroncini, G. T. Maniscalco, Sarah Rasia, Jessica Frau, Frau, J., Sormani, M. P., Signori, A., Realmuto, S., Baroncini, D., Annovazzi, P., Signoriello, E., Maniscalco, G. T., La Gioia, S., Cordioli, C., Frigeni, B., Rasia, S., Fenu, G., Grasso, R., Sartori, A., Lanzillo, R., Stromillo, M. L., Rossi, S., Forci, B., Cocco, E., Frau, J, Sormani, M P, Signori, A, Realmuto, S, Baroncini, D, Annovazzi, P, Signoriello, E, Maniscalco, G T, La Gioia, S, Cordioli, C, Frigeni, B, Rasia, S, Fenu, G, Grasso, R, Sartori, A, Lanzillo, R, Stromillo, M L, Rossi, S, Forci, B, and Cocco, E

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Disease, Cohort Studies, Multiple sclerosis, Immunosuppressive Agent, Young Adult, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Recurrence, Internal medicine, Humans, Medicine, 030212 general & internal medicine, Fingolimod, Reactivation, Rebound, Neurology, Neurology (clinical), Natural course, Fingolimod Hydrochloride, business.industry, medicine.disease, Magnetic Resonance Imaging, Discontinuation, Italy, Withholding Treatment, multiple sclerosi, Cohort, Female, Cohort Studie, business, Immunosuppressive Agents, 030217 neurology & neurosurgery, Human, medicine.drug
Abstract

Background and purpose There is debate as to whether the apparent rebound after fingolimod discontinuation is related to the discontinuation itself or whether it is due to the natural course of highly active multiple sclerosis (MS). Our aim was to survey the prevalence of severe reactivation and rebound after discontinuation of fingolimod in a cohort of Italian patients with MS. Methods Patients with relapsing-remitting MS who were treated with fingolimod for at least 6 months and who stopped treatment for reasons that were unrelated to inefficacy were included in the analysis. Results A total of 100 patients who had discontinued fingolimod were included in the study. Fourteen patients (14%) had a relapse within 3 months after fingolimod discontinuation, and an additional 12 (12%) had a relapse within 6 months. According to this study's criteria, 10 patients (10%) had a severe reactivation. Amongst these patients, five (5%) had a reactivation that was considered to be a rebound. Conclusions The present study showed that more than 26% of patients are at risk of having a relapse within 6 months after fingolimod discontinuation. Nevertheless, the risk of severe reactivations and rebound is lower than has been previously described.

Published
2018

9. 'Better explanations' in multiple sclerosis diagnostic workup

Author

Massimiliano Calabrese 1, Claudio Gasperini 2, Carla Tortorella 2, Gianmarco Schiavi 2, Giovanni Frisullo 2, Paolo Ragonese, Roberta Fantozzi 2, Luca Prosperini 2, Pietro Annovazzi 2, Cinzia Cordioli 2, Massimiliano Di Filippo 2, Diana Ferraro 2, Alberto Gajofatto 2, Simona Malucchi 2, Salvatore Lo Fermo 2, Giovanna De Luca 2, Maria L Stromillo 2, Eleonora Cocco 2, Antonio Gallo 2, Damiano Paolicelli 2, Roberta Lanzillo 2, Valentina Tomassini 2, Ilaria Pesci 2, Maria E Rodegher 2, Claudio Solaro 2, RIREMS group (Rising Italian Researchers in Multiple Sclerosis), Massimiliano Calabrese 1 , Claudio Gasperini 2 , Carla Tortorella 2 , Gianmarco Schiavi 2 , Giovanni Frisullo 2 , Paolo Ragonese , Roberta Fantozzi 2 , Luca Prosperini 2 , Pietro Annovazzi 2 , Cinzia Cordioli 2 , Massimiliano Di Filippo 2 , Diana Ferraro 2 , Alberto Gajofatto 2 , Simona Malucchi 2 , Salvatore Lo Fermo 2 , Giovanna De Luca 2 , Maria L Stromillo 2 , Eleonora Cocco 2 , Antonio Gallo 2 , Damiano Paolicelli 2 , Roberta Lanzillo 2 , Valentina Tomassini 2 , Ilaria Pesci 2 , Maria E Rodegher 2 , Claudio Solaro 2 , RIREMS group (Rising Italian Researchers in Multiple Sclerosis), Calabrese, M., Gasperini, C., Tortorella, C., Schiavi, G., Frisullo, G., Ragonese, P., Fantozzi, R., Prosperini, L., Annovazzi, P., Cordioli, C., Di Filippo, M., Ferraro, D., Gajofatto, A., Malucchi, S., Lo Fermo, S., De Luca, G., Stromillo, M. L., Cocco, E., Gallo, A., Paolicelli, D., Lanzillo, R., Tomassini, V., Pesci, I., Rodegher, M. E., Solaro, C., Calabrese, Massimiliano, Gasperini, Claudio, Tortorella, Carla, Schiavi, Gianmarco, Frisullo, Giovanni, Ragonese, Paolo, Fantozzi, Roberta, Prosperini, Luca, Annovazzi, Pietro, Cordioli, Cinzia, Di Filippo, Massimiliano, Ferraro, Diana, Gajofatto, Alberto, Malucchi, Simona, Lo Fermo, Salvatore, De Luca, Giovanna, Stromillo, Maria L, Cocco, Eleonora, Gallo, Antonio, Paolicelli, Damiano, Lanzillo, Roberta, Tomassini, Valentina, Pesci, Ilaria, Rodegher, Maria E, and Solaro, Claudio

Subjects
Male, Longitudinal Studie, Disease, 0302 clinical medicine, Multiple Sclerosi, Diagnosis, Medicine, 030212 general & internal medicine, Prospective Studies, Longitudinal Studies, Prospective cohort study, medicine.diagnostic_test, Magnetic Resonance Imaging, clinical practice, atypical MRI lesions, MS mimics, Disease Progression, Female, Settore MED/26 - Neurologia, Radiology, Human, Adult, multiple sclerosis, diagnostic criteria, medicine.medical_specialty, Multiple Sclerosis, omarkers / metabolism Diagnosis, Differential Female Follow-Up Studies Humans Longitudinal Studies Magnetic Resonance Imaging Male Multiple Sclerosis / diagnosis* Prospective Studies, Article, Follow-Up Studie, Diagnosis, Differential, 03 medical and health sciences, Humans, Neuromyelitis optica, business.industry, Multiple sclerosis, Biomarkers, Follow-Up Studies, Magnetic resonance imaging, Odds ratio, Biomarker, medicine.disease, Migraine, Differential, Neurology (clinical), Differential diagnosis, business, 030217 neurology & neurosurgery
Abstract

BackgroundThe exclusion of other diseases that can mimic multiple sclerosis (MS) is the cornerstone of current diagnostic criteria. However, data on the frequency of MS mimics in real life are incomplete.MethodsA total of 695 patients presenting with symptoms suggestive of MS in any of the 22 RIREMS centers underwent a detailed diagnostic workup, including a brain and spinal cord MRI scan, CSF and blood examinations, and a 3-year clinical and radiologic follow-up.FindingsA total of 667 patients completed the study. Alternative diagnoses were formulated in 163 (24.4%) cases, the most frequent being nonspecific neurologic symptoms in association with atypical MRI lesions of suspected vascular origin (40 patients), migraine with atypical lesions (24 patients), and neuromyelitis optica (14 patients). MS was diagnosed in 401 (60.1%) patients according to the 2017 diagnostic criteria. The multivariate analysis revealed that the absence of CSF oligoclonal immunoglobulin G bands (IgG-OB) (odds ratio [OR] 18.113), the presence of atypical MRI lesions (OR 10.977), the absence of dissemination in space (DIS) of the lesions (OR 5.164), and normal visual evoked potentials (OR 3.550) were all independent predictors of an alternative diagnosis.InterpretationThis observational, unsponsored, real-life study, based on clinical practice, showed that diseases that mimicked MS were many, but more than 45% were represented by nonspecific neurologic symptoms with atypical MRI lesions of suspected vascular origin, migraine, and neuromyelitis optica. The absence of IgG-OB and DIS, the presence of atypical MRI lesions, and normal visual evoked potentials should be considered suggestive of an alternative disease and red flags for the misdiagnosis of MS.

Published
2019

10. Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis

Author

Sormani, Maria P., Nicola De Rossi, Irene, Schiavetti, Luca, Carmisciano, Cinzia, Cordioli, Lucia, Moiola, Marta, Radaelli, Paolo, Immovilli, Marco, Capobianco, Maria, Trojano, Paola, Zaratin, Gioacchino, Tedeschi, Giancarlo, Comi, Battaglia, Mario A., Francesco, Patti, Marco, Salvetti, Agostino, Nozzolillo, Alessandra, Bellacosa, Alessandra, Protti, Alessia Di Sapio, Alessio, Signori, Alfredo, Petrone, Alvino, Bisecco, Aniello, Iovino, Anna, Dutto, Anna Maria Repice, Antonella, Conte, Antonio, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Arianna, Sartori, Bruno, Giometto, Carla, Tortorella, Carlo, Antozzi, Carlo, Pozzilli, Chiara Rosa Mancinelli, Chiara, Zanetta, Christian, Cordano, Cinzia, Scandellari, Clara, Guaschino, Claudio, Gasperini, Claudio, Solaro, Cristina, Fioretti, Daiana, Bezzini, Damiano, Marastoni, Damiano, Paolicelli, Domizia, Vecchio, Doriana, Landi, Elisabetta, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elvira, Sbragia, Emanuela Laura Susani, Erica, Curti, Eva, Milano, Fabiana, Marinelli, Federico, Camilli, Filippo Martinelli Boneschi, Flora, Govone, Francesca, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesco, Corea, Francesco, Crescenzo, Francesco, Teatini, Giulietta, Tabiadon, Franco, Granella, Giacomo, Boffa, Giacomo, Lus, Giampaolo, Brichetto, Giorgia Teresa Maniscalco, Giovanna, Borriello, Giovanna De Luca, Giovanna, Konrad, Giovanna, Vaula, Girolama Alessandra Marfia, Giulia, Mallucci, Giuseppe, Liberatore, Giuseppe, Salemi, Giuseppina, Miele, Grazia, Sibilia, Ilaria, Pesci, Laura, Brambilla, Leonardo, Lopiano, Leonardo, Sinisi, Pasquali, Livia, Lorenzo, Saraceno, Luca, Chiveri, Luca, Mancinelli, Grimaldi, Luigi M. E., Luisa Maria Caniatti, Marco Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Margherita Monti Bragadin, Maria, Buccafusca, Maria Chiara Buscarinu, Maria Grazia Celani, Maria Grazia Grasso, Maria Laura Stromillo, Maria, Petracca, Maria Pia Amato, Maria Pia Sormani, Maria Rita L'Episcopo, Maria, Sessa, Maria Teresa Ferrò, Maria Vittoria Ercolani, Mariangela, Bianco, Marianna Lo Re, Marika, Vianello, Marinella, Clerico, Mario Alberto Battaglia, Mario di Napoli, Marta, Ponzano, Marta Zaffira Conti, Massimiliano, Calabrese, Massimiliano, Mirabella, Massimo, Filippi, Matilde, Inglese, Matteo, Lucchini, Matteo, Pozzato, Maura Chiara Danni, Mauro, Zaffaroni, Mauro, Zampolini, Michela, Ponzio, Milena De Riz, Nicola De Stefano, Paola, Cavalla, Paola De Mitri, Paola, Grossi, Paolo, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Patrizia, Sola, Pietro, Annovazzi, Pietro, Iaffaldano, Raffaele, Nardone, Raffaella, Cerqua, Raffaella, Clerici, Roberta, Lanzillo, Roberta, Motta, Roberto, Balgera, Roberto, Bergamaschi, Rocco, Totaro, Rosa, Iodice, Ruggero, Capra, Sabrina, Marangoni, Sabrina, Realmuto, Salvatore, Cottone, Sara, Montepietra, Sarah, Rasia, Sebastiano, Arena, Sebastiano, Bucello, Silvia, Banfi, Simona, Bonavita, Simona, Malucchi, Simone, Tonietti, Stefano, Vollaro, Susanna, Cordera, Umberto, Aguglia, Valentina Torri Clerici, Valeria, Barcella, Valeria, Bergamaschi, Vincenzo Brescia Morra, Vincenzo, Dattola, and Vittorio Mantero, Sormani, M. P., De Rossi, N., Schiavetti, I., Carmisciano, L., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Trojano, M., Zaratin, P., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., P Sormani, Maria, De Rossi, Nicola, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Moiola, Lucia, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, Trojano, Maria, Zaratin, Paola, Tedeschi, Gioacchino, Comi, Giancarlo, A Battaglia, Mario, Patti, Francesco, Salvetti, Marco, Nozzolillo, Agostino, Bellacosa, Alessandra, Protti, Alessandra, Di Sapio, Alessia, Signori, Alessio, Petrone, Alfredo, Bisecco, Alvino, Iovino, Aniello, Dutto, Anna, Maria Repice, Anna, Conte, Antonella, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Antonio, Sartori, Arianna, Giometto, Bruno, Tortorella, Carla, Antozzi, Carlo, Pozzilli, Carlo, Rosa Mancinelli, Chiara, Zanetta, Chiara, Cordano, Christian, Scandellari, Cinzia, Guaschino, Clara, Gasperini, Claudio, Solaro, Claudio, Fioretti, Cristina, Bezzini, Daiana, Marastoni, Damiano, Paolicelli, Damiano, Vecchio, Domizia, Landi, Doriana, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elisabetta, Sbragia, Elvira, Laura Susani, Emanuela, Curti, Erica, Milano, Eva, Marinelli, Fabiana, Camilli, Federico, Martinelli Boneschi, Filippo, Govone, Flora, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesca, Corea, Francesco, Crescenzo, Francesco, Teatini, Francesco, Tabiadon, Giulietta, Granella, Franco, Boffa, Giacomo, Lus, Giacomo, Brichetto, Giampaolo, Teresa Maniscalco, Giorgia, Borriello, Giovanna, De Luca, Giovanna, Konrad, Giovanna, Vaula, Giovanna, Alessandra Marfia, Girolama, Mallucci, Giulia, Liberatore, Giuseppe, Salemi, Giuseppe, Miele, Giuseppina, Sibilia, Grazia, Pesci, Ilaria, Brambilla, Laura, Lopiano, Leonardo, Sinisi, Leonardo, Pasquali, Livia, Saraceno, Lorenzo, Chiveri, Luca, Mancinelli, Luca, E Grimaldi, Luigi M, Maria Caniatti, Luisa, Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Marco, Monti Bragadin, Margherita, Buccafusca, Maria, Chiara Buscarinu, Maria, Grazia Celani, Maria, Grazia Grasso, Maria, Laura Stromillo, Maria, Petracca, Maria, Pia Amato, Maria, Pia Sormani, Maria, Rita L'Episcopo, Maria, Sessa, Maria, Teresa Ferrò, Maria, Vittoria Ercolani, Maria, Bianco, Mariangela, Lo Re, Marianna, Vianello, Marika, Clerico, Marinella, Alberto Battaglia, Mario, di Napoli, Mario, Ponzano, Marta, Zaffira Conti, Marta, Calabrese, Massimiliano, Mirabella, Massimiliano, Filippi, Massimo, Inglese, Matilde, Lucchini, Matteo, Pozzato, Matteo, Chiara Danni, Maura, Zaffaroni, Mauro, Zampolini, Mauro, Ponzio, Michela, De Riz, Milena, De Stefano, Nicola, Cavalla, Paola, De Mitri, Paola, Grossi, Paola, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Paolo, Sola, Patrizia, Annovazzi, Pietro, Iaffaldano, Pietro, Nardone, Raffaele, Cerqua, Raffaella, Clerici, Raffaella, Lanzillo, Roberta, Motta, Roberta, Balgera, Roberto, Bergamaschi, Roberto, Totaro, Rocco, Iodice, Rosa, Capra, Ruggero, Marangoni, Sabrina, Realmuto, Sabrina, Cottone, Salvatore, Montepietra, Sara, Rasia, Sarah, Arena, Sebastiano, Bucello, Sebastiano, Banfi, Silvia, Bonavita, Simona, Malucchi, Simona, Tonietti, Simone, Vollaro, Stefano, Cordera, Susanna, Aguglia, Umberto, Torri Clerici, Valentina, Barcella, Valeria, Bergamaschi, Valeria, Brescia Morra, Vincenzo, Dattola, Vincenzo, Mantero, Vittorio, Mp, Sormani, N, De Rossi, I, Schiavetti, L, Carmisciano, C, Cordioli, L, Moiola, M, Radaelli, P, Immovilli, M, Capobianco, M, Trojano, P, Zaratin, G, Tedeschi, G, Comi, Ma, Battaglia, F, Patti, M, Salvetti, Study Group Agostino Nozzolillo, Musc-19, Grimaldi, Luigi M. E., Vittorio Mantero, And, Nozzolillo, A., Bellacosa, A., Protti, A., Di Sapio, A., Signori, A., Petrone, A., Bisecco, A., Iovino, A., Dutto, A., Repice, A. M., Conte, A., Bertolotto, A., Bosco, A., Gallo, A., Zito, A., Sartori, A., Giometto, B., Tortorella, C., Antozzi, C., Pozzilli, C., Mancinelli, C. R., Zanetta, C., Cordano, C., Scandellari, C., Guaschino, C., Gasperini, C., Solaro, C., Fioretti, C., Bezzini, D., Marastoni, D., Paolicelli, D., Vecchio, D., Landi, D., Bucciantini, E., Pedrazzoli, E., Signoriello, E., Sbragia, E., Susani, E. L., Curti, E., Milano, E., Marinelli, F., Camilli, F., Boneschi, F. M., Govone, F., Bovis, F., Calabria, F., Caleri, F., Rinaldi, F., Vitetta, F., Corea, F., Crescenzo, F., Teatini, F., Tabiadon, G., Granella, F., Boffa, G., Lus, G., Brichetto, G., Maniscalco, G. T., Borriello, G., De Luca, G., Konrad, G., Vaula, G., Marfia, G. A., Mallucci, G., Liberatore, G., Salemi, G., Miele, G., Sibilia, G., Pesci, I., Brambilla, L., Lopiano, L., Sinisi, L., Pasquali, L., Saraceno, L., Chiveri, L., Mancinelli, L., Grimaldi, L. M. E., Caniatti, L. M., Cava, M. D., Onofrj, M., Rovaris, M., Vercellino, M., Bragadin, M. M., Buccafusca, M., Buscarinu, M. C., Celani, M. G., Grasso, M. G., Stromillo, M. L., Petracca, M., Amato, M. P., L'Episcopo, M. R., Sessa, M., Ferro, M. T., Ercolani, M. V., Bianco, M., Re, M. L., Vianello, M., Clerico, M., di Napoli, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, M., Filippi, M., Inglese, M., Lucchini, M., Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., Mantero, V., Sormani M.P., De Rossi N., Schiavetti I., Carmisciano L., Cordioli C., Moiola L., Radaelli M., Immovilli P., Capobianco M., Trojano M., Zaratin P., Tedeschi G., Comi G., Battaglia M.A., Patti F., Salvetti M., Nozzolillo A., Bellacosa A., Protti A., Di Sapio A., Signori A., Petrone A., Bisecco A., Iovino A., Dutto A., Repice A.M., Conte A., Bertolotto A., Bosco A., Gallo A., Zito A., Sartori A., Giometto B., Tortorella C., Antozzi C., Pozzilli C., Mancinelli C.R., Zanetta C., Cordano C., Scandellari C., Guaschino C., Gasperini C., Solaro C., Fioretti C., Bezzini D., Marastoni D., Paolicelli D., Vecchio D., Landi D., Bucciantini E., Pedrazzoli E., Signoriello E., Sbragia E., Susani E.L., Curti E., Milano E., Marinelli F., Camilli F., Boneschi F.M., Govone F., Bovis F., Calabria F., Caleri F., Rinaldi F., Vitetta F., Corea F., Crescenzo F., Teatini F., Tabiadon G., Granella F., Boffa G., Lus G., Brichetto G., Maniscalco G.T., Borriello G., De Luca G., Konrad G., Vaula G., Marfia G.A., Mallucci G., Liberatore G., Salemi G., Miele G., Sibilia G., Pesci I., Brambilla L., Lopiano L., Sinisi L., Pasquali L., Saraceno L., Chiveri L., Mancinelli L., Grimaldi L.M.E., Caniatti L.M., Cava M.D., Onofrj M., Rovaris M., Vercellino M., Bragadin M.M., Buccafusca M., Buscarinu M.C., Celani M.G., Grasso M.G., Stromillo M.L., Petracca M., Amato M.P., L'Episcopo M.R., Sessa M., Ferro M.T., Ercolani M.V., Bianco M., Re M.L., Vianello M., Clerico M., di Napoli M., Ponzano M., Conti M.Z., Calabrese M., Mirabella M., Filippi M., Inglese M., Lucchini M., Pozzato M., Danni M.C., Zaffaroni M., Zampolini M., Ponzio M., De Riz M., De Stefano N., Cavalla P., De Mitri P., Grossi P., Confalonieri P., Gallo P., Ragonese P., Sola P., Annovazzi P., Iaffaldano P., Nardone R., Cerqua R., Clerici R., Lanzillo R., Motta R., Balgera R., Bergamaschi R., Totaro R., Iodice R., Capra R., Marangoni S., Realmuto S., Cottone S., Montepietra S., Rasia S., Arena S., Bucello S., Banfi S., Bonavita S., Malucchi S., Tonietti S., Vollaro S., Cordera S., Aguglia U., Clerici V.T., Barcella V., Bergamaschi V., Morra V.B., Dattola V., and Mantero V.

Subjects
Male, 0301 basic medicine, Dimethyl Fumarate, Neurodegenerative, multiple sclerosis, coronavirus, pneumonia, Severity of Illness Index, law.invention, Immunosuppressive Agent, Immunologic Factor, 0302 clinical medicine, Natalizumab, law, Monoclonal, Multiple Sclerosi, 80 and over, Lung, Humanized, Research Articles, Aged, 80 and over, Middle Aged, Intensive care unit, Hospitalization, Settore MED/26 - NEUROLOGIA, Intensive Care Units, Neurology, Methylprednisolone, Neurological, Pneumonia & Influenza, Interferon, Female, Immunosuppressive Agents, Research Article, Human, medicine.drug, Adult, medicine.medical_specialty, Musc-19 Study Group, Multiple Sclerosis, Adolescent, Clinical Sciences, Intensive Care Unit, Clinical Neurology, Settore MED/26, Antibodies, Monoclonal, Humanized, Autoimmune Disease, Antibodies, Young Adult, 03 medical and health sciences, Clinical Research, Internal medicine, Severity of illness, medicine, Humans, Immunologic Factors, Mortality, Aged, COVID-19, Fingolimod Hydrochloride, Interferons, SARS-CoV-2, Neurology & Neurosurgery, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Neurosciences, Pneumonia, Odds ratio, medicine.disease, Brain Disorders, Good Health and Well Being, 030104 developmental biology, Ocrelizumab, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18–4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (

Published
2021

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

Author

Domenico Ippolito, Sara La Gioia, Sabrina Esposito, Valentina Torri Clerici, Giorgia Teresa Maniscalco, Cinzia Cordioli, Lorena Pareja-Gutierrez, Elisabetta Signoriello, Cinzia Valeria Russo, Roberta Grasso, Doriana Landi, B. Frigeni, Andrea Visconti, Caterina Barrilà, Valeria Barcella, Raffaella Cerqua, Alice Laroni, Simona Bonavita, Stefania Barone, P. Perini, Sarah Rasia, Arianna Sartori, Maria Laura Stromillo, Roberta Lanzillo, Damiano Baroncini, Jessica Frau, Francesco Saccà, Luigi Lavorgna, Alessio Signori, Ignazio Roberto Zarbo, Giorgia Mataluni, Eleonora Cocco, Maria Pia Sormani, E Binello, Pietro Annovazzi, M Clerico, Simona Pontecorvo, Giuseppe Fenu, Alessia Di Sapio, Anna Maria Repice, Signori, A., Sacca, F., Lanzillo, R., Maniscalco, G. T., Signoriello, E., Repice, A. M., Annovazzi, P., Baroncini, D., Clerico, M., Binello, E., Cerqua, R., Mataluni, G., Perini, P., Bonavita, S., Lavorgna, L., Zarbo, I. R., Laroni, A., Pareja-Gutierrez, L., La Gioia, S., Frigeni, B., Barcella, V., Frau, J., Cocco, E., Fenu, G., Clerici, V. T., Sartori, A., Rasia, S., Cordioli, C., Stromillo, M. L., Di Sapio, A., Pontecorvo, S., Grasso, R., Barone, S., Barrila, C., Russo, C. V., Esposito, S., Ippolito, D., Landi, D., Visconti, A., Sormani, M. P., Signori, Alessio, Saccà, Francesco, Lanzillo, Roberta, Maniscalco, Giorgia Teresa, Signoriello, Elisabetta, Repice, Anna Maria, Annovazzi, Pietro, Baroncini, Damiano, Clerico, Marinella, Binello, Eleonora, Cerqua, Raffaella, Mataluni, Giorgia, Perini, Paola, Bonavita, Simona, Lavorgna, Luigi, Zarbo, Ignazio Roberto, Laroni, Alice, Pareja-Gutierrez, Lorena, La Gioia, Sara, Frigeni, Barbara, Barcella, Valeria, Frau, Jessica, Cocco, Eleonora, Fenu, Giuseppe, Clerici, Valentina Torri, Sartori, Arianna, Rasia, Sarah, Cordioli, Cinzia, Stromillo, Maria Laura, Di Sapio, Alessia, Pontecorvo, Simona, Grasso, Roberta, Barone, Stefania, Barrilà, Caterina, Russo, Cinzia Valeria, Esposito, Sabrina, Ippolito, Domenico, Landi, Doriana, Visconti, Andrea, and Sormani, Maria Pia

Subjects
Adult, Male, medicine.medical_specialty, Databases, Factual, Datasets as Topic, Settore MED/26, Placebo, Severity of Illness Index, law.invention, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Randomized controlled trial, law, Internal medicine, Outcome Assessment, Health Care, Severity of illness, medicine, Humans, Immunologic Factors, Multicenter Studies as Topic, Glatiramer acetate, Cladribine, Randomized Controlled Trials as Topic, Retrospective Studies, business.industry, Middle Aged, Fingolimod, Observational Studies as Topic, Neurology, Propensity score matching, Disease Progression, Female, Neurology (clinical), business, medicine.drug
Abstract

ObjectiveCladribine 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.MethodsData 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.ResultsAll 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; p < 0.001), glatiramer acetate (RR = 0.49; p < 0.001), and dimethyl fumarate (RR = 0.6; p = 0.001); a similar ARR to that with fingolimod (RR = 0.74; p = 0.24); and a significantly higher ARR than natalizumab (RR = 2.13; p = 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.ConclusionIn 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 evidenceThis 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.

Published
2020

12. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study

Author

Roberta Grasso, Doriana Landi, Luca Carmisciano, Simona Bonavita, Domenico Ippolito, Sara La Gioia, Marinella Clerico, Cinzia Valeria Russo, A. Repice, Maria Laura Stromillo, Roberta Lanzillo, Raffaella Cerqua, Alice Laroni, Lorena Pareja Gutierrez, Stefania Barone, Maria Pia Sormani, Simona Pontecorvo, E Binello, Pietro Annovazzi, Valentina Torri Clerici, Giorgia Mataluni, Cinzia Cordioli, Elisabetta Signoriello, Jessica Frau, Alessio Signori, Sarah Rasia, Arianna Sartori, Gabriella Turano, Francesco Saccà, Damiano Baroncini, Alessia Di Sapio, Ignazio Roberto Zarbo, Eleonora Cocco, Paola Perini, Luigi Lavorgna, Caterina Barrilà, Giorgia Teresa Maniscalco, B. Frigeni, Maniscalco, G. T., Sacca, F., Lanzillo, R., Annovazzi, P., Baroncini, D., Binello, E., Repice, A., Perini, P., Clerico, M., Mataluni, G., Bonavita, S., La Gioia, S., Gutierrez, L. P., Laroni, A., Frau, J., Cocco, E., Torri Clerici, V., Zarbo, I. R., Sartori, A., Signoriello, E., Rasia, S., Cordioli, C., Stromillo, M. L., Cerqua, R., Pontecorvo, S., Di Sapio, A., Grasso, R., Barone, S., Lavorgna, L., Barrila, C., Landi, D., Russo, C. V., Frigeni, B., Ippolito, D., Turano, G., Carmisciano, L., Sormani, M. P., and Signori, A.

Subjects
Male, medicine.medical_specialty, Dimethyl Fumarate, Settore MED/26, Logistic regression, Multiple sclerosis, 03 medical and health sciences, chemistry.chemical_compound, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Natalizumab, Internal medicine, Teriflunomide, Immunomodulatory therapy, Humans, Medicine, Relapsing-remitting, Multiple sclerosi, 030212 general & internal medicine, Glatiramer acetate, Determinants first therapy, Naive, Aged, Dimethyl fumarate, Fingolimod Hydrochloride, business.industry, General Medicine, medicine.disease, Fingolimod, Italy, Neurology, chemistry, Cohort, Neurology (clinical), business, Immunosuppressive Agents, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background: The approval of an increasing number of disease modifying drugs for the treatment of Multiple Sclerosis (MS) creates new challenges for patients and clinicians on the first treatment choice. The main aim of this study was to assess factors impacting first therapy choice in a large Italian MS cohort. Methods: Newly diagnosed relapsing-remitting (RR) MS patients (2010-2018) followed in 24 Italian MS centres were included in the study. We evaluated the association of baseline demographics, clinical and MRI characteristics to the first treatment choice by logistic regression models applied to pre-defined binary alternatives: dimethyl fumarate vs injectables (interferon and glatiramer acetate), teriflunomide vs injectables, fingolimod vs dimethyl fumarate and fingolimod vs natalizumab. Results: We enrolled 3025 patients in the period between January 2010 and June 2018. Relapses in the previous year (OR = 2.75; p = 0.001), presence of spinal cord lesions (OR = 1.80; p = 0.002) and higher number (>9) of T2 lesions on the baseline brain MRI scan (OR = 1.65; p = 0.022) were the factors associated to dimethyl fumarate choice as first therapy vs an injectable drug. Older age (OR = 1.06; p < 0.001), male sex (OR = 2.29; p = 0.001) and higher EDSS (OR = 1.36; p < 0.001) were the factors associated with the choice of teriflunomide vs injectables. In more recent years, dimethyl fumarate (OR = 3.23; p < 0.001) and teriflunomide (OR = 2.53; p < 0.001) were chosen more frequently than injectables therapies. The main determinant for the choice of fingolimod as compared with dimethyl fumarate was a higher EDSS (OR = 1.56; p = 0.001), while there was a weak association with a longer disease duration (p = 0.068) and a longer time from onset to diagnosis (p = 0.085). Compared to fingolimod, natalizumab was preferred in patients with a younger age (OR = 0.95; p = 0.003) and higher EDSS (OR = 1.45; p = 0.007) and a shorter disease duration (OR = 0.52; p = 0.076). Conclusion: Many factors guided therapeutic decision for our Italian cohort of MS patients; they are mainly related to MS disease activity, baseline EDSS, disease duration and age.

Published
2020

13. Progression of regional grey matter atrophy in multiple sclerosis

Author

Massimo Filippi, Viktor Wottschel, Lukas Pirpamer, Jeroen J. G. Geurts, Alan J. Thompson, Hugo Vrenken, Christian Enzinger, Niamh Cawley, Daniel C. Alexander, Sebastien Ourselin, M. Laura Stromillo, Razvan V. Marinescu, Jaume Sastre-Garriga, Serena Ruggieri, M. Jorge Cardoso, Marco Battaglini, Ferran Prados, Arman Eshaghi, Floriana De Angelis, Claudio Gasperini, Carmen Tur, Olga Ciccarelli, Alex Rovira, Frederik Barkhof, Wallace Brownlee, Maria A. Rocca, Cyra E. Leurs, Bernard M. J. Uitdehaag, Declan T. Chard, Alexandra L. Young, Nicholas C. Firth, Claudia Am Gandini Wheeler-Kingshott, Nicola De Stefano, Eshaghi, Arman, Marinescu, Razvan V., Young, Alexandra L., Firth, Nicholas C., Prados, Ferran, Jorge Cardoso, M., Tur, Carmen, De Angelis, Floriana, Cawley, Niamh, Brownlee, Wallace J, De Stefano, Nicola, Laura Stromillo, M., Battaglini, Marco, Ruggieri, Serena, Gasperini, Claudio, Filippi, Massimo, Rocca, Maria A, Rovira, Alex, Sastre-Garriga, Jaume, Geurts, Jeroen J G, Vrenken, Hugo, Wottschel, Viktor, Leurs, Cyra E, Uitdehaag, Bernard, Pirpamer, Luka, Enzinger, Christian, Ourselin, Sebastien, Gandini Wheeler-Kingshott, Claudia A, Chard, Declan, Thompson, Alan J, Barkhof, Frederik, Alexander, Daniel C, Ciccarelli, Olga, Anatomy and neurosciences, Amsterdam Neuroscience - Neuroinfection & -inflammation, Radiology and nuclear medicine, and Neurology

Subjects
Cingulate cortex, Adult, Male, Pathology, medicine.medical_specialty, Precuneus, grey matter, Grey matter, multiple sclerosis, 030218 nuclear medicine & medical imaging, Cuneus, 03 medical and health sciences, 0302 clinical medicine, Atrophy, Multiple Sclerosis, Relapsing-Remitting, atrophy, disability accumulation, Medicine, Humans, Gray Matter, 10. No inequality, multiple sclerosis, atrophy, grey matter, probabilistic modelling, disability accumulation, Retrospective Studies, Expanded Disability Status Scale, business.industry, Multiple sclerosis, probabilistic modelling, Neurology (clinical), Brain, Middle Aged, Multiple Sclerosis, Chronic Progressive, medicine.disease, medicine.anatomical_structure, Posterior cingulate, Case-Control Studies, multiple sclerosi, Disease Progression, Female, business, 030217 neurology & neurosurgery
Abstract

SummaryGrey matter atrophy is present from the earliest clinical stages of multiple sclerosis (MS), but the temporal ordering is poorly understood. We aimed to determine the sequence in which grey matter regions become atrophic in MS, and its association with disability accumulation.In this longitudinal study, we included 1,417 subjects: 253 with clinically-isolated syndrome (CIS), 708 relapsing-remitting MS (RRMS), 128 secondary-progressive MS (SPMS), 125 primary-progressive MS (PPMS), and 203 healthy controls from 7 European centres. Subjects underwent repeated MRI scanning (total number of scans 3,604); the mean follow-up for patients was 2.41yrs (SD±1.97). Disability was scored using the Expanded Disability Status Scale (EDSS). We calculated the volume of brain grey matter regions and brainstem using an unbiased within-subject template. We used an established data-driven event-based model (EBM) to determine the sequence of occurrence of atrophy and its uncertainty. We assigned each subject to a specific EBM stage, based on the number of their atrophic regions. We used nested linear mixed-effects regression models to explore the associations between the rate of increase in the EBM stages over time, disease duration and annual rate of EDSS gain.The first regions to become atrophic in CIS and relapse-onset MS patients (RRMS and SPMS) were the posterior cingulate cortex and precuneus, followed by the middle cingulate cortex, brainstem and thalamus. The sequence of atrophy in PPMS showed a similar involvement of the thalamus, cuneus, precuneus, and pallidum, followed by the brainstem and posterior cingulate cortex. The cerebellum, caudate and putamen showed early atrophy in relapse-onset MS and late atrophy in PPMS. Patients with SPMS showed the highest EBM stages (highest number of atrophic regions, all ppThis data-driven staging of atrophy progression in a large MS sample demonstrates that grey matter atrophy spreads to involve more regions over time. The sequence in which regions become atrophic is reasonably consistent across MS phenotypes. The spread of atrophy was associated with disease duration, and disability accumulation in RRMS.AbbreviationsMSmultiple sclerosisGMgrey matterFLAIRFluid Attenuated Inversion RecoveryPPMSprimary progressive multiple sclerosis; primary-progressive MS

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