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1. Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with Natalizumab: a multicenter, observational study

Author

Baroncini, Damiano, Ghezzi, Angelo, Guaschino, Clara, Moiola, Lucia, Filippi, Massimo, Ianniello, Antonio, Pozzilli, Carlo, Lanzillo, Roberta, Brescia-Morra, Vincenzo, Margoni, Monica, Gallo, Paolo, Callari, Graziella, Grimaldi, Luigi, Lus, Giacomo, Calabrese, Massimiliano, Simone, Marta, Marfia, Girolama Alessandra, Rasia, Sarah, Cargnelutti, Daniela, Comi, Giancarlo, and Zaffaroni, Mauro

Published
2022
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2. Is It Time for Ocrelizumab Extended Interval Dosing in Relapsing Remitting MS? Evidence from An Italian Multicenter Experience During the COVID-19 Pandemic

Author

Zanghì, Aurora, Avolio, Carlo, Signoriello, Elisabetta, Abbadessa, Gianmarco, Cellerino, Maria, Ferraro, Diana, Messina, Christian, Barone, Stefania, Callari, Graziella, Tsantes, Elena, Sola, Patrizia, Valentino, Paola, Granella, Franco, Patti, Francesco, Lus, Giacomo, Bonavita, Simona, Inglese, Matilde, and D’Amico, Emanuele

Published
2022
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3. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy

Author

Maglione, Alessandro, Sapio, Alessia Di, Signori, Alessio, Laroni, Alice, Iovino, Aniello, Maria Repice, Anna, Mannironi, Antonio, Uccelli, Antonio, Serrati, Carlo, Gabri Nicoletti, Carolina, Lapucci, Caterina, Mancinelli, Chiara Rosa, Cordioli, Cinzia, Bezzini, Daiana, Carmagnini, Daniele, Brogi, Davide, Franciotta, Diego, Landi, Doriana, Nobile Orazio, Eduardo, Cocco, Eleonora, Signoriello, Elisabetta, Nako, Enri, Assandrir, Ester, Marinelli, Fabiana, Baldi, Federica, Ansaldi, Filippo, Bovis, Francesca, Caleri, Francesca, Siciliano, Gabriele, Cola, Gaia, Perego, Germana, Lus, Giacomo, Brichetto, Giampaolo, Icardi, Giancarlo, Bellucci, Gianmarco, Da Rin, Giorgio, Alessandra Marfia, Girolama, Vazzoler, Giulia, Liberatore, Giuseppe, Trivelli, Giuseppe, Callari, Graziella, Gandoglia, Ilaria, Maietta, Ilaria, Schiavetti, Irene, Frau, Jessica, Sticchi, Laura, Pasquali, Livia, Lorefice, Lorena, Carmisciano, Luca, Ruggiero, Lucia, Manzino, Marcello, Salvetti, Marco, Monti Bragadin, Margherita, Chiara Buscarinu, Maria, Gagliardi, Maria, Laura Stromillo, Maria, Pia Sormani, Maria, Ferrò, Maria Teresa, Rilla, Maria Teresa, Clerico, Marinella, Alberto Battaglia, Mario, Ponzano, Marta, Fronza, Marzia, Del Sette, Massimo, Inglese, Matilde, Scialabba, Matteo, Bedognetti, Michele, Ulivelli, Monica, De Rossi, Nicola, De Stefano, Nicola, Gazzola, Paola, Bigi, Rachele, Dubbioso, Raffaele, Reniè, Roberta, Iodice, Rosa, Fabbri, Sabrina, Rasia, Sarah, Rolla, Simona, Platzgummer, Stefan, Cordera, Susanna, Tassinari, Tiziana, Carlini, Valentina, Sormani, Maria Pia, Visconti, Valeria, Stromillo, Maria Laura, Di Sapio, Alessia, Pizzorno, Matteo, Repice, Anna Maria, and Battaglia, Mario Alberto

Published
2022
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4. Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies

Author

Maglione, Alessandro, Di Sapio, Alessia, Signori, Alessio, Laroni, Alice, Iovino, Aniello, Repice, Anna Maria, Mannironi, Antonio, Uccelli, Antonio, Serrati, Carlo, Nicoletti, Carolina Gabri, Lapucci, Caterina, Mancinelli, Chiara Rosa, Cordioli, Cinzia, Bezzini, Daiana, Carmagnini, Daniele, Brogi, Davide, Franciotta, Diego, Landi, Doriana, Orazio, Eduardo Nobile, Cocco, Eleonora, Signoriello, Elisabetta, Nako, Enri, Assandri, Ester, Marinelli, Fabiana, Baldi, Federica, Ansaldi, Filippo, Bovis, Francesca, Caleri, Francesca, Siciliano, Gabriele, Cola, Gaia, Perego, Germana, Lus, Giacomo, Brichetto, Giampaolo, Icardi, Giancarlo, bellucci, gianmarco, Rin, Giorgio Da, Marfia, Girolama Alessandra, Vazzoler, Giulia, Liberatore, Giuseppe, Trivelli, Giuseppe, Callari, Graziella, Gandoglia, Ilaria, Maietta, Ilaria, Schiavetti, Irene, Frau, Jessica, Sticchi, Laura, Pasquali, Livia, Lorefice, Lorena, Carmisciano, Luca, Ruggiero, Lucia, Manzino, Marcello, Salvetti, Marco, Bragadin, Margherita Monti, Buscarinu, Maria Chiara, Gagliardi, Maria, Stromillo, Maria Laura, Sormani, Maria Pia, Ferrò, Maria Teresa, Rilla, Maria Teresa, Clerico, Marinella, Battaglia, Mario Alberto, Ponzano, Marta, Fronza, Marzia, Sette, Massimo Del, Inglese, Matilde, Scialabba, Matteo, Bedognetti, Michele, Ulivelli, Monica, De Rossi, Nicola, De Stefano, Nicola, Gazzola, Paola, Bigi, Rachele, Dubbioso, Raffaele, Reniè, Roberta, Iodice, Rosa, Fabbri, Sabrina, Rasia, Sarah, Rolla, Simona, Platzgummer, Stefan, Cordera, Susanna, Tassinari, Tiziana, Carlini, Valentina, and Da Rin, Giorgio

Published
2021
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5. Exit Strategies in Natalizumab-Treated RRMS at High Risk of Progressive Multifocal Leukoencephalopathy: a Multicentre Comparison Study

Author

Zanghì, Aurora, Gallo, Antonio, Avolio, Carlo, Capuano, Rocco, Lucchini, Matteo, Petracca, Maria, Bonavita, Simona, Lanzillo, Roberta, Ferraro, Diana, Curti, Erica, Buccafusca, Maria, Callari, Graziella, Barone, Stefania, Pontillo, Giuseppe, Abbadessa, Gianmarco, Di Francescantonio, Valeria, Signoriello, Elisabetta, Lus, Giacomo, Sola, Patrizia, Granella, Franco, Valentino, Paola, Mirabella, Massimiliano, Patti, Francesco, and D'Amico, Emanuele

Published
2021
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6. Real world experience with teriflunomide in multiple sclerosis: the TER-Italy study

Author

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

Published
2021
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10. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy

Author

Sormani, Maria Pia, primary, Schiavetti, Irene, additional, Inglese, Matilde, additional, Carmisciano, Luca, additional, Laroni, Alice, additional, Lapucci, Caterina, additional, Visconti, Valeria, additional, Serrati, Carlo, additional, Gandoglia, Ilaria, additional, Tassinari, Tiziana, additional, Perego, Germana, additional, Brichetto, Giampaolo, additional, Gazzola, Paola, additional, Mannironi, Antonio, additional, Stromillo, Maria Laura, additional, Cordioli, Cinzia, additional, Landi, Doriana, additional, Clerico, Marinella, additional, Signoriello, Elisabetta, additional, Cocco, Eleonora, additional, Frau, Jessica, additional, Ferrò, Maria Teresa, additional, Di Sapio, Alessia, additional, Pasquali, Livia, additional, Ulivelli, Monica, additional, Marinelli, Fabiana, additional, Pizzorno, Matteo, additional, Callari, Graziella, additional, Iodice, Rosa, additional, Liberatore, Giuseppe, additional, Caleri, Francesca, additional, Repice, Anna Maria, additional, Cordera, Susanna, additional, Battaglia, Mario Alberto, additional, Salvetti, Marco, additional, Franciotta, Diego, additional, Uccelli, Antonio, additional, Maglione, Alessandro, additional, Sapio, Alessia Di, additional, Signori, Alessio, additional, Iovino, Aniello, additional, Maria Repice, Anna, additional, Gabri Nicoletti, Carolina, additional, Mancinelli, Chiara Rosa, additional, Bezzini, Daiana, additional, Carmagnini, Daniele, additional, Brogi, Davide, additional, Nobile Orazio, Eduardo, additional, Nako, Enri, additional, Assandrir, Ester, additional, Baldi, Federica, additional, Ansaldi, Filippo, additional, Bovis, Francesca, additional, Siciliano, Gabriele, additional, Cola, Gaia, additional, Lus, Giacomo, additional, Icardi, Giancarlo, additional, Bellucci, Gianmarco, additional, Da Rin, Giorgio, additional, Alessandra Marfia, Girolama, additional, Vazzoler, Giulia, additional, Trivelli, Giuseppe, additional, Maietta, Ilaria, additional, Sticchi, Laura, additional, Lorefice, Lorena, additional, Ruggiero, Lucia, additional, Manzino, Marcello, additional, Monti Bragadin, Margherita, additional, Chiara Buscarinu, Maria, additional, Gagliardi, Maria, additional, Laura Stromillo, Maria, additional, Pia Sormani, Maria, additional, Rilla, Maria Teresa, additional, Alberto Battaglia, Mario, additional, Ponzano, Marta, additional, Fronza, Marzia, additional, Del Sette, Massimo, additional, Scialabba, Matteo, additional, Bedognetti, Michele, additional, De Rossi, Nicola, additional, De Stefano, Nicola, additional, Bigi, Rachele, additional, Dubbioso, Raffaele, additional, Reniè, Roberta, additional, Fabbri, Sabrina, additional, Rasia, Sarah, additional, Rolla, Simona, additional, Platzgummer, Stefan, additional, and Carlini, Valentina, additional

Published
2022
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13. Effect of SARS-CoV-2 mRNA vaccination in MS patients treated with disease modifying therapies

Author

Sormani, Maria Pia, primary, Inglese, Matilde, additional, Schiavetti, Irene, additional, Carmisciano, Luca, additional, Laroni, Alice, additional, Lapucci, Caterina, additional, Da Rin, Giorgio, additional, Serrati, Carlo, additional, Gandoglia, Ilaria, additional, Tassinari, Tiziana, additional, Perego, Germana, additional, Brichetto, Giampaolo, additional, Gazzola, Paola, additional, Mannironi, Antonio, additional, Stromillo, Maria Laura, additional, Cordioli, Cinzia, additional, Landi, Doriana, additional, Clerico, Marinella, additional, Signoriello, Elisabetta, additional, Frau, Jessica, additional, Ferrò, Maria Teresa, additional, Di Sapio, Alessia, additional, Pasquali, Livia, additional, Ulivelli, Monica, additional, Marinelli, Fabiana, additional, Callari, Graziella, additional, Iodice, Rosa, additional, Liberatore, Giuseppe, additional, Caleri, Francesca, additional, Repice, Anna Maria, additional, Cordera, Susanna, additional, Battaglia, Mario Alberto, additional, Salvetti, Marco, additional, Franciotta, Diego, additional, Uccelli, Antonio, additional, Maglione, Alessandro, additional, Signori, Alessio, additional, Iovino, Aniello, additional, Nicoletti, Carolina Gabri, additional, Mancinelli, Chiara Rosa, additional, Bezzini, Daiana, additional, Carmagnini, Daniele, additional, Brogi, Davide, additional, Orazio, Eduardo Nobile, additional, Cocco, Eleonora, additional, Nako, Enri, additional, Assandri, Ester, additional, Baldi, Federica, additional, Ansaldi, Filippo, additional, Bovis, Francesca, additional, Siciliano, Gabriele, additional, Cola, Gaia, additional, Lus, Giacomo, additional, Icardi, Giancarlo, additional, bellucci, gianmarco, additional, Rin, Giorgio Da, additional, Marfia, Girolama Alessandra, additional, Vazzoler, Giulia, additional, Trivelli, Giuseppe, additional, Maietta, Ilaria, additional, Sticchi, Laura, additional, Lorefice, Lorena, additional, Ruggiero, Lucia, additional, Manzino, Marcello, additional, Bragadin, Margherita Monti, additional, Buscarinu, Maria Chiara, additional, Gagliardi, Maria, additional, Sormani, Maria Pia, additional, Rilla, Maria Teresa, additional, Ponzano, Marta, additional, Fronza, Marzia, additional, Sette, Massimo Del, additional, Scialabba, Matteo, additional, Bedognetti, Michele, additional, De Rossi, Nicola, additional, De Stefano, Nicola, additional, Bigi, Rachele, additional, Dubbioso, Raffaele, additional, Reniè, Roberta, additional, Fabbri, Sabrina, additional, Rasia, Sarah, additional, Rolla, Simona, additional, Platzgummer, Stefan, additional, and Carlini, Valentina, additional

Published
2021
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18. Dimethyl fumarate vs Teriflunomide: an Italian time-to-event data analysis.

Author

D'Amico, Emanuele, Zanghì, Aurora, Sciandra, Mariangela, Lanzillo, Roberta, Callari, Graziella, Cortese, Antonio, Lus, Giacomo, Lucchini, Matteo, Buccafusca, Maria, Bonavita, Simona, Gallo, Antonio, Curti, Erica, Gajofatto, Alberto, Signoriello, Elisabetta, Bisecco, Alvino, Gobbin, Francesca, Ferrò, Maria Teresa, Ferrazzano, Gina, Sparaco, Maddalena, and Valentino, Paola

Subjects
DATA analysis, ETHANES, MULTIPLE sclerosis, TREATMENT effectiveness
Abstract

Background: The introduction of oral disease-modifying therapies (DMTs) for relapsing–remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. Objectives: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. Materials and Methods: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were "time-to-first-relapse", "time-to-Magnetic-Resonance-Imaging (MRI)-activity" and "time-to-disability-progression". Results: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34 months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2 years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p <.05) at baseline. Time-varying Cox-model for the event "time-to-first relapse" revealed that no differences were found between the two groups in the first 38 months of treatment (HRt < 38DMF = 0.73, CI = 0.52 to 1.03, p = 0.079). When the time-on-therapy exceeds 38 months patients on DMF had an approximately 0.3 times lower relapse hazard risk than those who took TRF (HRt>38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. Conclusions: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months on therapy. [ABSTRACT FROM AUTHOR]

Published
2020
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19. Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

Author

D’Amico, Emanuele, primary, Zanghì, Aurora, additional, Callari, Graziella, additional, Borriello, Giovanna, additional, Gallo, Antonio, additional, Graziano, Giusi, additional, Valentino, Paola, additional, Buccafusca, Maria, additional, Cottone, Salvatore, additional, Salemi, Giuseppe, additional, Ragonese, Paolo, additional, Bossio, Roberto Bruno, additional, Docimo, Renato, additional, Grimaldi, Luigi Maria Edoardo, additional, Pozzilli, Carlo, additional, Tedeschi, Gioacchino, additional, Zappia, Mario, additional, and Patti, Francesco, additional

Published
2018
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21. Multiple sclerosis survival: a population-based study in Sicily

Author

RAGONESE, Paolo, ARIDON, Paolo, MAZZOLA, Maria Antonietta, CALLARI, Graziella, PALMERI, Barbara, FAMOSO, Giorgia, TERRUSO, Valeria, SALEMI, Giuseppe, D'AMELIO, Marco, SAVETTIERI, Giovanni, Ragonese, P., Aridon, P., Mazzola, M., Callari, G., Palmeri, B., Famoso, G., Terruso, V., Salemi, G., D'Amelio, M., and Savettieri, G.

Subjects
Multiple sclerosis, Multiple sclerosis, survival, population-based study, prognosis, Settore MED/26 - Neurologia
Abstract

Background and purpose: There are few population-based surveys on multiple sclerosis (MS) survival. To investigate MS survival in MS patients recruited during surveys conducted in Sicily. Methods: Multiple sclerosis patients identified during previous surveys were randomly matched to two referent subjects by residence, year of birth, and gender. Living status was obtained by municipality records (end of follow-up June, 30th 2007) and, for the deceased, date and causes of death were searched. Kaplan-Meier plots were used to calculate differences in mortality between MS patients and referent subjects. MS risks for mortality with 95% confidence intervals (CI) were also calculated. Results: We included 194 MS patients and 388 matched persons. Thirty MS patients (15.5%) and 28 referents (7.2%) had died until the end of follow-up. Mean survival from onset of the disease to death was 20.6 years. Mean age at death was 55.5 for MS patients and 64.8 for the referents. Adjusted Hazard Ratios for mortality in MS was 1.81 (95% CI 1.36-2.40). Kaplan-Meier estimates showed a higher mortality amongst patients compared to referent subjects (P < 0.001). Conclusions: The present study confirms the higher mortality risk in MS patients with no significant gender difference. Causes of death are related to complications of high disability and to increasing age

Published
2010

22. A CASE-CONTROL STUDY ON THE ASSOCIATION BETWEEN DIABETES AND PD

Author

D'AMELIO, Marco, RAGONESE, Paolo, CALLARI, Graziella, PALMERI, Barbara, DI BENEDETTO, Norma, ARIDON, Paolo, TERRUSO, Valeria, SALEMI, Giuseppe, SAVETTIERI, Giovanni, D'AMELIO M, P RAGONESE, G CALLARI, B PALMERI, N DI BENEDETTO, P ARIDON, V TERRUSO, G SALEMI, and G SAVETTIERI

Published
2007

26. A post-marketing comparison study on disability modification in progressive multiple sclerosis after interferon beta-1b or mitoxantrone therapy

Author

SALEMI, Giuseppe, RAGONESE, Paolo, D'AMELIO, Marco, CALLARI, Graziella, GAMMINO, Matilde, GIGLIA, Giuseppe, TERRUSO, Valeria, LUPO, Innocenzo, SAVETTIERI, Giovanni, BATTAGLIERI F, CAMMARATA E, CONTE S, CUCCIA G, SALEMI G, RAGONESE P, D'AMELIO M, BATTAGLIERI F, CALLARI G, CAMMARATA E, CONTE S, CUCCIA G, GAMMINO M, GIGLIA G, TERRUSO V, LUPO I, and SAVETTIERI G

Published
2006

27. BODY MASS INDEX AND PARKINSON'S DISEASE: A CASE-CONTROL STUDY

Author

RAGONESE, Paolo, D'AMELIO, Marco, CALLARI, Graziella, DI BENEDETTO, Norma, PALMERI, Barbara, FAMOSO, Giorgia, SAVETTIERI, Giovanni, MAMAZZOLA, L. MORGANTE, P RAGONESE, M D'AMELIO, G CALLARI, N DI BENEDETTO, B PALMERI, MAMAZZOLA, G FAMOSO, L MORGANTE, and SAVETTIERI G

Published
2006

28. Use of antiepileptic drugs in women with polycystic ovary syndrome

Author

D'AMELIO, Marco, AMATO, Marco Calogero, RAGONESE, Paolo, MERLINO S, CALLARI, Graziella, DANIELE, Ornella, GIORDANO, Carla, GALLUZO A, SAVETTIERI, Giovanni, D'AMELIO M, AMATO MC, RAGONESE P, MERLINO S, CALLARI G, DANIELE O, GIORDANO C, GALLUZO A, and SAVETTIERI G

Subjects
polycystic ovary syndrome
Published
2005

30. Polycistic ovary syndrome and antiepileptic drugs: a cross-sectional study

Author

D'AMELIO, Marco, RAGONESE, Paolo, CALLARI, Graziella, DANIELE, Ornella, SALEMI, Giuseppe, SAVETTIERI, Giovanni, AMATO, Marco Calogero, MERLINO S, GIORDANO, Carla, GALLUZZO A, D'AMELIO M, AMATO MC, RAGONESE P, MERLINO S, CALLARI G, DANIELE O, GIORDANO C, SALEMI G, GALLUZZO A, and SAVETTIERI G

Published
2005

33. Tumor diagnosis after PD onset: a case-control study

Author

D'AMELIO, Marco, RAGONESE, Paolo, CALLARI, Graziella, GAMMINO, Matilde, SALEMI, Giuseppe, SAVETTIERI, Giovanni, MORGANTE L, EPIFANIO A, D'AMELIO M, RAGONESE P, MORGANTE L, CALLARI G, EPIFANIO A, GAMMINO M, SALEMI G, and SAVETTIERI G

Published
2004

36. Tumor diagnosis preceding Parkinson's disease: A case-control study

Author

D'AMELIO, Marco, RAGONESE, Paolo, MORGANTE, L, EPIFANIO, A, CALLARI, Graziella, SALEMI, Giuseppe, SAVETTIERI, Giovanni, D'AMELIO, M, RAGONESE, P, MORGANTE, L, EPIFANIO, A, CALLARI, G, SALEMI, G, and SAVETTIERI, G

Subjects
tumor, Parkinson’s disease, epidemiology
Abstract

Lower cancer risk in Parkinson’s disease (PD) patients compared to the general population has been reported. However, most of the studies were based on death certificates. We designed a case– control study to estimate the association of tumor preceding PD onset and PD. PD patients were matched by age and gender to PD-free individuals, randomly selected from the municipalities of residence of cases. Occurrence of tumors preceding PD onset was assessed through a structured questionnaire. Neoplasms were categorized as benign, malignant, or of uncertain classification, and endocrine-related or not. Odds ratios (OR) were calculated using conditional logistic regression and adjusted for tumor categories and risk factors. We included 222 PD patients. Frequency of cancer was 6.8% for cases, 12.6% for controls. PD patients had a decreased risk for neoplasms (adjusted OR, 0.4; 95% confidence interval [CI], 0.2– 0.7). Risk was reduced only for women (adjusted OR, 0.3; 95% CI, 0.1– 0.7). PD patients had a decreased risk both for malignant (adjusted OR, 0.6; 95% CI, 0.1–2.5) and nonmalignant neoplasms (adjusted OR, 0.3; 95% CI, 0.1– 0.7). Still, risk was decreased for endocrine-related tumors (adjusted OR, 0.3; 95% CI, 0.1– 0.9) and non–endocrine-related tumors (adjusted OR, 0.4; 95% CI, 0.1– 0.9). Our study confirms the inverse association between PD and neoplasms reported in previous epidemiologic studies.

Published
2004

43. Long-term follow-up (up to 11 years) of an Italian pediatric MS cohort treated with natalizumab: a multicenter, observational study

Author

Damiano, Baroncini, Angelo, Ghezzi, Clara, Guaschino, Lucia, Moiola, Massimo, Filippi, Antonio, Ianniello, Carlo, Pozzilli, Roberta, Lanzillo, Vincenzo, Brescia-Morra, Monica, Margoni, Paolo, Gallo, Graziella, Callari, Luigi, Grimaldi, Giacomo, Lus, Massimiliano, Calabrese, Marta, Simone, Girolama Alessandra, Marfia, Sarah, Rasia, Daniela, Cargnelutti, Giancarlo, Comi, Mauro, Zaffaroni, Gabriella, Coniglio, Baroncini, Damiano, Ghezzi, Angelo, Guaschino, Clara, Moiola, Lucia, Filippi, Massimo, Ianniello, Antonio, Pozzilli, Carlo, Lanzillo, Roberta, Brescia-Morra, Vincenzo, Margoni, Monica, Gallo, Paolo, Callari, Graziella, Grimaldi, Luigi, Lus, Giacomo, Calabrese, Massimiliano, Simone, Marta, Marfia, Girolama Alessandra, Rasia, Sarah, Cargnelutti, Daniela, Comi, Giancarlo, and Zaffaroni, Mauro

Subjects
Pediatric, Adult, Multiple Sclerosis, treatment, Natalizumab, Dermatology, General Medicine, multiple sclerosis, natalizumab, pediatric, Settore MED/26, Treatment, Psychiatry and Mental health, Multiple Sclerosis, Relapsing-Remitting, Recurrence, Multiple Sclerosi, Humans, Immunologic Factors, Female, Neurology (clinical), Child, Follow-Up Studies, Retrospective Studies
Abstract

Background Natalizumab (NAT) has a strong impact on disease activity of aggressive pediatric multiple sclerosis (MS), with no difference in safety profile compared to adult MS. However, available data are limited by short follow-up. Our aim was to report long-term follow-up data (up to 11 years) of a large Italian pediatric MS cohort treated with NAT. Materials and methods We retrospectively collected data of pediatric MS patients treated with NAT included in a previous study and prospectively followed in Italian MS centers. We compared disease activity pre, during, and post-NAT and we performed survival analyses of time to evidence of disease activity (EDA) during NAT, time to reach EDA post-NAT, and time to NAT discontinuation. Results Ninety-two patients were included from 19 MS centers in Italy. At NAT initiation, cohort's characteristics were as follows: 55 females; 14.7 +/- 2.4 (mean +/- SD) years of age; 34 naive to disease modifying therapies; 1-year pre-NAT annualized relapse rate (ARR): 2.2 +/- 1.2; EDSS (median [IQR]): 2.5 [2.0-3.0]; gadolinium-enhancing lesions: 2 [1-5]; 41 JCV positives. During NAT treatment (61.9 +/- 35.2 mean infusions), ARR lowered to 0.08 +/- 0.23 (p < 0.001), EDSS score to 1.5 [1.0-2.5] at last infusion (p < 0.001), and 51% patients had EDA (21% after 6 months of rebaseline). No serious adverse events were reported. Forty-nine patients discontinued NAT, mainly due to PML concern; the majority (29/49) had disease reactivation in the subsequent 12 months, of which three with a clinical rebound. Conclusion NAT treatment maintains its high efficacy for a long time in pediatric MS patients, with no new safety issues.

Published
2022

44. Breakthrough SARS-CoV-2 infections after COVID-19 mRNA vaccination in MS patients on disease modifying therapies during the Delta and the Omicron waves in Italy

Author

Maria Pia Sormani, Irene Schiavetti, Matilde Inglese, Luca Carmisciano, Alice Laroni, Caterina Lapucci, Valeria Visconti, Carlo Serrati, Ilaria Gandoglia, Tiziana Tassinari, Germana Perego, Giampaolo Brichetto, Paola Gazzola, Antonio Mannironi, Maria Laura Stromillo, Cinzia Cordioli, Doriana Landi, Marinella Clerico, Elisabetta Signoriello, Eleonora Cocco, Jessica Frau, Maria Teresa Ferrò, Alessia Di Sapio, Livia Pasquali, Monica Ulivelli, Fabiana Marinelli, Matteo Pizzorno, Graziella Callari, Rosa Iodice, Giuseppe Liberatore, Francesca Caleri, Anna Maria Repice, Susanna Cordera, Mario Alberto Battaglia, Marco Salvetti, Diego Franciotta, Antonio Uccelli, Alessandro Maglione, Alessio Signori, Aniello Iovino, Carolina Gabri Nicoletti, Chiara Rosa Mancinelli, Daiana Bezzini, Daniele Carmagnini, Davide Brogi, Eduardo Nobile Orazio, Enri Nako, Ester Assandrir, Federica Baldi, Filippo Ansaldi, Francesca Bovis, Gabriele Siciliano, Gaia Cola, Giacomo Lus, Giancarlo Icardi, Gianmarco Bellucci, Giorgio Da Rin, Girolama Alessandra Marfia, Giulia Vazzoler, Giuseppe Trivelli, Ilaria Maietta, Laura Sticchi, Lorena Lorefice, Lucia Ruggiero, Marcello Manzino, Margherita Monti Bragadin, Maria Chiara Buscarinu, Maria Gagliardi, Maria Teresa Rilla, Marta Ponzano, Marzia Fronza, Massimo Del Sette, Matteo Scialabba, Michele Bedognetti, Nicola De Rossi, Nicola De Stefano, Rachele Bigi, Raffaele Dubbioso, Roberta Reniè, Sabrina Fabbri, Sarah Rasia, Simona Rolla, Stefan Platzgummer, Valentina Carlini, Sormani, Maria Pia, Schiavetti, Irene, Inglese, Matilde, Carmisciano, Luca, Laroni, Alice, Lapucci, Caterina, Visconti, Valeria, Serrati, Carlo, Gandoglia, Ilaria, Tassinari, Tiziana, Perego, Germana, Brichetto, Giampaolo, Gazzola, Paola, Mannironi, Antonio, Stromillo, Maria Laura, Cordioli, Cinzia, Landi, Doriana, Clerico, Marinella, Signoriello, Elisabetta, Cocco, Eleonora, Frau, Jessica, Ferrò, Maria Teresa, Di Sapio, Alessia, Pasquali, Livia, Ulivelli, Monica, Marinelli, Fabiana, Pizzorno, Matteo, Callari, Graziella, Iodice, Rosa, Liberatore, Giuseppe, Caleri, Francesca, Repice, Anna Maria, Cordera, Susanna, Battaglia, Mario Alberto, Salvetti, Marco, Franciotta, Diego, and Uccelli, Antonio

Subjects
Vaccines, Synthetic, Vaccines, COVID-19 Vaccines, Multiple Sclerosis, SARS-CoV-2, Messenger, Vaccination, Synthetic, Breakthrough infections, COVID-19, Disease Modifying Treatments, Cohort Studies, Humans, Prospective Studies, RNA, Messenger, mRNA Vaccines, Viral Vaccines, General Medicine, Settore MED/26, General Biochemistry, Genetics and Molecular Biology, Breakthrough infection, RNA, Disease Modifying Treatment
Abstract

Background: In this study we aimed to monitor the risk of breakthrough SARS-CoV-2 infection in patients with MS (pwMS) under different DMTs and to identify correlates of reduced protection. Methods: This is a prospective Italian multicenter cohort study, long-term clinical follow-up of the CovaXiMS (Covid-19 vaccine in Multiple Sclerosis) study. 1855 pwMS scheduled for SARS-CoV-2 mRNA vaccination were enrolled and followed up to a mean time of 10 months. The cumulative incidence of breakthrough Covid-19 cases in pwMS was calculated before and after December 2021, to separate the Delta from the Omicron waves and to account for the advent of the third vaccine dose. Findings: 1705 pwMS received 2 m-RNA vaccine doses, 21/28 days apart. Of them, 1508 (88.5%) had blood assessment 4 weeks after the second vaccine dose and 1154/1266 (92%) received the third dose after a mean interval of 210 days (range 90-342 days) after the second dose. During follow-up, 131 breakthrough Covid-19 infections (33 during the Delta and 98 during the Omicron wave) were observed. The probability to be infected during the Delta wave was associated with SARS-CoV-2 antibody levels measured after 4 weeks from the second vaccine dose (HR=0.57, p&nbsp

Published
2022

45. Effect of SARS-CoV-2 mRNA Vaccination in MS Patients Treated With Disease Modifying Therapies

Author

Maria Pia Sormani, Matilde Inglese, Irene Schiavetti, Luca Carmisciano, Alice Laroni, Caterina Lapucci, Giorgio Da Rin, Carlo Serrati, Ilaria Gandoglia, Tiziana Tassinari, Germana Perego, Giampaolo Brichetto, Paola Gazzola, Antonio Mannironi, Maria Laura Stromillo, Cinzia Cordioli, Doriana Landi, Marinella Clerico, Elisabetta Signoriello, Jessica Frau, Maria Teresa Ferrò, Alessia Di Sapio, Livia Pasquali, Monica Ulivelli, Fabiana Marinelli, Graziella Callari, Rosa Iodice, Giuseppe Liberatore, Francesca Caleri, Anna Maria Repice, Susanna Cordera, Mario Alberto Battaglia, Marco Salvetti, Diego Franciotta, Antonio Uccelli, CovaXiMS Study Group, Pia Sormani, Maria, Inglese, Matilde, Schiavetti, Irene, Carmisciano, Luca, Laroni, Alice, Lapucci, Caterina, Da Rin, Giorgio, Serrati, Carlo, Gandoglia, Ilaria, Tassinari, Tiziana, Perego, Germana, Brichetto, Giampaolo, Gazzola, Paola, Mannironi, Antonio, Laura Stromillo, Maria, Cordioli, Cinzia, Landi, Doriana, Clerico, Marinella, Signoriello, Elisabetta, Frau, Jessica, Teresa Ferrò, Maria, Di Sapio, Alessia, Pasquali, Livia, Ulivelli, Monica, Marinelli, Fabiana, Callari, Graziella, Iodice, Rosa, Liberatore, Giuseppe, Caleri, Francesca, Maria Repice, Anna, Cordera, Susanna, Alberto Battaglia, Mario, Salvetti, Marco, Franciotta, Diego, Uccelli, Antonio, and Dubbioso, Raffaele

Subjects
Cellular immunity, medicine.medical_specialty, business.industry, Roche Diagnostics, Fingolimod, Vaccination, Informed consent, Internal medicine, Medicine, Rituximab, Ocrelizumab, business, medicine.drug, Cohort study
Abstract

Background: In patients with Multiple Sclerosis (pwMS) disease-modifying therapies (DMTs) are known to affect immune response to antigens and possibly to SARS-CoV2 vaccine. Therefore, post-vaccination serological assessments are needed to evaluate the effect of the vaccine on SARS-CoV-2 antibody response. Methods: We designed a prospective multicenter cohort study enrolling pwMS who were scheduled for SARS-Cov-2 vaccination with mRNA vaccines (BNT162b2, Pfizer/BioNTech, Inc or mRNA-1273, Moderna Tx, Inc). A blood collection for the measure of SARS-CoV-2 antibody before the first vaccine dose and 4 weeks after the second dose was planned, with a centralized serological assessment (electrochemiluminescence immunoassay, ECLIA, Roche Diagnostics). Findings: 780 pwMS (76% BNT162b2 and 24% mRNA-1273) had pre- and 4-week post-vaccination blood assessments. 87 (11·2%) were untreated, 154 (19·7%) on ocrelizumab, 25 (3·2%) on rituximab, 85 (10·9%) on fingolimod, 25 (3·2%) on cladribine and 404 (51·7%) on other DMTs. 677 patients (86·8%) had detectable post-vaccination SARS-CoV-2 antibodies. At multivariate analysis, the antibody levels of patients on ocrelizumab (178-fold decrease, p

Published
2021
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46. Exit Strategies in Natalizumab-Treated RRMS at High Risk of Progressive Multifocal Leukoencephalopathy: a Multicentre Comparison Study

Author

Gianmarco Abbadessa, Carlo Avolio, Patrizia Sola, Franco Granella, Graziella Callari, Stefania Barone, Elisabetta Signoriello, Simona Bonavita, Francesco Patti, Aurora Zanghì, Maria Buccafusca, Valeria Di Francescantonio, Antonio Gallo, Rocco Capuano, Diana Ferraro, Roberta Lanzillo, Paola Valentino, Matteo Lucchini, Erica Curti, Giuseppe Pontillo, Massimiliano Mirabella, Emanuele D'Amico, Maria Petracca, Giacomo Lus, Zanghì, Aurora, Gallo, Antonio, Avolio, Carlo, Capuano, Rocco, Lucchini, Matteo, Petracca, Maria, Bonavita, Simona, Lanzillo, Roberta, Ferraro, Diana, Curti, Erica, Buccafusca, Maria, Callari, Graziella, Barone, Stefania, Pontillo, Giuseppe, Abbadessa, Gianmarco, Di Francescantonio, Valeria, Signoriello, Elisabetta, Lus, Giacomo, Sola, Patrizia, Granella, Franco, Valentino, Paola, Mirabella, Massimiliano, Patti, Francesco, D'Amico, Emanuele, Zanghi, A., Gallo, A., Avolio, C., Capuano, R., Lucchini, M., Petracca, M., Bonavita, S., Lanzillo, R., Ferraro, D., Curti, E., Buccafusca, M., Callari, G., Barone, S., Pontillo, G., Abbadessa, G., Di Francescantonio, V., Signoriello, E., Lus, G., Sola, P., Granella, F., Valentino, P., Mirabella, M., Patti, F., and D'Amico, E.

Subjects
0301 basic medicine, Male, Immunosuppressive Agent, 0302 clinical medicine, Natalizumab, Immunologic Factor, Risk Factors, Retrospective Studie, Pharmacology (medical), Prospective Studies, Disease activity, Ocrelizumab, Drug Substitution, Progressive multifocal leukoencephalopathy, Leukoencephalopathy, Progressive Multifocal, Settore MED/26 - NEUROLOGIA, Original Article, Rituximab, Female, Immunosuppressive Agents, medicine.drug, Human, Adult, medicine.medical_specialty, Adolescent, Lower risk, Antibodies, Monoclonal, Humanized, Cladribine, Exit strategy, Follow-Up Studie, 03 medical and health sciences, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, Post-hoc analysis, medicine, Humans, Immunologic Factors, Retrospective Studies, Pharmacology, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Risk Factor, medicine.disease, Prospective Studie, 030104 developmental biology, Neurology (clinical), business, 030217 neurology & neurosurgery, Follow-Up Studies
Abstract

The main aim of the study is to evaluate the efficacy and safety profile of ocrelizumab (OCR), rituximab (RTX), and cladribine (CLA), employed as natalizumab (NTZ) exit strategies in relapsing–remitting multiple sclerosis (RRMS) patients at high-risk for progressive multifocal leukoencephalopathy (PML). This is a multicentre, retrospective, real-world study on consecutive RRMS patients from eleven tertiary Italian MS centres, who switched from NTZ to OCR, RTX, and CLA from January 1st, 2019, to December 31st, 2019. The primary study outcomes were the annualized relapse rate (ARR) and magnetic resonance imaging (MRI) outcome. Treatment effects were estimated by the inverse probability treatment weighting (IPTW), based on propensity-score (PS) approach. Additional endpoint included confirmed disability progression (CDP) as measured by Expanded Disability Status Scale and adverse events (AEs). Patients satisfying predefined inclusion and exclusion criteria were 120; 64 switched to OCR, 36 to RTX, and 20 to CLA. Patients from the 3 groups did not show differences for baseline characteristics, also after post hoc analysis. The IPTW PS-adjusted models revealed that patients on OCR had a lower risk for ARR than patients on CLA (ExpBOCR0.485, CI 95% 0.264–0.893,p = 0.020). This result was confirmed also for 12-month MRI activity (ExpBOCR0.248 CI 95% 0.065–0.948,p = 0.042). No differences were found in other pairwise comparisons (OCR vs RTX and RTX vs CLA) for the investigated outcomes. AEs were similar among the 3 groups. Anti-CD20 drugs were revealed to be effective and safe options as NTZ exit strategies. All investigated DMTs showed a good safety profile.

Published
2021

47. Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience

Author

Gioacchino Tedeschi, Giuseppe Salemi, Mario Zappia, Graziella Callari, Paolo Ragonese, Roberto Bruno Bossio, Maria Buccafusca, Francesco Patti, Giusi Graziano, Salvatore Cottone, Aurora Zanghì, Giovanna Borriello, Carlo Pozzilli, Luigi M.E. Grimaldi, Paola Valentino, Renato Docimo, Antonio Gallo, Emanuele D'Amico, D'Amico, Emanuele, Zanghì, Aurora, Callari, Graziella, Borriello, Giovanna, Gallo, Antonio, Graziano, Giusi, Valentino, Paola, Buccafusca, Maria, Cottone, Salvatore, Salemi, Giuseppe, Ragonese, Paolo, Bossio, Roberto Bruno, Docimo, Renato, Grimaldi, Luigi Maria Edoardo, Pozzilli, Carlo, Tedeschi, Gioacchino, Zappia, Mario, Patti, Francesco, and D’Amico, Emanuele

Subjects
safety, medicine.medical_specialty, dimethyl fumarate, efficacy, no evidence of disease activity 3, teriflunomide, pharmacology, neurology, neurology (clinical), Population, lcsh:RC346-429, Disease activity, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Internal medicine, Teriflunomide, Medicine, 030212 general & internal medicine, education, lcsh:Neurology. Diseases of the nervous system, Original Research, Pharmacology, education.field_of_study, Dimethyl fumarate, business.industry, Multiple sclerosis, medicine.disease, chemistry, Relapsing remitting, Neurology, Settore MED/26 - Neurologia, Real word, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

BACKGROUND: The aim of the study was to evaluate the achievement of 'no evidence of disease activity' (NEDA) over a 12-month period in a large multicenter population with relapsing remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) and teriflunomide (TRF) using a propensity-score adjustment. METHODS: A time-to-event method was used to determine the percentages of patients with RRMS (pwRRMS) in both groups achieving NEDA 3 (no relapses, no 12-week confirmed disability progression, and no new T2/gadolinium-enhancing brain lesions). We described the safety profile of the investigated drugs. RESULTS: Of the 587 pwRRMS treated with DMF and the 316 pwRRMS treated with TRF, 468 pwRRMS were successfully paired by propensity score: 234 on DMF and 234 on TRF. The percentages of pwRRMS who achieved NEDA 3 were 80.3% in the DMF group and 77.2% in the TRF group. Serious adverse events occurred in four (1.9%) pwRRMS on DMF and in three (1.3%) pwRRMS on TRF. CONCLUSIONS: DMF and TRF significantly impacted RRMS disease activity in our study. Serious safety concerns were recorded in less than 2% of the studied population.

Published
2018

48. Ocrelizumab Extended Interval Dosing in Primary Progressive Multiple Sclerosis: An Italian Experience.

Author

Zanghì A, Ferraro D, Callari G, Valentino P, Granella F, Patti F, Lus G, Bonavita S, Moretti MC, Avolio C, and D'Amico E

Subjects
Humans, Antibodies, Monoclonal, Humanized therapeutic use, Italy, Immunologic Factors therapeutic use, Immunologic Factors adverse effects, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive drug therapy, Multiple Sclerosis, Chronic Progressive chemically induced
Abstract

Background: The intervals between two courses of anti CD20 therapies in the COVID19 pandemic era provided the opportunity to individually delay therapy, known as extended interval dosing (EID)., Methods: We collect real-world data on patients with primary progressive MS (PPMS) treated with Ocrelizumab (OCR) during the COVID'19 pandemic. The observation period in which the standard interval dosing (SID) or EID occurred (always a maintenance cycle, 600 mg) was from January 2020 to June 2021. All patients had two infusions during the observation period. Our first aim was to compare confirmed disability progression (CDP) between SID and EID patients., Results: From a total cohort of 410 patients treated with OCR, 96 patients fulfilled the inclusion criteria. All patients received two infusions during the index window, 71 received only SID infusions whilst 25 received at least one EID infusion throughout the entire follow-up. During the entire available follow-up (median 10 months, IQR 7-11), CDP was recorded in 5 patients (3/71, 4.2% SID and 2/25, 8% EID, V-Cramer = 0.141, p-value = 0.167). EID regimen did not influence the risk of CDP during the investigated follow up., Conclusion: In our multicentre real-world cohort, the EID regimen in PPMS patients did not result in increased CDP during the available follow-up., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Published
2024
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49. Comparable efficacy and safety of dimethyl fumarate and teriflunomide treatment in Relapsing-Remitting Multiple Sclerosis: an Italian real-word multicenter experience.

Author

D'Amico E, Zanghì A, Callari G, Borriello G, Gallo A, Graziano G, Valentino P, Buccafusca M, Cottone S, Salemi G, Ragonese P, Bossio RB, Docimo R, Grimaldi LME, Pozzilli C, Tedeschi G, Zappia M, and Patti F

Abstract

Background: The aim of the study was to evaluate the achievement of 'no evidence of disease activity' (NEDA) over a 12-month period in a large multicenter population with relapsing remitting multiple sclerosis (RRMS) treated with delayed-release dimethyl fumarate (DMF) and teriflunomide (TRF) using a propensity-score adjustment., Methods: A time-to-event method was used to determine the percentages of patients with RRMS (pwRRMS) in both groups achieving NEDA 3 (no relapses, no 12-week confirmed disability progression, and no new T2/gadolinium-enhancing brain lesions). We described the safety profile of the investigated drugs., Results: Of the 587 pwRRMS treated with DMF and the 316 pwRRMS treated with TRF, 468 pwRRMS were successfully paired by propensity score: 234 on DMF and 234 on TRF. The percentages of pwRRMS who achieved NEDA 3 were 80.3% in the DMF group and 77.2% in the TRF group. Serious adverse events occurred in four (1.9%) pwRRMS on DMF and in three (1.3%) pwRRMS on TRF., Conclusions: DMF and TRF significantly impacted RRMS disease activity in our study. Serious safety concerns were recorded in less than 2% of the studied population., Competing Interests: Conflict of interest statement: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: ED, GC, GB, AG, and MB received personal fees from Biogen and Sanofi. ED, GC, GB, AG, PV, and MB received travel funding from Bayer Biogen and Merck. AZ received travel funding from Bayer Schering and Sanofi Genzyme outside the submitted work. PV received personal fees from Biogen, Sanofi, Novartis, and Roche. SC and GS received personal fees for speaking activities from Bayer Biogen, Merck, Novartis, and Teva. PR received travel expenses or honoraria for consultancy from Merck Serono, Biogen idec, Novartis, Sanofi Genzyme, and Teva. RBB served on the advisory board for Almirall and received grants for congress participation from Sanofi and Merck. LMEG and CP served on advisory boards for Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, and Teva. LMEG and CP also received personal fees for speaking activities at congresses or sponsored symposia. GT, MZ, and FP served on advisory boards for Bayer, Biogen, Celgene, Merck, Novartis, Roche, Sanofi, Teva, and Almirall. GT, MZ, and FP also received personal fees for speaking activities at congresses or sponsored symposia.

Published
2018
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