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151. A Chaos-Based Approach to Secure Communications

Author

Annovazzi-Lodi, Valerio, Argyris, Apostolos, Benedetti, Mauro, Hamacher, Michael, Merlo, Sabina, and Syvridis, Dimitris

Abstract

These authors describe a unique approach to safeguarding data transmission over the Internet-by embedding messages within optical chaos.

Published
2008

152. Progress in the methodological strategies for the detection in real samples of desmosine and isodesmosine, two biological markers of elastin degradation

Author

Viglio, Simona, Annovazzi, Laura, Luisetti, Maurizio, Stolk, Jan, Casado, Begoña, and Iadarola, Paolo

Abstract

Desmosines are crosslinking amino acids unique to mature elastin in humans. Owing to this unicity, they have been discussed as potentially attractive indicators of connective tissue disorders whose clinical manifestations are mostly the result of elastin degradation. This review covers advances in immunochemical, chromatographic, and electrophoretic procedures applied in the last 25 years to detect and quantitate these crosslinks in a variety of biological samples. Recent applications of CE with LIF detection (CE‐LIF) for investigating the content of desmosines in different fluids will also be discussed.

Published
2007
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153. Nuclear medicine imaging of inflammatoryinfective disorders of the abdomen

Author

Annovazzi, Alessio, Bagni, Bruno, Burroni, Luca, D'Alessandria, Calogero, and Signore, Alberto

Abstract

Different nuclear medicine modalities are currently used to study inflammatory and infective disorders of the abdomen. They are usually complementary to radiology and endoscopy, but they play a pivotal role in particular clinical situations. Several radiopharmaceuticals (e.g., 111In or 99mTc labelled white blood cells, monoclonal antibodies, human polyclonal immunoglobulins, 67Ga citrate) are commercially available, but they can not be used indifferently to study abdominal inflammatory disorders. The lack of comparative studies showing the accuracy of each radiopharmaceutical for the study of inflammatoryinfective abdominal diseases does not allow the best nuclear medicine technique(s) to be chosen in an evidence-based manner. To this end we performed a meta-analysis of peer reviewed articles published between 1984 and 2004 describing the use of nuclear medicine imaging for the study of inflammatory bowel disorders, appendicitis and vascular graft infections. A guideline for the optimal radiopharmaceutical(s) to be used in each clinical condition and for different aims is provided.

Published
2005
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154. 123I-Interleukin-2 biochemical characterization and in vivouse for imaging autoimmune diseases

Author

SIGNORE, A., PICARELLI, A., ANNOVAZZI, A., BRITTON, K. E., GROSSMAN, A. B., BONANNO, E., MARAS, B., BARRA, D., and POZZILLI, P.

Abstract

We describe in detail the labelling of interleukin-2 with 123I (123I-IL2), its biochemical characterization, the in vitrobinding assay and its use for the in vivodetection of tissues infiltrated with mononuclear cells. Human recombinant IL2 was labelled using an enzymatic method and its biochemical characterization was performed using high performance liquid chromatography (HPLC) analysis of cyanogen bromide-cleaved protein. In vitrobiological and binding assays were performed on CTLL-2 cell line and on activated peripheral blood lymphocytes. In vivostudies were performed 1 h after administration of 2-3 mCi of 123I-IL2 in 10 newly diagnosed type 1 diabetes patients, five pre-diabetic patients, 10 Hashimoto's thyroiditis patients, 10 coeliac disease patients and 10 normal volunteers. 123I-IL2 scintigraphy allowed the in vivodetection and quantification of activated mononuclear cells in several affected tissues. In detail, 123I-IL2 accumulation was detected in the thyroid of all patients affected by Hashimoto's thyroiditis, in the bowel of all coeliac disease patients and in the pancreas of all pre-type 1 diabetic patients. By contrast, in newly diagnosed type 1 diabetics, 123I-IL2 scan was positive in five of the 10 studied patients. 123I-IL2 scintigraphy may be useful for studying autoimmune phenomena in vivoand in diagnostic protocols to evaluate the presence of other tissue involvement in patients with an organ-specific autoimmune disease.

Published
2003

155. Nuclear Medicine Imaging For Prediction or Early Assessment of Response to Chemotherapy in Patients Suffering From Breast Carcinoma

Author

Wiele, Christophe van de, Dierckx, Rudi, Scopinaro, Francesco, Waterhouse, Rikki, Annovazzi, Alessio, Kolindou, Anna, and Signore, Alberto

Abstract

Reliable assays that could assess treatment response more rapidly or even predict responsiveness of breast tumours to chemotherapy would be very valuable as they would allow for adjustment of ineffective treatment and discontinuation of ineffective treatment in an early phase. As with effective cancer therapy, changes in tumour physiology, metabolism and proliferation do often precede volumetric changes routinely measured by morphological imaging modalities, for example, radiography and computerized tomography, assessment of these parameters by means of single photon emission computerized tomography (SPECT) or positron emission tomography may provide more sensitive and earlier markers of tumour cell death or growth inhibition. This paper reviews the available literature on the role of SPECT and PET in the measurement and visualisation of breast tumour metabolism (glucose utilization and protein synthesis rate), apoptosis induction and chemotherapy resistance mechanisms as predictors or early markers of tumour response or non-response to chemotherapeutic options in patients suffering from breast carcinoma.

Published
2002
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156. THE DEVELOPING ROLE OF CYTOKINES FOR IMAGING INFLAMMATION AND INFECTION

Author

Signore, A, Procaccini, E, Annovazzi, A, Chianelli, M, van der Laken, C, and Mire-Sluis, A

Abstract

The diagnosis of inflammatory processes is an important goal in medicine. In some cases the diagnosis is easy, based on the clinical history and the physical examination of the patient. Other cases are more difficult to diagnose because they are asymptomatic or with non-specific symptoms. Thus, several imaging techniques have been developed for the diagnosis of inflammatory processes, from the simple X-ray to the more sophisticated computerised tomography, magnetic resonance imaging and nuclear medicine scan. They provide different information and their role in different diseases will be discussed in this review with particular emphasis on the expanding field of the use of radiolabelled cytokines for imaging infection/inflammation. So far, IL-1, IL-1ra, IL-2, IL-6, IL-8, IL-10, IL-12 p40, G-CSF, IFN-γ and EGF have been radiolabelled for in vivo targetting of different leukocyte subsets with promising results for their clinical use.

Published
2000
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157. Patients with multiple sclerosis choose a collaborative role in making treatment decision: results from the Italian multicenter SWITCH study

Author

Patti, Francesco, Chisari, Clara Grazia, Toscano, Simona, Annovazzi, Pietro, Banfi, Paola, Bergamaschi, Roberto, Clerici, Raffaella, Conti, Marta Zaffira, Cortese, Antonio, Fantozzi, Roberta, Ferraro, Diana, Fischetti, Mariano, Frigo, Maura, Gatto, Maurizia, Immovilli, Paolo, Leoni, Stefania, Malucchi, Simona, Maniscalco, Giorgia, Marfia, Girolama Alessandra, Paolicelli, Damiano, Perini, Paola, Serrati, Carlo, Totaro, Rocco, Turano, Gabriella, Valentino, Paola, Zaffaroni, Mauro, Zuliani, Cristina, and Centonze, Diego

Abstract

•Cognitive profile and physician-based and patients-reported outcomes could have a considerable impact on the disease management and on treatment decision making•According to the Control Preference Scale, more than 50% of patients who needed to change therapy chose a “collaborative” role in making treatment decision.•Cognitive profile with SDMT seems to influence patients’ preference on treatment decision.

Published
2022
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158. Adverse events after endovascular treatment of chronic cerebro-spinal venous insufficiency (CCSVI) in patients with multiple sclerosis.

Author

Ghezzi, A, Annovazzi, P, Amato, MP, Capello, E, Cavalla, P, Cocco, E, Falcini, M, Gallo, A, Patti, F, Perini, P, Rodegher, ME, Rovaris, M, Rottoli, MR, and Comi, G

Subjects
*ADVERSE health care events, *ENDOVASCULAR surgery, *VENOUS insufficiency, *MULTIPLE sclerosis, *THROMBOSIS, *ATRIAL fibrillation, *STATUS epilepticus, *ASPIRATION pneumonia, *PATIENTS
Abstract

Although it is debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients undergo endovascular treatment (ET) of CCSVI. A study is ongoing in Italy to evaluate the clinical outcome of ET. Severe adverse events (AEs) occurred in 15/462 subjects at a variable interval after ET: jugular thrombosis in seven patients, tetraventricular hydrocephalus, stroke, paroxysmal atrial fibrillation, status epilepticus, aspiration pneumonia, hypertension with tachicardia, or bleeding of bedsore in the remaining seven cases. One patient died because of myocardial infarction 10 weeks after ET. The risk of severe AEs related to ET for CCSVI must be carefully considered. [ABSTRACT FROM PUBLISHER]

Published
2013
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160. Metal-Film Fiber Attenuators with Flat Spectral Response

Author

Annovazzi-Lodi, Valerio, Merlo, Sabina, Beltrami, Dario, and Galeotti, Roberto

Abstract

Metal-film fiber attenuators have been designed, fabricated, and tested. The devices feature a constant attenuation in the wavelength range 1.2–1.6 μm, short overall length (≈20 mm), high return loss (>50 dB), and low cost. After reviewing the manufacturing procedure, we show that an accurate finishing of the fiber end before metal deposition is a key point in increasing repeatability and reducing dispersion of the absolute attenuation value.

Published
1999
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161. Harmonization of real-world studies in multiple sclerosis: Retrospective analysis from the rirems group.

Author

Moccia, Marcello, Annovazzi, Pietro, Buscarinu, Maria Chiara, Calabrese, Massimiliano, Cavalla, Paola, Cordioli, Cinzia, Di Filippo, Massimiliano, Ferraro, Diana, Gajofatto, Alberto, Gallo, Antonio, Lanzillo, Roberta, Laroni, Alice, Lorefice, Lorena, Mallucchi, Simona, Nociti, Viviana, Paolicelli, Damiano, Pinardi, Federica, Prosperini, Luca, Radaelli, Marta, and Ragonese, Paolo

Published
2020
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162. Clinical and patient determinants of changing therapy in relapsing-remitting multiple sclerosis (SWITCH study).

Author

Patti, Francesco, Chisari, Clara Grazia, D'Amico, Emanuele, Annovazzi, Pietro, Banfi, Paola, Bergamaschi, Roberto, Clerici, Raffaella, Conti, Marta Zaffira, Cortese, Antonio, Fantozzi, Roberta, Fischetti, Mariano, Frigo, Maura, Gatto, Maurizia, Immovilli, Paolo, Leoni, Stefania, Malucchi, Simona, Maniscalco, Giorgia, Marfia, Girolama Alessandra, Paolicelli, Damiano, and Perini, Paola

Abstract

• The introduction of increasingly effective treatments has changed the MS scenario. • This study investigated the reasons that brought about modification of treatment. • In our study, out of 13,657 patients, 336 (3%) modified treatment. • 90.2% switched, 8.9% temporarily discontinued, and 0.9% permanently discontinued. • Efficacy remains the main driving force behind switching in 58.4% of patients. clinical factors and frequency of disease-modifying therapy (DMT) changes/interruptions in relapsing-remitting multiple sclerosis (RRMS) patients have not been well defined. The aim of this study was to describe reasons of MS treatment modifications in a large cohort of Italian MS patients. this multicenter, cross-sectional non interventional study (SWITCH) conducted at 28 Italian MS centers, screened, by visit/telephone contact between June 2016 and June 2017, all RRMS patients receiving stable DMT treatment and enrolled patients with change in DMT treatment. out of 13,657 recorded in the log, 409 (3%) changed therapy. Of these, 336 (2.5%), met the study criteria and were considered eligible. Among 303 (90.2% of 336) patients switching, the most common reason was "lack of efficacy" (58.4% of 303). Among 30 (8.9%) patients who interrupted treatment temporarily, the most common reason was pregnancy (40.0% of 30). Out of 3 (0.9%) patients who discontinued treatment permanently, 2 (66.7%) had as first reason as "patient decision". Multivariate analysis showed that EDSS was the only variable with statistically significant effect on changing treatments (r = 8.33; p -value of Type III Sum of Squares = 0.016). in our study, 303 (90.2% of eligible patients) switched treatment, 30 (8.9%) interrupted treatment temporarily, and 3 (0.9%) discontinued treatment permanently. Efficacy remains the main driving force behind switching behavior, as the primary aim of treatment is to be disease free or reduce disease activity. [ABSTRACT FROM AUTHOR]

Published
2020
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163. First therapy choice in newly diagnosed Multiple Sclerosis patients: A multicenter Italian study.

Author

Maniscalco, Giorgia T., Saccà, Francesco, Lanzillo, Roberta, Annovazzi, Pietro, Baroncini, Damiano, Binello, Eleonora, Repice, Annamaria, Perini, Paola, Clerico, Marinella, Mataluni, Giorgia, Bonavita, Simona, La Gioia, Sara, Gutierrez, Lorena Pareja, Laroni, Alice, Frau, Jessica, Cocco, Eleonora, Torri Clerici, Valentina, Zarbo, Ignazio Roberto, Sartori, Arianna, and Signoriello, Elisabetta

Abstract

• Patient's age is the most important factor in DMTs choice • Choice of oral drugs vs self-injectables ones is driven by unfavorable prognostic factors • Natalizumab preferred in early stage of severe disease and in younger patients 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. 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. 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). 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. [ABSTRACT FROM AUTHOR]

Published
2020
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164. Pediatric optic neuritis and anti MOG antibodies: a cohort of Italian patients.

Author

Giacomini, Thea, Foiadelli, Thomas, Annovazzi, Pietro, Nosadini, Margherita, Gastaldi, Matteo, Franciotta, Diego, Panarese, Claudio, Capris, Paolo, Camicione, Paola, Lanteri, Paola, De Grandis, Elisa, Prato, Giulia, Cordani, Ramona, Nobili, Lino, Morana, Giovanni, Rossi, Andrea, Pistorio, Angela, Cellerino, Maria, Uccelli, Antonio, and Sartori, Stefano

Abstract

• Optic disc edema at onset is suggestive for MOG positive optic neuritis. • Increased retinal nerve fiber layer at onset is suggestive for MOG positive optic neuritis. • Visual acuity impairment is similar at onset in MOG positive and seronegative optic neuritis. • MOG positive patients show better outcome. • Multiple sclerosis is frequent in seronegative optic neuritis, but is exceptionally rare in MOG positive optic neuritis. recent studies reported that anti myelin oligodendrocyte glycoprotein (MOG) antibody (ab) related optic neuritis (ON) tend to have characteristics that differ from seronegative ones. The aim of our study was to investigate the clinical characteristics of pediatric anti-MOG ON by comparing anti MOG-ab-seropositive and seronegative patients with ON. in this retrospective Italian multicentre study, participants were identified by chart review of patients evaluated for acquired demyelinating syndromes of the central nervous system (over the period 2009–2019). We selected patients presenting with ON as their first demyelinating event. Inclusion criteria were age < 18 years at symptoms onset; presentation consistent with ON; negativity of anti-aquaporin 4 antibodies (AQP4). Only patients who were tested for MOG-IgG1-ab with a live cell-based assay were included. 22 patients (10 MOG-ab-positive and 12 MOG-ab-negative) were included. Fundus oculi examination at onset showed disc swelling in 9/10 in the MOG-ab-positive cohort and 2/10 in the seronegative group (P = 0.002). Retinal Fiber Nerve Layer (RFNL) thickness measured by Spectral Domain Optical Coherence Tomography (S-OCT) was increased in the 5/5 MOG-ab-positive patients tested and was normal or reduced in the seronegative patients tested (4/4 patients) (P = 0.024). Visual acuity impairment at onset did not differ significantly between the two groups, but the MOG-ab-positive cohort showed better recovery at follow-up both regarding visual acuity (P = 0.025) and expanded disability status scale (EDSS) (P = 0.013). A final diagnosis of MS was frequent among seronegative patients (6/12, 50%), whereas none of the MOG-ab-positive group received a diagnosis of MS (P = 0.015). Clinical relapse frequency was low in both groups: 2/10 MOG-ab-positive and 2/12 seronegative cases relapsed, with a median follow up of 25 months. optic disc swelling and increased RFNL at baseline are strongly associated with MOG-ab positivity. MOG-ab-positive patients with ON showed better recovery compared to the seronegative ones. The relapse rate was low and did not differ among the two groups. Image, graphical abstract [ABSTRACT FROM AUTHOR]

Published
2020
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167. Fas and Fas ligand-mediated apoptosis and its role in autoimmune diabetes

Author

Signore, Alberto, Annovazzi, Alessio, Gradini, Roberto, Liddi, Roberto, and Ruberti, Giovina

Abstract

The relationship between Fas-mediated apoptosis and Type 1 diabetes is currently under investigation. Fas/Fas ligand interaction could be involved both in the insulitis process and in β-cell death. Nevertheless, different mechanisms appear to be involved in human Type 1 diabetes and in NOD mice. In the present work, we review recent evidence of the role of the Fas/Fas ligand system in human and NOD mouse diabetes, describing possible hypotheses for its involvement in the pathogenesis of the disease, with possible implications for therapy and islet transplantation. Copyright &copy; 1998 John Wiley & Sons, Ltd.

Published
1998
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169. Pregnancy does not prevent disease re-activation after natalizumab suspension in patients with multiple sclerosis

Author

Portaccio, E, Hakiki, B, Pasto, L, Giannini, M, Razzolini, L, Tortorella, C, D'Onghia, M, Trojano, M, Cocco, E, Melis, M, Marrosu, Mg, Di Tommaso, V, Farina, D, Lugaresi, A, Annovazzi, P, Ghezzi, A, Gasperini, C, Iudice, A, Fantozzi, R, Bellantonio, P, Patti, F, Chiavazza, C, Cavalla, P, Protti, A, Rossi, M, Totaro, R, De Giglio, L, Pozzilli, C, Uccelli, A, Sartori, A, Bosco, A, Amato, Mp, LANZILLO, ROBERTA, BRESCIA MORRA, VINCENZO, Portaccio, E, Hakiki, B, Pasto, L, Giannini, M, Razzolini, L, Tortorella, C, D'Onghia, M, Trojano, M, Cocco, E, Melis, M, Marrosu, Mg, Di Tommaso, V, Farina, D, Lugaresi, A, Annovazzi, P, Ghezzi, A, Gasperini, C, Iudice, A, Fantozzi, R, Bellantonio, P, Patti, F, Chiavazza, C, Cavalla, P, Protti, A, Rossi, M, Totaro, R, De Giglio, L, Pozzilli, C, Uccelli, A, Sartori, A, Bosco, A, Lanzillo, Roberta, BRESCIA MORRA, Vincenzo, and Amato, Mp

171. The diagnosis of multiple sclerosis: pinpointing the concept of 'no better explanation'

Author

Calabrese, M., Gasperini, C., Tortorella, C., Sormani, M. P., Frisullo, G., Ragonese, P., Fantozzi, R., Prosperini, L., Annovazzi, P., Cordioli, C., Diana Ferraro, Gajofatto, A., Malucchi, S., Lo Fermo, S., Luca, G., Strimllo, M. L., Cocco, E., Gallo, A., Paolicelli, D., Lanzillo, R., Tomassini, V., Pesci, I., Rodegher, M. E., Solaro, C., Calabrese, M, Gasperini, C, Tortorella, C., Sormani, Mp, Frisullo, G., Ragonese, P., Fantozzi, R., Prosperini, L., Annovazzi, P., Cordioli, C., Ferraro, D., Gajofatto, A., Malucchi, S., Lo Fermo, S, De Luca, G., Strimllo, Ml, Cocco, E., Gallo, A., Paolicelli, D., Lanzillo, Roberta, Tomassini, V., Pesci, I., Rodegher, Me, and Solaro, C.

172. Characteristics and treatment of Multiple Sclerosis-related trigeminal neuralgia: An Italian multi-centre study.

Author

Ferraro, Diana, Annovazzi, Pietro, Moccia, Marcello, Lanzillo, Roberta, De Luca, Giovanna, Nociti, Viviana, Fantozzi, Roberta, Paolicelli, Damiano, Ragonese, Paolo, Gajofatto, Alberto, Boffa, Laura, Cavalla, Paola, Lo Fermo, Salvatore, Buscarinu, Maria Chiara, Lorefice, Lorena, Cordioli, Cinzia, Calabrese, Massimiliano, Gallo, Antonio, Pinardi, Federica, and Tortorella, Carla

Abstract

• Long-term remission of Multiple Sclerosis-related trigeminal neuralgia is uncommon. • Patients with higher disability undergo surgery earlier and more frequently. • Higher disability is associated less frequently with long-term to pain remission. The prevalence of trigeminal neuralgia (TN) in Multiple Sclerosis (MS) patients is higher than in the general population and its management can be particularly challenging. Our aim is to describe the characteristics, treatment and prognostic factors of MS-related TN in a retrospective multicentre study. Neurologists members of the RIREMS group (Rising Researchers in MS) enrolled MS patients with a TN diagnosis and filled out a spreadsheet comprising their clinical data. Population consisted of 298 patients. First-choice preventive treatments were carbamazepine and oxcarbazepine. A surgical procedure was performed in 81 (30%) patients, most commonly gamma knife stereotactic radiosurgery (37%), followed by microvascular decompression (22%) and radiofrequency thermocoagulation (21%); one third of patients underwent at least two procedures. Surgery was associated with higher disability, male sex and longer interval between MS and TN onset. Patients (77%) who stayed on at least one preventive medication at most recent follow-up, after a mean period of 8 years, had a higher disability compared to the untreated group. Furthermore, patients with higher disability at TN onset were less likely to discontinue their first preventive medication due to pain remission, had bilateral TN more frequently and underwent surgical interventions earlier. MS patients with a higher disability at TN onset and with a longer interval between MS and TN onset had differing clinical features and outcomes: pain was more frequently bilateral, surgery was more frequent and anticipated, and preventive medication discontinuation due to pain remission was less common. [ABSTRACT FROM AUTHOR]

Published
2020
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173. Efficacy of different rituximab therapeutic strategies in patients with neuromyelitis optica spectrum disorders.

Author

Novi, Giovanni, Bovis, Francesca, Capobianco, Marco, Frau, Jessica, Mataluni, Giorgia, Curti, Erica, Zuliani, Luigi, Cavalla, Paola, Brambilla, Laura, Annovazzi, Pietro, Repice, Anna Maria, Lanzillo, Roberta, Esposito, Sabrina, Benedetti, Luana, Maietta, Ilaria, Sica, Francesco, Buttari, Fabio, Malucchi, Simona, Fenu, Giuseppe, and Landi, Doriana

Abstract

• RTX is effective in preventing attacks in patients with NMOSD. • No concerning safety issues occurred in our real-life cohort. • Use of specific induction and maintenance regimen might boost RTX efficacy. • RTX could be less effective in MOG-ab positive patients. To evaluate disease activity according to rituximab (RTX) induction and maintenance regimens in a multicenter real-life dataset of NMOSD patients. This is an observational-retrospective multicentre study including patients with NMOSD treated with RTX in 21 Italian and 1 Swiss centers. Demographics, relapse rate and adverse events over the follow-up were summarized taking into account induction strategy (two-1 g infusions at a 15-day interval (IND-A) vs. 375 mg/m2/week infusions for one month (IND-B)) and maintenance therapy (regimen A (M-A) with fixed time-points infusions vs. regimen B (M-B) based on cytofluorimetric driven reinfusion regimens, the least further subdivided according to CD19+ B cells (M-B1) or CD27+ memory B cells (M-B2) monitoring). 131 subjects were enrolled, 127 patients completed the induction regimen and 119 patients had at least one follow-up visit and were included in the outcome analysis. Median follow-up was 1.7 years (range 0.1–11.6). Annualized relapse rate (ARR) was 1.7 in the year before RTX start and decreased to 0.19 during the follow-up. Both ARR and Time to first relapse (TTFR) analysis showed a trend toward an increased disease activity for IND-B and M-A. No patients with MT-B2 experienced relapses during the follow-up. Number of relapses in the year before RTX initiation and having received a previous treatment were significantly associated with higher ARR and reduced TTFR in the multivariate analysis. We confirm RTX efficacy in NMOSD patients. Use of specific induction and maintenance protocols is warranted in order to foster RTX efficacy and to reduce costs and side effects. [ABSTRACT FROM AUTHOR]

Published
2019
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175. 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.

176. Comparative effectiveness of Cladribine tablets vs other drugs in relapsing-remitting multiple sclerosis: an approach merging randomized controlled trial with real life data

Author

Signori, A., Sacca, F., Lanzillo, R., Maniscalco, G. T., Signoriello, E., Repice, A., Annovazzi, P., Baroncini, D., Marinella CLERICO, Binello, E., Cerqua, R., Mataluni, G., Perini, P., Bonavita, S., Lavorgna, L., Zarbo, I. R., Laroni, A., Gutierrez, L. P., La Gioia, S., Frigeni, B., Barcella, V., Frau, J., Cocco, E., Fenu, G., Clerici, V. Torri, 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., and Sormani, M. P.

177. Shift from fingolimod to alemtuzumab: what happens next?

Author

Frau, J., Sacca, F., Signori, A., Baroncini, D., Fenu, G., Annovazzi, P., Capobianco, M., Signoriello, E., Laroni, A., La Gioia, S., Sartori, A., Maniscalco, G. T., Bonavita, S., Marinella CLERICO, Russo, C. V., Gallo, A., Lapucci, C., Sormani, M. P., and Cocco, E.

178. T helper subsets changes in alemtuzumab multiple sclerosis treated patients: the recovery of immune system capacity as a possible indicator to treatment

Author

Mercanti, S. F., Rolla, S., Cucci, A., Bardina, V., Vacca, A., Cocco, E., Vladic, A., Soldo-Butkovic, S., Habek, M., Adamec, I., Horakova, D., Annovazzi, P., Edan, G., Novelli, F., Durelli, L., Marinella CLERICO, Université de Turin, Cagliari University, Service de Neurologie [Rennes] = Neurology [Rennes], CHU Pontchaillou [Rennes], Centre d'Investigation Clinique [Rennes] (CIC), Université de Rennes 1 (UR1), Université de Rennes (UNIV-RENNES)-Université de Rennes (UNIV-RENNES)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM), Università degli Studi di Cagliari = University of Cagliari (UniCa), and Université de Rennes (UR)-Hôpital Pontchaillou-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
[SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS
Abstract

International audience; no abstract

179. Comorbidities affect treatment choice and persistence in RRMS: a multicenter study

Author

Laroni, A., Signori, A., Maniscalco, G., Lanzillo, R., Sacca, F., Clerico, M., Lo Fermo, S., Annovazzi, P., Bonavita, S., Baroncini, D., Rasia, S., Cordioli, C., Prosperini, L., Cocco, E., Clerici, V. Torri, Sartori, A., Signoriello, E., Repice, A., Zarbo, I. R., Cerqua, R., Pontecorvo, S., Di Sapio, A., Luigi Lavorgna, Barilla, C., La Gioia, S., Frigeni, B., Iaffaldano, P., Binello, E., Russo, C. V., Esposito, S., Frau, J., Gallo, F., and Sormani, M. P.

181. A real-world study of Alemtuzumab in a cohort of Italian patients

Author

Sacca, F., Russo, C. V., Frau, J., Annovazzi, P., Signoriello, E., Bonavita, S., Grasso, R., Clerico, M., Cordioli, C., Laroni, A., Capobianco, M., Clerici, V. Torri, Sartori, A., Cavalla, P., Maniscalco, G. T., La Gioia, S., Caleri, F., Giugno, A., Iodice, R., Carotenuto, A., Cocco, E., Fenu, G., Zaffaroni, M., Baronicini, D., Lus, G., Gallo, A., Mercanti, S. F., Caterina Lapucci, Di Francescantonio, V., Sormani, M. P., and Signori, A.

189. Defining the course of tumefactive multiple sclerosis: A large retrospective multicentre study

Author

Lorenzo Gaetani, Doriana Landi, Diana Ferraro, Paolo Ragonese, Alberto Gajofatto, Caterina Di Carmine, Paola Cavalla, Maria Pia Amato, Eleonora Cocco, Roberta Lanzillo, Alessia Manni, Roberta Fantozzi, Claudio Gasperini, D. Farina, Giuseppe Fenu, Sara Zagaglia, Raffaella Cerqua, Claudio Solaro, Antonio Gallo, Carolina Gabri Nicoletti, Pietro Iaffaldano, Federica Pinardi, Valentina Torri Clerici, Isabella Righini, Fabio Buttari, Damiano Paolicelli, Pietro Annovazzi, Carla Tortorella, Rocco Totaro, Giovanna De Luca, Chiara De Fino, Valentina Tomassini, Luca Prosperini, Marcello Moccia, Viviana Nociti, Maria Chiara Buscarinu, Maria Di Gregorio, Massimiliano Di Filippo, Di Gregorio M., Torri Clerici V.L.A., Fenu G., Gaetani L., Gallo A., Cavalla P., Ragonese P., Annovazzi P., Gajofatto A., Prosperini L., Landi D., Nicoletti C.G., Di Carmine C., Totaro R., Nociti V., De Fino C., Ferraro D., Tomassini V., Tortorella C., Righini I., Amato M.P., Manni A., Paolicelli D., Iaffaldano P., Lanzillo R., Moccia M., Buttari F., Fantozzi R., Cerqua R., Zagaglia S., Farina D., De Luca G., Buscarinu M.C., Pinardi F., Cocco E., Gasperini C., Solaro C.M., Di Filippo M., Di Gregorio, M., Torri Clerici, V. L. A., Fenu, G., Gaetani, L., Gallo, A., Cavalla, P., Ragonese, P., Annovazzi, P., Gajofatto, A., Prosperini, L., Landi, D., Nicoletti, C. G., Di Carmine, C., Totaro, R., Nociti, V., De Fino, C., Ferraro, D., Tomassini, V., Tortorella, C., Righini, I., Amato, M. P., Manni, A., Paolicelli, D., Iaffaldano, P., Lanzillo, R., Moccia, M., Buttari, F., Fantozzi, R., Cerqua, R., Zagaglia, S., Farina, D., De Luca, G., Buscarinu, M. C., Pinardi, F., Cocco, E., Gasperini, C., Solaro, C. M., and Di Filippo, M.

Subjects
Male, tumefactive demyelinating lesions (TDLs), 0302 clinical medicine, Retrospective Studie, Interquartile range, differential diagnosis, 030212 general & internal medicine, Prospective Studies, Young adult, Prospective cohort study, Child, treatment, Tumefactive multiple sclerosi, Tumefactive demyelinating lesions, Demyelinating Disease, Middle Aged, Magnetic Resonance Imaging, Differential diagnosis, Multiple sclerosis, Tumefactive demyelinating lesions, Tumefactive multiple sclerosis, Neurology, Multiple sclerosis, Tumefactive multiple sclerosis, Female, Human, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, differential diagnosi, Settore MED/26, 03 medical and health sciences, Young Adult, Oligoclonal Band, Internal medicine, medicine, Humans, Multiple sclerosi, Tumefactive multiple sclerosis (TuMS), Aged, Retrospective Studies, Tumefactive demyelinating lesion, Expanded Disability Status Scale, business.industry, Oligoclonal Bands, Retrospective cohort study, Odds ratio, medicine.disease, Confidence interval, Prospective Studie, Demyelinating Diseases, prognosis, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background and purpose: Tumefactive multiple sclerosis (TuMS) (i.e., MS onset presenting with tumefactive demyelinating lesions [TDLs]) is a diagnostic and therapeutic challenge. We performed a multicentre retrospective study to describe the clinical characteristics and the prognostic factors of TuMS. Methods: One hundred two TuMS patients were included in this retrospective study. Demographic, clinical, magnetic resonance imaging (MRI), laboratory data and treatment choices were collected. Results: TuMS was found to affect women more than men (female:male: 2.4), with a young adulthood onset (median age: 29.5years, range: 11–68 years, interquartile range [IQR]: 38 years). At onset, 52% of TuMS patients presented with the involvement of more than one functional system and 24.5% of them with multiple TDLs. TDLs most frequently presented with an infiltrative MRI pattern (38.7%). Cerebrospinal fluid immunoglobulin G oligoclonal bands were often demonstrated (76.6%). In 25.3% of the cases, more than one acute-phase treatment was administered, and almost one-half of the patients (46.6%) were treated with high-efficacy treatments. After a median follow-up of 2.3years (range: 0.1–10.7 years, IQR: 3.4 years), the median Expanded Disability Status Scale (EDSS) score was 1.5 (range: 0–7, IQR: 2). Independent risk factors for reaching an EDSS score ≥3 were a higher age at onset (odds ratio [OR]: 1.08, 95% confidence interval [CI]: 1.03–1.14, p&nbsp

Published
2021

190. 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

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

Author

Bombaci, Alessandro, Abbadessa, Gianmarco, Trojsi, Francesca, Leocani, Letizia, Bonavita, Simona, Lavorgna, Luigi, Gioacchino Tedeschi, Giovanni Mancardi, Alessandro Padovani, Marinella Clerico, Francesco Brigo, Roberta Lanzillo, Antonio Russo, Bruno Giometto, Giulia Straccia, Rosa Iodice, Sebastiano Bucello, Pietro Annovazzi, Marcello Moccia, Luca Prosperini, Maria Laura Stromillo, Anna Maria Repice, Giuseppina Miele, Alberto Lerario, Antonio De Martino, Francesco Iodice, Francesco Di Lorenzo, Luca Cuffaro, Michele Romoli, Marcello Silvestro, Carlo Alberto Artusi, Bombaci, Alessandro, Abbadessa, Gianmarco, Trojsi, Francesca, Leocani, Letizia, Bonavita, Simona, Lavorgna, Luigi, Bombaci, A., Abbadessa, G., Trojsi, F., Leocani, L., Bonavita, S., Lavorgna, L., Tedeschi, G., Mancardi, G., Padovani, A., Clerico, M., Brigo, F., Lanzillo, R., Russo, A., Giometto, B., Straccia, G., Iodice, R., Bucello, S., Annovazzi, P., Moccia, M., Prosperini, L., Stromillo, M. L., Repice, A. M., Miele, G., Lerario, A., De Martino, A., Iodice, F., Di Lorenzo, F., Cuffaro, L., Romoli, M., Silvestro, M., Artusi, C. A., Bombaci, A, Abbadessa, G, Trojsi, F, Leocani, L, Bonavita, S, Lavorgna, L, Tedeschi, G, Mancardi, G, Padovani, A, Clerico, M, Brigo, F, Lanzillo, R, Russo, A, Giometto, B, Straccia, G, Iodice, R, Bucello, S, Annovazzi, P, Moccia, M, Prosperini, L, Stromillo, M, Repice, A, Miele, G, Lerario, A, De Martino, A, Iodice, F, Di Lorenzo, F, Cuffaro, L, Romoli, M, Silvestro, M, Artusi, C, Alessandro, Bombaci, Gianmarco, Abbadessa, Francesca, Trojsi, Letizia, Leocani, Simona, Bonavita, Luigi, Lavorgna, Tedeschi, Gioacchino, Mancardi, Giovanni, Padovani, Alessandro, Clerico, Marinella, Brigo, Francesco, Lanzillo, Roberta, Russo, Antonio, Giometto, Bruno, Straccia, Giulia, Iodice, Rosa, Bucello, Sebastiano, Annovazzi, Pietro, Moccia, Marcello, Prosperini, Luca, Laura Stromillo, Maria, Maria Repice, Anna, Miele, Giuseppina, Lerario, Alberto, De Martino, Antonio, Iodice, Francesco, Di Lorenzo, Francesco, Cuffaro, Luca, Romoli, Michele, Silvestro, Marcello, and Alberto Artusi, Carlo

Subjects
medicine.medical_specialty, Telemedicine, Neurology, Coronavirus disease 2019 (COVID-19), Clinical Neurology, Monitoring, Ambulatory, Context (language use), Disease, Review Article, Dermatology, Tele-health, Teleneurology, ALS patients, COVID-19, Remote monitoring, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Pandemic, medicine, Humans, 030212 general & internal medicine, Amyotrophic lateral sclerosis, Intensive care medicine, business.industry, Amyotrophic Lateral Sclerosis, General Medicine, medicine.disease, Psychiatry and Mental health, ALS patient, Neurology (clinical), Neurosurgery, business, 030217 neurology & neurosurgery
Abstract

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.

Published
2020
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193. Characteristics and treatment of Multiple Sclerosis-related trigeminal neuralgia: An Italian multi-centre study

Author

Giorgia Teresa Maniscalco, Cinzia Cordioli, Maria Chiara Buscarinu, Diana Ferraro, Massimiliano Calabrese, Claudio Gasperini, Marcello Moccia, Alberto Gajofatto, Antonio Gallo, Eleonora Cocco, Valentina Camera, Pietro Annovazzi, Roberta Fantozzi, Marta Radaelli, Giovanna De Luca, Valentina Tomassini, Roberta Lanzillo, Claudio Solaro, Lorena Lorefice, Carla Tortorella, Federica Pinardi, Fabio Buttari, Paolo Ragonese, Paola Cavalla, Viviana Nociti, Salvatore Lo Fermo, Laura Boffa, Rirems, Damiano Paolicelli, Massimiliano Di Filippo, Ferraro, D., Annovazzi, P., Moccia, M., Lanzillo, R., De Luca, G., Nociti, V., Fantozzi, R., Paolicelli, D., Ragonese, P., Gajofatto, A., Boffa, L., Cavalla, P., Lo Fermo, S., Buscarinu, M. C., Lorefice, L., Cordioli, C., Calabrese, M., Gallo, A., Pinardi, F., Tortorella, C., Di Filippo, M., Camera, V., Maniscalco, G. T., Radaelli, M., Buttari, F., Tomassini, V., Cocco, E., Gasperini, C., Solaro, C., Ferraro D., Annovazzi P., Moccia M., Lanzillo R., De Luca G., Nociti V., Fantozzi R., Paolicelli D., Ragonese P., Gajofatto A., Boffa L., Cavalla P., Lo Fermo S., Buscarinu M.C., Lorefice L., Cordioli C., Calabrese M., Gallo A., Pinardi F., Tortorella C., Di Filippo M., Camera V., Maniscalco G.T., Radaelli M., Buttari F., Tomassini V., Cocco E., Gasperini C., and Solaro C.

Subjects
Pediatrics, medicine.medical_treatment, multiple sclerosis, microvascular decompression surgery, time factors, 0302 clinical medicine, Radiofrequency thermocoagulation, Trigeminal neuralgia, Multiple Sclerosi, Outcome Assessment, Health Care, italy, middle aged, pain, 030212 general & internal medicine, Oxcarbazepine, humans, education.field_of_study, trigeminal neuralgia, adult, Disability, Multiple Sclerosis, Pain, radiosurgery, General Medicine, Analgesics, Non-Narcotic, health care, follow-up studies, Settore MED/26 - NEUROLOGIA, aged, retrospective studies, female, Neurology, disability, analgesics, non-narcotic, male, severity of illness index, sex factors, neurosurgical procedures, outcome assessment, health care, analgesics, medicine.drug, medicine.medical_specialty, Population, Microvascular decompression, 03 medical and health sciences, medicine, education, outcome assessment, business.industry, Multiple sclerosis, Carbamazepine, medicine.disease, Discontinuation, non-narcotic, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background The prevalence of trigeminal neuralgia (TN) in Multiple Sclerosis (MS) patients is higher than in the general population and its management can be particularly challenging. Our aim is to describe the characteristics, treatment and prognostic factors of MS-related TN in a retrospective multicentre study. Methods Neurologists members of the RIREMS group (Rising Researchers in MS) enrolled MS patients with a TN diagnosis and filled out a spreadsheet comprising their clinical data. Results Population consisted of 298 patients. First-choice preventive treatments were carbamazepine and oxcarbazepine. A surgical procedure was performed in 81 (30%) patients, most commonly gamma knife stereotactic radiosurgery (37%), followed by microvascular decompression (22%) and radiofrequency thermocoagulation (21%); one third of patients underwent at least two procedures. Surgery was associated with higher disability, male sex and longer interval between MS and TN onset. Patients (77%) who stayed on at least one preventive medication at most recent follow-up, after a mean period of 8 years, had a higher disability compared to the untreated group. Furthermore, patients with higher disability at TN onset were less likely to discontinue their first preventive medication due to pain remission, had bilateral TN more frequently and underwent surgical interventions earlier. Conclusion MS patients with a higher disability at TN onset and with a longer interval between MS and TN onset had differing clinical features and outcomes: pain was more frequently bilateral, surgery was more frequent and anticipated, and preventive medication discontinuation due to pain remission was less common.

Published
2020

194. Harmonization of real-world studies in multiple sclerosis: Retrospective analysis from the rirems group

Author

Federica Pinardi, Simona Mallucchi, Paolo Ragonese, Eleonora Cocco, Valentina Tomassini, Alice Laroni, Lorena Lorefice, Claudio Solaro, Alberto Gajofatto, Cinzia Cordioli, Viviana Nociti, Maria Chiara Buscarinu, Claudio Gasperini, Marta Radaelli, Antonio Gallo, Luca Prosperini, Massimiliano Di Filippo, Massimiliano Calabrese, Damiano Paolicelli, Paola Cavalla, Diana Ferraro, Pietro Annovazzi, Roberta Lanzillo, Marcello Moccia, Carla Tortorella, Moccia, M., Annovazzi, P., Buscarinu, M. C., Calabrese, M., Cavalla, P., Cordioli, C., Di Filippo, M., Ferraro, D., Gajofatto, A., Gallo, A., Lanzillo, R., Laroni, A., Lorefice, L., Mallucchi, S., Nociti, V., Paolicelli, D., Pinardi, F., Prosperini, L., Radaelli, M., Ragonese, P., Tomassini, V., Tortorella, C., Cocco, E., Gasperini, C., Solaro, C., Moccia M., Annovazzi P., Buscarinu M.C., Calabrese M., Cavalla P., Cordioli C., Di Filippo M., Ferraro D., Gajofatto A., Gallo A., Lanzillo R., Laroni A., Lorefice L., Mallucchi S., Nociti V., Paolicelli D., Pinardi F., Prosperini L., Radaelli M., Ragonese P., Tomassini V., Tortorella C., Cocco E., Gasperini C., and Solaro C.

Subjects
Adult, Longitudinal study, medicine.medical_specialty, Harmonization, Outcome measures, Multiple sclerosis, Outcome measure, 03 medical and health sciences, 0302 clinical medicine, Real world, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, Age of Onset, Aged, Retrospective Studies, Expanded Disability Status Scale, business.industry, Retrospective cohort study, General Medicine, Variance (accounting), medicine.disease, Neurology, Italy, Family medicine, Observational study, Female, Neurology (clinical), business, 030217 neurology & neurosurgery, Multiple Sclerosis
Abstract

Background: Worldwide multiple sclerosis (MS) centers have coordinated their efforts to use data acquired in clinical practice for real-world observational studies. In this retrospective study, we aim to harmonize outcome measures, and to evaluate their heterogeneity within the Rising Italian Researchers in MS (RIReMS) study group. Methods: RIReMS members filled in a structured questionnaire evaluating the use of different outcome measures in clinical practice. Thereafter, thirty-four already-published papers from RIReMS centers were used for heterogeneity analyses, using the DerSimonian and Laird random-effects method to compute the between-study variance (τ2). Results: Based on questionnaire results, we defined basic modules for diagnosis and follow-up, consisting of outcome measures recorded by all participating centers at the time of diagnosis, and, then, at least annually; we also defined more detailed/optional modules, with outcome measures recorded less frequently and/or in the presence of specific clinical indications. Looking at heterogeneity, we found 5-year variance in age at onset (ES=27.34; 95%CI=26.18, 28.49; p41.4 years (ES=4.37; 95%CI=3.40, 5.35; p2 years (ES=5.41; 95%CI=3.22, 7.60; p = 0.02; τ2=1.00). Discussion: We suggest common sets of biomarkers to be acquired in clinical practice, that can be used for research purposes. Also, we provide researchers with specific indications for improving inclusion criteria and data analysis, ultimately allowing data harmonization and high-quality collaborative studies.

Published
2020

195. 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

196. A real‐world study of alemtuzumab in a cohort of Italian patients

Author

Paola Cavalla, Laura Brambilla, Roberta Grasso, Cinzia Cordioli, Alice Laroni, Alessia Giugno, Valentina Torri Clerici, Maria Pia Sormani, Pietro Annovazzi, Francesco Saccà, Eleonora Cocco, Jessica Frau, Elisabetta Signoriello, Antonio Gallo, Marinella Clerico, Stefania Federica De Mercanti, Antonio Carotenuto, Simona Bonavita, Cinzia Valeria Russo, Giuseppe Fenu, Caterina Lapucci, Giorgia Teresa Maniscalco, Arianna Sartori, Francesca Caleri, Marco Capobianco, Alessio Signori, Rosa Iodice, Sara La Gioia, Giacomo Lus, Mauro Zaffaroni, Damiano Baroncini, Valeria Di Francescantonio, Russo, C. V., Sacca, F., Frau, J., Annovazzi, P., Signoriello, E., Bonavita, S., Grasso, R., Clerico, M., Cordioli, C., Laroni, A., Capobianco, M., Torri Clerici, V., Sartori, A., Cavalla, P., Maniscalco, G. T., La Gioia, S., Caleri, F., Giugno, A., Iodice, R., Carotenuto, A., Cocco, E., Fenu, G., Zaffaroni, M., Baroncini, D., Lus, G., Gallo, A., De Mercanti, S. F., Lapucci, C., Di Francescantonio, V., Brambilla, L., Sormani, M. P., Signori, A., Russo, CINZIA VALERIA, Sacca', Francesco, Frau, Jessica, Annovazzi, Pietro, Signoriello, Elisabetta, Bonavita, Simona, Grasso, Roberta, Clerico, Marinella, Cordioli, Cinzia, Laroni, Alice, Capobianco, Marco, Torri Clerici, Valentina, Sartori, Arianna, Cavalla, Paola, Teresa Maniscalco, Giorgia, La Gioia, Sara, Caleri, Francesca, Giugno, Alessia, Iodice, Rosa, Carotenuto, Antonio, Cocco, Eleonora, Fenu, Giuseppe, Zaffaroni, Mauro, Baroncini, Damiano, Lus, Giacomo, Gallo, Antonio, Federica De Mercanti, Stefania, Lapucci, Caterina, Di Francescantonio, Valeria, Brambilla, Laura, Pia Sormani, Maria, and Signori, Alessio

Subjects
Adult, safety, medicine.medical_specialty, efficacy, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Internal medicine, alemtuzumab, medicine, Humans, Glatiramer acetate, real-world evidence, Retrospective Studies, Expanded Disability Status Scale, Fingolimod Hydrochloride, business.industry, Multiple sclerosis, Glatiramer Acetate, cohort, medicine.disease, Fingolimod, Neurology, Relative risk, Cohort, Alemtuzumab, Neurology (clinical), business, medicine.drug
Abstract

Background and purpose: Real-world data on alemtuzumab are limited and do not provide evidence of its effectiveness after various disease-modifying therapies (DMTs). Our aim was to provide real-world data on the impact of clinical variables and previous DMTs on clinical response to alemtuzumab. Methods: Sixteen Italian multiple sclerosis centers retrospectively included patients who started alemtuzumab from January 2015 to December 2018, and recorded demographics, previous therapies, washout duration, relapses, Expanded Disability Status Scale (EDSS) score, and magnetic resonance imaging data. Negative binomial regression models were used to assess the effect of factors on annualized relapse (ARR) after alemtuzumab initiation. Results: We studied 322 patients (mean age 36.8years, median EDSS score 3, median follow-up 1.94years). Previous treatments were: fingolimod (106), natalizumab (80), first-line oral agents (56), first-line injectables (interferon/glatiramer acetate; 30), and other drugs (15). Thirty-five patients were treatment-naïve. The pre-alemtuzumab ARR was 0.99 and decreased to 0.13 during alemtuzumab treatment (p&nbsp

Published
2021
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197. mRNA COVID-19 vaccines do not increase the short-term risk of clinical relapses in multiple sclerosis

Author

Paola Cavalla, Fabio Buttari, Alice Laroni, Cinzia Cordioli, Claudio Gasperini, Alberto Gajofatto, Paolo Ragonese, Massimiliano Di Filippo, Lorena Lorefice, Angela Borrelli, Giorgia Teresa Maniscalco, Viviana Nociti, Valentina Torri Clerici, Massimiliano Calabrese, Marta Radaelli, Antonio Gallo, Laura Boffa, Claudio Solaro, Roberta Lanzillo, Carla Tortorella, Eleonora Cocco, Simona Malucchi, Diana Ferraro, Paola Gazzola, Giovanna De Luca, Valentina Tomassini, Marinella Clerico, Pietro Annovazzi, Damiano Paolicelli, Roberta Fantozzi, Marcello Moccia, Luca Prosperini, Di Filippo M., Cordioli C., Malucchi S., Annovazzi P., Cavalla P., Torri Clerici V., Ragonese P., Nociti V., Radaelli M., Laroni A., Buttari F., Lorefice L., Ferraro D., Gajofatto A., Prosperini L., Fantozzi R., Boffa L., Lanzillo R., Moccia M., Clerico M., De Luca G., Tomassini V., Calabrese M., Borrelli A., Paolicelli D., Maniscalco G.T., Gazzola P., Gallo A., Solaro C., Cocco E., Gasperini C., Tortorella C., Di Filippo, Massimiliano, Cordioli, Cinzia, Malucchi, Simona, Annovazzi, Pietro, Cavalla, Paola, Torri Clerici, Valentina, Ragonese, Paolo, Nociti, Viviana, Radaelli, Marta, Laroni, Alice, Buttari, Fabio, Lorefice, Lorena, Ferraro, Diana, Gajofatto, Alberto, Prosperini, Luca, Fantozzi, Roberta, Boffa, Laura, Lanzillo, Roberta, Moccia, Marcello, Clerico, Marinella, De Luca, Giovanna, Tomassini, Valentina, Calabrese, Massimiliano, Borrelli, Angela, Paolicelli, Damiano, Maniscalco, Giorgia Teresa, Gazzola, Paola, Gallo, Antonio, Solaro, Claudio, Cocco, Eleonora, Gasperini, Claudio, and Tortorella, Carla

Subjects
Pediatrics, medicine.medical_specialty, education.field_of_study, Expanded Disability Status Scale, Coronavirus disease 2019 (COVID-19), business.industry, Multiple sclerosis, COVID-19, multiple sclerosis, neuroimmunology, Population, medicine.disease, Vaccination, Psychiatry and Mental health, Infectious disease (medical specialty), multiple sclerosi, Pandemic, medicine, Surgery, Observational study, multiple sclerosis, neuroimmunology, COVID-19, Neurology (clinical), business, education
Abstract

Multiple sclerosis (MS) is a chronic, immune-mediated disorder of the central nervous system. A novel coronavirus, namely SARS-CoV-2, has been recently responsible for the highly infectious disease referred as COVID-19, rapidly spreading all over the world. Many vaccines have been developed to control COVID-19 pandemic, including the mRNA vaccines Pfizer/BioNTech (BNT162b2) and Moderna (mRNA1273).1 The vaccination of people with MS (pwMS) has been recommended by several national and international MS societies. However, effectiveness and safety of anti-COVID-19 mRNA vaccines in MS need to be confirmed. The aim of this study was to evaluate the short-term risk of clinical relapses in pwMS in the 2 months after the first administration of an mRNA COVID-19 vaccine. Twenty-five Italian MS tertiary centres participated to this prospective, self-controlled, multicentric observational study. In Italy, COVID-19 population vaccination started at the end of December 2020 and first involved healthcare professionals. All pwMS, diagnosed according to McDonald’s 2017 criteria, who underwent the first dose of an mRNA COVID-19 vaccine within January 2021 were recruited from each participating centre. All patients received Pfizer/BioNTech BNT162b2 vaccine according to vaccine availability in Italy. Database lock was planned on 31 March so that all patients were followed for at least 2 months after the first dose. The following data were collected: (1) sex; (2) age and disease duration; (3) disease course (relapsing remitting; secondary progressive; primary progressive); (4) disability score (Expanded Disability Status Scale, EDSS); (5) clinical relapses in the year before vaccination, with specific regard to the 2 months immediately preceding vaccination; (6) MRI activity in the year before vaccination (new T2 or Gd enhancing—Gd+—lesions); (7) previous molecular swab confirmed SARS-CoV-2 infection; (8) vaccine administration date and (9) disease-modifying treatments at the time of vaccination. The presence, characteristics and number of relapses in the 60 days after the first administration of …

Published
2022

198. Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Author

Pietro Annovazzi, Fioravante Capone, Sofia Zywicki, Paola Cavalla, Claudio Gasperini, Roberta Fantozzi, Elisabetta Ferraro, Doriana Landi, Sebastiano Bucello, Maria Maddalena Filippi, Roberto Bergamaschi, Vincenzo Dattola, Luigi M.E. Grimaldi, Girolama Alessandra Marfia, Luca Prosperini, Paolo Ragonese, Paolo Manganotti, Cristina Zuliani, Marco Pisa, Maria Chiara Buscarinu, Giovanna Borriello, A. Bianchi, Massimiliano Mirabella, Antonio Cortese, Marta Altieri, Rosella Cavarretta, Valentina Liliana Adriana Torri-Clerici, Giovanna De Luca, Valentina Tomassini, Massimiliano Di Filippo, Graziella Callari, Massimo Filippi, Giulia Mallucci, Valeria Barcella, Mauro Zaffaroni, Marco Capobianco, Paola Perini, Margherita Russo, Sabrina Realmuto, Marianna Lo Re, Bucello S., Annovazzi P., Ragonese P., Altieri M., Barcella V., Bergamaschi R., Bianchi A., Borriello G., Buscarinu M.C., Callari G., Capobianco M., Capone F., Cavalla P., Cavarretta R., Cortese A., De Luca G., Di Filippo M., Dattola V., Fantozzi R., Ferraro E., Filippi M.M., Gasperini C., Grimaldi L.M.E., Landi D., Re M.L., Mallucci G., Manganotti P., Marfia G.A., Mirabella M., Perini P., Pisa M., Realmuto S., Russo M., Tomassini V., Torri-Clerici V.L.A., Zaffaroni M., Zuliani C., Zywicki S., Filippi M., and Prosperini L.

Subjects
medicine.medical_specialty, Neurology, Multiple Sclerosis, Toluidines, Hydroxybutyrates, Oral drugs, Disease, Relapsing-Remitting, Settore MED/26, Pregnancy planning, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, Teriflunomide, Nitriles, medicine, Humans, 030212 general & internal medicine, Adverse effect, Retrospective Studies, Expanded Disability Status Scale, business.industry, Multiple sclerosis, medicine.disease, Settore MED/26 - NEUROLOGIA, chemistry, Tolerability, Italy, Crotonates, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Objective: To identify baseline factors associated with disease activity in patients with relapsing–remitting multiple sclerosis (RRMS) under teriflunomide treatment. Methods: This was an independent, multi-centre, retrospective post-marketing study. We analysed data of 1,507 patients who started teriflunomide since October 2014 and were regularly followed in 28 Centres in Italy. We reported the proportions of patients who discontinued treatment (after excluding 32 lost to follow-up) and who experienced clinical disease activity, i.e., relapse(s) and/or confirmed disability worsening, as assessed by the Expanded Disability Status Scale (EDSS). Decision tree-based analysis was performed to identify baseline factors associated with clinical disease activity during teriflunomide treatment. Results: At database lock (September 2020), approximately 29% of patients (430 out of 1,475) discontinued teriflunomide because of disease activity (~ 46%), adverse events (~ 37%), poor tolerability (~ 15%), pregnancy planning (~ 2%). Approximately 28% of patients experienced disease activity over a median follow-up of 2.75years: ~ 9% had relapses but not disability worsening; ~ 13% had isolated disability worsening; ~ 6% had both relapses and disability worsening. The most important baseline factor associated with disease activity(especially disability worsening) was an EDSS > 4.0 (p < 0.001). In patients with moderate disability level (EDSS 2.0–4.0), disease activity occurred more frequently in case of ≥ 1 pre-treatment relapses (p = 0.025). In patients with milder disability level (EDSS < 2.0), disease activity occurred more frequently after previous exposure to ≥ 2 disease-modifying treatments (p = 0.007). Conclusions: Our study suggests a place-in-therapy for teriflunomide in naïve patients with mild disability level or in those who switched their initial treatment for poor tolerability. Adverse events related with teriflunomide were consistent with literature data, without any new safety concern.

Published
2021

199. '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

200. 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

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