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1. Epigenetics: An opportunity to shape innate and adaptive immune responses

Author

Antonietta Liotti, Anne Lise Ferrara, Stefania Loffredo, Maria Rosaria Galdiero, Gilda Varricchi, Francesca Di Rella, Giorgia Teresa Maniscalco, Martina Belardo, Roberta Vastano, Rosaria Prencipe, Laura Pignata, Roberta Romano, Giuseppe Spadaro, Paola de Candia, Antonio Pezone, Veronica De Rosa, Liotti, A, Ferrara, Al, Loffredo, S, Galdiero, Mr, Varricchi, G, Di Rella, F, Maniscalco, Gt, Belardo, M, Vastano, R, Prencipe, R, Pignata, L, Romano, R, Spadaro, G, de Candia, P, Pezone, A, De Rosa, V., Liotti, Antonietta, Ferrara, Anne Lise, Loffredo, Stefania, Galdiero, Maria Rosaria, Varricchi, Gilda, Di Rella, Francesca, Maniscalco, Giorgia Teresa, Belardo, Martina, Vastano, Roberta, Prencipe, Rosaria, Pignata, Laura, Romano, Roberta, Spadaro, Giuseppe, de Candia, Paola, Pezone, Antonio, and De Rosa, Veronica

Subjects
Epidrug, adaptive immunity, autoimmunity, epidrugs, epigenetics, Foxp3, innate immunity, T-celldifferentiation, Treg cell, Immunology, T cell differentiation, Immunity, Epigenetic, Autoimmunity, Cell Differentiation, Adaptive Immunity, DNA Methylation, Innate Immunity, Immunity, Innate, Epigenesis, Genetic, Histones, Foxp3, Immunology and Allergy, Treg cells
Abstract

Epigenetics connects genetic and environmental factors: it includes DNA methylation, histone post-translational modifications and the regulation of chromatin accessibility by non-coding RNAs, all of which control constitutive or inducible gene transcription. This plays a key role in harnessing the transcriptional programs of both innate and adaptive immune cells due to its plasticity and environmental-driven nature, piloting myeloid and lymphoid cell fate decision with no change in their genomic sequence. In particular, epigenetic marks at the site of lineage specific transcription factors and maintenance of cell type-specific epigenetic modifications, referred to as "epigenetic memory", dictate cell differentiation, cytokine production and functional capacity following repeated antigenic exposure in memory T cells. Moreover, metabolic and epigenetic reprogramming occurring during a primary innate immune response leads to enhanced responses to secondary challenges, a phenomenon known as "trained immunity". Here we discuss how stable and dynamic epigenetic states control immune cell identity and plasticity in physiological and pathological conditions. Dissecting the regulatory circuits of cell fate determination and maintenance is of paramount importance for understanding the delicate balance between immune cell activation and tolerance, in healthy conditions and in autoimmune diseases. This article is protected by copyright. All rights reserved.

Published
2022
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2. Three Doses of COVID-19 Vaccines: A Retrospective Study Evaluating the Safety and the Immune Response in Patients with Multiple Sclerosis

Author

Capuano, Giorgia Teresa Maniscalco, Daniele Di Giulio Cesare, Valerio Liguori, Valentino Manzo, Elio Prestipino, Simona Salvatore, Maria Elena Di Battista, Ornella Moreggia, Antonio Rosario Ziello, Vincenzo Andreone, Cristina Scavone, and Annalisa

Subjects
COVID-19, mRNA-based vaccine, safety, multiple sclerosis, AEFI, observational study, three doses
Abstract

Since the beginning of the mass immunization of patients with multiple sclerosis (MS), many data on the efficacy and safety of COVID-19 vaccines have been produced. Considering that MS is an autoimmune disease and that some disease-modifying therapies (DMTs) could decrease the antibody response against COVID-19 vaccines, we carried out this retrospective study with the aim to evaluate the safety of these vaccines in terms of AEFI occurrence and the antibody response after MS patients had received the third dose. Two hundred and ten patients (64.8% female; mean age: 46 years) received the third dose of the mRNA-based COVID-19 vaccine and were included in the study. Third doses were administered from October 2021 to January 2022. The majority of patients (n = 193) were diagnosed with RRMS and EDSS values were ≤3.0 in 72.4% of them. DMTs most commonly used by included patients were interferon Beta 1-a, dimethyl fumarate, natalizumab and fingolimod. Overall, 160 patients (68.8% female) experienced 294 AEFIs, of which about 90% were classified as short-term, while 9.2% were classified as long-term. The most commonly reported following the booster dose were pain at the injection site, flu-like symptoms, headache, fever and fatigue. Regarding the immune response, consistently with literature data, we found that patients receiving ocrelizumab and fingolimod had lower IgG titer than patients receiving other DMTs.

Published
2023
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3. The effect of air pollution on COVID‐19 severity in a sample of patients with multiple sclerosis

Author

Bergamaschi, Roberto, Ponzano, Marta, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Antonio, Confalonieri, Paolo, Marfia, Girolama Alessandra, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Pisoni, Enrico, Tedeschi, Gioacchino, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria Pia, Gianmarco Abbadessa, Umberto Aguglia, Lia Allegorico, Rossi Beatrice Maria Allegri, Anastasia Alteno, Maria Pia Amato, Pietro Annovazzi, Carlo Antozzi, Lucia Appendino, Sebastiano Arena, Viola Baione, Roberto Balgera, Valeria Barcella, Damiano Baroncini, Caterina Barrilà, Mario A Battaglia, Alessandra Bellacosa, Gianmarco Bellucci, Roberto Bergamaschi, Valeria Bergamaschi, Daiana Bezzini, Beatrice Biolzi, Alvino Bisecco, Simona Bonavita, Giovanna Borriello, Chiara Bosa, Antonio Bosco, Francesca Bovis, Marco Bozzali, Laura Brambilla, Morra Vincenzo Brescia, Giampaolo Brichetto, Maria Buccafusca, Elisabetta Bucciantini, Sebastiano Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano Calabrese, Francesca Calabria, Francesca Caleri, Federico Camilli, Luisa Maria Caniatti, Roberto Cantello, Marco Capobianco, Ruggero Capra, Rocco Capuano, Luca Carmisciano, Patrizia Carta, Paola Cavalla, Maria Grazia Celani, Maria Cellerino, Raffaella Cerqua, Clara Chisari, Raffaella Clerici, Marinella Clerico, Eleonora Cocco, Gaia Cola, Giancarlo Comi, Paolo Confalonieri, Antonella Conte, Marta Zaffira Conti, Christian Cordano, Susanna Cordera, Cinzia Cordioli, Francesco Corea, Claudio Correale, Salvatore Cottone, Francesco Crescenzo, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Maura Chiara Danni, Alessia d'Arma, Vincenzo Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Rossi, Nicola De Stefano, Cava Marco Della, Mario di Napoli, Alessia Di Sapio, Renato Docimo, Anna Dutto, Luana Evangelista, Salvatore Fanara, Diana Ferraro, Maria Teresa Ferrò, Massimo Filippi, Cristina Fioretti, Mario Fratta, Jessica Frau, Marzia Fronza, Roberto Furlan, Alberto Gajofatto, Antonio Gallo, Paolo Gallo, Claudio Gasperini, Anna Ghazaryan, Bruno Giometto, Francesca Gobbin, Flora Govone, Franco Granella, Erica Grange, Maria Grazia Grasso, Angelica Guareschi, Clara Guaschino, Simone Guerrieri, Donata Guidetti, Pietro Iaffaldano, Antonio Ianniello, Luigi Iasevoli, Paolo Immovilli, Daniele Imperiale, Maria Teresa Infante, Matilde Inglese, Rosa Iodice, Aniello Iovino, Giovanna Konrad, Doriana Landi, Roberta Lanzillo, Caterina Lapucci, Luigi Lavorgna, Maria Rita L'Episcopo, Serena Leva, Giuseppe Liberatore, Re Marianna Lo, Marco Longoni, Leonardo Lopiano, Lorena Lorefice, Matteo Lucchini, Giacomo Lus, Davide Maimone, Maria Malentacchi, Giulia Mallucci, Simona Malucchi, Chiara Rosa Mancinelli, Luca Mancinelli, Paolo Manganotti, Giorgia Teresa Maniscalco, Vittorio Mantero, Sabrina Marangoni, Damiano Marastoni, Girolama Alessandra Marfia, Fabiana Marinelli, Alessandro Marti, Boneschi Filippo Martinelli, Zoli Federco Masserano, Francesca Matta, Laura Mendozzi, Giuseppe Meucci, Silvia Miante, Giuseppina Miele, Eva Milano, Massimiliano Mirabella, Rosanna Missione, Marcello Moccia, Lucia Moiola, Sara Montepietra, Margherita MontiBragadin, Federico Montini, Roberta Motta, Raffaele Nardone, Carolina Gabri Nicoletti, Eduardo Nobile-Orazio, Agostino Nozzolillo, Marco Onofrj, Riccardo Orlandi, Anna Palmieri, Damiano Paolicelli, Livia Pasquali, Luisa Pastò, Francesco Patti, Elisabetta Pedrazzoli, Paola Perini, Ilaria Pesci, Maria Petracca, Alfredo Petrone, Carlo Piantadosi, Anna M Pietroboni, Federica Pinardi, Marta Ponzano, Emilio Portaccio, Mattia Pozzato, Carlo Pozzilli, Luca Prosperini, Alessandra Protti, Marta Radaelli, Paolo Ragonese, Sarah Rasia, Sabrina Realmuto, Anna Repice, Eleonora Rigoni, Maria Teresa Rilla, Francesca Rinaldi, Calogero Marcello Romano, Marco Ronzoni, Marco Rovaris, Francesca Ruscica, Loredana Sabattini, Giuseppe Salemi, Marco Salvetti, Lorenzo Saraceno, Alessia Sartori, Arianna Sartori, Elvira Sbragia, Cinzia Scandellari, Giuditta Ilaria Scarano, Valentina Scarano, Irene Schiavetti, Maria Sessa, Caterina Sgarito, Grazia Sibilia, Gabriele Siciliano, Alessio Signori, Elisabetta Signoriello, Leonardo Sinisi, Francesca Sireci, Patrizia Sola, Claudio Solaro, Maria Pia Sormani, Stefano Sotgiu, Maddalena Sparaco, Maria Laura Stromillo, Silvia Strumia, Emanuela Laura Susani, Giulietta Tabiadon, Francesco Teatini, Gioacchino Tedeschi, Valentina Tomassini, Simone Tonietti, Clerici Valentina Torri, Carla Tortorella, Simona Toscano, Rocco Totaro, Maria Trojano, Maria Trotta, Gabriella Turano, Monica Ulivelli, Manzo Valentino, Giovanna Vaula, Domizia Vecchio, Marco Vercellino, Elena Pinuccia Verrengia, Marika Vianello, Eleonora Virgilio, Francesca Vitetta, Stefano Vollaro, Mauro Zaffaroni, Mauro Zampolini, Ignazio Roberto Zarbo, Antonio Zito, Luigi Zuliani, Bergamaschi, R, Ponzano, M, Schiavetti, I, Carmisciano, L, Cordioli, C, Filippi, M, Radaelli, M, Immovilli, P, Capobianco, M, De Rossi, N, Brichetto, G, Cocco, E, Scandellari, C, Cavalla, P, Pesci, I, Zito, A, Confalonieri, P, Marfia, Ga, Perini, P, Inglese, M, Trojano, M, Brescia Morra, V, Pisoni, E, Tedeschi, G, Comi, G, Battaglia, Ma, Patti, F, Salvetti, M, Sormani, Mp, Abbadessa, Gianmarco, Umberto, Aguglia, Lia, Allegorico, Rossi Beatrice Maria Allegri, Anastasia, Alteno, Maria Pia Amato, Pietro, Annovazzi, Carlo, Antozzi, Lucia, Appendino, Sebastiano, Arena, Viola, Baione, Roberto, Balgera, Valeria, Barcella, Damiano, Baroncini, Caterina, Barrilà, Mario, A Battaglia, Alessandra, Bellacosa, Gianmarco, Bellucci, Roberto, Bergamaschi, Valeria, Bergamaschi, Daiana, Bezzini, Beatrice, Biolzi, Bisecco, Alvino, Bonavita, Simona, Giovanna, Borriello, Chiara, Bosa, Bosco, Antonio, Francesca, Bovi, Marco, Bozzali, Laura, Brambilla, Morra Vincenzo Brescia, Giampaolo, Brichetto, Maria, Buccafusca, Elisabetta, Bucciantini, Sebastiano, Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano, Calabrese, Francesca, Calabria, Francesca, Caleri, Federico, Camilli, Luisa Maria Caniatti, Roberto, Cantello, Marco, Capobianco, Ruggero, Capra, Capuano, Rocco, Luca, Carmisciano, Patrizia, Carta, Paola, Cavalla, Maria Grazia Celani, Maria, Cellerino, Raffaella, Cerqua, Clara, Chisari, Raffaella, Clerici, Marinella, Clerico, Eleonora, Cocco, Gaia, Cola, Giancarlo, Comi, Paolo, Confalonieri, Antonella, Conte, Marta Zaffira Conti, Christian, Cordano, Susanna, Cordera, Cinzia, Cordioli, Corea, Francesco, Claudio, Correale, Salvatore, Cottone, Francesco, Crescenzo, Erica, Curti, Alessandro, D'Ambrosio, Emanuele, D'Amico, Maura Chiara Danni, Alessia, D'Arma, Vincenzo, Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Rossi, Nicola De Stefano, Cava Marco Della, Mario di Napoli, Alessia Di Sapio, Docimo, Renato, Anna, Dutto, Luana, Evangelista, Salvatore, Fanara, Diana, Ferraro, Maria Teresa Ferrò, Massimo, Filippi, Cristina, Fioretti, Fratta, Mario, Jessica, Frau, Marzia, Fronza, Roberto, Furlan, Alberto, Gajofatto, Gallo, Antonio, Paolo, Gallo, Claudio, Gasperini, Anna, Ghazaryan, Bruno, Giometto, Francesca, Gobbin, Flora, Govone, Franco, Granella, Erica, Grange, Maria Grazia Grasso, Angelica, Guareschi, Clara, Guaschino, Simone, Guerrieri, Donata, Guidetti, Pietro, Iaffaldano, Antonio, Ianniello, Luigi, Iasevoli, Paolo, Immovilli, Daniele, Imperiale, Maria Teresa Infante, Matilde, Inglese, Rosa, Iodice, Aniello, Iovino, Giovanna, Konrad, Doriana, Landi, Roberta, Lanzillo, Caterina, Lapucci, Luigi, Lavorgna, Maria Rita L'Episcopo, Serena, Leva, Giuseppe, Liberatore, Re Marianna Lo, Marco, Longoni, Leonardo, Lopiano, Lorena, Lorefice, Matteo, Lucchini, Lus, Giacomo, Davide, Maimone, Maria, Malentacchi, Giulia, Mallucci, Simona, Malucchi, Chiara Rosa Mancinelli, Luca, Mancinelli, Paolo, Manganotti, Giorgia Teresa Maniscalco, Vittorio, Mantero, Sabrina, Marangoni, Damiano, Marastoni, Girolama Alessandra Marfia, Fabiana, Marinelli, Alessandro, Marti, Boneschi Filippo Martinelli, Zoli Federco Masserano, Francesca, Matta, Laura, Mendozzi, Giuseppe, Meucci, Silvia, Miante, Miele, Giuseppina, Eva, Milano, Massimiliano, Mirabella, Missione, Rosanna, Marcello, Moccia, Lucia, Moiola, Sara, Montepietra, Margherita, Montibragadin, Federico, Montini, Roberta, Motta, Raffaele, Nardone, Carolina Gabri Nicoletti, Eduardo, Nobile-Orazio, Agostino, Nozzolillo, Marco, Onofrj, Riccardo, Orlandi, Palmieri, Anna, Damiano, Paolicelli, Livia, Pasquali, Luisa, Pastò, Francesco, Patti, Elisabetta, Pedrazzoli, Paola, Perini, Ilaria, Pesci, Maria, Petracca, Alfredo, Petrone, Carlo, Piantadosi, Anna, M Pietroboni, Federica, Pinardi, Marta, Ponzano, Emilio, Portaccio, Mattia, Pozzato, Carlo, Pozzilli, Luca, Prosperini, Alessandra, Protti, Marta, Radaelli, Paolo, Ragonese, Sarah, Rasia, Sabrina, Realmuto, Anna, Repice, Eleonora, Rigoni, Maria Teresa Rilla, Francesca, Rinaldi, Calogero Marcello Romano, Marco, Ronzoni, Marco, Rovari, Francesca, Ruscica, Loredana, Sabattini, Giuseppe, Salemi, Marco, Salvetti, Lorenzo, Saraceno, Alessia, Sartori, Arianna, Sartori, Elvira, Sbragia, Cinzia, Scandellari, Giuditta Ilaria Scarano, Valentina, Scarano, Irene, Schiavetti, Maria, Sessa, Caterina, Sgarito, Grazia, Sibilia, Gabriele, Siciliano, Alessio, Signori, Signoriello, Elisabetta, Leonardo, Sinisi, Francesca, Sireci, Patrizia, Sola, Claudio, Solaro, Maria Pia Sormani, Stefano, Sotgiu, Sparaco, Maddalena, Maria Laura Stromillo, Silvia, Strumia, Emanuela Laura Susani, Giulietta, Tabiadon, Francesco, Teatini, Tedeschi, Gioacchino, Valentina, Tomassini, Simone, Tonietti, Clerici Valentina Torri, Carla, Tortorella, Simona, Toscano, Rocco, Totaro, Maria, Trojano, Trotta, Maria Consiglia, Gabriella, Turano, Monica, Ulivelli, Manzo, Valentino, Giovanna, Vaula, Domizia, Vecchio, Marco, Vercellino, Elena Pinuccia Verrengia, Marika, Vianello, Eleonora, Virgilio, Francesca, Vitetta, Stefano, Vollaro, Mauro, Zaffaroni, Mauro, Zampolini, Ignazio Roberto Zarbo, Zito, Guido Antonio, Bergamaschi, R., Ponzano, M., Schiavetti, I., Carmisciano, L., Cordioli, C., Filippi, M., Radaelli, M., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Cocco, E., Scandellari, C., Cavalla, P., Pesci, I., Zito, A., Confalonieri, P., Marfia, G. A., Perini, P., Inglese, M., Trojano, M., Brescia Morra, V., Pisoni, E., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Sormani, M. P., Bergamaschi, Roberto, Ponzano, Marta, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Antonio, Confalonieri, Paolo, Marfia, Girolama Alessandra, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Pisoni, Enrico, Comi, Giancarlo, Battaglia, Mario Alberto, Patti, Francesco, Salvetti, Marco, Sormani, Maria, Pia, Gianmarco, Abbadessa, Alvino, Bisecco, Simona, Bonavita, Antonio, Bosco, Rocco, Capuano, Francesco, Corea, Renato, Docimo, Mario, Fratta, Antonio, Gallo, Iodice, Rosa, Iovino, Aniello, Lanzillo, Roberta, Giacomo, Lu, Giuseppina, Miele, Rosanna, Missione, Moccia, Marcello, Anna, Palmieri, Elisabetta, Signoriello, Maddalena, Sparaco, Gioacchino, Tedeschi, Maria, Trotta, Antonio, Zito, and Luigi, Zuliani

Subjects
air pollution, coronavirus, multiple sclerosis, medicine.medical_specialty, Multivariate analysis, Coronavirus disease 2019 (COVID-19), Clinical Sciences, Air pollution, Sample (statistics), Neurodegenerative, Settore MED/26, medicine.disease_cause, Autoimmune Disease, law.invention, Sustainable Cities and Communities, Clinical Research, law, Humans, Medicine, Climate-Related Exposures and Conditions, Neurology & Neurosurgery, MuSC-19 study group, SARS-CoV-2, business.industry, Multiple sclerosis, Neurosciences, COVID-19, Retrospective cohort study, Original Articles, medicine.disease, Intensive care unit, Particulate Matter, Air Pollution, Multiple Sclerosis, Brain Disorders, coronaviru, Settore MED/26 - NEUROLOGIA, Good Health and Well Being, Neurology, multiple sclerosi, Emergency medicine, Original Article, Neurology (clinical), Ordered logit, business, Human
Abstract

Background and purpose Some studies have shown that air pollution, often assessed by thin particulate matter with diameter below 2.5 µg/m3 (PM2.5), may contribute to severe COVID‐19 courses, as well as play a role in the onset and evolution of multiple sclerosis (MS). However, the impact of air pollution on COVID‐19 has never been explored specifically amongst patients with MS (PwMS). This retrospective observational study aims to explore associations between PM2.5 and COVID‐19 severity amongst PwMS. Methods Data were retrieved from an Italian web‐based platform (MuSC‐19) which includes PwMS with COVID‐19. PM2.5 2016–2018 average concentrations were provided by the Copernicus Atmospheric Monitoring Service. Italian patients inserted in the platform from 15 January 2020 to 9 April 2021 with a COVID‐19 positive test were included. Ordered logistic regression models were used to study associations between PM2.5 and COVID‐19 severity. Results In all, 1087 patients, of whom 13% required hospitalization and 2% were admitted to an intensive care unit or died, were included. Based on the multivariate analysis, higher concentrations of PM2.5 increased the risk of worse COVID‐19 course (odds ratio 1.90; p = 0.009). Conclusions Even if several other factors explain the unfavourable course of COVID‐19 in PwMS, the role of air pollutants must be considered and further investigated., Air pollution, often assessed by particulate matter with diameter below 2.5 µg/m3, may contribute to severe COVID‐19 courses. 1087 patients were included, of whom 13% required hospitalization and 2% were admitted to an intensive care unit or died. Even if several other factors explain the unfavourable course of COVID‐19 in patients with multiple sclerosis, the role of air pollutants must be considered and further investigated.

Published
2021
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4. Flu vaccination in multiple sclerosis patients: a monocentric prospective vaccine-vigilance study

Author

Giorgia Teresa, Maniscalco, Cristina, Scavone, Ornella, Moreggia, Daniele, Di Giulio Cesare, Maria Luisa, Aiezza, Gaspare, Guglielmi, Giuseppe, Longo, Massimo, Maiolo, Eliana, Raiola, Giuseppe, Russo, and Annalisa, Capuano

Subjects
COVID-19 Vaccines, Multiple Sclerosis, Influenza Vaccines, Recurrence, Vaccination, COVID-19, Humans, Pharmacology (medical), General Medicine
Abstract

In 2020, the Italian Medicines Agency recommended to bring forward the flu vaccination campaign, whose importance was also emphasized for patients with Multiple Sclerosis (MS). We aimed to assess the safety profile of flu vaccines in terms of occurrence of short-term and long-term Adverse Events Following Immunization (AEFIs).This is an observational study that enrolled MS patients who were eligible for any of the flu vaccines recommended by the Italian medicines Agency.194 patients were enrolled. Out of 133 patients who accepted to be vaccinated, 45 experienced not serious short-term AEFIs (pain at the injection site, headache, flu-like symptoms, fatigue). Long-term AEs were detected in 12 vaccinated patients (flu-like symptoms, COVID-19 and MS relapse). No statistically significant differences in terms of infections or MS relapse were found between vaccinated and unvaccinated groups. Using Kaplan-Meier analysis we observed no differences in the cumulative survival rate in both groups.Flu vaccines were well tolerated in MS patients, who mainly experienced not serious short term AEFIs. Considering that COVID-19 vaccines campaign is still ongoing among MS patients, our results might bring new knowledge concerning the safety profile of vaccines in this frail population.

Published
2022
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6. Management of hepatitis B virus prophylaxis in patients treated with disease-modifying therapies for multiple sclerosis: a multicentric Italian retrospective study

Author

Antonio Riccardo, Buonomo, Giulio, Viceconte, Massimiliano, Calabrese, Giovanna, De Luca, Valentina, Tomassini, Paola, Cavalla, Giorgia Teresa, Maniscalco, Diana, Ferraro, Viviana, Nociti, Marta, Radaelli, Maria Chiara, Buscarinu, Damiano, Paolicelli, Alberto, Gajofatto, Pietro, Annovazzi, Federica, Pinardi, Massimiliano, Di Filippo, Cinzia, Cordioli, Emanuela, Zappulo, Riccardo, Scotto, Ivan, Gentile, Antonio Luca, Spiezia, Martina, Petruzzo, Marcello, De Angelis, Vincenzo, Brescia Morra, Claudio, Solaro, Claudio, Gasperini, Eleonora, Cocco, Marcello, Moccia, Roberta, Lanzillo, Buonomo, ANTONIO RICCARDO, Viceconte, Giulio, Calabrese, Massimiliano, De Luca, Giovanna, Tomassini, Valentina, Cavalla, Paola, Maniscalco Giorgia, Teresa, Ferraro, Diana, Nociti, Viviana, Radaelli, Marta, Buscarinu Maria, Chiara, Paolicelli, Damiano, Gajofatto, Alberto, Annovazzi, Pietro, Pinardi, Federica, Di Filippo, Massimiliano, Cordioli, Cinzia, Zappulo, Emanuela, Scotto, Riccardo, Gentile, Ivan, Spiezia, Antonio, Petruzzo, Martina, DE ANGELIS, Marcello, BRESCIA MORRA, Vincenzo, Solaro, Claudio, Gasperini, Claudio, Cocco, Eleonora, Moccia, Marcello, and Lanzillo, Roberta

Subjects
Hepatitis B virus, Multiple Sclerosis, Vaccination, Middle Aged, Hepatitis B, Antiviral Agents, Neurology, DNA, Viral, Cladribine, Humans, Virus Activation, Ocrelizumab, Neurology (clinical), Rituximab, Retrospective Studies
Abstract

Background Patients with multiple sclerosis (MS) often receive disease-modifying therapies (DMTs) that can expose them to reactivation of potential occult hepatitis B virus (HBV) infection (pOBI). We aimed to evaluate the MS Centers behavior regarding HBV screening and prophylaxis in a large cohort of MS patients receiving anti-CD20 or cladribine. Methods Retrospective, multicentric study recruiting Italian MS patients treated with rituximab, ocrelizumab and cladribine. Results We included 931 MS patients from 15 centers. All but 38 patients performed a complete HBV screening. Patients’ age > 50 years was significantly associated with no history of vaccination and HBsAb titres p p = 0.5), pre-or post-therapy vaccination (p = 0.2) and number of previous DMTs (p = 0.2). Among pOBI patients (n = 53), 21 received antiviral prophylaxis, while only 13 had HBV DNA monitoring and 19 patients neither monitored HBV DNA nor received prophylaxis. Conclusions Baseline HBV screening in patients receiving anti-CD20 and cladribine is a consolidated practice. Nonetheless, HBV vaccination coverage is still lacking in such population and age is a significant factor associated with low HBV protection. Rituximab, ocrelizumab and cladribine did not impair HBV vaccine response. Almost 35% of pOBI patients fail to receive HBVr prevention. Management of HBV prophylaxis could be improved in MS patients and further prospective studies are needed to assess the effectiveness of prophylactic strategies in such patients.

Published
2022
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7. Unmet needs and gaps in the identification of secondary progression in multiple sclerosis: a Southern Italy healthcare professionals' perspective

Author

Giacomo Lus, Marco André Bassano, Vincenzo Brescia Morra, Simona Bonavita, Antonio Gallo, Davide Maimone, Laura Malerba, Giorgia Teresa Maniscalco, Francesco Saccà, Giuseppe Salemi, Renato Turrini, Salvatore Cottone, Edoardo Sessa, Maria Buccafusca, Luigi Maria Edoardo Grimaldi, Lus, Giacomo, Bassano, Marco André, Brescia Morra, Vincenzo, Bonavita, Simona, Gallo, Antonio, Maimone, Davide, Malerba, Laura, Maniscalco, Giorgia Teresa, Saccà, Francesco, Salemi, Giuseppe, Turrini, Renato, Cottone, Salvatore, Sessa, Edoardo, Buccafusca, Maria, and Grimaldi, Luigi Maria Edoardo

Subjects
Secondary progressive multiple sclerosis (SPMS), Dermatology, General Medicine, Biomarker, Multiple Sclerosis, Chronic Progressive, Multiple sclerosis, Psychiatry and Mental health, Multiple Sclerosis, Relapsing-Remitting, Italy, Expert opinion, Diagnosis, Quality of Life, Disease Progression, Humans, Multiple sclerosi, Settore MED/26 - Neurologia, Neurology (clinical), Neoplasm Recurrence, Local, Atrophy, Delivery of Health Care, Biomarkers, Diagnosi
Abstract

Objective Multiple sclerosis (MS) is a chronic disease with different clinical courses and a tendency to worsening. The relapsing–remitting MS presents acute onset and relapses of neurological symptoms, followed by their remission. This form can convert to secondary progressive MS (SPMS) with irreversible neurological worsening and disability. The identification of signs, symptoms, markers of progression, and strategies to manage MS patients is mandatory to allow early identification of those at higher risk of conversion to SPMS, for prompt intervention to cope with the progression of the disease. Methods A panel of Italian experts from Southern Italy have reviewed the current knowledge on MS and its management and identified the crucial tools for SPMS recognition. Results More effective communication between patients and clinicians should be established, with the support of digital tools. Moreover, the improvement in the clinical use of biomarkers for progression (cellular structures and tissue organization, such as neurofilaments and chitinase 3-like 1, axonal and neurons density) and of instrumental analyses for recognition of whole-brain atrophy, chronic active lesions, spinal cord lesions and atrophy, and the improvement the combination of the Expanded Disability Status Scale and the evaluation of cognitive dysfunction are discussed. Conclusion Given the availability of a pharmacological option, adequate education both for patients, regarding the evolution of the disease and the specific treatment, and for professionals, to allow more effective and sensitive communication and the best use of diagnostic and management tools, could represent a strategy to improve patient management and their quality of life.

Published
2023

8. A score that predicts aquaporin-4-IgG positivity in patients with longitudinally extensive transverse myelitis

Author

Lucia Campetella, Claudia Papi, Gregorio Spagni, Eleonora Sabatelli, Sara Mariotto, Matteo Gastaldi, Gianvito Masi, Sara Carta, Lara Ahmad, Francesca Rossi, Giorgia Teresa Maniscalco, Giovanna De Luca, and Raffaele Iorio

Subjects
Aquaporin 4, Settore MED/26 - NEUROLOGIA, Neurology, Neuromyelitis Optica, Neurology (clinical), Myelitis, Myelitis, Transverse, Transverse
Published
2023

9. Health related quality of life in the domain of physical activity predicts confirmed disability progression in people with relapsing remitting multiple sclerosis

Author

Gianmarco Abbadessa, Marta Ponzano, Floriana Bile, Giuseppina Miele, Alessio Signori, Simone Cepparulo, Maddalena Sparaco, Elisabetta Signoriello, Giorgia Teresa Maniscalco, Roberta Lanzillo, Vincenzo Brescia Morra, Giacomo Lus, Maria Pia Sormani, Luigi Lavorgna, Simona Bonavita, Abbadessa, Gianmarco, Ponzano, Marta, Bile, Floriana, Miele, Giuseppina, Signori, Alessio, Cepparulo, Simone, Sparaco, Maddalena, Signoriello, Elisabetta, Maniscalco, Giorgia Teresa, Lanzillo, Roberta, Morra, Vincenzo Brescia, Lus, Giacomo, Sormani, Maria Pia, Lavorgna, Luigi, and Bonavita, Simona

Subjects
Neurology, Disability assessment, PROs, Multiple sclerosi, Neurology (clinical), General Medicine, Disability progression, PROM
Abstract

Introduction: The diagnosis of the progression phase of Multiple Sclerosis (MS) is still retrospective and based on the objectivation of clinical disability accumulation. Objectives: To assess whether the Patient Reported Outcomes Measures (PROMs) scores predict the occurrence of disease progression within three years of follow-up. Methods: Observational prospective multicenter study. Stable Relapsing-Remitting MS (RRMS) patients were enrolled. At enrollment, patients completed the following PROMs: Beck Depression Inventory- II, The Treatment Satisfaction Questionnaire for Medications, Medical Outcomes Study Short Form 36- Item (SF36), Fatigue Severity Scale. EDSS was assessed at enrollment and three years later. The outcome measure was defined as the occurrence of confirmed disability progression (CDP) within three years of follow-up. Univariable and multivariable logistic regression models were performed to study the association between the final score of each test and the outcome. Results: SF36-Physical Functioning (SF36-PF) was the only independent variable associated with the outcome. The ROC curve analysis determined a score of 77.5 at SF36-PF as the cut-off point identifying patients experiencing CDP within three years of follow-up [AUC: 0.66 (95% CI: 0.56-0.75)]. Conclusions: RRMS patients scoring higher (>77.5) at SF36-PF subscale have a higher likelihood to experience CDP within the next three years.

Published
2023

10. 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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11. Progression is independent of relapse activity in early multiple sclerosis: a real-life cohort study

Author

Emilio Portaccio, Angelo Bellinvia, Mattia Fonderico, Luisa Pastò, Lorenzo Razzolini, Rocco Totaro, Daniele Spitaleri, Alessandra Lugaresi, Eleonora Cocco, Marco Onofrj, Franco Di Palma, Francesco Patti, Davide Maimone, Paola Valentino, Paolo Confalonieri, Alessandra Protti, Patrizia Sola, Giacomo Lus, Giorgia Teresa Maniscalco, Vincenzo Brescia Morra, Giuseppe Salemi, Franco Granella, Ilaria Pesci, Roberto Bergamaschi, Umberto Aguglia, Marika Vianello, Marta Simone, Vito Lepore, Pietro Iaffaldano, Massimo Filippi, Maria Trojano, Maria Pia Amato, Portaccio, Emilio, Bellinvia, Angelo, Fonderico, Mattia, Pastò, Luisa, Razzolini, Lorenzo, Totaro, Rocco, Spitaleri, Daniele, Lugaresi, Alessandra, Cocco, Eleonora, Onofrj, Marco, Di Palma, Franco, Patti, Francesco, Maimone, Davide, Valentino, Paola, Confalonieri, Paolo, Protti, Alessandra, Sola, Patrizia, Lus, Giacomo, Maniscalco, Giorgia Teresa, Brescia Morra, Vincenzo, Salemi, Giuseppe, Granella, Franco, Pesci, Ilaria, Bergamaschi, Roberto, Aguglia, Umberto, Vianello, Marika, Simone, Marta, Lepore, Vito, Iaffaldano, Pietro, Filippi, Massimo, Trojano, Maria, and Amato, Maria Pia

Subjects
Multiple Sclerosis, relapse-associated worsening, progression independent of relapse activity, relapsing multiple sclerosis, Cohort Studies, Multiple Sclerosis, Relapsing-Remitting, relapse associated worsening, Recurrence, Chronic Disease, Disease Progression, Humans, Settore MED/26 - Neurologia, Neurology (clinical), Retrospective Studies
Abstract

Portaccio et al. report that in early relapsing-onset multiple sclerosis, progression independent of relapse activity is an important contributor to disability accumulation. Insidious progression occurs even in the earliest disease phases, suggesting that inflammation and degeneration may represent a single disease continuum.Disability accrual in multiple sclerosis may occur as relapse-associated worsening or progression independent of relapse activity. The role of progression independent of relapse activity in early multiple sclerosis is yet to be established. The objective of this multicentre, observational, retrospective cohort study was to investigate the contribution of relapse-associated worsening and progression independent of relapse activity to confirmed disability accumulation in patients with clinically isolated syndrome and early relapsing-remitting multiple sclerosis, assessed within one year from onset and with follow-up >= 5 years (n = 5169). Data were extracted from the Italian Multiple Sclerosis Register. Confirmed disability accumulation was defined by an increase in Expanded Disability Status Scale score confirmed at 6 months, and classified per temporal association with relapses. Factors associated with progression independent of relapse activity and relapse-associated worsening were assessed using multivariable Cox regression models. Over a follow-up period of 11.5 +/- 5.5 years, progression independent of relapse activity occurred in 1427 (27.6%) and relapse-associated worsening in 922 (17.8%) patients. Progression independent of relapse activity was associated with older age at baseline [hazard ratio (HR) = 1.19; 95% confidence interval (CI) 1.13-1.25, P < 0.001], having a relapsing-remitting course at baseline (HR = 1.44; 95% CI 1.28-1.61, P < 0.001), longer disease duration at baseline (HR = 1.56; 95% CI 1.28-1.90, P < 0.001), lower Expanded Disability Status Scale at baseline (HR = 0.92; 95% CI 0.88-0.96, P < 0.001) and lower number of relapses before the event (HR = 0.76; 95% CI 0.73-0.80, P < 0.001). Relapse-associated worsening was associated with younger age at baseline (HR = 0.87; 95% CI 0.81-0.93, P < 0.001), having a relapsing-remitting course at baseline (HR = 1.55; 95% CI 1.35-1.79, P < 0.001), lower Expanded Disability Status Scale at baseline (HR = 0.94; 95% CI 0.89-0.99, P = 0.017) and a higher number of relapses before the event (HR = 1.04; 95% CI 1.01-1.07, P < 0.001). Longer exposure to disease-modifying drugs was associated with a lower risk of both progression independent of relapse activity and relapse-associated worsening (P < 0.001). This study provides evidence that in an early relapsing-onset multiple sclerosis cohort, progression independent of relapse activity was an important contributor to confirmed disability accumulation. Our findings indicate that insidious progression appears even in the earliest phases of the disease, suggesting that inflammation and neurodegeneration can represent a single disease continuum, in which age is one of the main determinants of disease phenomenology.

Published
2022

12. Towards a validated definition of the clinical transition to secondary progressive multiple sclerosis: A study from the Italian MS Register

Author

Pietro Iaffaldano, Giuseppe Lucisano, Tommaso Guerra, Francesco Patti, Marco Onofrj, Vincenzo Brescia Morra, Mauro Zaffaroni, Carlo Pozzilli, Eleonora Cocco, Patrizia Sola, Giuseppe Salemi, Matilde Inglese, Roberto Bergamaschi, Claudio Gasperini, Antonella Conte, Marco Salvetti, Giacomo Lus, Giorgia Teresa Maniscalco, Rocco Totaro, Marika Vianello, Franco Granella, Elisabetta Ferraro, Umberto Aguglia, Maurizia Gatto, Francesca Sangalli, Clara Grazia Chisari, Giovanna De Luca, Antonio Carotenuto, Damiano Baroncini, Delia Colombo, Mihaela Nica, Damiano Paolicelli, Giancarlo Comi, Massimo Filippi, Maria Pia Amato, Maria Trojano, Iaffaldano, Pietro, Lucisano, Giuseppe, Guerra, Tommaso, Patti, Francesco, Onofrj, Marco, Brescia Morra, Vincenzo, Zaffaroni, Mauro, Pozzilli, Carlo, Cocco, Eleonora, Sola, Patrizia, Salemi, Giuseppe, Inglese, Matilde, Bergamaschi, Roberto, Gasperini, Claudio, Conte, Antonella, Salvetti, Marco, Lus, Giacomo, Maniscalco, Giorgia Teresa, Totaro, Rocco, Vianello, Marika, Granella, Franco, Ferraro, Elisabetta, Aguglia, Umberto, Gatto, Maurizia, Sangalli, Francesca, Chisari, Clara Grazia, De Luca, Giovanna, Carotenuto, Antonio, Baroncini, Damiano, Colombo, Delia, Nica, Mihaela, Paolicelli, Damiano, Comi, Giancarlo, Filippi, Massimo, Amato, Maria Pia, and Trojano, Maria

Subjects
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive, Multiple sclerosis, Multiple Sclerosis, Relapsing-Remitting, Neurology, big data, Area Under Curve, data-driven algorithm, disease registry, secondary progressive, Humans, Settore MED/26 - Neurologia, Neurology (clinical), prognosis
Abstract

Background: Definitions for reliable identification of transition from relapsing-remitting multiple sclerosis (MS) to secondary progressive (SP)MS in clinical cohorts are not available. Objectives: To compare diagnostic performances of two different data-driven SPMS definitions. Methods: Data-driven SPMS definitions based on a version of Lorscheider’s algorithm (DDA) and on the EXPAND trial inclusion criteria were compared, using the neurologist’s definition (ND) as gold standard, in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), Akaike information criterion (AIC) and area under the curve (AUC). Results: A cohort of 10,240 MS patients with ⩾5 years of follow-up was extracted from the Italian MS Registry; 880 (8.5%) patients were classified as SPMS according to the neurologist definition, 1806 (17.6%) applying the DDA and 1134 (11.0%) with the EXPAND definition. The DDA showed greater discrimination power (AUC: 0.8 vs 0.6) and a higher sensitivity (77.1% vs 38.0%) than the EXPAND definition, with similar specificity (88.0% vs 91.5%). PPV and NPV were higher using the DDA than considering EXPAND definition (37.5% vs 29.5%; 97.6% vs 94.0%). Conclusion: Data-driven definitions demonstrated greater ability to capture SP transition than neurologist’s definition and the global accuracy of DDA seems to be higher than the EXPAND definition.

Published
2022

13. Anti-MOG-associated demyelinating disorders: two sides of the same coin

Author

Marianna Pezzella, Valentino Manzo, Sergio Ferrari, Elisa Capone, Michele Spiniello, Massimo Napolitano, Lia Allegorico, Giorgia Teresa Maniscalco, Sara Mariotto, Lidia Altomare, Gennaro Alfieri, Giovanna Servillo, Rosaria Renna, and Angelo Ranieri

Subjects
medicine.medical_specialty, Optic Neuritis, Neurology, Dermatology, Disease, Antibodies, 03 medical and health sciences, 0302 clinical medicine, medicine, Plasma exchange, Humans, Optic neuritis, 030212 general & internal medicine, Demyelinating Disorder, Autoantibodies, Anti-myelin oligodendrocyte glycoprotein (MOG) antibodies, business.industry, Anti-MOG-associated disorders (MOGAD), General Medicine, medicine.disease, Oligodendrocyte, Psychiatry and Mental health, medicine.anatomical_structure, Immunology, Encephalitis, Myelin-Oligodendrocyte Glycoprotein, Rituximab, Neurology (clinical), Neurosurgery, business, 030217 neurology & neurosurgery, Demyelinating Diseases, medicine.drug
Abstract

Anti-myelin oligodendrocyte glycoprotein antibody-associated disorders (MOGAD) are new emerging diseases with heterogeneous course, treatment, response, and prognosis. We herein present 2 cases with antibodies to MOG, one with a cerebellar/brainstem monophasic syndrome which partially improved after treatment, and the other with an optic neuritis onset then relapsed with cortical encephalitis and presented a subsequent complete recovery. We further discuss elements possibly associated with disease heterogeneity and influencing treatment choices. MOGAD is an extremely variable disease which can relapse and accumulate disability over time. An early diagnosis and correct timely treatment is fundamental to improve clinical outcome.

Published
2020
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14. Brain Radionecrosis After Adjuvant Radiation Therapy for a Primary Intracerebral Undifferentiated Sarcoma

Author

Gianfranco De Dominicis, Angelo Ranieri, Massimo Napolitano, Pasquale Caiazzo, Ferdinando Riccardi, and Giorgia Teresa Maniscalco

Subjects
medicine.medical_specialty, education.field_of_study, Chemotherapy, Bevacizumab, business.industry, medicine.medical_treatment, Population, Brain tumor, medicine.disease, Radiosurgery, Radiation therapy, 03 medical and health sciences, 0302 clinical medicine, Tumor progression, 030220 oncology & carcinogenesis, medicine, Surgery, Neurology (clinical), Sarcoma, Radiology, education, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Background Primary intracranial sarcomas of the central nervous system are rare tumors. They mainly arise from intracranial mesenchymal tissue present in the meninges and can occur at any age. Sometimes osteosarcoma can involve the skull rather than long body bones. In this latter case it is the more common subtype. Surgery, when possible, is a mandatory option often associated with radiation therapy (RT) and chemotherapy. Brain radionecrosis (BRN) is commonly observed due to the growing use of radiosurgery and higher cumulative doses of radiation therapy. The combination of perfusion magnetic resonance imaging and 18fluoro-deoxy-glucose positron emission tomography can help to differentiate tumor progression from radiation injury. Steroids, anticoagulants, and bevacizumab usually control BRN. However, BRN can also have an unfavorable course. Case Description Here, we present a case of a 60-year-old male who underwent surgery for a brain tumor. The examination showed a primary undifferentiated high-grade sarcoma. Adjuvant RT was given with a total dose of 60 Gy. Six months later, the patient underwent a second surgery that revealed a BRN progressing despite different pharmacologic attempts. Conclusions Primary intracranial sarcomas of the central nervous system are less prevalent among older adults with respect to the younger population. The use of RT alone or combined with chemotherapy is aimed at prolonging survival. However, it is not clearly defined if adjuvant treatments affect this parameter in older patients. RT should be carefully discussed owing to its potential severe neurologic toxicity. Indeed, a BRN can have a significant impact on quality of life and lead to death in certain cases.

Published
2020
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15. Epileptic seizures of suspected autoimmune origin: a multicentre retrospective study

Author

Silvia Bozzetti, Gaetano Cantalupo, Giampietro Zanette, Giuseppina Vitale, Marco Turatti, Romana Hoeftberger, Francesca Rossi, Carmela Zuco, Giorgia Teresa Maniscalco, Fabio Marchioretto, Eugen Trinka, Luca Di Tizio, Salvatore Monaco, Sergio Ferrari, Tiziano Zanoni, Sara Mariotto, Fabio Soldani, Morena Cadaldini, Fabio Rossini, and Rachele Delogu

Subjects
Male, Neurology, Hippocampus, Epilepsy, Status Epilepticus, 0302 clinical medicine, Cerebellum, Neoplasms, Child, Aged, 80 and over, 0303 health sciences, Movement Disorders, biology, Mental Disorders, Middle Aged, Psychiatry and Mental health, Treatment Outcome, Child, Preschool, Cohort, Anticonvulsants, Female, Immunotherapy, medicine.symptom, Antibody, Adult, medicine.medical_specialty, Adolescent, Primary Dysautonomias, Status epilepticus, neuroimmunology, Young Adult, 03 medical and health sciences, Autoimmune Diseases of the Nervous System, Internal medicine, medicine, Animals, Humans, Cognitive Dysfunction, Aged, Autoantibodies, Retrospective Studies, 030304 developmental biology, Autoimmune encephalitis, Dyskinesias, business.industry, Autoantibody, Infant, Reproducibility of Results, Retrospective cohort study, medicine.disease, autoimmune encephalitis, Rats, biology.protein, Surgery, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

ObjectiveTo analyse autoantibody status in a well-defined European multicentre cohort of patients with epilepsy of unknown aetiology and to validate the recently proposed Antibody Prevalence in Epilepsy (APE2) and Response to ImmunoTherapy in Epilepsy (RITE2) scores.MethodsWe retrospectively collected clinical and paraclinical data of 92 patients referred to the Neurology Units of Verona and Salzburg between January 2014 and July 2019 with new-onset epilepsy, status epilepticus or chronic epilepsy of unknown aetiology. Fixed and live cell-based assays, tissue-based assays, immunoblot, and live rat hippocampal cell cultures were performed in paired serum/cerebrospinal fluid (CSF) to detect antineuronal and antiglial antibodies. The APE2 and RITE2 scores were then calculated and compared with clinical and laboratory data.ResultsAutoantibodies were detected in 29/92 patients (31.5%), with multiple positivity observed in 6/29 cases. The APE2 score (median 5, range 1–15) significantly correlated with antibody positivity (p=0.014), especially for the presence of neuropsychiatric symptoms (pConclusionsThis is the first study that independently validates the APE2 and RITE2 scores and includes the largest cohort of patients whose paired serum and CSF samples have been tested for autoantibodies possibly associated with autoimmune epilepsy.

Published
2020
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16. Immuno-metabolic impact of the multiple sclerosis patients’ sera on endothelial cells of the blood-brain barrier

Author

S. Mercurio, V. De Rosa, Simon McArthur, Egle Solito, Rodrigo Azevedo Loiola, Giorgia Teresa Maniscalco, Madeeha H Sheikh, Alessandra Colamatteo, Sian M. Henson, Sheikh, M. H., Henson, S. M., Loiola, R. A., Mercurio, S., Colamatteo, A., Maniscalco, G. T., De Rosa, V., Mcarthur, S., and Solito, E.

Subjects
Adult, Male, 0301 basic medicine, medicine.medical_specialty, Endothelium, Immunology, Blood–brain barrier, lcsh:RC346-429, Capillary Permeability, Multiple sclerosis, 03 medical and health sciences, Cellular and Molecular Neuroscience, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Immune system, Internal medicine, medicine, Humans, Multiple sclerosi, Cells, Cultured, Tight junction, Cytoskeleton, lcsh:Neurology. Diseases of the nervous system, Blood-brain barrier, Autoimmune disease, Cell adhesion molecule, Chemistry, Research, General Neuroscience, Transendothelial and Transepithelial Migration, medicine.disease, Extravasation, Endothelial stem cell, 030104 developmental biology, Endocrinology, medicine.anatomical_structure, Metabolism, Neurology, Female, Endothelium, Vascular, Signal transduction, 030217 neurology & neurosurgery
Abstract

Background Multiple sclerosis (MS) is an autoimmune disease which results from the invasion of the brain by activated immune cells across the endothelial cells (ECs) of the blood-brain barrier (BBB), due to loss of immune self-tolerance. Many reports define the metabolic profile of immune cells in MS, however little is known about the metabolism of the BBB ECs during the disease. We aim to determine whether circulating factors in MS induce metabolic alterations of the BBB ECs compared to a healthy state, which can be linked with disruption of BBB integrity and subsequent immune cell extravasation. Methods and results In this report, we used an in vitro model to study the effect of sera from naïve-to-treatment, relapsing-remitting MS (RRMS) patients on the human brain microvascular endothelium, comparing effects to age/sex-matched healthy donor (HD) sera. Our data show that RRMS serum components affect brain endothelial cells by impairing intercellular tightness through the down-modulation of occludin and VE-cadherin, and facilitating immune cell extravasation through upregulation of intercellular adhesion molecules (ICAM-1) and P-glycoprotein (P-gp). At a metabolic level, the treatment of the endothelial cells with RRMS sera reduced their glycolytic activity (measured through the extracellular acidification rate-ECAR) and oxygen consumption rate (oxidative phosphorylation rate-OCR). Such changes were associated with the down-modulation of endothelial glucose transporter 1 (GLUT-1) expression and by altered mitochondrial membrane potential. Higher level of reactive oxygen species released from the endothelial cells treated with RRMS sera indicate a pro-inflammatory status of the cells together with the higher expression of ICAM-1, endothelial cell cytoskeleton perturbation (stress fibres) as well as disruption of the cytoskeleton signal transduction MSK1/2 and β-catenin phosphorylation. Conclusions Our data suggest that circulating factors present in RRMS patient serum induce physiological and biochemical alterations to the BBB, namely reducing expression of essential tightness regulators, as well as reduced engagement of glycolysis and alteration of mitochondrial potential. As these last changes have been linked with alterations in nutrient usage and metabolic function in immune cells; we propose that the BBB endothelium of MS patients may similarly undergo metabolic dysregulation, leading to enhanced permeability and increased disease susceptibility.

Published
2020
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17. Effects of THC/CBD oromucosal spray on spasticity-related symptoms in people with multiple sclerosis: results from a retrospective multicenter study

Author

Domenico Ippolito, Giorgia Teresa Maniscalco, Damiano Paolicelli, Daniele Spitaleri, Francesco Patti, Gianfranco Costantino, Margherita Russo, Clara Grazia Chisari, Letizia Castelli, Giovanna Salamone, Roberto Bruno Bossio, Maria Trotta, Claudio Solaro, Eliana Berra, Roberta Lanzillo, Elisabetta Signoriello, Raffaella Cerqua, Isabella Righini, Fabio Buttari, Gabriella Spinicci, Loredana Petrucci, Angelica Guareschi, Manuela Matta, Mario Zappia, Simona Pontecorvo, Maria Donata Benedetti, Paola Cavalla, Assunta Bianco, Claudio Gasperini, Eleonora Tavazzi, Francesco Saccà, Mauro Zaffaroni, Patti, F., Chisari, C. G., Solaro, C., Benedetti, M. D., Berra, E., Bianco, A., Bruno Bossio, R., Buttari, F., Castelli, L., Cavalla, P., Cerqua, R., Costantino, G., Gasperini, C., Guareschi, A., Ippolito, D., Lanzillo, R., Maniscalco, G. T., Matta, M., Paolicelli, D., Petrucci, L., Pontecorvo, S., Righini, I., Russo, M., Saccà, Francesco, Salamone, G., Signoriello, E., Spinicci, G., Spitaleri, D., Tavazzi, E., Trotta, M., Zaffaroni, M., Zappia, M., Patti, Francesco, Grazia Chisari, Clara, Solaro, Claudio, Donata Benedetti, Maria, Berra, Eliana, Bianco, Assunta, Bruno Bossio, Roberto, Buttari, Fabio, Castelli, Letizia, Cavalla, Paola, Cerqua, Raffaella, Costantino, Gianfranco, Gasperini, Claudio, Guareschi, Angelica, Ippolito, Domenico, Lanzillo, Roberta, Teresa Maniscalco, Giorgia, Matta, Manuela, Paolicelli, Damiano, Petrucci, Loredana, Pontecorvo, Simona, Righini, Isabella, Russo, Margherita, Salamone, Giovanna, Signoriello, Elisabetta, Spinicci, Gabriella, Spitaleri, Daniele, Tavazzi, Eleonora, Trotta, Maria, Zaffaroni, Mauro, and Zappia, Mario

Subjects
medicine.medical_specialty, Multiple Sclerosis, THC, Neurology, Dermatology, Clinical practice, Spasticity-related symptom, CBD, Multiple sclerosis, Spasticity-related symptoms, 03 medical and health sciences, 0302 clinical medicine, Rating scale, Internal medicine, medicine, Cannabidiol, Humans, Multiple sclerosi, Dronabinol, 030212 general & internal medicine, Spasticity, Oromucosal spray, Retrospective Studies, Plant Extracts, business.industry, General Medicine, medicine.disease, nervous system diseases, Clinical Practice, Drug Combinations, Psychiatry and Mental health, Italy, Muscle Spasticity, Neurology (clinical), Neurosurgery, medicine.symptom, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

Introduction: The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice. Materials and methods: MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms. Results: Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group. Conclusion: Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients. © 2020, Fondazione Società Italiana di Neurologia.

Published
2020
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18. Long term persistence of SARS-CoV-2 humoral response in multiple sclerosis subjects

Author

Giorgia Teresa Maniscalco, Anne Lise Ferrara, Antonietta Liotti, Valentino Manzo, Maria Elena Di Battista, Simona Salvatore, Daniela Graziano, Assunta Viola, Gerardino Amato, Ornella Moreggia, Daniele Di Giulio Cesare, Gennaro Alfieri, Walter Di Iorio, Gennaro Della Rocca, Vincenzo Andreone, and Veronica De Rosa

Subjects
Vaccines, Synthetic, COVID-19 Vaccines, Multiple Sclerosis, SARS-CoV-2, Dimethyl Fumarate, Natalizumab, COVID-19, General Medicine, Glatiramer Acetate, Antibodies, Viral, Neurology, Immunoglobulin G, Humans, Neurology (clinical), mRNA Vaccines, BNT162 Vaccine, Interferon beta-1a
Abstract

The persistence of the severe acute respiratory syndrome coronavirus (SARS-CoV)-2 pandemic, partly due to the appearance of highly infectious variants, has made booster vaccinations necessary for vulnerable groups. Here, we present data regarding the decline of the SARS-CoV-2 BNT162b2 mRNA vaccine-induced humoral immune response in a monocentric cohort of MS patients.96 MS patients undergoing eight different DMTs, all without previous SARS-CoV-2 infection, were evaluated for anti-Spike IgG levels, 21 days (T1) and 5-6 months (T2) after the second SARS-CoV-2 BNT162b2 mRNA vaccine dose. The anti-Spike IgG titre from MS subjects was compared with 21 age- and sex-matched healthy controls (HC).When compared with SARS-CoV-2 IgG levels at T2 in HC, we observed comparable levels in interferon-β 1a-, dimethyl fumarate-, teriflunomide- and natalizumab-treated MS subjects, but an impaired humoral response in MS subjects undergoing glatiramer acetate-, cladribine-, fingolimod- and ocrelizumab-treatments. Moreover, comparison between SARS-CoV-2 IgG Spike titre at T1 and T2 revealed a faster decline of the humoral response in patients undergoing dimethyl fumarate-, interferon-β 1a- and glatiramer acetate-therapies, while those receiving teriflunomide and natalizumab showed higher persistence compared to healthy controls.The prominent decline in humoral response in MS subjects undergoing dimethyl fumarate-, interferon-β 1a- and glatiramer acetate-therapies should be considered when formulating booster regimens as these subjects would benefit of early booster vaccinations.

Published
2022

19. Late-onset neutropenia (LON) recur in a MS patient after the second cycle of ocrelizumab: a case report

Author

Maria Elena Di Battista, Valentino Manzo, Simona Salvatore, Giorgia Teresa Maniscalco, Lia Allegorico, and Mario Annunziata

Subjects
Pediatrics, medicine.medical_specialty, Neurology, business.industry, MEDLINE, Dermatology, General Medicine, Late onset neutropenia, Psychiatry and Mental health, Medicine, Ocrelizumab, Neurology (clinical), Neurosurgery, business, medicine.drug, Neuroradiology
Published
2021
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20. Paraneoplastic Cerebellar Degeneration Associated with Anti-Yo Antibodies Appearing as a Leptomeningeal Cerebellar Carcinomatosis at MRI: a Case Report

Author

Fabio Zeccolini, Angelo Ranieri, Valentino Manzo, Gennaro Alfieri, Giorgia Teresa Maniscalco, Amedeo Boscaino, and Massimo Napolitano

Subjects
Pathology, medicine.medical_specialty, Contrast enhancement, biology, business.industry, Paraneoplastic cerebellar degeneration, medicine.disease, Anti yo antibody, humanities, Hyperintensity, Cerebrospinal fluid, medicine.anatomical_structure, Cortex (anatomy), otorhinolaryngologic diseases, biology.protein, Medicine, Cerebellar atrophy, Antibody, business
Abstract

Anti Yo antibodies (AYA) are the antibodies most frequently identified with Paraneoplastic Cerebellar Degeneration (PCD). They are detected above all in PCD associated with breast and gynecologic malignancies. Here, we report a third case of PCD with cerebellar contrast enhancement findings at MRI. In fact, AYA cross anti cerebellar cortex immune reaction leads mainly to hyperintensity signals in T2-weighted-MRI sequences, followed by cerebellar atrophy. As such, meningeal contrast enhancement could lead to a diagnostic pitfall as it can be considered a carcinomatosis - above all in serum antibody negative cases as well as when a metastatic tumour is found. Our patient had no tumoral cells in the cerebrospinal fluid and her neurological syndrome remained stable after immunoglobulin treatment. AYA serum finding was diriment for PCD diagnosis.

Published
2021
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21. Prognostic Markers of Ocrelizumab Effectiveness in Multiple Sclerosis: A Real World Observational Multicenter Study

Author

Roberta Lanzillo, Antonio Carotenuto, Elisabetta Signoriello, Rosa Iodice, Giuseppina Miele, Alvino Bisecco, Giorgia Teresa Maniscalco, Leonardo Sinisi, Felice Romano, Maria Di Gregorio, Luigi Lavorgna, Francesca Trojsi, Marcello Moccia, Mario Fratta, Nicola Capasso, Raffaele Dubbioso, Maria Petracca, Antonio Luca Spiezia, Antonio Gallo, Martina Petruzzo, Marcello De Angelis, Simona Bonavita, Giacomo Lus, Gioacchino Tedeschi, Vincenzo Brescia Morra, Lanzillo, R., Carotenuto, A., Signoriello, E., Iodice, R., Miele, G., Bisecco, A., Maniscalco, G. T., Sinisi, L., Romano, F., Di Gregorio, M., Lavorgna, L., Trojsi, F., Moccia, M., Fratta, M., Capasso, N., Dubbioso, R., Petracca, M., Spiezia, A. L., Gallo, A., Petruzzo, M., De Angelis, M., Bonavita, S., Lus, G., Tedeschi, G., Morra, V. B., Lanzillo, Roberta, Carotenuto, Antonio, Signoriello, Elisabetta, Iodice, Rosa, Miele, Giuseppina, Bisecco, Alvino, Maniscalco, Giorgia Teresa, Sinisi, Leonardo, Romano, Felice, Di Gregorio, Maria, Lavorgna, Luigi, Trojsi, Francesca, Moccia, Marcello, Fratta, Mario, Capasso, Nicola, Dubbioso, Raffaele, Petracca, Maria, Spiezia, Antonio Luca, Gallo, Antonio, Petruzzo, Martina, De Angelis, Marcello, Bonavita, Simona, Lus, Giacomo, Tedeschi, Gioacchino, and Brescia Morra, Vincenzo

Subjects
real-world, ocrelizumab, multiple sclerosi, disease-modifying treatment, progression, General Medicine, multiple sclerosis
Abstract

Pivotal trials showed the effectiveness of the monoclonal antibody ocrelizumab in relapsing and progressive multiple sclerosis (MS). However, data on everyday practice in MS patients and markers of treatment effectiveness are scarce. We aimed to collect real-world data from ocrelizumab-treated MS patients, relapsing-remitting (RR) and progressive MS patients (PMS), including active secondary progressive MS (aSPMS) and primary progressive MS (PPMS) patients, and to explore potential prognostic factors of clinical outcome. Patients were enrolled at MS centres in the Campania region, Italy. We collected clinic-demographic features retrospectively one year before ocrelizumab start (T−1), at ocrelizumab start (T0), and after one year from ocrelizumab start (T1). We explored possible clinical markers of treatment effectiveness in those patients receiving ocrelizumab treatment for at least one year using multilevel-mixed models. We included a total of 383 MS patients (89 RRMS and 294 PMS; 205 females, mean age: 45.8 ± 11.2, disease duration: 12.7 ± 11.6 years). Patients had a mean follow-up of 12.4 ± 8.2 months, and 217 patients completed one-year ocrelizumab treatment. Overall, EDSS increased from T−1 to T0 (coeff. = 0.30, 95% coefficient interval [CI] = 0.19–0.41, p < 0.001) without a further change between T0 and T1 (p = 0.61). RRMS patients did not show an EDSS change between T−1 and T0 nor between T0 and T1. Conversely, PMS patients showed EDSS increase from T−1 to T0 (coeff. = 0.34, 95% CI = 0.22–0.45, p < 0.001) without a further change between T0 and T1 (p = 0.21). PMS patients with a time from conversion shorter than 2 years showed increased EDSS from T−1 to T0 (coeff. = 0.63, 95% CI = 0.18–1.08, p = 0.006) without a further change between T0 and T1 (p = 0.94), whereas PMS patients with a time from conversion longer than 2 years showed increased EDSS from T0 to T1 (coeff. = 0.30, 95% CI = 0.11–0.49, p = 0.002). Naïve patients showed an EDSS decrease between T0 and T1 (coeff. = −0.30, 95% CI = −0.50–−0.09, p = 0.004). In conclusion, our study highlighted that early ocrelizumab treatment is effective in modifying the disability accrual in MS patients.

Published
2022

22. Risk of Getting COVID-19 in People With Multiple Sclerosis: A Case-Control Study

Author

Pietro Iaffaldano, Giuseppe Lucisano, Alessia Manni, Damiano Paolicelli, Francesco Patti, Marco Capobianco, Vincenzo Brescia Morra, Patrizia Sola, Ilaria Pesci, Giacomo Lus, Giovanna De Luca, Alessandra Lugaresi, Paola Cavalla, Sara Montepietra, Giorgia Teresa Maniscalco, Franco Granella, Paolo Ragonese, Marika Vianello, Laura Brambilla, Rocco Totaro, Simona Toscano, Simona Malucchi, Maria Petracca, Lucia Moiola, Diana Ferraro, Vito Lepore, Paola Mosconi, Michela Ponzio, Gioacchino Tedeschi, Giancarlo Comi, Mario Alberto Battaglia, Massimo Filippi, Maria Pia Amato, Maria Trojano, Iaffaldano, Pietro, Lucisano, Giuseppe, Manni, Alessia, Paolicelli, Damiano, Patti, Francesco, Capobianco, Marco, Brescia Morra, Vincenzo, Sola, Patrizia, Pesci, Ilaria, Lus, Giacomo, De Luca, Giovanna, Lugaresi, Alessandra, Cavalla, Paola, Montepietra, Sara, Maniscalco, Giorgia Teresa, Granella, Franco, Ragonese, Paolo, Vianello, Marika, Brambilla, Laura, Totaro, Rocco, Toscano, Simona, Malucchi, Simona, Petracca, Maria, Moiola, Lucia, Ferraro, Diana, Lepore, Vito, Mosconi, Paola, Ponzio, Michela, Tedeschi, Gioacchino, Comi, Giancarlo, Battaglia, Mario Alberto, Filippi, Massimo, Amato, Maria Pia, and Trojano, Maria

Subjects
Adult, Male, Multiple Sclerosis, Time Factors, Dimethyl Fumarate, Sex Factor, Relapsing-Remitting, Severity of Illness Index, Article, Immunosuppressive Agent, Sex Factors, Multiple Sclerosis, Relapsing-Remitting, Risk Factors, Multiple Sclerosi, Odds Ratio, Humans, Age Factor, g COVID-19, Fingolimod Hydrochloride, SARS-CoV-2, Natalizumab, Risk Factor, Age Factors, COVID-19, Glatiramer Acetate, Interferon-beta, Middle Aged, Multiple Sclerosis, Chronic Progressive, Chronic Progressive, Neurology, Italy, Case-Control Studies, Female, Immunosuppressive Agents, Neurology (clinical), Case-Control Studie, Human
Abstract

Background and ObjectivesSeveral studies have assessed risk factors associated with the severity of COVID-19 outcomes in people with multiple sclerosis (PwMS). The potential role of disease-modifying therapies (DMTs) and demographic and clinical factors on the risk of acquiring SARS-CoV-2 infection has not been evaluated so far. The objective of this study was to assess risk factors of contracting SARS-CoV-2 infection in PwMS by using data collected in the Italian MS Register (IMSR).MethodsA case-control (1:2) study was set up. Cases included PwMS with a confirmed diagnosis of COVID-19, and controls included PwMS without a confirmed diagnosis of COVID-19. Both groups were propensity score–matched by the date of COVID-19 diagnosis, the date of last visit, and the region of residence. No healthy controls were included in this study. COVID-19 risk was estimated by multivariable logistic regression models including demographic and clinical covariates. The impact of DMTs was assessed in 3 independent logistic regression models including one of the following covariates: last administered DMT, previous DMT sequences, or the place where the last treatment was administered.ResultsA total of 779 PwMS with confirmed COVID-19 (cases) were matched to 1,558 PwMS without COVID-19 (controls). In all 3 models, comorbidities, female sex, and a younger age were significantly associated (p < 0.02) with a higher risk of contracting COVID-19. Patients receiving natalizumab as last DMT (OR [95% CI]: 2.38 [1.66–3.42], p < 0.0001) and those who underwent an escalation treatment strategy (1.57 [1.16–2.13], p = 0.003) were at significantly higher COVID-19 risk. Moreover, PwMS receiving their last DMT requiring hospital access (1.65 [1.34–2.04], p < 0.0001) showed a significant higher risk than those taking self-administered DMTs at home.DiscussionThis case-control study embedded in the IMSR showed that PwMS at higher COVID-19 risk are younger, more frequently female individuals, and with comorbidities. Long-lasting escalation approach and last therapies that expose patients to the hospital environment seem to significantly increase the risk of SARS-CoV2 infection in PwMS.Classification of EvidenceThis study provides Class III evidence that among patients with MS, younger age, being female individuals, having more comorbidities, receiving natalizumab, undergoing an escalating treatment strategy, or receiving treatment at a hospital were associated with being infected with COVID-19. Among patients with MS who were infected with COVID-19, a severe course was associated with increasing age and having a progressive form of MS, whereas not being on treatment or receiving an interferon beta agent was protective.

Published
2022

23. Comparing Natural History of Early and Late Onset Pediatric Multiple Sclerosis

Author

Ermelinda De Meo, Massimo Filippi, Maria Trojano, Giancarlo Comi, Francasco Patti, Vincenzo Brescia Morra, Giuseppe Salemi, Marco Onofrj, Giacomo Lus, Eleonora Cocco, Mattia Fonderico, Valentina Torri Clerici, Giorgia Teresa Maniscalco, Paola Valentino, Antonio Bertolotto, Alessandra Lugaresi, Roberto Bergamaschi, Marco Rovaris, Patrizia Sola, Gioacchino Tedeschi, Ilaria Pesci, Umberto Aguglia, Paola Cavalla, Davide Maimone, Franco Granella, Marika Vianello, Marta Simone, Emilio Portaccio, Maria Pia Amato, De Meo, E., Filippi, M., Trojano, M., Comi, G., Patti, F., Brescia Morra, V., Salemi, G., Onofrj, M., Lus, G., Cocco, E., Fonderico, M., Torri Clerici, V., Maniscalco, G. T., Valentino, P., Bertolotto, A., Lugaresi, A., Bergamaschi, R., Rovaris, M., Sola, P., Tedeschi, G., Pesci, I., Aguglia, U., Cavalla, P., Maimone, D., Granella, F., Vianello, M., Simone, M., Portaccio, E., Amato, M. P., De Meo, Ermelinda, Filippi, Massimo, Trojano, Maria, Comi, Giancarlo, Patti, Francasco, Brescia Morra, Vincenzo, Salemi, Giuseppe, Onofrj, Marco, Lus, Giacomo, Cocco, Eleonora, Fonderico, Mattia, Torri Clerici, Valentina, Maniscalco, Giorgia Teresa, Valentino, Paola, Bertolotto, Antonio, Lugaresi, Alessandra, Bergamaschi, Roberto, Rovaris, Marco, Sola, Patrizia, Tedeschi, Gioacchino, Pesci, Ilaria, Aguglia, Umberto, Cavalla, Paola, Maimone, Davide, Granella, Franco, Vianello, Marika, Simone, Marta, Portaccio, Emilio, Amato, Maria Pia, De Meo, E, Filippi, M, Trojano, M, Comi, G, Patti, F, Brescia Morra, V, Salemi, G, Onofrj, M, Lus, G, Cocco, E, Fonderico, M, Torri Clerici, V, Maniscalco, Gt, Valentino, P, Bertolotto, A, Lugaresi, A, Bergamaschi, R, Rovaris, M, Sola, P, Tedeschi, G, Pesci, I, Aguglia, U, Cavalla, P, Maimone, D, Granella, F, Vianello, M, Simone, M, Portaccio, E, and Amato, Mp

Subjects
Male, Natural History of Multiple Sclerosis, Multiple Sclerosis, Neurology, Recurrence, Pediatric Multiple Sclerosis, Disease Progression, Humans, Disabled Persons, Settore MED/26 - Neurologia, Neurology (clinical), Child, Prognosis
Abstract

Objective: This study was undertaken to describe and compare disease course and prognosis of early (ie, disease onset before age 11 years) and late (ie, disease onset after age 11 years) onset pediatric multiple sclerosis. Methods: Prospectively collected clinical information from Italian Multiple Sclerosis Register of 1993 pediatric multiple sclerosis patients, of whom 172 had early onset, was analyzed. Cox models adjusted for sex, baseline Expanded Disability Status Scale score, and disease-modifying treatments and stratified for diagnostic criteria adopted (Poser vs McDonald) were used to assess the risk of reaching irreversible Expanded Disability Status Scale scores of 3, 4, and 6, and conversion to secondary progressive phenotype in early versus late onset pediatric patients. Prognostic factors were also evaluated. Results: A greater proportion of males, isolated brainstem involvement, and longer time interval between first and second clinical episode were observed in early versus late onset pediatric patients. Compared to late onset, early onset pediatric patients took longer from disease onset to convert to secondary progressive phenotype and to reach all disability milestones. Recovery from first demyelinating event, time to first relapse, annualized relapse rate during the first 3 years of disease, and disease-modifying treatment exposure were independent predictors for long-term disability in early onset pediatric patients. In late onset pediatric patients, isolated optic neuritis, multifocal symptoms, and progressive course at disease onset were additional predictors for long-term disability. Interpretation: These findings point toward the existence of a different natural history in early versus late onset pediatric multiple sclerosis patients. ANN NEUROL 2022.

Published
2022

24. Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study

Author

Maria Petracca, Serena Ruggieri, Elena Barbuti, Antonio Ianniello, Roberta Fantozzi, Giorgia Teresa Maniscalco, Vincenzo Andreone, Doriana Landi, Girolama Alessandra Marfia, Maria Di Gregorio, Rosa Iodice, Leonardo Sinisi, Elisabetta Maida, Rosanna Missione, Cinzia Coppola, Simona Bonavita, Giovanna Borriello, Diego Centonze, Giacomo Lus, Carlo Pozzilli, Elisabetta Signoriello, Petracca, Maria, Ruggieri, Serena, Barbuti, Elena, Ianniello, Antonio, Fantozzi, Roberta, Maniscalco, Giorgia Teresa, Andreone, Vincenzo, Landi, Doriana, Marfia, Girolama Alessandra, Di Gregorio, Maria, Iodice, Rosa, Sinisi, Leonardo, Maida, Elisabetta, Missione, Rosanna, Coppola, Cinzia, Bonavita, Simona, Borriello, Giovanna, Centonze, Diego, Lus, Giacomo, Pozzilli, Carlo, and Signoriello, Elisabetta

Subjects
Multiple sclerosis, Neurology, Cladribine, NEDA-3, Predictors, Safety, Multiple sclerosi, Neurology (clinical), Settore MED/26, Predictor
Abstract

Cladribine administration has been approved for the treatment of relapsing-remitting multiple sclerosis (MS) in 2017; thus, data on cladribine in a real-world setting are still emerging.We report on cladribine effectiveness, safety profile, and treatment response predictors in 243 patients with MS followed at eight tertiary MS centers. Study outcomes were: (1) No Evidence of Disease Activity-3 (NEDA-3) status and its components (absence of clinical relapses, MRI activity, and sustained disability worsening); (2) development of grade III/IV lymphopenia. The relationship between baseline features and the selected outcomes was tested via multivariate logistic models.Of the 243 subjects included in the study (66.5% female, age 34.2 ± 10 years, disease duration 6.6 ± 9.6 years), 64% showed NEDA-3 at median follow-up (22 months). Patients with higher number of previous treatments had lower probability to retain NEDA-3 [odds ratio (OR) 0.64, 95% confidence interval (CI) 0.41-0.98, p = 0.04] and were more prone to experience clinical relapses (OR 1.6, 95% CI 1-2.6, p = 0.04). The presence of active lesions at baseline was associated with follow-up magnetic resonance imaging (MRI) activity (OR 1.92, 95% CI 1.04-3.55, p = 0.04). Patients with higher rate of relapses in the year prior to cladribine start were at higher risk of developing sustained disability worsening (OR 2.95% CI 1-4.2, p = 0.04). Lymphopenia grade III/IV over the follow-up was associated with baseline lymphocyte count (OR 0.998, 95% CI 0.997-0.999, p = 0.01).In this large cohort, we confirm previous data about cladribine effectiveness on disease activity and disability worsening and provide information on response predictors that might inform therapeutic choices.

Published
2022

25. 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

26. GAD65 autoimmunity after treatment with nivolumab: a multifocal presentation

Author

Lia Allegorico, Sergio Ferrari, Valentino Manzo, Sara Mariotto, Angelo Ranieri, Massimo Napolitano, Luigi Della Gatta, Giorgia Teresa Maniscalco, Anastasia Zekeridou, and Marianna Pezzella

Subjects
Male, medicine.medical_specialty, Ataxia, Dermatology, Gastroenterology, Autoimmune Diseases, 03 medical and health sciences, Epilepsy, Fatal Outcome, 0302 clinical medicine, Stiff person syndrome, Checkpoint inhibitor, Limbic Encephalitis, Internal medicine, medicine, Humans, 030212 general & internal medicine, Cerebellar ataxia, Glutamate Decarboxylase, business.industry, Limbic encephalitis, General Medicine, Middle Aged, medicine.disease, Discontinuation, Psychiatry and Mental health, Nivolumab, GAD65, Encephalitis, Neurology (clinical), Epileptic seizure, Neoplasm Recurrence, Local, medicine.symptom, business, 030217 neurology & neurosurgery
Abstract

Neurological disorders are considered rare complications of immune-checkpoint inhibitor. We report a 63-year-old man with recurrence of melanoma who presented epilepsy, limbic encephalitis, cerebellar ataxia, and stiff person syndrome soon after treatment with nivolumab, an immune-checkpoint inhibitor. On autoimmune screening, serum and CSF GAD65 were detected. Significant response to steroids and intravenous immunoglobulins were observed, but cancer recurred after nivolumab discontinuation in parallel with epileptic seizure and worsening of cognitive impairment and the patient died. This case expands the spectrum of GAD65-associated conditions induced by immune-checkpoint inhibitor and underlines treatment complexity when both neurological complications and tumour recurrence occur.

Published
2021
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27. Humoral efficacy of the third SARS-CoV-2 vaccine dose in Multiple Sclerosis subjects undergoing different disease-modifying therapies

Author

Giorgia Teresa Maniscalco, Antonietta Liotti, Anne Lise Ferrara, Elio Prestipino, Simona Salvatore, Maria Elena Di Battista, Ornella Moreggia, Daniele Di Giulio Cesare, Roberta Vastano, Martina Belardo, Massimo Napolitano, Angelo Ranieri, Katia Longo, Vincenzo Andreone, and Veronica De Rosa

Subjects
Neurology, Neurology (clinical), General Medicine
Abstract

It remains unclear how vaccine doses and combinations of vaccination and infection affect the magnitude and quality of immune responses, particularly against novel SARS-CoV-2 variants in subjects with immune-related disorders, such as people with multiple sclerosis (pwMS). Several studies have evaluated the duration of anti-SARS-CoV-2 immune protection in healthy individuals; however clinical data suggest an attenuated short-term humoral response to SARS-CoV-2 vaccines in pwMS receiving disease-modifying therapies (DMTs).In this prospective study, we evaluated the humoral response to the third (3rd) BNT162b2 vaccine (booster) dose in a monocentric cohort of pwMS undergoing eight different DMTs, all without previous SARS-CoV-2 infection. Quantitative determination of SARS-CoV-2 IgG Spike titre was carried out by anti-SARS-CoV-2 S assay in 65 pwMS and 9 healthy controls, all without previous SARS-CoV-2 infection. Moreover, these measurements were also compared to their relative levels at 21 days (T1) and ∼6 months (T2) after the second (2nd) vaccination.We observed that the humoral response to the booster dose in Interferon β-1a-, Dimethyl fumarate- and Teriflunomide-treated pwMS is comparable to healthy controls, while increased in Cladribine-treated pwMS. Additionally, the 3rd dose elicits a seroconversion in the 100% of pwMS under Fingolimod and in the 65% of those under Ocrelizumab. Moreover, multivariate regression analysis showed that treatment with Interferon β-1a, Dimethyl fumarate and Cladribine positively associates with an increased humoral response.Taken together this evidence strongly indicates the importance of the booster dose to enhance SARS-CoV-2-specific immunity especially in immunocompromised subjects, such as pwMS under DMTs.

Published
2022
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28. Risk of disease relapse following COVID-19 vaccination in patients with AQP4-IgG-positive NMOSD and MOGAD

Author

Paolo Manganotti, Vincenzo Andreone, Alberto Gajofatto, Sara Mariotto, Paolo Solla, Alessandro Dinoto, Alessandra Maccabeo, Riccardo Orlandi, Sarah Rasia, Arianna Sartori, Giorgia Teresa Maniscalco, Elia Sechi, Sergio Ferrari, Ruggero Capra, and Chiara Rosa Mancinelli

Subjects
medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), NMOSD, NMOSD, neuromyelitis optica spectrum disorder, Disease, MOGAD, Recurrence, Internal medicine, Correspondence, medicine, Humans, MOG, In patient, BNT162 Vaccine, Autoantibodies, Retrospective Studies, Aquaporin 4, SARS-CoV-2, Severe acute respiratory syndrome coronavirus 2, business.industry, SARS-CoV-2, Multiple sclerosis, Neuromyelitis Optica, Vaccination, COVID-19, General Medicine, medicine.disease, AQP4, AQP4, aquaporin-4-IgG, Neurology, MOGAD, myelin oligodendrocyte glycoprotein associated disease, Immunoglobulin G, Myelin-Oligodendrocyte Glycoprotein, Neurology (clinical), business, DISEASE RELAPSE
Abstract

Post-vaccination disease relapses have been reported in patients with MOGAD and AQP4-IgG+NMOSD. In this retrospective multicenter Italian study we assessed the frequency of relapses after SARS-CoV-2 vaccination. We included 56 cases: MOGAD, 30; AQP4-IgG+NMOSD, 26. Vaccines received were BNT162b2-Pfizer-BioNTech in 42 patients and mRNA-1273-Moderna in 14 patients. Six patients had a history of SARS-CoV-2 infection; two of them experienced a post-infection disease relapse (MOGAD). The frequency of relapses within one month of SARS-CoV-2 vaccination was 4% (1/26) in the AQP4-IgG+NMOSD group and 0% in the MOGAD group. In these patients the potential benefits of vaccination overcome the risk of relapses.

Published
2021

29. Interferon Beta-1a treatment promotes SARS-CoV-2 mRNA vaccine response in multiple sclerosis subjects

Author

Giorgia Teresa Maniscalco, Valentino Manzo, Anne Lise Ferrara, Alessandro Perrella, Mariaelena Di Battista, Simona Salvatore, Daniela Graziano, Assunta Viola, Gerardino Amato, Ornella Moreggia, Daniele Di Giulio Cesare, Stefano Barbato, Giovanna Servillo, Katia Longo, Mario Di Giovanni, Barbara Scarpati, Simona Maria Muggianu, Giuseppe Longo, Giuseppe Russo, Vincenzo Andreone, and Veronica De Rosa

Subjects
COVID-19 Vaccines, Multiple Sclerosis, BNT162b2-mRNA coronavirus-19 vaccine, Antibodies, Viral, Article, CLAD, Cladribine, Disease modifying therapies, TERI, Teriflunomide, Humans, DMF, Dimethyl fumatate, DMTs, Disease modifying therapies, Humoral response, NAT, Natalizumab, Pandemics, OCRE, Ocrelizumab, BNT162 Vaccine, Vaccines, Synthetic, COVID-19, Coronavirus disease 2019, IgG, Immunoglobulin G, MS, Multiple sclerosis, SARS-CoV-2, COVID-19, GA, Glatiramer acetate, General Medicine, IQR, Interquartile range, WBC, White blood cells, SARS-CoV-2 spike protein, EDSS, Expanded disability status scale, FTY, Fingolimod, Neurology, Spike Glycoprotein, Coronavirus, Neurology (clinical), mRNA Vaccines, GMTR, Geometric mean titre ratio, Interferon beta-1a, HC, Healthy controls, IFN, Interferon β-1a
Abstract

Background Several concerns exist on the immunogenicity of SARS-CoV-2 vaccines in multiple sclerosis (MS) subjects due to their immunomodulating disease modifying therapies (DMTs). Here we report a comparison of the humoral response to BNT162b2-mRNA coronavirus (COVID)-19 vaccine and the immunological phenotype in a cohort of 125 MS subjects undergoing different DMTs, with no history of SARS-CoV-2 infection. Methods We collected serum and blood samples at the first day of vaccine (T0) and 21 days after the second vaccine dose (T1) from 125 MS subjects, undergoing eight different DMTs. Sera were tested using the Elecsys anti-SARS-CoV-2-IgG assay for the detection of IgG antibodies to SARS-CoV-2 spike protein. The anti-spike IgG titres from MS subjects were compared with 24 age- and sex-matched healthy controls (HC). Percentage and absolute number of B and T lymphocytes were evaluated by cytofluorimetric analysis in the same study cohort. Results When compared with SARS-CoV-2 IgG levels in HC (n = 24, median 1089 (IQR 652.5–1625) U/mL), we observed an increased secretion of SARS-CoV-2 IgG in interferon-beta 1a (IFN)-treated MS subjects (n = 22, median 1916 (IQR 1024–2879) U/mL) and an impaired humoral response in MS subjects undergoing cladribine (CLAD) (n = 10, median 396.9 (IQR 37.52–790.9) U/mL), fingolimod (FTY) (n = 19, median 7.9 (IQR 4.8–147.6) U/mL) and ocrelizumab (OCRE) (n = 15, median 0.67 (IQR 0.4–5.9) U/mL) treatment. Moreover, analysis of geometric mean titre ratio (GMTR) between different DMT's groups of MS subjects revealed that, when compared with IFN-treated MS subjects, intrinsic antibody production was impaired in teriflunomide (TERI)-, natalizumab (NAT)-, CLAD-, FTY- and OCRE-, while preserved in DMF- and GA-treated MS subjects. Conclusion Humoral response to BNT162b2-mRNA-vaccine was increased in IFN-treated MS subjects while clearly blunted in those under CLAD, FTY and OCRE treatment. This suggests that the DMTs could have a key role in the protection from SARS-CoV-2 related disease and complication in MS subjects, underlying a novel aspect that should be considered in the selection of the most appropriate therapy under COVID-19 pandemic.

Published
2021

30. Adie’s Tonic Pupil Disclosing a Metastatic Breast Cancer: Case Report

Author

Ciro Florio, Ferdinando Riccardi, Gennaro Alfieri, Massimo Napolitano, Angelo Ranieri, and Giorgia Teresa Maniscalco

Subjects
Pathology, medicine.medical_specialty, Tonic pupil, genetic structures, business.industry, Ciliary ganglion, Autonomic disorder, medicine.disease, Metastatic breast cancer, eye diseases, Pupil, Breast cancer, Pilocarpine, Medicine, sense organs, Differential diagnosis, business, medicine.drug
Abstract

Tonic pupil, or Adie’s pupil, is an autonomic disorder due to a loss of function of parasympathetic ciliary ganglion cells. Upon examination, the pupil appears tonically dilated and shrinks poorly to light, while reacting better to accommodation stimulus. The denervated iris sphincter is very sensitive to topical parasympathomimetic pilocarpine drops. Indeed, if Adie is present, the dilated pupil will constrict more than the normal pupil. Most cases are idiopathic or due to a viral infection and have a benign course. They usually occur in women between 20 and 40 years of age. Other reported causes of tonic pupils can be vascular, traumatic, inflammatory, paraneoplastic, and neoplastic. Breast cancer generally metastasizes to the brain in advanced stages and orbital localizations have sometimes been reported. In our case, a meningeal and retro-orbit cancer invasion caused a dysfunction of the parasympathetic fibers which lead to the pupil through the optical foramen. Indeed, first ophthalmic symptoms were only an enlarged pupil poorly responsive to light. This unusual clinical sign led to the discovery of an unknown breast cancer in an advanced stage. In young adult women, unilateral tonic pupils are considered a benign parasympathetic ocular disorder that is rarely observed in clinical practice. However, it can be found in numerous systemic diseases; thus instrumental and laboratory findings are mandatory. Tumors can also represent etiologic agents and secondary localizations from breast cancer to extra parenchymal CNS structures should be considered in differential diagnosis hypothesis.

Published
2020
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31. GABAA receptor autoimmunity after alemtuzumab treatment for multiple sclerosis

Author

Massimo Napolitano, Paolo Candelaresi, Sara Mariotto, Marianna Spatola, Silvia Bozzetti, Ruggero Capra, Simonetta Gerevini, Ciro Florio, Giovanna Servillo, Sergio Ferrari, Romana Höftberger, Giorgia Teresa Maniscalco, and Valentino Manzo

Subjects
Pathology, medicine.medical_specialty, business.industry, Multiple sclerosis, JC virus, Epilepsia partialis continua, Status epilepticus, medicine.disease_cause, medicine.disease, Fingolimod, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, N/A, medicine, Alemtuzumab, 030212 general & internal medicine, Neurology (clinical), medicine.symptom, Pleocytosis, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

A 68-year-old man with a 9-year history of relapsing-remitting multiple sclerosis previously treated with natalizumab and fingolimod achieved clinical and radiologic stability with alemtuzumab. Sixteen months after administration of the second cycle, he developed behavioral changes and focal seizures, characterized by aphasia and motor automatisms. Seizures were refractory to multiple antiepileptic drugs and evolved into epilepsia partialis continua and, after 1 week, into generalized status epilepticus (see timeline, [doi.org/10.5061/dryad.pvmcvdnht][1]). EEG showed bilateral temporal slowing and epileptiform discharges. Brain MRI revealed new large multifocal nonenhancing cortical/subcortical abnormalities involving bilaterally the frontal and temporal lobes (figure 1, A and B). Routine blood analyses were unremarkable, except for a reduced lymphocyte count (730/μL; B cells 50%, T cells 36%). CSF analysis showed pleocytosis (12 cells/μL) and increased proteins (53.8 mg/dL), whereas extensive screening for infections (including JC virus, herpes simplex virus 1-2-6, varicella-zoster virus, cytomegalovirus, Enterovirus , Listeria , Haemophilus , Cryptococcus , and bacterial and fungi cultures) yielded negative results. Fixed cell-based and Western Blot commercial assays (Euroimmun, Lubeck) excluded the presence of neuronal antibodies, including Hu, Yo, Ri, Tr, GAD65, CV2/CRMP5, Ma2, SOX1, amphiphysin, N-methyl-D-aspartate receptor, LGI1, CASPR2, AMPAR1/2, gamma-aminobutyric acid-B receptor, and dipeptidyl peptidase-like protein 6. Whole-body computed axial tomography did not show any malignancies. A right parietal brain biopsy showed unspecific gliosis without inflammatory infiltrates. [1]: https://doi.org/10.5061/dryad.pvmcvdnht

Published
2020
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32. Visual hallucinations as psychiatric onset of a primary central nervous system lymphoma: a case report and a brief review of literature on neoplasm-correlated neuropsychiatric disorders

Author

Valentino Manzo, Ferdinando Riccardi, Angelo Ranieri, Massimo Napolitano, and Giorgia Teresa Maniscalco

Subjects
medicine.medical_specialty, Neurology, business.industry, MEDLINE, Primary central nervous system lymphoma, Dermatology, General Medicine, medicine.disease, Visual Hallucination, Psychiatry and Mental health, medicine, Neoplasm, Neurology (clinical), Neurosurgery, business, Psychiatry, Neuroradiology
Published
2020
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33. The application of Kubler-Ross model in Newly Diagnosed Patients with Relapsing-Remitting Multiple Sclerosis

Author

Valentina Panetta, Giorgia Teresa Maniscalco, Giovanni Improta, Giovanni Guarcello, Antonio Rosario Ziello, and Ciro Florio

Subjects
Pediatrics, medicine.medical_specialty, business.industry, Multiple sclerosis, General Medicine, Newly diagnosed, Disease, medicine.disease, Affect (psychology), Relapsing remitting, medicine, Anxiety, medicine.symptom, business
Abstract

Background: Anxiety and depressive disorders affect Multiple Sclerosis (MS) patients since the early stages of the disease. Although the presence of these symptoms is widely recognized, the beginning and the psychological mechanisms at the basis of these disorders have rarely been examined in detail.

Published
2019
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34. Reduced Annexin A1 Expression Associates with Disease Severity and Inflammation in Multiple Sclerosis Patients

Author

Fabio Buttari, Veronica De Rosa, Francesco Perna, Elisa Maggioli, Madeeha H Sheikh, Bruno Zuccarelli, Giorgia Teresa Maniscalco, Gaetano Calì, Rodrigo Azevedo Loiola, Maria Mottola, Dario Bruzzese, Mario Galgani, Silvana Cassano, Roberta Lanzillo, Egle Solito, Diego Centonze, Alessandra Colamatteo, Colamatteo, Alessandra, Maggioli, Elisa, Azevedo Loiola, Rodrigo, Hamid Sheikh, Madeeha, Calì, Gaetano, Bruzzese, Dario, Maniscalco, Giorgia Teresa, Centonze, Diego, Buttari, Fabio, Lanzillo, Roberta, Perna, Francesco, Zuccarelli, Bruno, Mottola, Maria, Cassano, Silvana, Galgani, Mario, Solito, Egle, and De Rosa, Veronica

Subjects
Adult, Male, STAT3 Transcription Factor, endocrine system, Multiple Sclerosis, T cell, Immunology, Inflammation, Settore MED/26, Lymphocyte Activation, Severity of Illness Index, Monocytes, Proinflammatory cytokine, Annexin A1, 03 medical and health sciences, 0302 clinical medicine, Humans, Immunology and Allergy, Medicine, IL-2 receptor, Neuroinflammation, Cell Proliferation, Autoimmune disease, business.industry, Multiple sclerosis, Middle Aged, Th1 Cells, medicine.disease, medicine.anatomical_structure, Gene Expression Regulation, Th17 Cells, Female, medicine.symptom, business, Glycolysis, 030215 immunology
Abstract

Chronic neuroinflammation is a key pathological hallmark of multiple sclerosis (MS) that suggests that resolution of inflammation by specialized proresolving molecules is dysregulated in the disease. Annexin A1 (ANXA1) is a protein induced by glucocorticoids that facilitates resolution of inflammation through several mechanisms that include an inhibition of leukocyte recruitment and activation. In this study, we investigated the ability of ANXA1 to influence T cell effector function in relapsing/remitting MS (RRMS), an autoimmune disease sustained by proinflammatory Th1/Th17 cells. Circulating expression levels of ANXA1 in naive-to-treatment RRMS subjects inversely correlated with disease score and progression. At the cellular level, there was an impaired ANXA1 production by CD4+CD25− conventional T and CD4+RORγt+ T (Th17) cells from RRMS subjects that associated with an increased migratory capacity in an in vitro model of blood brain barrier. Mechanistically, ANXA1 impaired monocyte maturation secondarily to STAT3 hyperactivation and potently reduced T cell activation, proliferation, and glycolysis. Together, these findings identify impaired disease resolution pathways in RRMS caused by dysregulated ANXA1 expression that could represent new potential therapeutic targets in RRMS.

Published
2019
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35. The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study

Author

Giorgia Teresa Maniscalco, Cristina Scavone, Annamaria Mascolo, Valentino Manzo, Elio Prestipino, Gaspare Guglielmi, Maria Luisa Aiezza, Santolo Cozzolino, Adele Bracco, Ornella Moreggia, Daniele Di Giulio Cesare, Antonio Rosario Ziello, Angela Falco, Marida Massa, Massimo Majolo, Eliana Raiola, Roberto Soprano, Giuseppe Russo, Giuseppe Longo, Vincenzo Andreone, Annalisa Capuano, Maniscalco, Giorgia Teresa, Scavone, Cristina, Mascolo, Annamaria, Manzo, Valentino, Prestipino, Elio, Guglielmi, Gaspare, Aiezza, Maria Luisa, Cozzolino, Santolo, Bracco, Adele, Moreggia, Ornella, Di Giulio Cesare, Daniele, Ziello, Antonio Rosario, Falco, Angela, Massa, Marida, Majolo, Massimo, Raiola, Eliana, Soprano, Roberto, Russo, Giuseppe, Longo, Giuseppe, Andreone, Vincenzo, and Capuano, Annalisa

Subjects
AEFI, safety, COVID-19, mRNA-based vaccine, multiple sclerosis, observational study, multiple sclerosi, General Medicine
Abstract

In the current COVID-19 pandemic, patients diagnosed with multiple sclerosis (MS) are considered to be one of the highest priority categories, being recognized as extremely vulnerable people. For this reason, mRNA-based COVID-19 vaccines are strongly recommended for these patients. Despite encouraging results on the efficacy and safety profile of mRNA-based COVID-19 vaccines, to date, in frail populations, including patients diagnosed with MS, this information is rather limited. We carried out a retrospective observational study with the aim to evaluate the safety profile of mRNA-based COVID-19 vaccines by retrieving real-life data of MS patients who were treated and vaccinated at the Multiple Sclerosis Center of the Hospital A.O.R.N. A. Cardarelli. Three-hundred and ten medical records of MS patients who received the first dose of the mRNA-based COVID-19 vaccine were retrieved (63% female; mean age: 45.9 years). Of these patients, 288 also received the second dose. All patients received the Pfizer-BioNTech vaccine. Relapsing-Remitting Multiple Sclerosis (RRSM) was the most common form of MS. The Expanded Disability Status Scale (EDSS) values were

Published
2022
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36. PML risk is the main factor driving the choice of discontinuing natalizumab in a large multiple sclerosis population: results from an Italian multicenter retrospective study

Author

Clara G, Chisari, Giancarlo, Comi, Massimo, Filippi, Damiano, Paolicelli, Pietro, Iaffaldano, Mauro, Zaffaroni, Vincenzo, Brescia Morra, Eleonora, Cocco, Girolama Alessandra, Marfia, Luigi Maria, Grimaldi, Matilde, Inglese, Simona, Bonavita, Alessandra, Lugaresi, Giuseppe, Salemi, Giovanna, De Luca, Salvatore, Cottone, Antonella, Conte, Patrizia, Sola, Umberto, Aguglia, Giorgia Teresa, Maniscalco, Claudio, Gasperini, Maria Teresa, Ferrò, Ilaria, Pesci, Maria Pia, Amato, Marco, Rovaris, Claudio, Solaro, Giacomo, Lus, Davide, Maimone, Roberto, Bergamaschi, Franco, Granella, Alessia, Di Sapio, Antonio, Bertolotto, Rocco, Totaro, Marika, Vianello, Paola, Cavalla, Paolo, Bellantonio, Vito, Lepore, Francesco, Patti, Simonetta, Venturi, Chisari, Clara G, Comi, Giancarlo, Filippi, Massimo, Paolicelli, Damiano, Iaffaldano, Pietro, Zaffaroni, Mauro, Brescia Morra, Vincenzo, Cocco, Eleonora, Marfia, Girolama Alessandra, Grimaldi, Luigi Maria, Inglese, Matilde, Bonavita, Simona, Lugaresi, Alessandra, Salemi, Giuseppe, De Luca, Giovanna, Cottone, Salvatore, Conte, Antonella, Sola, Patrizia, Aguglia, Umberto, Maniscalco, Giorgia Teresa, Gasperini, Claudio, Ferrò, Maria Teresa, Pesci, Ilaria, Amato, Maria Pia, Rovaris, Marco, Solaro, Claudio, Lus, Giacomo, Maimone, Davide, Bergamaschi, Roberto, Granella, Franco, Di Sapio, Alessia, Bertolotto, Antonio, Totaro, Rocco, Vianello, Marika, Cavalla, Paola, Bellantonio, Paolo, Lepore, Vito, Patti, Francesco, and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE

Subjects
Adult, medicine.medical_specialty, Discontinuation rate, Neurology, Reasons for discontinuation, Population, Progressive Multifocal, Relapsing-Remitting, Settore MED/26, Multiple sclerosis, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Multiple Sclerosis, Relapsing-Remitting, Leukoencephalopathy, Internal medicine, parasitic diseases, medicine, Effective treatment, Humans, Immunologic Factors, Multiple sclerosi, 030212 general & internal medicine, education, Retrospective Studies, education.field_of_study, Female, Middle Aged, Leukoencephalopathy, Progressive Multifocal, Multiple Sclerosis, business.industry, Progressive multifocal leukoencephalopathy, Retrospective cohort study, medicine.disease, Discontinuation, Settore MED/26 - Neurologia, Neurology (clinical), business, 030217 neurology & neurosurgery, medicine.drug
Abstract

none 38 no BACKGROUND: Natalizumab (NTZ) is an effective treatment for relapsing-remitting multiple sclerosis (RRMS). However, patients and physicians may consider discontinuing NTZ therapy due to safety or efficacy issues. The aim of our study was to evaluate the NTZ discontinuation rate and reasons of discontinuation in a large Italian population of RRMS patients. MATERIALS AND METHODS: The data were extracted from the Italian MS registry in May 2018 and were collected from 51,845 patients in 69 Italian multiple sclerosis centers. MS patients with at least one NTZ infusion in the period between June 1st 2012 to May 15th 2018 were included. Discontinuation rates at each time point were calculated. Reasons for NTZ discontinuation were classified as "lack of efficacy", "progressive multifocal leukoencephalopathy (PML) risk" or "other". RESULTS: Out of 51,845, 5151 patients, 3019 (58.6%) females, with a mean age of 43.6 ± 10.1years (median 40), were analyzed. Out of 2037 (39.5%) who discontinued NTZ, a significantly higher percentage suspended NTZ because of PML risk compared to lack of efficacy [1682 (32.7% of 5151) vs 221 (4.3%), p

Published
2021

37. Influenza Vaccine Hesitancy in Patients with Multiple Sclerosis: A Monocentric Observational Study

Author

Stefano Barbato, Maria Elena Di Battista, Giorgia Teresa Maniscalco, Ornella Moreggia, Antonio Rosario Ziello, Simona Salvatore, Lia Allegorico, Anna Sagnelli, Valentino Manzo, Annalisa Capuano, Daniele Di Giulio Cesare, Cristina Scavone, Ziello, A., Scavone, C., Di Battista, M. E., Salvatore, S., Giulio Cesare, D. D., Moreggia, O., Allegorico, L., Sagnelli, A., Barbato, S., Manzo, V., Capuano, A., and Maniscalco, G. T.

Subjects
Pediatrics, medicine.medical_specialty, Influenza vaccine, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Neurosciences. Biological psychiatry. Neuropsychiatry, multiple sclerosis, Article, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Natalizumab, Teriflunomide, medicine, Multiple sclerosi, In patient, 030212 general & internal medicine, business.industry, General Neuroscience, Multiple sclerosis, medicine.disease, Vaccination, chemistry, Observational study, observational study, hesitancy, influenza vaccine, business, 030217 neurology & neurosurgery, RC321-571, medicine.drug
Abstract

Background. The so-called “vaccine hesitancy” still represents a common phenomenon that undermines the effectiveness of vaccination campaigns. In 2020, the Italian Medicines Agency recommended to bring forward the flu vaccination campaign, whose importance was also emphasized for patients with Multiple Sclerosis (MS). We aimed to assess vaccination behavior in patients with MS to prepare for the upcoming SARS-CoV-2 vaccination challenge. Methods. This is an observational study carried out in one MS clinical Centre that enrolled all MS patients who were eligible for any of the flu vaccines recommended by the Italian medicines Agency. Results. 194 patients were enrolled. Patients’ mean age was 43.9 years and 66% were female. Comorbidities, mainly represented by non-autoimmune diseases, were identified in 52% of patients. Almost all patients were receiving a DMT during the study period, mainly dimethyl fumarate, natalizumab, teriflunomide, and interferon. Out of 194 patients, 58.2% accepted to be vaccinated. No statistically significant differences were found, except for the use of natalizumab, which was higher among vaccinated patients. Conclusion. The results of our study emphasize the importance of education and communication campaigns addressed both to healthcare providers and patients with MS, especially considering that MS patients are currently receiving COVID-19 vaccinations.

Published
2021

38. Safety profile of SARS-CoV-2 vaccination in patients with antibody-mediated CNS disorders

Author

Alessandro Dinoto, Matteo Gastaldi, Raffaele Iorio, Sofia Marini, Valentina Damato, Antonio Farina, Marco Zoccarato, Elia Sechi, Francesca Pinna, Giorgia Teresa Maniscalco, Ruggero Barnabei, Luigi Zuliani, Sergio Ferrari, and Sara Mariotto

Subjects
COVID-19 Vaccines, SARS-CoV-2, Vaccination, COVID-19, Viral Vaccines, General Medicine, Antibodies, Viral, Neurology, Humans, Neurology (clinical), Neoplasm Recurrence, Local, Autoimmune encephalitis, Safety, CNS autoantibodies, BNT162 Vaccine, Autoantibodies
Abstract

In this retrospective multicenter study, we evaluated the safety of SARS-CoV-2 vaccination in patients harboring autoantibodies targeting neuronal surface and/or synaptic antigens.From eight Italian Neurology Units, we included patients with: a) serum and/or CSF positivity for specific neuronal autoantibodies; b) a compatible neurological syndrome; and c) available follow-up ≥6 weeks after vaccination with any of the approved SARS-CoV-2 vaccines. Demographics, clinical data, and information regarding previous SARS-CoV-2 infection and vaccination were collected. Disease relapses were considered "post-infectious" or "post-vaccination" when occurring within 6 weeks from infection/vaccination.We included 66 patients; 7/66 (11%) had a previous history of SARS-CoV-2 infection and 1/7 (14%) had post-infection relapses. BNT162b2-Pfizer-BioNTec was administered in 55 cases (83.3%) and mRNA-1273-Moderna in 11 (16.7%). The median number of doses administered per patient was 2 (1-3) and50% of patients did not experience side effects. Five patients (8%) had post-vaccination relapses (seizure 3/5); 4/5 improved after immunotherapy, while one did not receive immunotherapy and worsened. Patients with post-vaccination relapses had higher disability scores at vaccination (p = 0.025), a trend favoring Leucine-rich glioma-inactivated protein 1 LGI1 glutamic acid decarboxylase 65 (GAD65) antibodies (p = 0.054) and shorter time from last relapse (p = 0.057).Our data support the safety of SARS-CoV-2 vaccines in patients with neurological disorders associated with antibodies to neuronal and synaptic antigens.

Published
2022
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39. Signals of pseudo-starvation unveil the amino acid transporter SLC7A11 as key determinant in the control of Treg cell proliferative potential

Author

Maria Lepore, Dario Di Silvestre, Fabio Buttari, Claudia La Rocca, Antonio Uccelli, Paola de Candia, Giuseppe Matarese, Danila Vella, Alessandra Colamatteo, Giusy De Rosa, Pierluigi Mauri, Sarah Grossi, Claudia Russo, Roberta Lanzillo, Vincenzo Brescia Morra, Mario Galgani, Maria Mottola, Giorgia Teresa Maniscalco, Paola Campomenosi, Claudio Procaccini, Diego Centonze, Marco Salvetti, Silvia Garavelli, Deriggio Faicchia, Bruno Zuccarelli, Francesco Prattichizzo, Fortunata Carbone, Dario Greco, Procaccini, C., Garavelli, S., Carbone, F., Di Silvestre, D., La Rocca, C., Greco, D., Colamatteo, A., Lepore, M. T., Russo, C., De Rosa, G., Faicchia, D., Prattichizzo, F., Grossi, S., Campomenosi, P., Buttari, F., Mauri, P., Uccelli, A., Salvetti, M., Brescia Morra, V., Vella, D., Galgani, M., Mottola, M., Zuccarelli, B., Lanzillo, R., Maniscalco, G. T., Centonze, D., de Candia, P., and Matarese, G.

Subjects
0301 basic medicine, Male, Antiporter, T-Lymphocytes, SLC7A11, Relapsing-Remitting, medicine.disease_cause, T-Lymphocytes, Regulatory, Autoimmunity, 0302 clinical medicine, Immunology and Allergy, Homeostasis, Cells, Cultured, Cultured, dimethyl fumarate, biology, autoimmunity, Glutamate receptor, hemic and immune systems, Regulatory, Transmembrane protein, Cell biology, Infectious Diseases, 030220 oncology & carcinogenesis, multiple sclerosi, Female, Human, leptin, metabolism, multiple sclerosis, proliferation, starvation, Treg cells, xCT, Adult, Amino Acid Transport System y+, Cell Proliferation, Humans, Immune Tolerance, Multiple Sclerosis, Relapsing-Remitting, NF-E2-Related Factor 2, Multiple Sclerosis, Cells, Immunology, chemical and pharmacologic phenomena, Settore MED/26, 03 medical and health sciences, Homeostasi, medicine, Amino acid transporter, Treg cell, Solute carrier family, 030104 developmental biology, biology.protein
Abstract

Summary Human CD4+CD25hiFOXP3+ regulatory T (Treg) cells are key players in the control of immunological self-tolerance and homeostasis. Here, we report that signals of pseudo-starvation reversed human Treg cell in vitro anergy through an integrated transcriptional response, pertaining to proliferation, metabolism, and transmembrane solute carrier transport. At the molecular level, the Treg cell proliferative response was dependent on the induction of the cystine/glutamate antiporter solute carrier (SLC)7A11, whose expression was controlled by the nuclear factor erythroid 2-related factor 2 (NRF2). SLC7A11 induction in Treg cells was impaired in subjects with relapsing-remitting multiple sclerosis (RRMS), an autoimmune disorder associated with reduced Treg cell proliferative capacity. Treatment of RRMS subjects with dimethyl fumarate (DMF) rescued SLC7A11 induction and fully recovered Treg cell expansion. These results suggest a previously unrecognized mechanism that may account for the progressive loss of Treg cells in autoimmunity and unveil SLC7A11 as major target for the rescue of Treg cell proliferation.

Published
2021

40. Injectable Versus Oral First-Line Disease-Modifying Therapies: Results from the Italian MS Register

Author

Marco Onofrj, Giacomo Lus, Damiano Paolicelli, Matilde Inglese, Giorgia Teresa Maniscalco, Massimo Filippi, Emanuele D'Amico, M. Vianello, Simonetta Galgani, Vincenzo Brescia Morra, Francesco Patti, Antonio Gallo, Aurora Zanghì, Paolo Confalonieri, Giuseppe Salemi, Giovanna De Luca, Maria Trojano, Carlo Avolio, Maria Pia Amato, Eleonora Cocco, Marzia Romeo, D'Amico, E., Zanghi, A., Romeo, M., Cocco, E., Maniscalco, G. T., Brescia Morra, V., Paolicelli, D., De Luca, G., Galgani, S., Amato, M. P., Salemi, G., Inglese, M., Confalonieri, P. A., Lus, G., Avolio, C., Gallo, A., Vianello, M., Onofrj, M., Filippi, M., Trojano, M., Patti, F., D'Amico, Emanuele, Zanghì, Aurora, Romeo, Marzia, Cocco, Eleonora, Maniscalco, Giorgia Teresa, Brescia Morra, Vincenzo, Paolicelli, Damiano, De Luca, Giovanna, Galgani, Simonetta, Amato, Maria Pia, Salemi, Giuseppe, Inglese, Matilde, Confalonieri, Paolo Agostino, Lus, Giacomo, Avolio, Carlo, Gallo, Antonio, Vianello, Marika, Onofrj, Marco, Filippi, Massimo, Trojano, Maria, and Patti, Francesco

Subjects
Male, oral DMTs, oral DMT, Administration, Oral, Disease, Relapsing-Remitting, Cohort Studies, 0302 clinical medicine, Immunologic, injectable DMT, Pharmacology (medical), 030212 general & internal medicine, Registries, Subcutaneous, Middle Aged, Italy, EDSS score, injectable DMTs, Multiple sclerosis, real-world setting, Adjuvants, Immunologic, Adult, Female, Follow-Up Studies, Glatiramer Acetate, Humans, Immunologic Factors, Injections, Subcutaneous, Interferon-beta, Multiple Sclerosis, Relapsing-Remitting, Retrospective Studies, Administration, Cohort, Settore MED/26 - Neurologia, Original Article, Neurosurgery, Cohort study, Oral, medicine.medical_specialty, Lower risk, Injections, 03 medical and health sciences, Internal medicine, medicine, Multiple sclerosi, Adjuvants, Pharmacology, business.industry, medicine.disease, Discontinuation, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

The current study aims to compare injectable and oral first-line disease-modifying therapies (DMTs) for time to first relapse, time to confirmed disability progression (CDP), and time to discontinuation using a cohort of relapsing remitting multiple sclerosis (RRMS) patients, with data extracted from the Italian MS Register. This multicenter, observational, retrospectively acquired, and propensity-adjusted cohort study utilized RRMS-naïve patients from the Italian MS Register who started either injectable or oral first-line DMTs between January 1, 2010, and December 31, 2017, to evaluate the impact on disability outcomes in patients. Enrolled patients were divided into two groups, namely the injectable group (IG) and the oral group (OG). Of a cohort of 11,416 patients, 4602 were enrolled (3919 in the IG and 683 in the OG). The IG had a higher rate of women (67.3% vs 63.4%, p p p p = 0.941), while a lower risk of DMT was found in the OG (HR = 0.72; CI 95% 0.58–0.88, p = 0.002) for the event time to discontinuation. Real-world data from the Italian MS Register suggests that first-line oral DMTs are associated with a lower risk of experiencing a new relapse and of therapy discontinuation compared to injectable DMTs.

Published
2021

41. COVID-19 Severity in Multiple Sclerosis: Putting Data Into Context

Author

Maria Pia Sormani, Irene Schiavetti, Luca Carmisciano, Cinzia Cordioli, Massimo Filippi, Marta Radaelli, Paolo Immovilli, Marco Capobianco, Nicola De Rossi, Giampaolo Brichetto, Eleonora Cocco, Cinzia Scandellari, Paola Cavalla, Ilaria Pesci, Antonio Zito, Paolo Confalonieri, Girolama Alessandra Marfia, Paola Perini, Matilde Inglese, Maria Trojano, Vincenzo Brescia Morra, Gioacchino Tedeschi, Giancarlo Comi, Mario Alberto Battaglia, Francesco Patti, Marco Salvetti, Gianmarco Abbadessa, Umberto Aguglia, Lia Allegorico, Beatrice Maria Allegri Rossi, Maria Pia Amato, Pietro Annovazzi, Carlo Antozzi, Lucia Appendino, Sebastiano Arena, Viola Baione, Roberto Balgera, Valeria Barcella, Damiano Baroncini, Caterina Barrilà, Alessandra Bellacosa, Gianmarco Bellucci, Roberto Bergamaschi, Valeria Bergamaschi, Daiana Bezzini, Beatrice Biolzi, Alvino Bisecco, Simona Bonavita, Giovanna Borriello, Chiara Bosa, Antonio Bosco, Francesca Bovis, Marco Bozzali, Laura Brambilla, Maria Buccafusca, Elisabetta Bucciantini, Sebastiano Bucello, Maria Chiara Buscarinu, Maria Paola Cabboi, Massimiliano Calabrese, Francesca Calabria, Francesca Caleri, Federico Camilli, Luisa Maria Caniatti, Roberto Cantello, Ruggero Capra, Rocco Capuano, Patrizia Carta, Maria Grazia Celani, Maria Cellerino, Raffaella Cerqua, Clara Chisari, Raffaella Clerici, Marinella Clerico, Gaia Cola, Antonella Conte, Marta Zaffira Conti, Christian Cordano, Susanna Cordera, Francesco Corea, Claudio Correale, Salvatore Cottone, Francesco Crescenzo, Erica Curti, Alessandro d'Ambrosio, Emanuele D'Amico, Maura Chiara Danni, Alessia d'Arma, Vincenzo Dattola, Stefano de Biase, Giovanna De Luca, Stefania Federica De Mercanti, Paolo De Mitri, Nicola De Stefano, Marco Della Cava, Mario di Napoli, Alessia Di Sapio, Renato Docimo, Anna Dutto, Luana Evangelista, Salvatore Fanara, Ferraro Diana, Maria Teresa Ferrò, Cristina Fioretti, Mario Fratta, Jessica Frau, Marzia Fronza, Roberto Furlan, Alberto Gajofatto, Antonio Gallo, Paolo Gallo, Claudio Gasperini, Anna Ghazaryan, Bruno Giometto, Francesca Gobbin, Flora Govone, Franco Granella, Erica Grange, Maria Grazia Grasso, Angelica Guareschi, Clara Guaschino, Simone Guerrieri, Donata Guidetti, Pietro Iaffaldano, Antonio Ianniello, Luigi Iasevoli, Daniele Imperiale, Maria Teresa Infante, Rosa Iodice, Aniello Iovino, Giovanna Konrad, Doriana Landi, Roberta Lanzillo, Caterina Lapucci, Luigi Lavorgna, Maria Rita L'Episcopo, Serena Leva, Giuseppe Liberatore, Marianna Lo Re, Marco Longoni, Leonardo Lopiano, Lorena Lorefice, Matteo Lucchini, Giacomo Lus, Davide Maimone, Maria Malentacchi, Giulia Mallucci, Simona Malucchi, Chiara Rosa Mancinelli, Luca Mancinelli, Paolo Manganotti, Giorgia Teresa Maniscalco, Vittorio Mantero, Sabrina Marangoni, Damiano Marastoni, Fabiana Marinelli, Alessandro Marti, Filippo Martinelli Boneschi, Federco Masserano Zoli, Francesca Matta, Laura Mendozzi, Giuseppe Meucci, Silvia Miante, Giuseppina Miele, Eva Milano, Massimiliano Mirabella, Rosanna Missione, Marcello Moccia, Lucia Moiola, Sara Montepietra, Margherita MontiBragadin, Federico Montini, Roberta Motta, Raffaele Nardone, Carolina Gabri Nicoletti, Eduardo Nobile-Orazio, Agostino Nozzolillo, Marco Onofrj, Riccardo Orlandi, Anna Palmieri, Damiano Paolicelli, Livia Pasquali, Luisa Pastò, Elisabetta Pedrazzoli, Maria Petracca, Alfredo Petrone, Carlo Piantadosi, Anna M Pietroboni, Federica Pinardi, Marta Ponzano, Emilio Portaccio, Mattia Pozzato, Carlo Pozzilli, Luca Prosperini, Alessandra Protti, Paolo Ragonese, Sarah Rasia, Sabrina Realmuto, Anna Repice, Eleonora Rigoni, Maria Teresa Rilla, Francesca Rinaldi, Calogero Marcello Romano, Marco Ronzoni, Marco Rovaris, Francesca Ruscica, Loredana Sabattini, Giuseppe Salemi, Lorenzo Saraceno, Alessia Sartori, Arianna Sartori, Elvira Sbragia, Giuditta Ilaria Scarano, Valentina Scarano, Valentina Schillaci, Maria Sessa, Caterina Sgarito, Grazia Sibilia, Gabriele Siciliano, Alessio Signori, Elisabetta Signoriello, Leonardo Sinisi, Francesca Sireci, Patrizia Sola, Claudio Solaro, Stefano Sotgiu, Maddalena Sparaco, Maria Laura Stromillo, Silvia Strumia, Emanuela Laura Susani, Giulietta Tabiadon, Francesco Teatini, Valentina Tomassini, Simone Tonietti, Clerici Valentina Torri, Carla Tortorella, Simona Toscano, Rocco Totaro, Maria Trotta, Gabriella Turano, Monica Ulivelli, Manzo Valentino, Giovanna Vaula, Domizia Vecchio, Marco Vercellino, Elena Pinuccia Verrengia, Marika Vianello, Eleonora Virgilio, Francesca Vitetta, Stefano Vollaro, Mauro Zaffaroni, Mauro Zampolini, Ignazio Roberto Zarbo, Luigi Zuliani, Pia Sormani, Maria, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Filippi, Massimo, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, De Rossi, Nicola, Brichetto, Giampaolo, Cocco, Eleonora, Scandellari, Cinzia, Cavalla, Paola, Pesci, Ilaria, Zito, Guido Antonio, Confalonieri, Paolo, Alessandra Marfia, Girolama, Perini, Paola, Inglese, Matilde, Trojano, Maria, Brescia Morra, Vincenzo, Tedeschi, Gioacchino, Comi, Giancarlo, Alberto Battaglia, Mario, Patti, Francesco, Salvetti, Marco, Abbadessa, Gianmarco, Aguglia, Umberto, Allegorico, Lia, Maria Allegri Rossi, Beatrice, Pia Amato, Maria, Annovazzi, Pietro, Antozzi, Carlo, Appendino, Lucia, Arena, Sebastiano, Baione, Viola, Balgera, Roberto, Barcella, Valeria, Baroncini, Damiano, Barrilà, Caterina, Bellacosa, Alessandra, Bellucci, Gianmarco, Bergamaschi, Roberto, Bergamaschi, Valeria, Bezzini, Daiana, Biolzi, Beatrice, Bisecco, Alvino, Bonavita, Simona, Borriello, Giovanna, Bosa, Chiara, Bosco, Antonio, Bovis, Francesca, Bozzali, Marco, Brambilla, Laura, Buccafusca, Maria, Bucciantini, Elisabetta, Bucello, Sebastiano, Chiara Buscarinu, Maria, Paola Cabboi, Maria, Calabrese, Massimiliano, Calabria, Francesca, Caleri, Francesca, Camilli, Federico, Maria Caniatti, Luisa, Cantello, Roberto, Capra, Ruggero, Capuano, Rocco, Carta, Patrizia, Grazia Celani, Maria, Cellerino, Maria, Cerqua, Raffaella, Chisari, Clara, Clerici, Raffaella, Clerico, Marinella, Cola, Gaia, Conte, Antonella, Zaffira Conti, Marta, Cordano, Christian, Cordera, Susanna, Corea, Francesco, Correale, Claudio, Cottone, Salvatore, Crescenzo, Francesco, Curti, Erica, D'Ambrosio, Alessandro, D'Amico, Emanuele, Chiara Danni, Maura, D'Arma, Alessia, Dattola, Vincenzo, de Biase, Stefano, De Luca, Giovanna, Federica De Mercanti, Stefania, De Mitri, Paolo, De Stefano, Nicola, Della Cava, Marco, di Napoli, Mario, Di Sapio, Alessia, Docimo, Renato, Dutto, Anna, Evangelista, Luana, Fanara, Salvatore, Diana, Ferraro, Teresa Ferrò, Maria, Fioretti, Cristina, Fratta, Mario, Frau, Jessica, Fronza, Marzia, Furlan, Roberto, Gajofatto, Alberto, Gallo, Antonio, Gallo, Paolo, Gasperini, Claudio, Ghazaryan, Anna, Giometto, Bruno, Gobbin, Francesca, Govone, Flora, Granella, Franco, Grange, Erica, Grazia Grasso, Maria, Guareschi, Angelica, Guaschino, Clara, Guerrieri, Simone, Guidetti, Donata, Iaffaldano, Pietro, Ianniello, Antonio, Iasevoli, Luigi, Imperiale, Daniele, Teresa Infante, Maria, Iodice, Rosa, Iovino, Aniello, Konrad, Giovanna, Landi, Doriana, Lanzillo, Roberta, Lapucci, Caterina, Lavorgna, Luigi, Rita L'Episcopo, Maria, Leva, Serena, Liberatore, Giuseppe, Lo Re, Marianna, Longoni, Marco, Lopiano, Leonardo, Lorefice, Lorena, Lucchini, Matteo, Lus, Giacomo, Maimone, Davide, Malentacchi, Maria, Mallucci, Giulia, Malucchi, Simona, Rosa Mancinelli, Chiara, Mancinelli, Luca, Manganotti, Paolo, Teresa Maniscalco, Giorgia, Mantero, Vittorio, Marangoni, Sabrina, Marastoni, Damiano, Marinelli, Fabiana, Marti, Alessandro, Martinelli Boneschi, Filippo, Masserano Zoli, Federco, Matta, Francesca, Mendozzi, Laura, Meucci, Giuseppe, Miante, Silvia, Miele, Giuseppina, Milano, Eva, Mirabella, Massimiliano, Missione, Rosanna, Moccia, Marcello, Moiola, Lucia, Montepietra, Sara, Montibragadin, Margherita, Montini, Federico, Motta, Roberta, Nardone, Raffaele, Gabri Nicoletti, Carolina, Nobile-Orazio, Eduardo, Nozzolillo, Agostino, Onofrj, Marco, Orlandi, Riccardo, Palmieri, Anna, Paolicelli, Damiano, Pasquali, Livia, Pastò, Luisa, Pedrazzoli, Elisabetta, Petracca, Maria, Petrone, Alfredo, Piantadosi, Carlo, M Pietroboni, Anna, Pinardi, Federica, Ponzano, Marta, Portaccio, Emilio, Pozzato, Mattia, Pozzilli, Carlo, Prosperini, Luca, Protti, Alessandra, Ragonese, Paolo, Rasia, Sarah, Realmuto, Sabrina, Repice, Anna, Rigoni, Eleonora, Teresa Rilla, Maria, Rinaldi, Francesca, Marcello Romano, Calogero, Ronzoni, Marco, Rovaris, Marco, Ruscica, Francesca, Sabattini, Loredana, Salemi, Giuseppe, Saraceno, Lorenzo, Sartori, Alessia, Sartori, Arianna, Sbragia, Elvira, Ilaria Scarano, Giuditta, Scarano, Valentina, Schillaci, Valentina, Sessa, Maria, Sgarito, Caterina, Sibilia, Grazia, Siciliano, Gabriele, Signori, Alessio, Signoriello, Elisabetta, Sinisi, Leonardo, Sireci, Francesca, Sola, Patrizia, Solaro, Claudio, Sotgiu, Stefano, Sparaco, Maddalena, Laura Stromillo, Maria, Strumia, Silvia, Laura Susani, Emanuela, Tabiadon, Giulietta, Teatini, Francesco, Tomassini, Valentina, Tonietti, Simone, Valentina Torri, Clerici, Tortorella, Carla, Toscano, Simona, Totaro, Rocco, Trotta, Maria Consiglia, Turano, Gabriella, Ulivelli, Monica, Valentino, Manzo, Vaula, Giovanna, Vecchio, Domizia, Vercellino, Marco, Pinuccia Verrengia, Elena, Vianello, Marika, Virgilio, Eleonora, Vitetta, Francesca, Vollaro, Stefano, Zaffaroni, Mauro, Zampolini, Mauro, Roberto Zarbo, Ignazio, Zuliani, Luigi, Sormani, M. P., Schiavetti, I., Carmisciano, L., Cordioli, C., Filippi, M., Radaelli, M., Immovilli, P., Capobianco, M., De Rossi, N., Brichetto, G., Cocco, E., Scandellari, C., Cavalla, P., Pesci, I., Zito, A., Confalonieri, P., Marfia, G. A., Perini, P., Inglese, M., Trojano, M., Brescia Morra, V., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., Zito, Antonio, BRESCIA MORRA, Vincenzo, Trotta, Maria, Sormani, Maria Pia, Marfia, Girolama Alessandra, and Battaglia, Mario Alberto

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Coronavirus disease 2019 (COVID-19), Population, Intensive Care Unit, COVID-19, Cohort Studies, Comorbidity, Female, Hospitalization, Humans, Intensive Care Units, Italy, Middle Aged, Retrospective Studies, Risk Factors, Severity of Illness Index, Context (language use), Settore MED/26, Lower risk, Retrospective Studie, Internal medicine, Multiple Sclerosi, Medicine, In patient, National level, education, education.field_of_study, Expanded Disability Status Scale, business.industry, Risk Factor, Ethics committee, medicine.disease, Icu admission, Settore MED/26 - NEUROLOGIA, Neurology, Relative risk, Family medicine, Cohort, Honorarium, Observational study, Neurology (clinical), Cohort Studie, business, Human
Abstract

Background: It is unclear how multiple sclerosis (MS) affects the severity of Covid-19. Methods: Hospitalization, Intensive Care Unit (ICU) admission and death after Covid-19 diagnosis of 1362 MS patients were compared to the age and sex-matched Italian population in a retrospective observational case-cohort study with population-based control. The observed vs the expected events were compared in the whole MS cohort and in different subgroups (higher-risk: EDSS>3 or at least one comorbidity, lower-risk: EDSS

Published
2021

42. Autoimmune encephalitis: a retrospective monocentric experience

Author

Giorgia Teresa Maniscalco, Mariana Rippa, Claudio Santangelo, Sergio Ferrari, Assunta Viola, Walter Di Iorio, Gennaro Alfieri, Giovanna Servillo, Rosaria Renna, Luigi Della Gatta, Silvia Bozzetti, Massimo Napolitano, Valentino Manzo, Angelo Ranieri, Rosa Peluso, Paolo Candelaresi, Sara Mariotto, and Fabio Zeccolini

Subjects
Autoimmune encephalitis, Onconeural antibodies, business.industry, medicine.medical_treatment, Multiple sclerosis, Autoantibody, Hashimoto Disease, General Medicine, Immunotherapy, medicine.disease, Immunosupressive treatments, Surface antigens antibodies, Neurology, Immunology, medicine, Encephalitis, Humans, Neurology (clinical), business, Retrospective Studies, Autoantibodies
Published
2021

43. The Framingham cardiovascular risk score and 5-year progression of multiple sclerosis

Author

Fabrizio Luiso, Antonio Reia, Antonio Carotenuto, Vincenzo Brescia Morra, Lia Allegorico, Martina Petruzzo, Roberta Lanzillo, Giorgia Teresa Maniscalco, Marcello Moccia, Cinzia Valeria Russo, Raffaele Palladino, Petruzzo, Martina, Reia, Antonio, Maniscalco, Giorgia Teresa, Luiso, Fabrizio, Lanzillo, Roberta, Russo, Cinzia Valeria, Carotenuto, Antonio, Allegorico, Lia, Palladino, Raffaele, Brescia Morra, Vincenzo, and Moccia, Marcello

Subjects
medicine.medical_specialty, Clinical Neurology, multiple sclerosis, PROFILE, DISABILITY PROGRESSION, DISEASE, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Diabetes mellitus, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, BRAIN ATROPHY, Retrospective Studies, Macrovascular disease, relapse, Framingham Risk Score, Science & Technology, Neurology & Neurosurgery, business.industry, cardiovascular, Hazard ratio, Neurosciences, Retrospective cohort study, 1103 Clinical Sciences, MS, medicine.disease, Confidence interval, COMORBIDITIES, LIFE, Blood pressure, Neurology, disability, Cardiovascular Diseases, Heart Disease Risk Factors, Disease Progression, Neurology (clinical), Neurosciences & Neurology, CIGARETTE-SMOKING, business, FOLLOW-UP, 1109 Neurosciences, Body mass index, Life Sciences & Biomedicine, 030217 neurology & neurosurgery
Abstract

Background and purpose Cardiovascular risk factors and comorbidities can affect the prognosis of multiple sclerosis (MS). The Framingham risk score is an algorithm that can estimate the 10-year risk of developing macrovascular disease. Our objectives were to evaluate the possible association between the Framingham risk score at baseline and MS relapses, disability, and disease-modifying therapy (DMT) choices over a 5-year follow-up. Methods This is a retrospective cohort study including 251 MS subjects. At baseline, we calculated the Framingham risk score considering the following variables: age, sex, diabetes, smoking, systolic blood pressure, and body mass index. MS outcomes including relapses, disability, and treatments were collected over 5 years. Cox proportional regression models were employed to estimate hazard ratios (HRs). Results A one-point increase in the Framingham risk score was associated with 31% higher risk of relapse (HR = 1.31; 95% confidence interval [CI] = 1.03, 1.68), 19% higher risk of reaching of EDSS 6.0 (HR = 1.19; 95% CI = 1.05, 3.01), and 62% higher risk of DMT escalation (HR = 1.62; 95% CI = 1.22, 3.01). Conclusions Higher cardiovascular risk was associated with higher risk of relapses, disability, and DMT escalation in MS. Early identification, correction, and treatment of cardiovascular comorbidities should be carefully considered within MS management.

Published
2021

44. 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

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

Author

Maria Pia Sormani, Antonio Carotenuto, Jessica Frau, Doriana Landi, Girolama Alessandra Marfia, Alessio Signori, Erica Curti, Francesco Saccà, Giorgia Teresa Maniscalco, Simone Cepparulo, Elisabetta Signoriello, Francesca Caleri, Mauro Zaffaroni, Damiano Baroncini, Carolina Gabri Nicoletti, Simona Bonavita, Giacomo Lus, Roberta Lanzillo, Viviana Nociti, Arianna Sartori, Signoriello, E., Lus, G., Bonavita, S., Lanzillo, R., Sacca, F., Landi, D., Frau, J., Baroncini, D., Zaffaroni, M., Maniscalco, G. T., Curti, E., Sartori, A., Cepparulo, S., Marfia, G. A., Nicoletti, C. G., Carotenuto, A., Nociti, V., Caleri, F., Sormani, M. P., Signori, A., Signoriello, Elisabetta, Lus, Giacomo, Bonavita, Simona, Lanzillo, Roberta, Sacc??, Francesco, Landi, Doriana, Frau, Jessica, Baroncini, Damiano, Zaffaroni, Mauro, Teresa Maniscalco, Giorgia, Curti, Erica, Sartori, Arianna, Cepparulo, Simone, Alessandra Marfia, Girolama, Gabri Nicoletti, Carolina, Carotenuto, Antonio, Nociti, Viviana, Caleri, Francesca, Pia Sormani, Maria, and Signori, Alessio

Subjects
Oncology, medicine.medical_specialty, Antibodies, Monoclonal, Humanized, Settore MED/26, Disease activity, Multiple sclerosis, 03 medical and health sciences, 0302 clinical medicine, Natalizumab, Multiple Sclerosis, Relapsing-Remitting, natalizumab, ocrelizumab, Internal medicine, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, Anti cd20, fingolimod, switch, Retrospective Studies, business.industry, Fingolimod Hydrochloride, medicine.disease, Fingolimod, Disease control, Neurology, Ocrelizumab, Neurology (clinical), business, 030217 neurology & neurosurgery, Immunosuppressive Agents, medicine.drug
Abstract

Objectives: Switching between treatments is an opportunity for patients with multiple sclerosis (MS) to ameliorate disease control or safety. The aim of this study was to investigate the impact of switching from fingolimod (FTY) or natalizumab (NTZ) to ocrelizumab (OCR) on disease activity. Methods: We retrospectively enrolled 165 patients treated with OCR from 11 MS centres. We assessed the association of demographic and clinical characteristics on relapse rate (RR) and activity on magnetic resonance imaging (MRI) during wash-out and after 6 months of treatment with OCR through univariable and multivariable negative binomial regression models. Results: We registered a total of 35 relapses during the wash-out period. Previous treatment with FTY, relapses in the previous year, and relapsing-remitting course were associated with higher RR. In the first 6 months of OCR, 12 patients had clinical or MRI disease activity. Higher Expanded Disability Status Scale (EDSS) and higher lymphocyte count at OCR start were associated with a reduced probability of relapse. Discussion and Conclusion: This study confirms that withdrawal from sequestering agents as FTY increases the risk of relapses in the wash-out period. Nevertheless, starting OCR before achieving complete immune reconstitution could limit its effectiveness in the first 6 months probably because trapped lymphocytes escape the CD20-mediated depletion.

Published
2021

46. The Impact of Covid-19 Lockdown on Stroke Admissions and Treatments in Campania

Author

Giorgia Teresa Maniscalco, Vincenzo Palma, Simona Salvatore, Daniele Spitaleri, Florindo D'Onofrio, Maria Pia Mazzaferro, Giuseppe Leone, Salvatore Ascione, Vincenzo Andreone, Valentino Manzo, Paolo Candelaresi, Daniele Giuseppe Romano, Gioacchino Martusciello, Giovanna Servillo, Elisa Capone, Renato Saponiero, Carla Schettino, Paolo Barone, Mario Muto, Stefania Miniello, and Rosa Napoletano

Subjects
Male, medicine.medical_specialty, Time Factors, Coronavirus disease 2019 (COVID-19), medicine.medical_treatment, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Clinical Neurology, Article, Time-to-Treatment, 03 medical and health sciences, 0302 clinical medicine, Patient Admission, Pandemic, Lockdown, medicine, Humans, Thrombolytic Therapy, Stroke, Medical attention, Aged, Retrospective Studies, Thrombectomy, Aged, 80 and over, business.industry, Incidence (epidemiology), Incidence, Rehabilitation, Retrospective cohort study, Thrombolysis, Middle Aged, medicine.disease, Italy, Emergency medicine, Female, Surgery, Neurology (clinical), business, Covid-19, Cardiology and Cardiovascular Medicine, 030217 neurology & neurosurgery
Abstract

Objectives The enforcement of complete lockdown with home confinement has been necessary to limit SARS-CoV-2 contagions in Italy, one the most affected countries worldwide. Simultaneously, in several Emergency Departments, a reduction in cardio- and cerebrovascular presentations was noticed. This study analyses the impact of Covid-19 pandemic and lockdown measures on the incidence of stroke, in Campania, the most densely-populated region in Italy. Materials and Methods We retrospectively analyzed data regarding acute stroke patients presenting at 5 Campania stroke hubs, before and after the issue of lockdown in Italy on March 9th, 2020. Results Compared to the pre-lockdown, we observed a significant reduction in the number of acute reperfusion treatments in stroke (P for interact 0.001); however the global number of patients presenting with acute stroke did not significantly differ. The time to reach medical attention was significantly longer in the lockdown phase (230 versus 154 min, P 0.016). For patients who underwent acute reperfusion treatment we also observed significantly longer time-to-imaging (30 versus 40 min, P 0.0005) and a trend to longer time-to-needle (75 versus 90 min P 0.23), but not time-to-groin. Conclusions This study showed the reduction in acute reperfusion treatments for acute ischemic stroke and the slowdown of stroke pathways, during the lockdown phase of Covid-19 pandemic, in Campania, the third-most-populous and the most-densely populated Italian Region. In the next future, the risk for high-grade disability and death, due to delayed or even avoided hospital presentation due to fear of contagion, may be high.

Published
2021
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47. Comparative effectiveness of early intensive or escalation treatment strategies on long term disability trajectories in relapsing multiple sclerosis patients

Author

Roberto Bergamaschi, Damiano Paolicelli, Davide Mainome, F Caputo, Valentina Torri Clerici, Pietro Iaffaldano, Rocco Totaro, Mauro Zaffaroni, Paolo Bellantonio, Claudio Gasperini, Giancarlo Comi, Giuseppe Lucisano, Eleonora Cocco, Patrizia Sola, Giacomo Lus, Massimo Filippi, Marco Salvetti, Maria Trojano, Franco Granella, Marco Capobianco, Antonella Conte, Vincenzo Brescia Morra, Marco Rovaris, Francesco Patti, Giovanna De Luca, Maria Pia Amato, Carlo Pozzilli, Giorgia Teresa Maniscalco, Matilde Inglese, and Giuseppe Salemi

Subjects
medicine.medical_specialty, Neurology, business.industry, Multiple sclerosis, medicine, Treatment strategy, Neurology (clinical), Long term disability, Intensive care medicine, business, medicine.disease
Published
2021
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48. Ocrelizumab treatment in multiple sclerosis: Prospective real world observational multi-center study in Campania, Italy

Author

Vincenzo Brescia Morra, Leonardo Sinisi, Marcello Moccia, Rosa Iodice, Roberta Lanzillo, Gioacchino Tedeschi, Giacomo Lus, Simona Bonavita, Giuseppina Miele, Fratta Mario, Alvino Bisecco, Giorgia Teresa Maniscalco, Maria Petracca, Romano Felice, Raffaele Dubbioso, Maria Di Gregorio, Antonio Luca Spiezia, Nicola Capasso, Elisabetta Signoriello, and Antonio Carotenuto

Subjects
medicine.medical_specialty, Neurology, business.industry, Multiple sclerosis, Multi center study, Medicine, Observational study, Ocrelizumab, Medical physics, Neurology (clinical), business, medicine.disease, medicine.drug
Published
2021
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49. Long-term disability progression in childhood and adolescent onset multiple sclerosis patients

Author

Mattia Fonderico, Alessandra Lugaresi, Maria Trojano, Franco Granella, Davide Maimone, Antonio Bertolotto, Paola Cavalla, Eleonora Cocco, Giacomo Lus, Vincenzo Brescia Morra, Marco Rovaris, Maria Pia Amato, Patrizia Sola, Paolo Confalonieri, Giuseppe Salemi, Marta Simone, Paola Valentino, Francesco Patti, Marco Onofrj, Ermelinda De Meo, Roberto Bergamaschi, Massimo Filippi, Giorgia Teresa Maniscalco, Ilaria Pesci, and Raffaello Bonacchi

Subjects
Pediatrics, medicine.medical_specialty, Adolescent onset, Neurology, business.industry, Multiple sclerosis, medicine, Neurology (clinical), Long term disability, medicine.disease, business
Published
2021
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50. Progression independent of relapse activity in early multiple sclerosis patients

Author

Franco Di Palma, Angelo Bellinvia, Marta Simone, Eleonora Cocco, Vito Lepore, Lorenzo Razzolini, Paola Valentino, Maria Pia Amato, Francesco Patti, Massimo Filippi, Daniele Spitaleri, Pietro Iaffaldano, Luisa Pastò, Rocco Totaro, Davide Maimone, Giacomo Lus, A. Protti, Ilaria Pesci, Patrizia Sola, Marco Onofrj, Mattia Fonderico, Alessandra Lugaresi, Roberto Bergamaschi, Giorgia Teresa Maniscalco, M. Vianello, Vincenzo Brescia Morra, Maria Trojano, Franco Granella, Emilio Portaccio, Paolo Confalonieri, Umberto Aguglia, and Giuseppe Salemi

Subjects
Oncology, medicine.medical_specialty, Neurology, business.industry, Internal medicine, Multiple sclerosis, medicine, Neurology (clinical), medicine.disease, business
Published
2021
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