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1. Associations between fatigue impact and physical and neurobehavioural factors: An exploration in people with progressive multiple sclerosis

Author: Connolly, L, Chatfield, S, Freeman, J, Salter, A, Amato, MP, Brichetto, G, Chataway, J, Chiaravalloti, ND, Cutter, G, DeLuca, J, Dalgas, U, Farrell, R, Feys, P, Filippi, M, Inglese, M, Meza, C, Moore, NB, Motl, RW, Rocca, MA, Sandroff, BM, and Feinstein, A
Published: 2024
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2. Instrumental gait assessment in early-stage multiple sclerosis

Author: Marliani, V., primary, Pasquini, G., additional, Gerli, F., additional, Portaccio, E., additional, Betti, M., additional, Pancani, S., additional, Sawacha, Z., additional, Amato, MP., additional, and Mannini, A., additional
Published: 2023
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3. Data monitoring roadmap. The experience of the Italian Multiple Sclerosis and Related Disorders Register.

Author: Mosconi, Paola, Guerra, Tommaso, Paletta, Pasquale, D'Ettorre, Antonio, Ponzio, Michela, Battaglia, Mario Alberto, Amato, Maria Pia, Bergamaschi, Roberto, Capobianco, Marco, Comi, Giancarlo, Gasperini, Claudio, Patti, Francesco, Pugliatti, Maura, Ulivelli, Monica, Trojano, Maria, Lepore, Vito, Aguglia, U., Amato, MP., Ancona, AL., and Ardito, B.
Subjects: MULTIPLE sclerosis, QUALITY control, REPORTING of diseases, WEB-based user interfaces, MISSING data (Statistics)
Abstract: Introduction: Over the years, disease registers have been increasingly considered a source of reliable and valuable population studies. However, the validity and reliability of data from registers may be limited by missing data, selection bias or data quality not adequately evaluated or checked. This study reports the analysis of the consistency and completeness of the data in the Italian Multiple Sclerosis and Related Disorders Register. Methods: The Register collects, through a standardized Web-based Application, unique patients. Data are exported bimonthly and evaluated to assess the updating and completeness, and to check the quality and consistency. Eight clinical indicators are evaluated. Results: The Register counts 77,628 patients registered by 126 centres. The number of centres has increased over time, as their capacity to collect patients. The percentages of updated patients (with at least one visit in the last 24 months) have increased from 33% (enrolment period 2000–2015) to 60% (enrolment period 2016–2022). In the cohort of patients registered after 2016, there were ≥ 75% updated patients in 30% of the small centres (33), in 9% of the medium centres (11), and in all the large centres (2). Clinical indicators show significant improvement for the active patients, expanded disability status scale every 6 months or once every 12 months, visits every 6 months, first visit within 1 year and MRI every 12 months. Conclusions: Data from disease registers provide guidance for evidence-based health policies and research, so methods and strategies ensuring their quality and reliability are crucial and have several potential applications. [ABSTRACT FROM AUTHOR]
Published: 2023
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4. Disease Reactivation After Cessation of Disease-Modifying Therapy in Patients With Relapsing-Remitting Multiple Sclerosis

Author: Roos, I, Malpas, C, Leray, E, Casey, R, Horakova, D, Havrdova, EK, Debouverie, M, Patti, F, De Seze, J, Izquierdo, G, Eichau, S, Edan, G, Prat, A, Girard, M, Ozakbas, S, Grammond, P, Zephir, H, Ciron, J, Maillart, E, Moreau, T, Amato, MP, Labauge, P, Alroughani, R, Buzzard, K, Skibina, O, Terzi, M, Laplaud, DA, Berger, E, Grand'Maison, F, Lebrun-Frenay, C, Cartechini, E, Boz, C, Lechner-Scott, J, Clavelou, P, Stankoff, B, Prevost, J, Kappos, L, Pelletier, J, Shaygannejad, V, Yamout, B, Khoury, SJ, Gerlach, O, Spitaleri, DLA, Van Pesch, V, Gout, O, Turkoglu, R, Heinzlef, O, Thouvenot, E, McCombe, PA, Soysal, A, Bourre, B, Slee, M, Castillo-Trivino, T, Bakchine, S, Ampapa, R, Butler, EG, Wahab, A, Macdonell, RA, Aguera-Morales, E, Cabre, P, Ben, NH, Van der Walt, A, Laureys, G, Van Hijfte, L, Ramo-Tello, CM, Maubeuge, N, Hodgkinson, S, Sanchez-Menoyo, JL, Barnett, MH, Labeyrie, C, Vucic, S, Sidhom, Y, Gouider, R, Csepany, T, Sotoca, J, de Gans, K, Al-Asmi, A, Fragoso, YD, Vukusic, S, Butzkueven, H, Kalincik, T, Roos, I, Malpas, C, Leray, E, Casey, R, Horakova, D, Havrdova, EK, Debouverie, M, Patti, F, De Seze, J, Izquierdo, G, Eichau, S, Edan, G, Prat, A, Girard, M, Ozakbas, S, Grammond, P, Zephir, H, Ciron, J, Maillart, E, Moreau, T, Amato, MP, Labauge, P, Alroughani, R, Buzzard, K, Skibina, O, Terzi, M, Laplaud, DA, Berger, E, Grand'Maison, F, Lebrun-Frenay, C, Cartechini, E, Boz, C, Lechner-Scott, J, Clavelou, P, Stankoff, B, Prevost, J, Kappos, L, Pelletier, J, Shaygannejad, V, Yamout, B, Khoury, SJ, Gerlach, O, Spitaleri, DLA, Van Pesch, V, Gout, O, Turkoglu, R, Heinzlef, O, Thouvenot, E, McCombe, PA, Soysal, A, Bourre, B, Slee, M, Castillo-Trivino, T, Bakchine, S, Ampapa, R, Butler, EG, Wahab, A, Macdonell, RA, Aguera-Morales, E, Cabre, P, Ben, NH, Van der Walt, A, Laureys, G, Van Hijfte, L, Ramo-Tello, CM, Maubeuge, N, Hodgkinson, S, Sanchez-Menoyo, JL, Barnett, MH, Labeyrie, C, Vucic, S, Sidhom, Y, Gouider, R, Csepany, T, Sotoca, J, de Gans, K, Al-Asmi, A, Fragoso, YD, Vukusic, S, Butzkueven, H, and Kalincik, T
Abstract: BACKGROUND AND OBJECTIVES: To evaluate the rate of return of disease activity after cessation of multiple sclerosis (MS) disease-modifying therapy. METHODS: This was a retrospective cohort study from 2 large observational MS registries: MSBase and OFSEP. Patients with relapsing-remitting MS who had ceased a disease-modifying therapy and were followed up for the subsequent 12 months were included in the analysis. The primary study outcome was annualized relapse rate in the 12 months after disease-modifying therapy discontinuation stratified by patients who did, and did not, commence a subsequent therapy. The secondary endpoint was the predictors of first relapse and disability accumulation after treatment discontinuation. RESULTS: A total of 14,213 patients, with 18,029 eligible treatment discontinuation epochs, were identified for 7 therapies. Annualized rates of relapse (ARRs) started to increase 2 months after natalizumab cessation (month 2-4 ARR 0.47, 95% CI 0.43-0.51). Commencement of a subsequent therapy within 2-4 months reduced the magnitude of disease reactivation (mean ARR difference: 0.15, 0.08-0.22). After discontinuation of fingolimod, rates of relapse increased overall (month 1-2 ARR: 0.80, 0.70-0.89) and stabilized faster in patients who started a new therapy within 1-2 months (mean ARR difference: 0.14, -0.01 to 0.29). The magnitude of disease reactivation for other therapies was low but reduced further by commencement of another treatment 1-10 months after treatment discontinuation. Predictors of relapse were a higher relapse rate in the year before cessation, female sex, younger age, and higher EDSS score. Commencement of a subsequent therapy reduced both the risk of relapse (HR 0.76, 95% CI 0.72-0.81) and disability accumulation (0.73, 0.65-0.80). DISCUSSION: The rate of disease reactivation after treatment cessation differs among MS treatments, with the peaks of relapse activity ranging from 1 to 10 months in untreated cohorts that discontinued di
Published: 2022

5. Cost-Effectiveness Analysis of Cannabinoid Oromucosal Spray Use for the Management of Spasticity in Subjects with Multiple Sclerosis

Author: Mantovani, Lg, Cozzolino, P, Cortesi, Pa, Patti, F, Messina, S, Solaro, C, Amato, Mp, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, Gf, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, Md, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, L, Cozzolino, P, Cortesi, P, Patti, F, Messina, S, Solaro, C, Amato, M, Bergamaschi, R, Bonavita, S, Bruno Bossio, R, Brescia Morra, V, Costantino, G, Cavalla, P, Centonze, D, Comi, G, Cottone, S, Danni, M, Francia, A, Gajofatto, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, G, Marrosu, M, Matta, M, Mirabella, M, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, E, Spitaleri, D, Trojano, M, Valentino, P, Zappia, M, Benedetti, M, Bertolotto, A, Berra, E, Bianco, A, Buttari, F, Cerqua, R, Florio, C, Fuiani, A, Guareschi, A, Ippolito, D, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Sacca, F, Salomone, G, Signoriello, E, Spinicci, G, Russo, M, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Mantovani, Lorenzo G, Cozzolino, Paolo, Cortesi, Paolo A, Patti, Francesco, Amato, Mp, Costantino, Gf, Maniscalco, Gt, Marrosu, Mg, Benedetti, Md, Saccà, F, Zaffaroni, M., Mantovani, L. G., Cozzolino, P., Cortesi, P. A., Patti, F., Messina, S., Solaro, C., Amato, M. P., Bergamaschi, R., Bonavita, S., Bruno Bossio, R., Brescia Morra, V., Costantino, G. F., Cavalla, P., Centonze, D., Comi, G., Cottone, S., Danni, M., Francia, A., Gajofatto, A., Gasperini, C., Ghezzi, A., Iudice, A., Lus, G., Maniscalco, G. T., Marrosu, M. G., Matta, M., Mirabella, M., Montanari, E., Pozzilli, C., Rovaris, M., Sessa, E., Spitaleri, D., Trojano, M., Valentino, P., Zappia, M., Benedetti, M. D., Bertolotto, A., Berra, E., Bianco, A., Buttari, F., Cerqua, R., Florio, C., Fuiani, A., Guareschi, A., Ippolito, D., Nuara, A., Palmieri, V., Paolicelli, D., Petrucci, L., Pontecorvo, S., Sacca, F., Salomone, G., Signoriello, E., Spinicci, G., Russo, M., Tavazzi, E., Trabucco, E., and Trotta, M.
Subjects: Adult, Male, medicine.medical_specialty, Cost effectiveness, Cost-Benefit Analysis, MEDLINE, 030204 cardiovascular system & hematology, Settore MED/26, multiple sclerosis, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Cannabidiol, Dronabinol, Drug Combinations, Female, Humans, Italy, Middle Aged, Multiple Sclerosis, Muscle Spasticity, Quality of Life, Quality-Adjusted Life Years, Medicine, Pharmacology (medical), Spasticity, spasticity, multiple sclerosis, cannabinoid, health care economics and organizations, Cost-Effectiveness Analysis, Spasticity, Cannabinoid, Multiple Sclerosis, Cost–benefit analysis, business.industry, Multiple sclerosis, spasticity, General Medicine, Cost-effectiveness analysis, cannabinoid, medicine.disease, Quality-adjusted life year, Settore MED/26 - NEUROLOGIA, Physical therapy, medicine.symptom, business
Abstract: Introduction: Multiple sclerosis (MS) is a highly symptomatic disease, with a wide range of disabilities affecting many bodily functions, even in younger persons with a short disease history. The availability of a cannabinoid oromucosal spray (Sativex) for the management of treatment-resistant MS spasticity has provided a new opportunity for many patients. Objective: Our study aimed to assess the cost effectiveness of Sativex in Italian patients with treatment-resistant MS spasticity. The analysis was based on the real-world data of a large registry of Italian patients. Methods: A cost-utility analysis was conducted using data collected prospectively from an electronic registry of all patients who began to use Sativex for MS-resistant spasticity between January 2014 and February 2015 in 30 specialized MS units across Italy and were followed up for ≤ 6months. Data on drug consumption and spasticity/utility were used to estimate the incremental cost-effectiveness ratio (ICER) of Sativex, as compared with no intervention. No costs or spasticity/utility changes were assumed for no treatment intervention. The ICER was expressed as quality-adjusted life-years (QALYs) gained, using the Italian NHS perspective and a 6-month time horizon. Results: Sativex effectiveness and consumption was estimated analyzing data of 1350 patients from the registry. These patients reported a mean (SD) utility increment of 0.087 (0.069) after 1month of treatment, 0.118 (0.073) after 3months’ treatment and 0.127 (0.080) after 6months’ treatment. The 6-month cost of treating the entire population with Sativex was €1,361,266, with a €1008 cost and 0.0284 QALYs gained per patient. The estimated ICER was €35,516 per QALY gained, with little variability around the central estimate of cost-effectiveness, as shown by the cost-effectiveness acceptability curve. Conclusion: The use of Sativex could improve the quality of life of patients with a reasonable incremental cost resulting as a cost-effective option for patients with MS-resistant spasticity. These results could help clinicians and decision makers to develop improved management strategies for spasticity in patients with MS, optimizing the use of available resources.
Published: 2020

6. Developing a tool to assess environmental exposures in the Italian pediatric-onset multiple sclerosis (PEQ-IT)

Author: Pilotto, S, Gencarelli, J, Bova, Sm, Gerosa, L, Baroncini, D, Olivotto, S, Alfei, E, Zaffaroni, M, Suppiej, A, Cocco, E, Trojano, M, Amato, Mp, D'Alfonso, S, Martinelli-Boneschi, F, Waubant, E, Ghezzi, A, Bergamaschi, R, and Pugliatti, M
Subjects: NO
Published: 2021

7. Natalizumab, Fingolimod, and Dimethyl Fumarate Use and Pregnancy-Related Relapse and Disability in Women With Multiple Sclerosis

Author: Yeh, WZ, Widyastuti, PA, Van der Walt, A, Stankovich, J, Havrdova, E, Horakova, D, Vodehnalova, K, Ozakbas, S, Eichau, S, Duquette, P, Kalincik, T, Patti, F, Boz, C, Terzi, M, Yamout, B, Lechner-Scott, J, Sola, P, Skibina, OG, Barnett, M, Onofrj, M, Sa, MJ, McCombe, PA, Grammond, P, Ampapa, R, Grand'Maison, F, Bergamaschi, R, Spitaleri, DLA, Van Pesch, V, Cartechini, E, Hodgkinson, S, Soysal, A, Saiz, A, Gresle, M, Uher, T, Maimone, D, Turkoglu, R, Hupperts, RM, Amato, MP, Granella, F, Oreja-Guevara, C, Altintas, A, Macdonell, RA, Castillo-Trivino, T, Butzkueven, H, Alroughani, R, Jokubaitis, VG, Yeh, WZ, Widyastuti, PA, Van der Walt, A, Stankovich, J, Havrdova, E, Horakova, D, Vodehnalova, K, Ozakbas, S, Eichau, S, Duquette, P, Kalincik, T, Patti, F, Boz, C, Terzi, M, Yamout, B, Lechner-Scott, J, Sola, P, Skibina, OG, Barnett, M, Onofrj, M, Sa, MJ, McCombe, PA, Grammond, P, Ampapa, R, Grand'Maison, F, Bergamaschi, R, Spitaleri, DLA, Van Pesch, V, Cartechini, E, Hodgkinson, S, Soysal, A, Saiz, A, Gresle, M, Uher, T, Maimone, D, Turkoglu, R, Hupperts, RM, Amato, MP, Granella, F, Oreja-Guevara, C, Altintas, A, Macdonell, RA, Castillo-Trivino, T, Butzkueven, H, Alroughani, R, and Jokubaitis, VG
Abstract: OBJECTIVE: To investigate pregnancy-related disease activity in a contemporary multiple sclerosis (MS) cohort. METHODS: Using data from the MSBase Registry, we included pregnancies conceived after 31 Dec 2010 from women with relapsing-remitting MS or clinically isolated syndrome. Predictors of intrapartum relapse, and postpartum relapse and disability progression were determined by clustered logistic regression or Cox regression analyses. RESULTS: We included 1998 pregnancies from 1619 women with MS. Preconception annualized relapse rate (ARR) was 0.29 (95% CI 0.27-0.32), fell to 0.19 (0.14-0.24) in third trimester, and increased to 0.59 (0.51-0.67) in early postpartum. Among women who used fingolimod or natalizumab, ARR before pregnancy was 0.37 (0.28-0.49) and 0.29 (0.22-0.37), respectively, and increased during pregnancy. Intrapartum ARR decreased with preconception dimethyl fumarate use. ARR spiked after delivery across all DMT groups. Natalizumab continuation into pregnancy reduced the odds of relapse during pregnancy (OR 0.76 per month [0.60-0.95], p=0.017). DMT re-initiation with natalizumab protected against postpartum relapse (HR 0.11 [0.04-0.32], p<0.0001). Breastfeeding women were less likely to relapse (HR 0.61 [0.41-0.91], p=0.016). 5.6% of pregnancies were followed by confirmed disability progression, predicted by higher relapse activity in pregnancy and postpartum. CONCLUSION: Intrapartum and postpartum relapse probabilities increased among women with MS after natalizumab or fingolimod cessation. In women considered to be at high relapse risk, use of natalizumab before pregnancy and continued up to 34 weeks gestation, with early re-initiation after delivery is an effective option to minimize relapse risks. Strategies of DMT use have to be balanced against potential fetal/neonatal complications.
Published: 2021

8. Postpartum relapses increase the risk of disability progression in multiple sclerosis: the role of disease modifying drugs

Author: Portaccio, Emilio, Ghezzi, Angelo, Hakiki, Bahia, Sturchio, Andrea, Martinelli, Vittorio, Moiola, Lucia, Patti, Francesco, Mancardi, Gian Luigi, Solaro, Claudio, Tola, Maria Rosaria, Pozzilli, Carlo, De Giglio, Laura, Totaro, Rocco, Lugaresi, Alessandra, De Luca, Giovanna, Paolicelli, Damiano, Marrosu, Maria Giovanna, Comi, Giancarlo, Trojano, Maria, Amato, Maria Pia, Amato, MP, Portaccio, E, Hakiki, B, Sturchio, A, Pastò, L, Giannini, M, Razzolini, L, Piscolla, E, Siracusa, G, Ghezzi, A, Rizzo, A, Zaffaroni, M, Martinelli, V, Radaelli, M, Moiola, L, Comi, G, Protti, A, Spreafico, C, Marazzi, R, Cavalla, P, Masera, S, Bergamaschi, R, Mancardi, G, Capello, E, Solaro, C, Tola, MR, Caniatti, L, Granella, F, Immovilli, P, Annunziata, P, De Santi, L, Plewnia, K, Guidi, L, Bartolozzi, ML, Mazzoni, M., Pozzilli, C, De Giglio, L, Totaro, R, Carolei, A, Rossi, M, Lugaresi, A, De Luca, G., Di Tommaso, V, Trojano, M, Paolicelli, D, Carrozzo, A, DʼOnghia, M, Marrosu, MG, Musu, L, Patti, F, Carmela, L, and Lo Fermo, S
Published: 2014
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9. The Italian multiple sclerosis register

Author: Trojano, M, Bergamaschi, R, Amato, Mp, Comi, G, Ghezzi, A, Lepore, V, 7, Marrosu, Mg, Mosconi, P, Patti, F, Ponzio, M, Zaratin, P, Battaglia, Ma1, Acquistapace D, Italian Multiple Sclerosis Register Centers Group., Aguglia, U, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, Rb, Bramanti, P, Brescia Morra, V, Brioschi, Am, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, Lm, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, Mg, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, C, Coniglio, Mg, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D'Andrea, F, Danni, Mc, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, Mt, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, Mg, Grimaldi, Lme, Imperiale, D, Lo Russo, L, Logullo, Fo, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, Ml, Pizio, Nr, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, Mg, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, Gp, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M., Trojano M., Bergamaschi R., Amato M.P., Comi G., Ghezzi A., Lepore V., Marrosu M.G., Mosconi P., Patti F., Ponzio M., Zaratin P., Battaglia M.A., Acquistapace D., Aguglia U., Annunziata P., Ardito B., Avolio C., Balgera R., Bandini F., Banfi P., Barone P., Bellantonio P., Bertolotto A., Bertora P., Bombardi R., Bosco Zimatore G., Bossio R.B., Bramanti P., Brescia Morra V., Brioschi A.M., Bruzzone M., Buccafusca M., Busillo V., Caneve G., Caniatti L.M., Capone L., Capone F., Cappellani A., Cargnelutti D., Cavaletti G., Cavalla P., Celani M.G., Centonze D., Chiveri L., Clerici R., Clerico M., Cocco E., Comi C., Coniglio M.G., Cordera S., Corea F., Cortese A., Costantino G., Cottone S., Crociani P., D'Andrea F., Danni M.C., De Luca G., de Pascalis D., De Robertis F., De Stefano N., Di Battista G., Di Napoli M., Falcini M., Fausto F., Ferro M.T., Florio C., Fortunato M., Frittelli C., Galgani S., Gallo P., Gatto M., Gazzola P., Geda C., Giordano A., Granella F., Grasso M.G., Grimaldi L.M.E., Imperiale D., Lo Russo L., Logullo F.O., Lugaresi A., Lus G., Maccarrone G., Maimone D., Malagu S., Marconi R., Maritato P., Massacesi L., Mazzoni M., Meucci G., Mirabella M., Montepietra S., Nasuelli D., Neri W., Orefice G., Parodi S., Pasquali L., Passarella B., Peresson M., Perla F., Pesci I., Piantadosi C., Piras M.L., Pizio N.R., Pozzilli C., Protti A., Pugliatti M., Quatrale R., Ragno M., Rezzonico M., Ribizzi G., Riva M., Ronzoni M., Rosso M.G., Rottoli M., Rovaris M., Salemi G., Salvetti M., Santangelo M., Santangelo G., Santuccio G., Sarchielli P., Scarpini E., Sechi G.P., Severi S., Sinisi L., Sola P., Spitaleri D., Tassinari T., Tedeschi G., Tonietti S., Torri Clerici V., Totaro R., Traccis S., Turla M., Uccelli A., Ulivelli M., Valentino P., Valeriani M., Venturi S., Vianello M., Zaffaroni M., Trojano M, Bergamaschi R, Amato M.P, Comi G, Ghezzi A, Lepore V, Marrosu M.G, Mosconi P, Patti F, Ponzio M, Zaratin P, Battaglia M.A, Acquistapace D., Aguglia U., Annunziata P., Ardito B., Avolio C., Balgera R., Bandini F., Banfi P., Barone P., Bellantonio P., Bertolotto A., Bertora P., Bombardi R., Bosco Zimatore G., Bossio R.B., Bramanti P., Brescia Morra V., Brioschi A.M., Bruzzone M., Buccafusca M., Busillo V., Caneve G., Caniatti L.M., Capone L., Capone F., Cappellani A., Cargnelutti D., Cavaletti G., Cavalla P., Celani M.G., Centonze D., Chiveri L., Clerici R., Clerico M., Cocco E., Comi C., Coniglio M.G., Cordera S., Corea F., Cortese A., Costantino G., Cottone S., Crociani P., D’Andrea F., Danni M.C., De Luca G., de Pascalis D., De Robertis F., De Stefano N., Di Battista G., Di Napoli M., Falcini M., Fausto F., Ferrò M.T., Florio C., Fortunato M., Frittelli C., Galgani S., Gallo P., Gatto M., Gazzola P., Geda C., Giordano A., Granella F., Grasso M.G., Grimaldi L.M.E., Imperiale D., Lo Russo L., Logullo F.O., Lugaresi A., Lus G., Maccarrone G., Maimone D., Malagù S., Marconi R., Maritato P., Massacesi L., Mazzoni M., Meucci G., Mirabella M., Montepietra S., Nasuelli D., Neri W., Orefice G., Parodi S., Pasquali L., Passarella B., Peresson M., Perla F., Pesci I., Piantadosi C., Piras M.L., Pizio N.R., Pozzilli C., Protti A., Pugliatti M., Quatrale R., Ragno M., Rezzonico M., Ribizzi G., Riva M., Ronzoni M., Rosso M.G., Rottoli M., Rovaris M., Salemi G., Salvetti M., Santangelo M., Santangelo G., Santuccio G., Sarchielli P., Scarpini E., Sechi G.P., Severi S., Sinisi L., Sola P, Spitaleri D., Tassinari T., Tedeschi G., Tonietti S., Torri Clerici V., Totaro R., Traccis S., Turla M., Uccelli A., Ulivelli M., Valentino P., Valeriani M., Venturi S., Vianello M., Zaffaroni M., Trojano, Maria, Bergamaschi, Roberto, Amato, Maria Pia, Comi, Giancarlo, Ghezzi, Angelo, Lepore, Vito, Marrosu, Maria Giovanna, Mosconi, Paola, Patti, Francesco, Ponzio, Michela, Zaratin, Paola, Battaglia, Mario Alberto, Acquistapace, D, Aguglia, U, Amato, Mp, Annunziata, P, Ardito, B, Avolio, C, Balgera, R, Bandini, F, Banfi, P, Barone, P, Bellantonio, P, Bergamaschi, R, Bertolotto, A, Bertora, P, Bombardi, R, Bosco Zimatore, G, Bossio, Rb, Bramanti, P, Brescia Morra, V, Brioschi, Am, Bruzzone, M, Buccafusca, M, Busillo, V, Caneve, G, Caniatti, Lm, Capone, L, Capone, F, Cappellani, A, Cargnelutti, D, Cavaletti, G, Cavalla, P, Celani, Mg, Centonze, D, Chiveri, L, Clerici, R, Clerico, M, Cocco, E, Comi, G, Comi, C, Coniglio, Mg, Cordera, S, Corea, F, Cortese, A, Costantino, G, Cottone, S, Crociani, P, D'Andrea, F, Danni, Mc, De Luca, G, de Pascalis, D, De Robertis, F, De Stefano, N, Di Battista, G, Di Napoli, M, Falcini, M, Fausto, F, Ferrò, Mt, Florio, C, Fortunato, M, Frittelli, C, Galgani, S, Gallo, P, Gatto, M, Gazzola, P, Geda, C, Giordano, A, Granella, F, Grasso, Mg, Grimaldi, Lme, Imperiale, D, Lo Russo, L, Logullo, Fo, Lugaresi, A, Lus, G, Maccarrone, G, Maimone, D, Malagù, S, Marconi, R, Maritato, P, Massacesi, L, Mazzoni, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Neri, W, Orefice, G, Parodi, S, Pasquali, L, Passarella, B, Patti, F, Peresson, M, Perla, F, Pesci, I, Piantadosi, C, Piras, Ml, Pizio, Nr, Pozzilli, C, Protti, A, Pugliatti, M, Quatrale, R, Ragno, M, Rezzonico, M, Ribizzi, G, Riva, M, Ronzoni, M, Rosso, Mg, Rottoli, M, Rovaris, M, Salemi, G, Salvetti, M, Santangelo, M, Santangelo, G, Santuccio, G, Sarchielli, P, Scarpini, E, Sechi, Gp, Severi, S, Sinisi, L, Sola, P, Spitaleri, D, Tassinari, T, Tedeschi, G, Tonietti, S, Torri Clerici, V, Totaro, R, Traccis, S, Trojano, M, Turla, M, Uccelli, A, Ulivelli, M, Valentino, P, Valeriani, M, Venturi, S, Vianello, M, Zaffaroni, M., Amato, M, Ghezzi, A, Lepore, V, Marrosu, M, Mosconi, P, Ponzio, M, Zaratin, P, Battaglia, M, Bossio, R, Brioschi, A, Caniatti, L, Celani, M, Coniglio, M, D’Andrea, F, Danni, M, Ferrò, M, Grasso, M, Grimaldi, L, Logullo, F, Piras, M, Pizio, N, Rosso, M, Sechi, G, and Zaffaroni, M
Subjects: Register (sociolinguistics), Adult, Male, Knowledge management, Databases, Factual, Epidemiology, media_common.quotation_subject, Disease epidemiology, Multiple sclerosis, Quality of care, Register, Longitudinal Studie, Dermatology, NO, Cohort Studies, Databases, 03 medical and health sciences, 0302 clinical medicine, Multiple Sclerosi, Humans, Quality (business), Longitudinal Studies, 030212 general & internal medicine, Registries, Epidemiology, Multiple sclerosis, Quality of care, Register, Adult, Cohort Studies, Data Collection, Databases, Factual, Female, Humans, Italy, Longitudinal Studies, Male, Multiple Sclerosis, Registries, Factual, media_common, Data collection, business.industry, Data Collection, Correction, Female, Italy, Multiple Sclerosis, General Medicine, Register data, Psychiatry and Mental Health, Observational study, Original Article, Settore MED/26 - Neurologia, Business, Neurology (clinical), Cohort Studie, 030217 neurology & neurosurgery, 2708, Human
Abstract: The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups. The past decade has seen extraordinary increase in worldwide availability of and access to several large multiple sclerosis (MS) databases and registries. MS registries represent powerful tools to provide meaningful information on the burden, natural history, and long-term safety and effectiveness of treatments. Moreover, patients, physicians, industry, and policy makers have an active interest in real-world observational studies based on register data, as they have the potential to answer the questions that are most relevant to daily treatment decision-making. In 2014, the Italian MS Foundation, in collaboration with the Italian MS clinical centers, promoted and funded the creation of the Italian MS Register, a project in continuity with the existing Italian MS Database Network set up from 2001. Main objective of the Italian MS Register is to create an organized multicenter structure to collect data of all MS patients for better defining the disease epidemiology, improving quality of care, and promoting research projects in high-priority areas. The aim of this article is to present the current framework and network of the Italian MS register, including the methodology used to improve the quality of data collection and to facilitate the exchange of data and the collaboration among national and international groups.
Published: 2019

10. Delay from treatment start to full effect of immunotherapies for multiple sclerosis

Author: Roos, I, Leray, E, Frascoli, F, Casey, R, Brown, WJL, Horakova, D, Havrdova, EK, Trojano, M, Patti, F, Izquierdo, G, Eichau, S, Onofrj, M, Lugaresi, A, Prat, A, Girard, M, Grammond, P, Sola, P, Ferraro, D, Ozakbas, S, Bergamaschi, R, Sá, MJ, Cartechini, E, Boz, C, Granella, F, Hupperts, R, Terzi, M, Lechner-Scott, J, Spitaleri, D, van Pesch, V, Soysal, A, Olascoaga, J, Prevost, J, Aguera-Morales, E, Slee, M, Csepany, T, Turkoglu, R, Sidhom, Y, Gouider, R, van Wijmeersch, B, McCombe, P, Macdonell, R, Coles, A, Malpas, CB, Butzkueven, H, Vukusic, S, Kalincik, T, Duquette, P, Grand'Maison, F, Iuliano, G, Ramo-Tello, C, Solaro, C, Cabrera-Gomez, JA, Rio, ME, Bolaños, RF, Shaygannejad, V, Oreja-Guevara, C, Sanchez-Menoyo, JL, Petersen, T, Altintas, A, Barnett, M, Flechter, S, Fragoso, Y, Amato, MP, Moore, F, Ampapa, R, Verheul, F, Hodgkinson, S, Cristiano, E, Yamout, B, Laureys, G, Dominguez, JA, Zwanikken, C, Deri, N, Dobos, E, Vrech, C, Butler, E, Rozsa, C, Petkovska-Boskova, T, Karabudak, R, Rajda, C, Alkhaboori, J, Saladino, ML, Shaw, Cameron, Shuey, N, Vucic, S, Sempere, AP, Campbell, J, Piroska, I, Taylor, B, van der Walt, A, Kappos, L, Roullet, E, Gray, O, Simo, M, Sirbu, CA, Brochet, B, Cotton, F, de Sèze, J, Dion, A, Douek, P, Roos, I, Leray, E, Frascoli, F, Casey, R, Brown, WJL, Horakova, D, Havrdova, EK, Trojano, M, Patti, F, Izquierdo, G, Eichau, S, Onofrj, M, Lugaresi, A, Prat, A, Girard, M, Grammond, P, Sola, P, Ferraro, D, Ozakbas, S, Bergamaschi, R, Sá, MJ, Cartechini, E, Boz, C, Granella, F, Hupperts, R, Terzi, M, Lechner-Scott, J, Spitaleri, D, van Pesch, V, Soysal, A, Olascoaga, J, Prevost, J, Aguera-Morales, E, Slee, M, Csepany, T, Turkoglu, R, Sidhom, Y, Gouider, R, van Wijmeersch, B, McCombe, P, Macdonell, R, Coles, A, Malpas, CB, Butzkueven, H, Vukusic, S, Kalincik, T, Duquette, P, Grand'Maison, F, Iuliano, G, Ramo-Tello, C, Solaro, C, Cabrera-Gomez, JA, Rio, ME, Bolaños, RF, Shaygannejad, V, Oreja-Guevara, C, Sanchez-Menoyo, JL, Petersen, T, Altintas, A, Barnett, M, Flechter, S, Fragoso, Y, Amato, MP, Moore, F, Ampapa, R, Verheul, F, Hodgkinson, S, Cristiano, E, Yamout, B, Laureys, G, Dominguez, JA, Zwanikken, C, Deri, N, Dobos, E, Vrech, C, Butler, E, Rozsa, C, Petkovska-Boskova, T, Karabudak, R, Rajda, C, Alkhaboori, J, Saladino, ML, Shaw, Cameron, Shuey, N, Vucic, S, Sempere, AP, Campbell, J, Piroska, I, Taylor, B, van der Walt, A, Kappos, L, Roullet, E, Gray, O, Simo, M, Sirbu, CA, Brochet, B, Cotton, F, de Sèze, J, Dion, A, and Douek, P
Published: 2020

11. Sex effects across the lifespan in women with multiple sclerosis

Author: Krysko, KM, Graves, JS, Dobson, R, Altintas, A, Amato, MP, Bernard, J, Bonavita, S, Bove, R, Cavalla, P, Clerico, M, Corona, T, Doshi, A, Fragoso, Y, Jacobs, D, Jokubaitis, V, Landi, D, Llamosa, G, Longbrake, EE, Maillart, E, Marta, M, Midaglia, L, Shah, S, Tintore, M, van der Walt, A, Voskuhl, R, Wang, Y, Zabad, RK, Zeydan, B, Houtchens, M, Hellwig, K, Krysko, KM, Graves, JS, Dobson, R, Altintas, A, Amato, MP, Bernard, J, Bonavita, S, Bove, R, Cavalla, P, Clerico, M, Corona, T, Doshi, A, Fragoso, Y, Jacobs, D, Jokubaitis, V, Landi, D, Llamosa, G, Longbrake, EE, Maillart, E, Marta, M, Midaglia, L, Shah, S, Tintore, M, van der Walt, A, Voskuhl, R, Wang, Y, Zabad, RK, Zeydan, B, Houtchens, M, and Hellwig, K
Abstract: Multiple sclerosis (MS) is an autoimmune inflammatory demyelinating central nervous system disorder that is more common in women, with onset often during reproductive years. The female:male sex ratio of MS rose in several regions over the last century, suggesting a possible sex by environmental interaction increasing MS risk in women. Since many with MS are in their childbearing years, family planning, including contraceptive and disease-modifying therapy (DMT) counselling, are important aspects of MS care in women. While some DMTs are likely harmful to the developing fetus, others can be used shortly before or until pregnancy is confirmed. Overall, pregnancy decreases risk of MS relapses, whereas relapse risk may increase postpartum, although pregnancy does not appear to be harmful for long-term prognosis of MS. However, ovarian aging may contribute to disability progression in women with MS. Here, we review sex effects across the lifespan in women with MS, including the effect of sex on MS susceptibility, effects of pregnancy on MS disease activity, and management strategies around pregnancy, including risks associated with DMT use before and during pregnancy, and while breastfeeding. We also review reproductive aging and sexual dysfunction in women with MS.
Published: 2020

12. Aggressive multiple sclerosis (2): Treatment.

Author: Arrambide, G, Iacobaeus, E, Amato, MP, Derfuss, T, Vukusic, S, Hemmer, B, Brundin, L, Tintore, M, 2018 ECTRIMS Focused Workshop Group, Arrambide, G, Iacobaeus, E, Amato, MP, Derfuss, T, Vukusic, S, Hemmer, B, Brundin, L, Tintore, M, and 2018 ECTRIMS Focused Workshop Group
Abstract: The natural history of multiple sclerosis (MS) is highly heterogeneous. A subgroup of patients has what might be termed aggressive MS. These patients may have frequent, severe relapses with incomplete recovery and are at risk of developing greater and permanent disability at the earlier stages of the disease. Their therapeutic window of opportunity may be narrow, and while it is generally considered that they will benefit from starting early with a highly efficacious treatment, a unified definition of aggressive MS does not exist and data on its treatment are largely lacking. Based on discussions at an international focused workshop sponsored by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), we review our current knowledge about treatment of individuals with aggressive MS. We analyse the available evidence, identify gaps in knowledge and suggest future research needed to fill those gaps. A companion paper details the difficulties in developing a consensus about what defines aggressive MS.
Published: 2020

13. Aggressive multiple sclerosis (1): Towards a definition of the phenotype.

Author: Iacobaeus, E, Arrambide, G, Amato, MP, Derfuss, T, Vukusic, S, Hemmer, B, Tintore, M, Brundin, L, 2018 ECTRIMS Focused Workshop Group, Iacobaeus, E, Arrambide, G, Amato, MP, Derfuss, T, Vukusic, S, Hemmer, B, Tintore, M, Brundin, L, and 2018 ECTRIMS Focused Workshop Group
Abstract: While the major phenotypes of multiple sclerosis (MS) and relapsing-remitting, primary and secondary progressive MS have been well characterized, a subgroup of patients with an active, aggressive disease course and rapid disability accumulation remains difficult to define and there is no consensus about their management and treatment. The current lack of an accepted definition and treatment guidelines for aggressive MS triggered a 2018 focused workshop of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on aggressive MS. The aim of the workshop was to discuss approaches on how to describe and define the disease phenotype and its treatments. Unfortunately, it was not possible to come to consensus on a definition because of unavailable data correlating severe disease with imaging and molecular biomarkers. However, the workshop highlighted the need for future research needed to define this disease subtype while also focusing on its treatment and management. Here, we review previous attempts to define aggressive MS and present characteristics that might, with additional research, eventually help characterize it. A companion paper summarizes data regarding treatment and management.
Published: 2020

14. Clinical trials of disease-modifying agents in pediatric MS Opportunities, challenges, and recommendations from the IPMSSG

Author: Waubant, E, Banwell, B, Wassmer, E, Sormani, MP, Amato, MP, Hintzen, Rogier, Krupp, L, Rostasy, K, Tenembaum, S, Chitnis, T, Waubant, E, Banwell, B, Wassmer, E, Sormani, MP, Amato, MP, Hintzen, Rogier, Krupp, L, Rostasy, K, Tenembaum, S, and Chitnis, T
Published: 2019

15. Management of pregnancy-related issues in multiple sclerosis patients: the need for an interdisciplinary approach

Author: Amato MP, Bertolotto A, Brunelli R, Cavalla P, Goretti B, Marrosu MG, Patti F, Pozzilli C, Provinciali L, Rizzo N, Strobelt N, Tedeschi G, Trojano M, Comi G., and Amato MP, Bertolotto A, Brunelli R, Cavalla P, Goretti B, Marrosu MG, Patti F, Pozzilli C, Provinciali L, Rizzo N, Strobelt N, Tedeschi G, Trojano M, Comi G.
Subjects: Treatment, Glatiramer acetate, Pregnancy, Multiple sclerosi, Interdisciplinary approach, Relapse
Abstract: Multiple sclerosis (MS) is a demyelinating and neurodegenerative disease of the central nervous system (CNS), most probably autoimmune in origin, usually occurring in young adults with a female/male prevalence of approximately 3:1. Women with MS in the reproductive age may face challenging issues in reconciling the desire for parenthood with their condition, owing to the possible influence both on the ongoing or planned treatment with the possible consequences on the disease course and on the potential negative effects of treatments on foetal and pregnancy outcomes. At MS diagnosis, timely counselling should promote informed parenthood, while disease evolution should be assessed before making therapeutic decisions. Current guidelines advise the discontinuation of any treatment during pregnancy, with possible exceptions for some treatments in patients with very active disease. Relapses decline during pregnancy but are more frequent during puerperium, when MS therapy should be promptly resumed in most of the cases. First-line immunomodulatory agents, such as interferon-β (IFN-β) and glatiramer acetate (GA), significantly reduce the post-partum risk of relapse. Due to substantial evidence of safety with the use of GA during pregnancy, a recent change in European marketing authorization removed the pregnancy contraindication for GA. This paper reports a consensus of Italian experts involved in MS management, including neurologists, gynaecologists and psychologists. This consensus, based on a review of the available scientific evidence, promoted an interdisciplinary approach to the management of pregnancy in MS women.
Published: 2017

16. Gender Inequities in the Multiple Sclerosis Community: A Call for Action

Author: Waubant, E, Amezcua, L, Sicotte, N, Hellwig, K, Krupp, L, Weinstock-Guttman, B, Yeh, A, Lucas, RM, Longbrake, EE, Yadav, V, Rensel, M, Mar, S, Hersh, C, Block, V, Zipp, F, Han, MH, Spain, R, Kelland, EE, Charvet, L, Dimitri, D, Papeix, C, Cross, AH, Inglese, M, Amato, MP, Airas, L, Leray, E, Sormani, MP, Van der Walt, A, Vukusic, S, Castillo-Trivino, T, Tenembaum, S, Ciccarelli, O, Bommarito, G, Petracca, M, Celius, EG, Carson, MJ, Hua, LH, Van der Mei, I, Lubetzki, C, Jokubaitis, V, Trojano, M, Voskuhl, R, Tintore, M, Harbo, H, Asgari, N, Piccio, L, Burton, JM, Tremlett, H, Goldman, MD, Michel, L, Zhang, Y, Bove, R, Quandt, JA, Costello, F, Ionete, C, Lebrun-Frenay, C, Pakpoor, J, Bevan, C, Morrow, SA, Waldman, AT, Oh, J, Jacobs, D, Palace, J, Marrie, RA, Tiwari-Woodruff, SK, Metz, LM, Cortese, R, Chitnis, T, Benson, L, Benveniste, ET, Conway, J, Sand, IK, Murphy, JO, Kita, M, Riley, C, Goverman, JM, Langer-Gould, AM, Azevedo, CJ, Morales, IB, Barcellos, LF, Crabtree, E, Plummer, P, Shirani, A, Whartenby, K, Brilot-Turville, F, Kingwell, E, Coyle, P, Mowry, E, Zabad, R, Bielekova, B, Monson, N, Laule, C, Burnett, M, Schreiner, T, Grinspan, J, Dobson, R, Akassoglou, K, Graves, J, Gray, O, Smyth, P, Havrdova, EK, Preiningerova, JL, Banwell, B, Makhani, N, Lucchinetti, C, Arrambide, G, Maillart, E, Macklin, W, Gilmore, W, Waubant, E, Amezcua, L, Sicotte, N, Hellwig, K, Krupp, L, Weinstock-Guttman, B, Yeh, A, Lucas, RM, Longbrake, EE, Yadav, V, Rensel, M, Mar, S, Hersh, C, Block, V, Zipp, F, Han, MH, Spain, R, Kelland, EE, Charvet, L, Dimitri, D, Papeix, C, Cross, AH, Inglese, M, Amato, MP, Airas, L, Leray, E, Sormani, MP, Van der Walt, A, Vukusic, S, Castillo-Trivino, T, Tenembaum, S, Ciccarelli, O, Bommarito, G, Petracca, M, Celius, EG, Carson, MJ, Hua, LH, Van der Mei, I, Lubetzki, C, Jokubaitis, V, Trojano, M, Voskuhl, R, Tintore, M, Harbo, H, Asgari, N, Piccio, L, Burton, JM, Tremlett, H, Goldman, MD, Michel, L, Zhang, Y, Bove, R, Quandt, JA, Costello, F, Ionete, C, Lebrun-Frenay, C, Pakpoor, J, Bevan, C, Morrow, SA, Waldman, AT, Oh, J, Jacobs, D, Palace, J, Marrie, RA, Tiwari-Woodruff, SK, Metz, LM, Cortese, R, Chitnis, T, Benson, L, Benveniste, ET, Conway, J, Sand, IK, Murphy, JO, Kita, M, Riley, C, Goverman, JM, Langer-Gould, AM, Azevedo, CJ, Morales, IB, Barcellos, LF, Crabtree, E, Plummer, P, Shirani, A, Whartenby, K, Brilot-Turville, F, Kingwell, E, Coyle, P, Mowry, E, Zabad, R, Bielekova, B, Monson, N, Laule, C, Burnett, M, Schreiner, T, Grinspan, J, Dobson, R, Akassoglou, K, Graves, J, Gray, O, Smyth, P, Havrdova, EK, Preiningerova, JL, Banwell, B, Makhani, N, Lucchinetti, C, Arrambide, G, Maillart, E, Macklin, W, and Gilmore, W
Published: 2018

17. Long-term disability trajectories in primary progressive MS patients: A latent class growth analysis

Author: Signori, A, Izquierdo, G, Lugaresi, A, Hupperts, R, Grand'Maison, F, Sola, P, Horakova, D, Havrdova, E, Prat, A, Girard, M, Duquette, P, Boz, C, Grammond, P, Terzi, M, Singhal, B, Alroughani, R, Petersen, T, Ramo, C, Oreja-Guevara, C, Spitaleri, D, Shaygannejad, V, Butzkueven, H, Kalincik, T, Jokubaitis, V, Slee, M, Fernandez Bolanos, R, Luis Sanchez-Menoyo, J, Pucci, E, Granella, F, Lechner-Scott, J, Iuliano, G, Hughes, S, Bergamaschi, R, Taylor, B, Verheul, F, Rio, ME, Amato, MP, Sajedi, SA, Majdinasab, N, Van Pesch, V, Sormani, MP, Trojano, M, Signori, A, Izquierdo, G, Lugaresi, A, Hupperts, R, Grand'Maison, F, Sola, P, Horakova, D, Havrdova, E, Prat, A, Girard, M, Duquette, P, Boz, C, Grammond, P, Terzi, M, Singhal, B, Alroughani, R, Petersen, T, Ramo, C, Oreja-Guevara, C, Spitaleri, D, Shaygannejad, V, Butzkueven, H, Kalincik, T, Jokubaitis, V, Slee, M, Fernandez Bolanos, R, Luis Sanchez-Menoyo, J, Pucci, E, Granella, F, Lechner-Scott, J, Iuliano, G, Hughes, S, Bergamaschi, R, Taylor, B, Verheul, F, Rio, ME, Amato, MP, Sajedi, SA, Majdinasab, N, Van Pesch, V, Sormani, MP, and Trojano, M
Abstract: BACKGROUND: Several natural history studies on primary progressive multiple sclerosis (PPMS) patients detected a consistent heterogeneity in the rate of disability accumulation. OBJECTIVES: To identify subgroups of PPMS patients with similar longitudinal trajectories of Expanded Disability Status Scale (EDSS) over time. METHODS: All PPMS patients collected within the MSBase registry, who had their first EDSS assessment within 5 years from onset, were included in the analysis. Longitudinal EDSS scores were modeled by a latent class mixed model (LCMM), using a nonlinear function of time from onset. LCMM is an advanced statistical approach that models heterogeneity between patients by classifying them into unobserved groups showing similar characteristics. RESULTS: A total of 853 PPMS (51.7% females) from 24 countries with a mean age at onset of 42.4 years (standard deviation (SD): 10.8 years), a median baseline EDSS of 4 (interquartile range (IQR): 2.5-5.5), and 2.4 years of disease duration (SD: 1.5 years) were included. LCMM detected three different subgroups of patients with a mild ( n = 143; 16.8%), moderate ( n = 378; 44.3%), or severe ( n = 332; 38.9%) disability trajectory. The probability of reaching EDSS 6 at 10 years was 0%, 46.4%, and 81.9% respectively. CONCLUSION: Applying an LCMM modeling approach to long-term EDSS data, it is possible to identify groups of PPMS patients with different prognosis.
Published: 2018

18. Guidelines on the clinical use for the detection of neutralizing antibodies (NAbs) to IFN beta in multiple sclerosis therapy: report from the Italian Multiple Sclerosis Study group

Author: Bertolotto A, Capobianco M, Amato MP, Capello E, Capra R, Centonze D, Di Ioia M, Grimaldi L, Imberti L, Lugaresi A, Mancinelli C, Marrosu MG, Moiola L, Montanari E, Romano S, Musu L, Paolicelli D, Patti F, Pozzilli C, Rossi S, Salvetti M, Tola MR, Troiano M, Zaffaroni M, Malucchi S, Italian Multiple Sclerosis Study group, GALLO, Antonio, TEDESCHI, Gioacchino, Bertolotto A, Capobianco M, Amato MP, Capello E, Capra R, Centonze D, Di Ioia M, Gallo A, Grimaldi L, Imberti L, Lugaresi A, Mancinelli C, Marrosu MG, Moiola L, Montanari E, Romano S, Musu L, Paolicelli D, Patti F, Pozzilli C, Rossi S, Salvetti M, Tedeschi G, Tola MR, Troiano M, Zaffaroni M, Malucchi S, Bertolotto, A, Capobianco, M, Amato, Mp, Capello, E, Capra, R, Centonze, D, Di Ioia, M, Gallo, Antonio, Grimaldi, L, Imberti, L, Lugaresi, A, Mancinelli, C, Marrosu, Mg, Moiola, L, Montanari, E, Romano, S, Musu, L, Paolicelli, D, Patti, F, Pozzilli, C, Rossi, S, Salvetti, M, Tedeschi, Gioacchino, Tola, Mr, Troiano, M, Zaffaroni, M, Malucchi, S, and Italian Multiple Sclerosis Study, Group
Subjects: Myxovirus Resistance Proteins, Oncology, medicine.medical_specialty, Multiple Sclerosis, Neurology, neutralizing antibodies, guidelines, immunogenicity, ifnβ, multiple sclerosis, ifn beta, interferon, antibodies, multiple sclerosis, Dermatology, Disease activity, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Humans, Immunologic Factors, Clinical significance, Beta (finance), Randomized Controlled Trials as Topic, medicine.diagnostic_test, biology, business.industry, Multiple sclerosis, Magnetic resonance imaging, Interferon-beta, General Medicine, medicine.disease, Antibodies, Neutralizing, Magnetic Resonance Imaging, Psychiatry and Mental health, Early Diagnosis, Italy, Immunology, biology.protein, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, Antibody, business
Abstract: Interferon beta (IFNβ) was the first specific disease-modifying treatment licensed for relapsing-remitting multiple sclerosis, and is still one of the most commonly prescribed treatments. A strong body of evidence supports the effectiveness of IFNβ preparations in reducing the annual relapse rate, magnetic resonance (MRI) disease activity and disease progression. However, the development of binding/neutralizing antibodies (BAbs/NAbs) during treatment negatively affects clinical and MRI outcomes. Therefore, guidelines for the clinical use for the detection of NAbs in MS may result in better treatment of these patients. In October 2012, a panel of Italian neurologists from 17 MS clinics convened in Milan to review and discuss data on NAbs and their clinical relevance in the treatment of MS. In this paper, we report the panel's recommendations for the use of IFNβ Nabs detection in the early identification of IFNβ non-responsiveness and the management of patients on IFNβ treatment in Italy, according to a model of therapeutically appropriate care.
Published: 2014

19. Subcutaneous interferon β-1a may protect against cognitive impairment in patients with relapsing-remitting multiple sclerosis: 5-year follow-up of the COGIMUS study

Author: Patti, F, Lo, S, Messina, S, Vecchio, R, Maimone, D, Gasperini, C, Orefice, G, Brescia Morra, V, Florio, C, Amato, Mp, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, Paolo, Perini, Paola, Gigli, Gl, Giuliani, G, Grimaldi, Lm, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, G, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, Mr, Caniatti, L, Tonali, P, Batocchi, Ap, Trojano, M, Di Monte, E, De Caro MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, Tartaglione, A., Patti, F, Lo, S, Messina, S, Vecchio, R, Maimone, D, Gasperini, C, Orefice, G, Brescia-Morra, V, Florio, C, Amato, MP, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, G, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, MR, Caniatti, L, Tonali, P, Batocchi, AP, Trojano, M, Di Monte, E, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, Tartaglione, A, BRESCIA MORRA, Vincenzo, Amato, Mp, Bastianello, S, Tola, Mr, Plant, A, Orefice, Giuseppe, and G.
Subjects: Adult, Male, medicine.medical_specialty, 5 year follow up, Multiple Sclerosis, Adolescent, Science, Injections, Subcutaneous, Brain damage, Young Adult, Interferon, Recurrence, Internal medicine, medicine, Humans, In patient, Young adult, Cognitive impairment, Sex Characteristics, Multidisciplinary, medicine.diagnostic_test, business.industry, Multiple sclerosis, Multiple Sclerosis, Subcutaneous interferon β-1a, cognitive impairment, Magnetic resonance imaging, Interferon-beta, medicine.disease, Treatment Outcome, Immunology, Medicine, Female, Settore MED/26 - Neurologia, medicine.symptom, Safety, business, Cognition Disorders, Interferon beta-1a, medicine.drug, Research Article, Follow-Up Studies
Abstract: ObjectiveTo assess the effects of subcutaneous (sc) interferon (IFN) -1a on cognition over 5 years in mildly disabled patients with relapsing-remitting multiple sclerosis (RRMS).MethodsPatients aged 18-50 years with RRMS (Expanded Disability Status Scale score ≤4.0) who had completed the 3-year COGIMUS study underwent standardized magnetic resonance imaging, neurological examination, and neuropsychological testing at years 4 and 5. Predictors of cognitive impairment at year 5 were identified using multivariate analysis.ResultsOf 331 patients who completed the 3-year COGIMUS study, 265 participated in the 2-year extension study, 201 of whom (75.8%; sc IFN β-1a three times weekly: 44 µg, n = 108; 22 µg, n = 93) completed 5 years' follow-up. The proportion of patients with cognitive impairment in the study population overall remained stable between baseline (18.0%) and year 5 (22.6%). The proportion of patients with cognitive impairment also remained stable in both treatment groups between baseline and year 5, and between year 3 and year 5. However, a significantly higher proportion of men than women had cognitive impairment at year 5 (26.5% vs 14.4%, p = 0.046). Treatment with the 22 versus 44 µg dose was predictive of cognitive impairment at year 5 (hazard ratio 0.68; 95% confidence interval 0.48-0.97).ConclusionsThis study suggests that sc IFN β-1a dose-dependently stabilizes or delays cognitive impairment over a 5-year period in most patients with mild RRMS. Women seem to be more protected against developing cognitive impairment, which may indicate greater response to therapy or the inherently better prognosis associated with female sex in MS.
Published: 2013

20. Endovascular treatment of CCSVI in patients with multiple sclerosis: clinical outcome of 462 cases

Author: Ghezzi A, Annovazzi P, Cocco E, Coarelli G, Lugaresi A, Rovaris M, Patti F, Capello E, Rodegher ME, Moiola L, Malucchi S, Salemi G, De Rossi N, Provinciali L, Perini P, Bergamaschi R, Scarpini E, Lus G, Gallo A, Tola MR, Amato MP, Rottoli MR, Bianchi A, MS Study Group Italian Society of Neurology, COMI , GIANCARLO, Ghezzi, A, Annovazzi, P, Cocco, E, Coarelli, G, Lugaresi, A, Rovaris, M, Patti, F, Capello, E, Rodegher, Me, Moiola, L, Malucchi, S, Salemi, G, De Rossi, N, Provinciali, L, Perini, P, Bergamaschi, R, Scarpini, E, Lus, G, Gallo, A, Tola, Mr, Amato, Mp, Rottoli, Mr, Bianchi, A, Comi, Giancarlo, MS Study Group Italian Society of, Neurology, Ghezzi A, Annovazzi P, Cocco E, Coarelli G, Lugaresi A, Rovaris M, Patti F, Capello E, Rodegher ME, Moiola L, Malucchi S, Salemi G, De Rossi N, Provinciali L, Perini P, Bergamaschi R, Scarpini E, Lus G, Gallo A, Tola MR, Amato MP, Rottoli MR, Bianchi A, Comi G, The MS Study Group-Italian Society of Neurology, Lus, Giacomo, Gallo, Antonio, Comi, G, The MS Study Group Italian Society of, Neurology, Rodegher, ME, Tola, MR, Amato, MP, and Rottoli, MR
Subjects: Adult, Male, Pediatrics, medicine.medical_specialty, Multiple Sclerosis, medicine.medical_treatment, endovascular, multiple sclerosis, treatment, venous, Dermatology, Balloon dilatation, Cohort Studies, Surveys and Questionnaires, Medicine, Humans, In patient, Endovascular treatment, Adverse effect, Beneficial effects, business.industry, Multiple sclerosis, Endovascular Procedures, Stent, Brain, Retrospective cohort study, General Medicine, Middle Aged, medicine.disease, Surgery, Psychiatry and Mental health, Treatment Outcome, Spinal Cord, Venous Insufficiency, Settore MED/26 - Neurologia, Female, Neurology (clinical), business, Multiple sclerosis CCSVI Endovascular treatment, Follow-Up Studies
Abstract: Although it is still debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients underwent endovascular treatment (ET) of CCSVI. The objective of the study is to evaluate the outcome and safety of ET in Italian MS patients. Italian MS centers that are part of the Italian MS Study Group were all invited to participate to this retrospective study. A structured questionnaire was used to collect detailed clinical data before and after the ET. Data from 462 patients were collected in 33 centers. ET consisted of balloon dilatation (93 % of cases) or stent application. The mean follow-up duration after ET was 31 weeks. Mean EDSS remained unchanged after ET (5.2 vs. 4.9), 144 relapses occurred in 98/462 cases (21 %), mainly in RR-MS patients. Fifteen severe adverse events were recorded in 3.2 % of cases. Given the risk of severe adverse events and the lack of objective beneficial effects, our findings confirm that at present ET should not be recommended to patients with MS.
Published: 2013

21. Natalizumab therapy of multiple sclerosis: recommendations of the Multiple Sclerosis Study Group-Italian Neurological Society

Author: GHEZZI A, GRIMALDI LM, MARROSU MG, POZZILLI C, COMI G, BERTOLOTTO A, TROJANO M, GALLO P, CAPRA R, CENTONZE D, MILLEFIORINI E, SOTGIU S, BRESCIA MORRA V, AMATO MP, LUGARESI A, MANCARDI G, CAPUTO D, MONTANARI E, PROVINCIALI L, DURELLI L, BERGAMASCHI R, BELLANTONIO P, TOLA MR, COTTONE S, SAVETTIERI G, MS SIN STUDY GROUP, TEDESCHI, Gioacchino, Ghezzi, A, Grimaldi, Lm, Marrosu, Mg, Pozzilli, C, Comi, G, Bertolotto, A, Trojano, M, Gallo, P, Capra, R, Centonze, D, Millefiorini, E, Sotgiu, S, BRESCIA MORRA, V, Amato, Mp, Lugaresi, A, Mancardi, G, Caputo, D, Montanari, E, Provinciali, L, Durelli, L, Bergamaschi, R, Bellantonio, P, Tola, Mr, Cottone, S, Savettieri, G, Tedeschi, Gioacchino, MS SIN STUDY, Group, Comi, Giancarlo, Brescia Morra, V, Tedeschi, G, MS SIN Study, Group, Ghezzi A, Grimaldi LM, Marrosu MG, Pozzilli C, Comi G, Bertolotto A, Trojano M, Gallo P, Capra R, Centonze D, Millefiorini E, Sotgiu S, Brescia Morra V, Amato MP, Lugaresi A, Mancardi G, Caputo D, Montanari E, Provinciali L, Durelli L, Bergamaschi R, Bellantonio P, Tola MR, Cottone S, Savettieri G, Tedeschi G, MS-SIN Study Group, BRESCIA MORRA, Vincenzo, Ghezzi,A, Grimaldi,LM, Marrosu,MG, Comi,G, Bertolotto,A, Centonze. D, Amato,MP, Tola, MR, and MS-SIN Study Group.
Subjects: medicine.medical_specialty, Pediatrics, pml, iris, multiple sclerosis, natalizumab, Multiple Sclerosis, Neurology, MEDLINE, Progressive Multifocal, Dermatology, Relapsing-Remitting, Antibodies, Monoclonal, Humanized, Antibodies, Leukoencephalopathy, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Monoclonal, medicine, Humans, Adverse effect, Humanized, Antibodies, therapeutic use, Humans, Leukoencephalopathy, chemically induced, Multiple Sclerosis, drug therapy, Humanized, Multiple sclerosis, Natalizumab, PML, IRIS, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Leukoencephalopathy, Progressive Multifocal, Antibodies, Monoclonal, General Medicine, medicine.disease, Psychiatry and Mental health, therapeutic use, chemically induced, natalizumab, multiple sclerosis, treatment, guidelines, Physical therapy, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, business, medicine.drug
Abstract: Three years after the introduction of natalizumab (NA) therapy for the second line treatment of relapsing-remitting multiple sclerosis (MS), Italian MS centers critically reviewed the scientific literature and their own clinical experience. Natalizumab was shown to be highly efficacious in the treatment of MS. However, the risk of progressive multifocal leukoencephalopathy was confirmed and defined better. This article summarizes the MS-SIN Study Group recommendations on the use of NA in MS, with particular reference to the appropriate selection and monitoring of patients as well as to the management of adverse events.
Published: 2011

22. Towards personalized therapy for multiple sclerosis: prediction of individual treatment response

Author: Kalincik, T, Manouchehrinia, A, Sobisek, L, Jokubaitis, V, Spelman, T, Horakova, D, Havrdova, E, Trojano, M, Izquierdo, G, Lugaresi, A, Girard, M, Prat, A, Duquette, P, Grammond, P, Sola, P, Hupperts, R, Grand'Maison, F, Pucci, E, Boz, C, Alroughani, R, Van Pesch, V, Lechner-Scott, J, Terzi, M, Bergamaschi, R, Iuliano, G, Granella, F, Spitaleri, D, Shaygannejad, V, Oreja-Guevara, C, Slee, M, Ampapa, R, Verheul, F, McCombe, P, Olascoaga, J, Amato, MP, Vucic, S, Hodgkinson, S, Ramo-Tello, C, Flechter, S, Cristiano, E, Rozsa, C, Moore, F, Luis Sanchez-Menoyo, J, Laura Saladino, M, Barnett, M, Hillert, J, Butzkueven, H, Kalincik, T, Manouchehrinia, A, Sobisek, L, Jokubaitis, V, Spelman, T, Horakova, D, Havrdova, E, Trojano, M, Izquierdo, G, Lugaresi, A, Girard, M, Prat, A, Duquette, P, Grammond, P, Sola, P, Hupperts, R, Grand'Maison, F, Pucci, E, Boz, C, Alroughani, R, Van Pesch, V, Lechner-Scott, J, Terzi, M, Bergamaschi, R, Iuliano, G, Granella, F, Spitaleri, D, Shaygannejad, V, Oreja-Guevara, C, Slee, M, Ampapa, R, Verheul, F, McCombe, P, Olascoaga, J, Amato, MP, Vucic, S, Hodgkinson, S, Ramo-Tello, C, Flechter, S, Cristiano, E, Rozsa, C, Moore, F, Luis Sanchez-Menoyo, J, Laura Saladino, M, Barnett, M, Hillert, J, and Butzkueven, H
Abstract: Timely initiation of effective therapy is crucial for preventing disability in multiple sclerosis; however, treatment response varies greatly among patients. Comprehensive predictive models of individual treatment response are lacking. Our aims were: (i) to develop predictive algorithms for individual treatment response using demographic, clinical and paraclinical predictors in patients with multiple sclerosis; and (ii) to evaluate accuracy, and internal and external validity of these algorithms. This study evaluated 27 demographic, clinical and paraclinical predictors of individual response to seven disease-modifying therapies in MSBase, a large global cohort study. Treatment response was analysed separately for disability progression, disability regression, relapse frequency, conversion to secondary progressive disease, change in the cumulative disease burden, and the probability of treatment discontinuation. Multivariable survival and generalized linear models were used, together with the principal component analysis to reduce model dimensionality and prevent overparameterization. Accuracy of the individual prediction was tested and its internal validity was evaluated in a separate, non-overlapping cohort. External validity was evaluated in a geographically distinct cohort, the Swedish Multiple Sclerosis Registry. In the training cohort (n = 8513), the most prominent modifiers of treatment response comprised age, disease duration, disease course, previous relapse activity, disability, predominant relapse phenotype and previous therapy. Importantly, the magnitude and direction of the associations varied among therapies and disease outcomes. Higher probability of disability progression during treatment with injectable therapies was predominantly associated with a greater disability at treatment start and the previous therapy. For fingolimod, natalizumab or mitoxantrone, it was mainly associated with lower pretreatment relapse activity. The probability of disability
Published: 2017

23. Prognostic Indicators in Pediatric Clinically Isolated Syndrome

Author: Iaffaldano, P, Simone, M, Lucisano, G, Ghezzi, A, Coniglio, G, Morra, VB, Salemi, G, Patti, F, Lugaresi, A, Izquierdo, G, Bergamaschi, R, Cabrera-Gomez, JA, Pozzilli, C, Millefiorini, E, Alroughani, R, Boz, C, Pucci, E, Zimatore, GB, Sola, P, Lus, G, Maimone, D, Avolio, C, Cocco, E, Sajedi, SA, Costantino, G, Duquette, P, Shaygannejad, V, Petersen, T, Fernandez Bolanos, R, Paolicelli, D, Tortorella, C, Spelman, T, Margari, L, Amato, MP, Comi, G, Butzkueven, H, Trojano, M, Iaffaldano, P, Simone, M, Lucisano, G, Ghezzi, A, Coniglio, G, Morra, VB, Salemi, G, Patti, F, Lugaresi, A, Izquierdo, G, Bergamaschi, R, Cabrera-Gomez, JA, Pozzilli, C, Millefiorini, E, Alroughani, R, Boz, C, Pucci, E, Zimatore, GB, Sola, P, Lus, G, Maimone, D, Avolio, C, Cocco, E, Sajedi, SA, Costantino, G, Duquette, P, Shaygannejad, V, Petersen, T, Fernandez Bolanos, R, Paolicelli, D, Tortorella, C, Spelman, T, Margari, L, Amato, MP, Comi, G, Butzkueven, H, and Trojano, M
Abstract: OBJECTIVE: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients. METHODS: A cohort of 770 pCIS patients was followed up for at least 10 years. Cox proportional hazard models and Recursive Partitioning and Amalgamation (RECPAM) tree-regression were used to analyze data. RESULTS: In pCIS, female sex and a multifocal onset were risk factors for a second clinical attack (hazard ratio [HR], 95% confidence interval [CI] = 1.28, 1.06-1.55; 1.42, 1.10-1.84, respectively), whereas disease-modifying drug (DMD) exposure reduced this risk (HR, 95% CI = 0.75, 0.60-0.95). After pediatric onset MS (POMS) diagnosis, age at onset younger than 15 years and DMD exposure decreased the risk of a first Expanded Disability Status Scale (EDSS)-worsening event (HR, 95% CI = 0.59, 0.42-0.83; 0.75, 0.71-0.80, respectively), whereas the occurrence of relapse increased this risk (HR, 95% CI = 5.08, 3.46-7.46). An exploratory RECPAM analysis highlighted a significantly higher incidence of a first EDSS-worsening event in patients with multifocal or isolated spinal cord or optic neuritis involvement at onset in comparison to those with an isolated supratentorial or brainstem syndrome. A Cox regression model including RECPAM classes confirmed DMD exposure as the most protective factor against EDSS-worsening events and relapses as the most important risk factor for attaining EDSS worsening. INTERPRETATION: This work represents a step forward in identifying predictors of unfavorable course in pCIS and POMS and supports a protective effect of early DMD treatment in preventing MS development and disability accumulation in this population. Ann Neurol 2017;81:729-739.
Published: 2017

24. Highly active immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced multiple sclerosis

Author: Lizak, N, Lugaresi, A, Alroughani, R, Lechner-Scott, J, Slee, M, Havrdova, E, Horakova, D, Trojano, M, Izquierdo, G, Duquette, P, Girard, M, Prat, A, Grammond, P, Hupperts, R, Grand'Maison, F, Sola, P, Pucci, E, Bergamaschi, R, Oreja-Guevara, C, Van Pesch, V, Ramo, C, Spitaleri, D, Iuliano, G, Boz, C, Granella, F, Olascoaga, J, Verheul, F, Rozsa, C, Cristiano, E, Flechter, S, Hodgkinson, S, Amato, MP, Deri, N, Jokubaitis, V, Spelman, T, Butzkueven, H, Kalincik, T, Lizak, N, Lugaresi, A, Alroughani, R, Lechner-Scott, J, Slee, M, Havrdova, E, Horakova, D, Trojano, M, Izquierdo, G, Duquette, P, Girard, M, Prat, A, Grammond, P, Hupperts, R, Grand'Maison, F, Sola, P, Pucci, E, Bergamaschi, R, Oreja-Guevara, C, Van Pesch, V, Ramo, C, Spitaleri, D, Iuliano, G, Boz, C, Granella, F, Olascoaga, J, Verheul, F, Rozsa, C, Cristiano, E, Flechter, S, Hodgkinson, S, Amato, MP, Deri, N, Jokubaitis, V, Spelman, T, Butzkueven, H, and Kalincik, T
Abstract: OBJECTIVE: To evaluate variability and predictability of disability trajectories in moderately advanced and advanced multiple sclerosis (MS), and their modifiability with immunomodulatory therapy. METHODS: The epochs between Expanded Disability Status Scale (EDSS) steps 3-6, 4-6 and 6-6.5 were analysed. Patients with relapse-onset MS and having reached 6-month confirmed baseline EDSS step (3/4/6) were identified in MSBase, a global observational MS cohort study. We used multivariable survival models to examine the impact of disease-modifying therapy, clinical and demographic factors on progression to the outcome EDSS step (6/6.5). Sensitivity analyses with varying outcome definitions and inclusion criteria were conducted. RESULTS: For the EDSS 3-6, 4-6 and 6-6.5 epochs, 1560, 1504 and 1231 patients were identified, respectively. Disability trajectories showed large coefficients of variance prebaseline (0.92-1.11) and postbaseline (2.15-2.50), with no significant correlations. The probability of reaching the outcome step was not associated with prebaseline variables, but was increased by higher relapse rates during each epoch (HRs 1.58-3.07; p<0.001). A greater proportion of each epoch treated with higher efficacy therapies was associated with lower risk of reaching the outcome disability step (HRs 0.72-0.91 per 25%; p≤0.02). 3 sensitivity analyses confirmed these results. CONCLUSIONS: Disease progression during moderately advanced and advanced MS is highly variable and amnesic to prior disease activity. Lower relapse rates and greater time on higher efficacy immunomodulatory therapy after reaching EDSS steps 3, 4 and 6 are associated with a decreased risk of accumulating further disability. Highly effective immunomodulatory therapy ameliorates accumulation of disability in moderately advanced and advanced relapse-onset MS.
Published: 2017

25. No evidence of beneficial effects of plasmapheresis in natalizumab-associated PML

Author: Landi, D, De Rossi, N, Zagaglia, S, Scarpazza, C, Prosperini, L, Albanese, M, Buttari, F, Mori, F, Marfia, G, Sormani, M, Capra, R, Centonze, D, Amato, M, Bandini, F, Bertolotto, A, Brescia Morra, V, Cavaletti, G, Cavalla, P, Capobianco, M, Clerico, M, D'Aleo, G, de Riz, M, Deotto, L, Durelli, L, Falcini, M, Ferrari, E, Fusco, M, Gasperini, C, Gerevini, S, Ghezzi, A, Grimaldi, L, Guidotti, M, Lugaresi, A, Naldi, P, Moiola, L, Perrone, P, Pizzorno, M, Pozzilli, C, Rezzonico, M, Rovaris, M, Salemi, G, Salvetti, M, Santuccio, G, Scarpini, E, Sessa, E, Solaro, C, Tabiadon, G, Tortorella, C, Trojano, M, Amato, MP, Fusco, ML, Trojano, M., CAVALETTI, GUIDO ANGELO, Landi, D, De Rossi, N, Zagaglia, S, Scarpazza, C, Prosperini, L, Albanese, M, Buttari, F, Mori, F, Marfia, G, Sormani, M, Capra, R, Centonze, D, Amato, M, Bandini, F, Bertolotto, A, Brescia Morra, V, Cavaletti, G, Cavalla, P, Capobianco, M, Clerico, M, D'Aleo, G, de Riz, M, Deotto, L, Durelli, L, Falcini, M, Ferrari, E, Fusco, M, Gasperini, C, Gerevini, S, Ghezzi, A, Grimaldi, L, Guidotti, M, Lugaresi, A, Naldi, P, Moiola, L, Perrone, P, Pizzorno, M, Pozzilli, C, Rezzonico, M, Rovaris, M, Salemi, G, Salvetti, M, Santuccio, G, Scarpini, E, Sessa, E, Solaro, C, Tabiadon, G, Tortorella, C, Trojano, M, Amato, MP, Fusco, ML, Trojano, M., and CAVALETTI, GUIDO ANGELO
Abstract: Objective: To examine retrospectively the effects of plasmapheresis (PLEX) on the survival and clinical outcomes of patients with multiple sclerosis (MS) and natalizumab (NTZ)-associated progressive multifocal leukoencephalopathy (PML).Methods: The medical literature was searched for the terms natalizumab and progressive multifocal leukoencephalopathy. A total of 193 international and 34 Italian NTZ-PML cases were included. Clinical outcome was determined by comparing the patients' clinical status at PML diagnosis with status after PML resolution. The effects on survival and clinical outcome of PLEX, sex, age, country, pre-PML Expanded Disability Status Scale score, NTZ infusion number, prior immunosuppressant exposure, PML symptoms, PML lesion location at diagnosis, CSF JC virus status and copies, additional PML treatments and steroids, and PML immune reconstitution inflammatory syndrome ( IRIS) development were investigated with both univariate and multivariate analyses.Results: A total of 219 NTZ-PML cases were analyzed, and 184 (84%) underwent PLEX, which did not reduce the mortality risk or the likelihood of poor vs favorable outcomes. Country was predictive of mortality and poor outcome, while PML-IRIS development was predictive of poor outcome.Conclusions: PLEX did not improve the survival or clinical outcomes of Italian or international patients with MS and NTZ-PML, suggesting that this treatment should be performed cautiously in the future. Classification of evidence: This study provides Class III evidence that for patients with NTZ-PML, PLEX does not improve survival. The study lacks the statistical precision to exclude an important benefit or harm of PLEX.
Published: 2017

26. Neuropsychological features in childhood and juvenile multiple sclerosis: five-year follow-up

Author: Amato MP, Goretti B, Ghezzi A, Hakiki B, Niccolai C, Lori S, Moiola L, Falautano M, Viterbo RG, Patti F, Cilia S, Pozzilli C, Bianchi V, Roscio M, Martinelli V, Portaccio E, Trojano M., COMI , GIANCARLO, Amato, Mp, Goretti, B, Ghezzi, A, Hakiki, B, Niccolai, C, Lori, S, Moiola, L, Falautano, M, Viterbo, Rg, Patti, F, Cilia, S, Pozzilli, C, Bianchi, V, Roscio, M, Martinelli, V, Comi, Giancarlo, Portaccio, E, and Trojano, M.
Published: 2014

27. Cognitive impairment and its relation with disease measures in mildly disabled patients with relapsing-remitting multiple sclerosis: baseline results from the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study

Author: Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Goretti, B, Caniatti, L, DI MONTE, E, Ferrazza, P, BRESCIA MORRA, V, LO FERMO, S, Picconi, O, Luccichenti, G, Vecchio, R, Maimone, D, Messina, S, Gasperini, C, Orefice, V, Florio, C, Portaccio, E, Zipoli, V, Bertolotto, A, Bramant, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, Gian Luigi, Giuliani, G, Grimald, Lm, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, S, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tonali, P, Batocchi, Ap, DE CARO MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Todaro, M, Spitaleri, D, Tartaglione, A., Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Goretti, B, Caniatti, L, Di Monte, E, Ferrazza, P, BRESCIA MORRA, Vincenzo, Lo Fermo, S, Picconi, O, Luccichenti, G, COGIMUS Study, Group, Vecchio, R, Maimone, D, Messina, S, Gasperini, C, Orefice, V, Brescia Morra, V, Florio, C, Amato, MP, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Centonze, D, Cottone, S, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, S, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Tola, MR, Tonali, P, Batocchi, AP, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Todaro, M, Spitaleri, D, Tartaglione, A, DI MONTE, E, BRESCIA MORRA, V, LO FERMO, S, and Zorzon, Marino
Subjects: Male, Pediatrics, Intelligence, Relapsing-Remitting, Neuropsychological Tests, Severity of Illness Index, Disability Evaluation, Cognition, Risk Factors, Odds Ratio, Prevalence, Neuropsychological assessment, Prospective Studies, Neurologic Examination, medicine.diagnostic_test, Cognitive impairmet. Cognitive function. Multiple Sclerosis. Neuropsychological assessment, Cognitive disorder, Neuropsychology, Age Factors, Middle Aged, Magnetic Resonance Imaging, Cognitive test, Treatment Outcome, Neurology, Italy, Female, Settore MED/26 - Neurologia, Psychology, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Neurological examination, Risk Assessment, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Predictive Value of Tests, Immunologic Factors, Humans, Interferon-beta, Cognition Disorders, Cross-Sectional Studies, medicine, Expanded Disability Status Scale, Multiple sclerosis, McDonald criteria, medicine.disease, Physical therapy, Neurology (clinical)
Abstract: Background Cognitive impairment is a common symptom of multiple sclerosis (MS), but the association between cognitive impairment and magnetic resonance imaging (MRI) disease measures in patients with relapsing–remitting (RR) MS is unclear. Objectives To study the prevalence of cognitive impairment and its relation with MRI disease measures in mildly disabled patients with RRMS. Methods Patients aged 18–50 years with RRMS (McDonald criteria) and an Expanded Disability Status Scale (EDSS) score ≤4.0, who were enrolled in the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study, underwent baseline standardized MRI complete neurological examination and neuropsychological testing. Results A total of 550 patients were enrolled, 327 of whom underwent MRI assessments. Cognitive impairment (impaired performance in ≥3 cognitive tests) was present in approximately 20% of all patients and in the subgroup who underwent MRI. T2 hyperintense and T1 hypointense lesion volumes were significantly higher in patients with cognitive impairment (defined as impaired performance on at least three tests of the Rao’s battery) than those without. EDSS score was also significantly higher in cognitively impaired than in cognitively preserved patients. Disease duration, depression, and years in formal education did not differ significantly between cognitively impaired and cognitively preserved patients. T2 lesion volume, performance intelligence quotient, and age were significant predictors of cognitive impairment in this population. Weak correlations were found between performance on individual cognitive tests and specific MRI measures, with T1 and T2 lesion volumes correlating with performance on most cognitive tests. Conclusions Cognitive impairment occurs in approximately one-fifth of mildly disabled patients with MS and is associated with specific MRI disease measures. Assessment of cognitive function at diagnosis could facilitate the identification of patients who may benefit from therapeutic intervention with disease-modifying therapies to prevent further lesion development.
Published: 2009

28. Autologous haematopoietic stem cell transplantation with an intermediate intensity conditioning regimen in multiple sclerosis: the Italian multi-centre experience

Author: Mancardi, Gl, Sormani, Mp, Di Gioia, M, Vuolo, L, Gualandi, F, Amato, Mp, Capello, E, Currò, D, Uccelli, A, Bertolotto, A, Gasperini, C, Lugaresi, A, Merelli, E, Meucci, G, Motti, L, Tola, Mr, Scarpini, E, Repice, Am, Massacesi, L, Saccardi, R, Donnini, I, Bosi, A, Guidi, S, Bagigalupo, A, Bonzano, L, Bruzzi, P, Roccatagliata, L, Antenucci, R, Granella, F, Martino, G, Rottoli, M, Solaro, C, Salvi, F, Ursino, E, Barilaro, A, Capobianco, M., Mancardi G, Sormani M, Di Gioia M, Vuolo L, Gualandi F, Amato M, Capello E, Currò D, Uccelli A, Bertolotto A, Gasperini C, Lugaresi A, Merelli E, Meucci G, Motti L, Tola M, Scarpini E, Repice A, Massacesi L, and Saccardi R
Subjects: Adult, medicine.medical_specialty, Time Factors, Transplantation Conditioning, Adolescent, medicine.medical_treatment, multiple sclerosis, treatment, prognosis, autologous stem cell transplantation, Kaplan-Meier Estimate, Severity of Illness Index, Transplantation, Autologous, Disease-Free Survival, Disability Evaluation, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Autologous stem-cell transplantation, Refractory, Predictive Value of Tests, medicine, Humans, Registries, Multi centre, Chi-Square Distribution, business.industry, Multiple sclerosis, Hematopoietic Stem Cell Transplantation, Immunosuppression, Middle Aged, Multiple Sclerosis, Chronic Progressive, medicine.disease, Magnetic Resonance Imaging, Surgery, Transplantation, Haematopoiesis, Treatment Outcome, Italy, Neurology, Disease Progression, Neurology (clinical), Stem cell, business
Abstract: Background: Over recent years numerous patients with severe forms of multiple sclerosis (MS) refractory to conventional therapies have been treated with intense immunosuppression followed by autologous haematopoietic stem cell transplantation (AHSCT). The clinical outcome and the toxicity of AHSCT can be diverse, depending on the various types of conditioning protocols and on the disease phase. Objectives: To report the Italian experience on all the consecutive patients with MS treated with AHSCT with an intermediate intensity conditioning regimen, named BEAM/ATG, in the period from 1996 to 2008. Methods: Clinical and magnetic resonance imaging outcomes of 74 patients were collected after a median follow-up period of 48.3 (range = 0.8–126) months. Results: Two patients (2.7%) died from transplant-related causes. After 5 years, 66% of patients remained stable or improved. Among patients with a follow-up longer than 1 year, eight out of 25 subjects with a relapsing–remitting course (31%) had a 6–12 months confirmed Expanded Disability Status Scale improvement > 1 point after AHSCT as compared with one out of 36 (3%) patients with a secondary progressive disease course ( p = 0.009). Among the 18 cases with a follow-up longer than 7 years, eight (44%) remained stable or had a sustained improvement while 10 (56%), after an initial period of stabilization or improvement with median duration of 3.5 years, showed a slow disability progression. Conclusions: This study shows that AHSCT with a BEAM/ATG conditioning regimen has a sustained effect in suppressing disease progression in aggressive MS cases unresponsive to conventional therapies. It can also cause a sustained clinical improvement, especially if treated subjects are still in the relapsing–remitting phase of the disease.
Published: 2011

29. A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis

Author: Giovannoni, G, Comi, G, Cook, S, Rammohan, K, Rieckmann, P, Soelberg Sørensen, P, Vermersch, P, Sandberg Wollheim, M, Cuzick, J, Juliusson, G, Reingold, S, King, J, Pollard, J, Sedal, L, Aichner, F, Eggers, C, Dive, D, Medaer, R, Ferreira, M, Manchev, I, Milanov, I, Haralanov, L, Deleva, N, Petrova, N, Bozhinov, P, Zahariev, Z, Stamenov, B, Shotekov, P, Petrov, I, Moskov, R, Emond, F, Freedman, M, Grand'Maison, F, Jacques, F, Vorobeychik, G, Demarin, V, Kovacicek, M, Lusic, I, Perhat Bucevic, T, Havrdova, E, Talab, R, Kanovsky, P, Petersen, T, Gross Paju, K, Kalbe, I, Toomsoo, T, Elovaara, I, Eralinna, Jp, Reunanen, M, Clavelou, P, Damier, P, Debouverie, M, Edan, G, Gout, O, Labauge, P, Laplaud, D, Wiertlewski, S, Heidenreich, F, Mäurer, M, Kieseier, B, Limmroth, V, Oschmann, P, Schimrigk, S, Steinbrecher, A, Zettl, U, Ziemann, U, Karageorgiou, K, Kyritsis, A, Papadimitriou, A, Amato, Mp, Bernardi, G, Morra, Vb, Galgani, S, Gallo, Paolo, Patti, F, Marrosu, M, Pozzilli, C, Trojano, M, Mancardi, Gl, Gebeily, S, Koussa, S, Wehbe, M, Yamout, B, Vaitkus, A, Metra, M, Messouak, O, Mossaddaq, R, Slassi, I, Yahyaoui, M, Hupperts, Rm, Czlonkowska, A, Kozubski, W, Nyka, W, Selmaj, K, Szczudlik, A, Figueiredo, J, Pedrosa, R, Alifirova, V, Balyazin, V, Barbarash, O, Belova, A, Boyko, A, Gusev, E, Elchaninov, A, Jacoupov, E, Julev, N, Kotov, S, Kudryavtsev, A, Laskov, V, Lesnyak, O, Odinak, M, Pasechnik, E, Poverennonva, I, Skoromets, A, Spirin, N, Stolyarov, I, Vorobieva, O, Voskresenskaya, O, Zaslavskiy, L, Zonova, E, Bohlega, S, El Jumah, M, Drulovic, J, Nadj, C, Goebels, N, Schluep, M, Ayed Frih, M, Hentati, F, Mhiri, C, Mrabet, A, Mrissa, R, Idiman, E, Karabudak, R, Turan, Of, Ahmed, F, Constantinescu, C, Hawkins, C, Palace, J, Sharrack, B, Loganovsky, K, Moskovko, S, Nehrych, T, Voloshyna, Np, Carlini, W, English, J, Garmany, G, Glyman, S, Huddlestone, J, Hurwitz, B, Kresa Reahl, K, Mikol, D, Pardo, G, Rao, H, Reif, M, Thrower, B, Royal, W, Webb, R, Wynn, D, Naga, C, Allen, N, Lin, K, Stefoski, D, Balabanov, R., Klinische Neurowetenschappen, RS: MHeNs School for Mental Health and Neuroscience, G., Giovannoni, G., Comi, S., Cook, K., Rammohan, P., Rieckmann, P. S., Sorensen, P., Vermersch, P., Chang, A., Hamlett, B., Musch, S. J., Greenberg, Altri, and BRESCIA MORRA, Vincenzo
Subjects: Male, Medizin, Placebo-controlled study, Administration, Oral, Relapsing-Remitting, drug therapy/pathology, Gastroenterology, Disability Evaluation, Cladribine, Hazard ratio, Brain, General Medicine, Middle Aged, Administration, Oral, Adolescent, Adult, Aged, Analysis of Variance, Brain, pathology, Cladribine, adverse effects/therapeutic use, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Herpes Zoster, etiology, Humans, Immunosuppressive Agents, adverse effects/therapeutic use, Intention to Treat Analysis, Lymphopenia, chemically induced, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, drug therapy/pathology, Young Adult, Magnetic Resonance Imaging, Intention to Treat Analysis, adverse effects/therapeutic use, Disease Progression, chemically induced, Female, Immunosuppressive Agents, medicine.drug, Oral, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, etiology, cladribine, immunomodulation, multiple sclerosis, trial, Lower risk, Placebo, DIAGNOSIS, Herpes Zoster, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Double-Blind Method, Lymphopenia, Internal medicine, medicine, Humans, Adverse effect, Aged, Analysis of Variance, business.industry, MS, medicine.disease, Confidence interval, Surgery, CELLS, pathology, Lymphocytopenia, business
Abstract: Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing–remitting multiple sclerosis. We randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks. Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33 ; P
Published: 2010

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

Author: Ghezzi A, Annovazzi P, Amato MP, Capello E, Cavalla P, Cocco E, Falcini M, Patti F, Perini P, Rodegher ME, Rovaris M, Rottoli MR, Comi G, MS Study Group Italian Society of Neurology, GALLO, Antonio, Ghezzi, A, Annovazzi, P, Amato, Mp, Capello, E, Cavalla, P, Cocco, E, Falcini, M, Gallo, Antonio, Patti, F, Perini, P, Rodegher, Me, Rovaris, M, Rottoli, Mr, Comi, G, MS Study Group Italian Society of, Neurology, Gallo, A, and Comi, Giancarlo
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Status epilepticus, Aspiration pneumonia, Internal medicine, medicine, Humans, Myocardial infarction, Adverse effect, Stroke, business.industry, Multiple sclerosis, Endovascular Procedures, Brain, medicine.disease, Thrombosis, Hydrocephalus, Surgery, Spinal Cord, Venous Insufficiency, Neurology, Cardiology, Female, Neurology (clinical), medicine.symptom, business
Abstract: Although it is debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients undergo endovascular treatment (ET) of CCSVI. A study is ongoing in Italy to evaluate the clinical outcome of ET. Severe adverse events (AEs) occurred in 15/462 subjects at a variable interval after ET: jugular thrombosis in seven patients, tetraventricular hydrocephalus, stroke, paroxysmal atrial fibrillation, status epilepticus, aspiration pneumonia, hypertension with tachicardia, or bleeding of bedsore in the remaining seven cases. One patient died because of myocardial infarction 10 weeks after ET. The risk of severe AEs related to ET for CCSVI must be carefully considered.
Published: 2013

31. THC:CBD discontinuation in a large population of Italian multiple sclerosis patients (SA.FE. study)

Author: Patti, F, Messina, S, Amato, Mp, Benedetti, Md, Bergamaschi, R, Morra, Vb, Buttari, F, Cavalla, P, Danni, M, Fuiani, A, Gasperini, C, Ippolito, D, Maniscalco, Gt, Matta, M, Mirabella, M, Montanari, E, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Pozzilli, C, Russo, M, Salamone, G, Signoriello, E, Spinicci, G, Spitaleri, D, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Solaro, C, and Zappia, M
Published: 2015

32. THC:CBD oromucosal spray as an add-on therapy in a large population of Italian multiple sclerosis patients (SA.FE. study)

Author: Patti, F, Messina, S, Amato, Mp, Benedetti, Md, Bergamaschi, R, Morra, Vb, Buttari, F, Cavalla, P, Danni, M, Fuiani, A, Gasperini, C, D'Ippolito, Gennaro, Maniscalco, Gt, Matta, M, Mirabella, M, Montanari, E, Nuara, A, Palmieri, V, Paolicelli, D, Petrucci, L, Pontecorvo, S, Pozzilli, C, Russo, M, Salamone, G, Signoriello, E, Spinicci, G, Spitaleri, D, Tavazzi, E, Trabucco, E, Trotta, M, Zaffaroni, M, Solaro, C, and Zappia, M
Published: 2015

33. Multicenter, prospective, observational study aimed at evaluating SAtivex efFEcts (effectiveness and tolerability) in a large population of Italian multiple sclerosis patients: SA. FE. study

Author: Patti, F, Messina, S, Amato, Mp, Benedetti, Md, Bergamaschi, R, Bertolotto, A, Bonavita, S, Bossio, Rb, Morra, Vb, Cavalla, P, Centonze, DANILO CORRADO, Comi, G, Cottone, S, Danni, M, Francia, A, Fuiani, A, Gasperini, C, Ghezzi, A, Iudice, A, Lus, G, Maniscalco, Gt, Marrosu, Mg, Mirabella, FRANCESCA MARIA ELENA, Montanari, E, Pozzilli, C, Rovaris, M, Sessa, Ettore, Spitaleri, DAVIDE SCIPIONE MARIA, Trojano, M, Valentino, P, Zappia, M, and Solaro, C
Published: 2015

34. Disease-modifying drugs in childhood-juvenile multiple sclerosis: results of an Italian co-operative study

Author: Ghezzi, A, Amato, Mp, Capobianco, M, Gallo, P, Marrosu, G, Martinelli, V, Milani, N, Milanese, C, Moiola, L, Patti, F, Pilato, V, Pozzilli, Carlo, Trojano, M, Zaffaroni, M, Comi, G, and IMMUNOMODULATORY TREATMENT OF EARLY ONSET MS GROUP
Subjects: Male, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Disease, Drug Administration Schedule, Central nervous system disease, 03 medical and health sciences, 0302 clinical medicine, Degenerative disease, Adjuvants, Immunologic, Recurrence, Internal medicine, medicine, Humans, 030212 general & internal medicine, Age of Onset, Glatiramer acetate, Child, business.industry, Multiple sclerosis, Interferon-beta, medicine.disease, Surgery, Treatment Outcome, Neurology, Tolerability, El Niño, Female, Neurology (clinical), Age of onset, business, Interferon beta-1a, 030217 neurology & neurosurgery, medicine.drug
Abstract: Objective: Immunomodulatory drugs (IDs) (interferon beta (IFNβ) and glatiramer acetate (GA)) reduce relapse rate and disease progression in relapsing-remitting multiple sclerosis (RRMS) but extensive data are not available on the effectiveness and tolerability of these drugs in childhood or adolescence. The aim of this study was to evaluate the impact of IFNβ and GA in MS patients treated before 16 years of age. Methods: A research group (Immunomodulatory Treatment of Early onset MS (ITEMS)) was promoted in Italy to collect a large series of patients affected by clinically definite and RRMS and treated with IDs before 16 years of age. Fifteen centres recognized subjects suitable for inclusion: 76 patients (52 females) were collected with a mean age at onset of 12.4 (SD 2.5) years, a mean disease duration of 18.6 (SD 14.7) and a relapse rate of 3.1 (SD 2.9). Results: Results were evaluated in 65 (45 females) subjects with a pretreatment and a treatment duration >3 months: 38 were treated with IFNβ-1a once weekly (Avonex), 18 with IFNβ three times weekly (16 with Rebif, 2 with Betaferon) and nine with GA (Copaxone). The mean pretreatment period was respectively 20, 18 and 9.2 months. The treatment duration lasted respectively 23.3, 40.7 and 33.3 months. The mean annualized relapse rate decreased dramatically during the treatment: from 2.4 to 0.4 in the Avonex group, from 3.2 to 0.8 in the Rebif-Betaferon group and from 2.8 to 0.25 in the GA group. The mean final EDSS scores were respectively (in brackets the initial scores): 1.3 (1.4), 1.6 (1.8) and 0.6 (1.1). In the whole group, the final score was unchanged or reduced in all subjects except eight. Clinical side effects were recorded in 41/65 subjects (mainly in subjects treated with IFNβ), abnormal laboratory findings were observed in 13/65 subjects: they were transient in most cases. IFNβ was stopped in six cases: in four because of inefficacy and in two cases because of side effects. Conclusions: Sixty-five clinically definite MS subjects were treated during childhood or adolescence with IDs. The treatment reduced the relapse rate and the progression of the disease in most cases. Side effects were common in subjects treated with IFNβ, but were well tolerated in most cases.
Published: 2005

35. Defining secondary progressive multiple sclerosis

Author: Lorscheider, J, Buzzard, K, Jokubaitis, V, Spelman, T, Havrdova, E, Horakova, D, Trojano, M, Izquierdo, G, Girard, M, Duquette, P, Prat, A, Lugaresi, A, Grand'Maison, F, Grammond, P, Hupperts, R, Alroughani, R, Sola, P, Boz, C, Pucci, E, Lechner-Scott, J, Bergamaschi, R, Oreja-Guevara, C, Iuliano, G, Van Pesch, V, Granella, F, Ramo-Tello, C, Spitaleri, D, Petersen, T, Slee, M, Verheul, F, Ampapa, R, Amato, MP, McCombe, P, Vucic, S, Sanchez Menoyo, JL, Cristiano, E, Barnett, MH, Hodgkinson, S, Olascoaga, J, Laura Saladino, M, Gray, O, Shaw, C, Moore, F, Butzkueven, H, Kalincik, T, Lorscheider, J, Buzzard, K, Jokubaitis, V, Spelman, T, Havrdova, E, Horakova, D, Trojano, M, Izquierdo, G, Girard, M, Duquette, P, Prat, A, Lugaresi, A, Grand'Maison, F, Grammond, P, Hupperts, R, Alroughani, R, Sola, P, Boz, C, Pucci, E, Lechner-Scott, J, Bergamaschi, R, Oreja-Guevara, C, Iuliano, G, Van Pesch, V, Granella, F, Ramo-Tello, C, Spitaleri, D, Petersen, T, Slee, M, Verheul, F, Ampapa, R, Amato, MP, McCombe, P, Vucic, S, Sanchez Menoyo, JL, Cristiano, E, Barnett, MH, Hodgkinson, S, Olascoaga, J, Laura Saladino, M, Gray, O, Shaw, C, Moore, F, Butzkueven, H, and Kalincik, T
Published: 2016

36. The effect of oral immunomodulatory therapy on treatment uptake and persistence in multiple sclerosis

Author: Warrender-Sparkes, M, Spelman, T, Izquierdo, G, Trojano, M, Lugaresi, A, Grand'Maison, F, Havrdova, E, Horakova, D, Boz, C, Oreja-Guevara, C, Alroughani, R, Iuliano, G, Duquette, P, Girard, M, Terzi, M, Hupperts, R, Grammond, P, Petersen, T, Fernandez-Bolanos, R, Fiol, M, Pucci, E, Lechner-Scott, J, Verheul, F, Cristiano, E, Van Pesch, V, Petkovska-Boskova, T, Moore, F, Kister, I, Bergamaschi, R, Laura Saladino, M, Slee, M, Barnett, M, Amato, MP, Shaw, C, Shuey, N, Young, C, Gray, O, Kappos, L, Butzkueven, H, Kalincik, T, Jokubaitis, V, Warrender-Sparkes, M, Spelman, T, Izquierdo, G, Trojano, M, Lugaresi, A, Grand'Maison, F, Havrdova, E, Horakova, D, Boz, C, Oreja-Guevara, C, Alroughani, R, Iuliano, G, Duquette, P, Girard, M, Terzi, M, Hupperts, R, Grammond, P, Petersen, T, Fernandez-Bolanos, R, Fiol, M, Pucci, E, Lechner-Scott, J, Verheul, F, Cristiano, E, Van Pesch, V, Petkovska-Boskova, T, Moore, F, Kister, I, Bergamaschi, R, Laura Saladino, M, Slee, M, Barnett, M, Amato, MP, Shaw, C, Shuey, N, Young, C, Gray, O, Kappos, L, Butzkueven, H, Kalincik, T, and Jokubaitis, V
Abstract: OBJECTIVE: We aimed to analyse the effect of the introduction of fingolimod, the first oral disease-modifying therapy, on treatment utilisation and persistence in an international cohort of patients with multiple sclerosis (MS). METHODS: MSBASIS, a prospective, observational sub-study of the MSBase registry, collects demographic, clinical and paraclinical data on patients followed from MS onset (n=4718). We conducted a multivariable conditional risk set survival analysis to identify predictors of treatment discontinuation, and to assess if the introduction of fingolimod has altered treatment persistence. RESULTS: A total of 2640 patients commenced immunomodulatory therapy. Following the introduction of fingolimod, patients were more likely to discontinue all other treatments (hazard ratio 1.64, p<0.001) while more patients switched to fingolimod than any other therapy (42.3% of switches). Patients switched to fingolimod due to convenience. Patients treated with fingolimod were less likely to discontinue treatment compared with other therapies (p<0.001). Female sex, country of residence, younger age, a high Expanded Disability Status Scale score and relapse activity were all independently associated with higher rates of treatment discontinuation. CONCLUSION: Following the availability of fingolimod, patients were more likely to discontinue injectable treatments. Those who switched to fingolimod were more likely to do so for convenience. Persistence was improved on fingolimod compared to other medications.
Published: 2016

37. Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone

Author: Martinelli, V., Cocco, E., Capra, R., Salemi, G., Gallo, P., Capobianco, M., Pesci, I., Ghezzi, A., Pozzilli, Carlo, Lugaresi, A., Bellantonio, P., Amato, M. P., Grimaldi, L. M., Trojano, M., Mancardi, G. L., Bergamaschi, R., Gasperini, Claudio, Rodegher, M., Straffi, L., Ponzio, M., Comi, G., For The Italian Mitoxantrone Group, Radaelli, M, Esposito, F, Moiola, L, Colombo, B, Rossi, P, Marrosu, Mg, Frau, J, Lorefice, L, Coghe, G, Savettieri, Giovanni, Ragonese, P, Cusimano, V, Perini, P, Rinaldi, F, Vidali, A, Bertolotto, A, Malucchi, S, Di Sapio, A, Montanari, E, Guareschi, A, Rizzo, A, Zaffaroni, M, Baldini, S, De Rossi, N, Cordioli, C, Rasia, S, Salvetti, M, Buttinelli, C, AUSILI CEFARO, Luca, De Luca, G, Tommaso, D, Farina, D, Fantozzi, R, Ruggieri, S, Amato, Mp, Hakiki, B, Zipoli, V, Portaccio, E, Bartolozzi, Ml, Scandellari, C, Stecchi, S, Marchello, Lp, Palmeri, B, Vitello, G, Iaffaldano, P, Lucchese, G, Dattola, V, Buccafusca, M, Sola, P, Simone, Am, Barreca, F, Patti, F, Laisa, P, Cavalla, P, Masera, S, Tavazzi, E, Galgani, S, Tedeschi, G, Sacco, R, Provinciali, L, Maura, D, Lus, G, Alfieri, G, Ticca, A, Piras, Ml, Maimone, D, Bianca, M, Iudice, A, Giro, Me, Galeotti, M, Florio, C, Spitalieri, P, La Mantia, L, Motti, L, Rottoli, Mr, Granella, F, Solaro, C, Scarpini, E, Servillo, G, Cavaletti, G., Martinelli, V., Cocco, E., Capra, R., Salemi, G., Gallo, P., Capobianco, M., Pesci, I., Ghezzi, A., Pozzilli, C., Lugaresi, A., Bellantonio, P., Amato, M. P., Grimaldi, L. M., Trojano, M., Mancardi, G. L., Bergamaschi, R., Gasperini, C., Rodegher, M., Straffi, L., Ponzio, M., Comi, G., Radaelli, M., Esposito, F., Moiola, L., Colombo, B., Rossi, P., Marrosu, M. G., Frau, J., Lorefice, L., Coghe, G., Savettieri, G., Ragonese, P., Cusimano, V., Perini, P., Rinaldi, F., Vidali, A., Bertolotto, A., Malucchi, S., Di Sapio, A., Montanari, E., Guareschi, A., Rizzo, A., Zaffaroni, M., Baldini, S., De Rossi, N., Cordioli, C., Rasia, S., Salvetti, M., Buttinelli, C., Ausili Cefaro, L., De Luca, Giovanna, Tommaso, D., Farina, D., Fantozzi, R., Ruggieri, S., Hakiki, B., Zipoli, V., Portaccio, E., Bartolozzi, M. L., Scandellari, C., Stecchi, S., Marchello, L. P., Palmeri, B., Vitello, G., Iaffaldano, P., Lucchese, G., Dattola, V., Buccafusca, M., Sola, P., Simone, A. M., Barreca, F., Patti, F., Laisa, P., Cavalla, P., Masera, S., Tavazzi, E., Galgani, S., Tedeschi, G., Sacco, R., Provinciali, L., Maura, D., Lus, G., Alfieri, G., Ticca, A., Piras, M. L., Maimone, D., Bianca, M., Iudice, A., Giro, M. E., Galeotti, M., Florio, C., Spitalieri, P., La Mantia, L., Motti, L., Rottoli, M. R., Granella, F., Solaro, C., Scarpini, E., Servillo, G., Cavaletti, G., Radaelli, M, Esposito, F, Moiola, L, Colombo, B, Rossi, P, Marrosu, MG, Frau, J, Lorefice, L, Coghe, G, Savettieri, G, Ragonese, P, Cusimano, V, Perini, P, Rinaldi, F, Vidali, A, Bertolotto, A, Malucchi, S, Di Sapio, A, Montanari, E, Guareschi, A, Rizzo, A, Zaffaroni, M, Baldini, S, De Rossi, N, Cordioli, C, Rasia, S, Salvetti, M, Buttinelli, C, Ausili Cefaro, L, De Luca, G, Tommaso, D, Farina, D, Fantozzi, R, Ruggieri, S, Amato, MP, Hakiki, B, Zipoli, V, Portaccio, E, Bartolozzi, ML, Scandellari, C, Stecchi, S, Marchello, LP, Palmeri, B, Vitello, G, Iaffaldano, P, Lucchese G, Dattola V, Buccafusca M, Sola, P, Simone, AM, Barreca, F, Patti, F, Laisa, P, Cavalla, P, Masera, S, Tavazzi, E, Galgani, S, Tedeschi, G, Sacco, R, Provinciali, L, Maura, D, Lus, G, Alfieri, G, Ticca, A, Piras, ML, Maimone, D, Bianca, M, Iudice, A, Giro, ME, Galeotti, M, Florio, C, Spitalieri, P, La Mantia, L, Motti, L, Rottoli, MR, Granella, F, Solaro, C, Scarpini, E, Servillo, G, Cavalletti, G, Salemi, G, Martinelli, V, Cocco, E, Capra, R, Gallo, P, Capobianco, M, Pesci, I, Ghezzi, A, Pozzilli, C, Lugaresi, A, Bellantonio, P, Amato, M, Grimaldi, L, Trojano, M, Mancardi, G, Bergamaschi, R, Gasperini, C, Rodegher, M, Straffi, L, Ponzio, M, Comi, G, Cavaletti, G, and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE
Subjects: Male, medicine.medical_specialty, Myeloid, mitoxantrone, acute myelocytic leukemia, multiple sclerosis, Population, Statistics, Nonparametric, Follow-Up Studie, Arts and Humanities (miscellaneous), Retrospective Studie, Internal medicine, Multiple Sclerosi, medicine, Humans, multiple sclerosis, leukemia, mitoxantrone, Prospective cohort study, education, Retrospective Studies, Aged, Analgesics, education.field_of_study, Mitoxantrone, Cumulative dose, business.industry, Multiple sclerosis, Incidence (epidemiology), leukemia, Myeloid leukemia, Retrospective cohort study, medicine.disease, Confidence interval, Surgery, Leukemia, Leukemia, Myeloid, Acute, medicine.anatomical_structure, Italy, Cohort, Settore MED/26 - Neurologia, Analgesic, Female, Neurology (clinical), business, Follow-Up Studies, medicine.drug, Human
Abstract: none 25 no Abstract OBJECTIVES: To evaluate the incidence and dose-dependency of mitoxantrone (MTX)-associated acute myelocytic leukemia (AML) in the network of Italian multiple sclerosis (MS) clinics. METHODS: We performed a multicenter retrospective cohort study of patients treated with MTX in MS centers under the Italian national health care system between 1998 and 2008. Demographic, disease, treatment, and follow-up information were collected using hospital records. RESULTS: Data were available for 3,220 patients (63% women) from 40 Italian centers. Follow-up (mean ± SD) was 49 ± 29 months (range 12-140 months). We observed 30 cases of AML (incidence 0.93% [95% confidence interval 0.60%-1.26%]). The mean cumulative dose was higher in patients with AML (78 vs 65 mg/m(2), p = 0.028). The median interval from the start of therapy to AML diagnosis was longer than expected at 33 months (range 13-84 months); 8 patients (27%) developed AML 4 years or more after the first MTX infusion. The rate of mortality associated with AML was 37%. CONCLUSIONS: This higher than expected risk of AML and related mortality requires that treatment decisions must be made jointly between clinicians and patients who understand their prognosis, treatment options, and treatment-related risks. The now large exposed MS population must be monitored for hematologic abnormalities for at least 6 years from the end of therapy, to ensure the rapid actions needed for early diagnosis and treatment of AML. none Martinelli V; Cocco E; Capra R; Salemi G; Gallo P; Capobianco M; Pesci I; Ghezzi A; Pozzilli C; Lugaresi A; Bellantonio P; Amato MP; Grimaldi LM; Trojano M; Mancardi GL; Bergamaschi R; Gasperini C; Rodegher M; Straffi L; Ponzio M; Comi G; For The Italian Mitoxantrone Group; De Luca G; Di Tommaso V; Farina D Martinelli V; Cocco E; Capra R; Salemi G; Gallo P; Capobianco M; Pesci I; Ghezzi A; Pozzilli C; Lugaresi A; Bellantonio P; Amato MP; Grimaldi LM; Trojano M; Mancardi GL; Bergamaschi R; Gasperini C; Rodegher M; Straffi L; Ponzio M; Comi G; For The Italian Mitoxantrone Group; De Luca G; Di Tommaso V; Farina D
Published: 2011

38. Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone

Author: Martinelli V, Cocco E, Capra R, Salemi G, Gallo P, Capobianco M, Pesci I, Ghezzi A, Pozzilli C, Lugaresi A, Bellantonio P, Amato MP, Grimaldi LM, Trojano M, Mancardi GL, Bergamaschi R, Gasperini C, Rodegher M, Straffi L, Ponzio M, Comi G, Italian Mitoxantrone G.r.o.u.p. COLLABORATORS: Radaelli M, Esposito F, Moiola L, Colombo B, Rossi P, Marrosu MG, Frau J, Lorefice L, Coghe G, Savettieri G, Ragonese P, Cusimano V, Perini P, Rinaldi F, Vidali A, Bertolotto A, Malucchi S, Di Sapio A, Montanari E, Guareschi A, Rizzo A, Zaffaroni M, Baldini S, De Rossi N, Cordioli C, Rasia S, Salvetti M, Buttinelli C, Ausili Cefaro L, De Luca G, Tommaso D, Farina D, Fantozzi R, Ruggieri S, Hakiki B, Zipoli V, Portaccio E, Bartolozzi ML, Scandellari C, Stecchi S, Marchello LP, Palmeri B, Vitello G, Iaffaldano P, Lucchese G, Dattola V, Buccafusca M, Sola P, Simone AM, Barreca F, Patti F, Laisa P, Cavalla P, Masera S, Tavazzi E, Galgani S, Sacco R, Provinciali L, Maura D, LUS, Giacomo, Alfieri G, Ticca A, Piras ML, Maimone D, Bianca M, Iudice A, Giro ME, Galeotti M, Florio C, Spitalieri P, La Mantia L, Motti L, Rottoli MR, Granella F, Solaro C, Scarpini E, Servillo G, Cavalletti G., TEDESCHI, Gioacchino, Martinelli, V, Cocco, E, Capra, R, Salemi, G, Gallo, P, Capobianco, M, Pesci, I, Ghezzi, A, Pozzilli, C, Lugaresi, A, Bellantonio, P, Amato, Mp, Grimaldi, Lm, Trojano, M, Mancardi, Gl, Bergamaschi, R, Gasperini, C, Rodegher, M, Straffi, L, Ponzio, M, Comi, G, COLLABORATORS: Radaelli M, Italian Mitoxantrone G. r. o. u. p., Esposito, F, Moiola, L, Colombo, B, Rossi, P, Marrosu, Mg, Frau, J, Lorefice, L, Coghe, G, Savettieri, G, Ragonese, P, Cusimano, V, Perini, P, Rinaldi, F, Vidali, A, Bertolotto, A, Malucchi, S, Di Sapio, A, Montanari, E, Guareschi, A, Rizzo, A, Zaffaroni, M, Baldini, S, De Rossi, N, Cordioli, C, Rasia, S, Salvetti, M, Buttinelli, C, Ausili Cefaro, L, De Luca, G, Tommaso, D, Farina, D, Fantozzi, R, Ruggieri, S, Hakiki, B, Zipoli, V, Portaccio, E, Bartolozzi, Ml, Scandellari, C, Stecchi, S, Marchello, Lp, Palmeri, B, Vitello, G, Iaffaldano, P, Lucchese, G, Dattola, V, Buccafusca, M, Sola, P, Simone, Am, Barreca, F, Patti, F, Laisa, P, Cavalla, P, Masera, S, Tavazzi, E, Galgani, S, Tedeschi, Gioacchino, Sacco, R, Provinciali, L, Maura, D, Lus, Giacomo, Alfieri, G, Ticca, A, Piras, Ml, Maimone, D, Bianca, M, Iudice, A, Giro, Me, Galeotti, M, Florio, C, Spitalieri, P, La Mantia, L, Motti, L, Rottoli, Mr, Granella, F, Solaro, C, Scarpini, E, Servillo, G, and Cavalletti, G.
Published: 2011

39. Voxel-wise assessment of white and gray matter damage in pediatric multiple sclerosis at 3.0 Tesla

Author: FILIPPI , MASSIMO, Absinta M, Rocca MA, Moiola L, Ghezzi A, Amato MP, Milani N, Veggiotti P, Falini A, Comi G., Filippi, Massimo, Absinta, M, Rocca, Ma, Moiola, L, Ghezzi, A, Amato, Mp, Milani, N, Veggiotti, P, Falini, A, and Comi, G.
Published: 2011

40. Pregnancy and fetal outcomes after interferonbeta exposure in multiple sclerosis

Author: AMATO MP, PORTACCCIO E. GHEZZI A, HAKIKI B, ZIPOLI V, MARTINELLI V, MOIOLA L, PATTI F, LA MANTIA L, MANCARDI GL, SOLARO C, TOLA MR, POZZILLI C, DE GIGLIO L, TOTANO R, LUGARSIA, DI TOMMASO V, PAOLOCELLI D, MARROSU MG, PELLEGRINI F, TROJANO M., COMI , GIANCARLO, Amato, Mp, PORTACCCIO E., GHEZZI A, Hakiki, B, Zipoli, V, Martinelli, V, Moiola, L, Patti, F, LA MANTIA, L, Mancardi, Gl, Solaro, C, Tola, Mr, Pozzilli, C, DE GIGLIO, L, Totano, R, Lugarsia, DI TOMMASO, V, Paolocelli, D, Marrosu, Mg, Comi, Giancarlo, Pellegrini, F, and Trojano, M.
Published: 2010

41. evolving expectations around early management of multiple sclerosis

Author: GOLD R, WOLINSKY JS, AMATO MP, COMI , GIANCARLO, Gold, R, Wolinsky, J, Amato, Mp, and Comi, Giancarlo
Published: 2010

42. Effects of immunomodulatory treatment with subcutaneous interferon beta-1a oncognitive decline in mildly disabled patients with relapsing-remitting multiplesclerosis

Author: Patti F, Amato MP, Bastianello S, Caniatti L, Di Monte E, Ferrazza P, Goretti B, Gallo P, BRESCIA MORRA, VINCENZO, Lo Fermo S, Picconi O, Tola MR, Trojano M, COGIMUS S.t.u.d.y.G.r.o.u.p., Patti, F, Amato, Mp, Bastianello, S, Caniatti, L, Di Monte, E, Ferrazza, P, Goretti, B, Gallo, P, BRESCIA MORRA, Vincenzo, Lo Fermo, S, Picconi, O, Tola, Mr, Trojano, M, and Cogimus, S. t. u. d. y. G. r. o. u. p.
Published: 2010

43. Cognitive and psychosocial features in childhood and juvenile Ms: two year follow up

Author: AMATO MP, GORETTI B, GHEZZI A, LORI S, ZIPOLI V, MOIOLA L, FALAUTANO M, DE CARRO MF, VITERBO R, PATTI F, VECCHIO R, POZZILLI C, BIANCHI V, ROSCIO M, MARTINELLI V, PORTACCIO E, TROJANO M., COMI , GIANCARLO, Amato, Mp, Goretti, B, Ghezzi, A, Lori, S, Zipoli, V, Moiola, L, Falautano, M, DE CARRO, Mf, Viterbo, R, Patti, F, Vecchio, R, Pozzilli, C, Bianchi, V, Roscio, M, Martinelli, V, Comi, Giancarlo, Portaccio, E, and Trojano, M.
Published: 2010

44. Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment

Author: Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Portaccio, E, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, Marinella, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Iaffaldano, P, Direnzo, V, D'Onghia, M, Lepore, V, Livrea, P, Comi, G, Amato, Mp, Italian Multiple Sclerosis Database Network Group, Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., Patti, F., Ghezzi, A., Portaccio, E., Rossi, P., Pozzilli, C., Salemi, G., Lugaresi, A., Bergamaschi, R., Millefiorini, E., Clerico, M., Lus, Giacomo, Vianello, M., Avolio, C., Cavalla, P., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lepore, V., Livrea, P., Comi, G., Amato, M., ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK, . ., Trojano M, Pellegrini F, Paolicelli D, Fuiani A, Zimatore GB, Tortorella C, Simone IL, Patti F, Ghezzi A, Portaccio E, Rossi P, Pozzilli C, Salemi G, Lugaresi A, Bergamaschi R, Millefiorini E, Clerico M, Lus G, Vianello M, Avolio C, Cavalla P, Iaffaldano P, Direnzo V, D'Onghia M, Lepore V, Livrea P, Comi G, Amato MP, M Trojano, F Pellegrini, D Paolicelli, A Fuiani, GB Zimatore, C Tortorella C, IL Simone, F Patti, A Ghezzi, E Portaccio, P Rossi, C Pozzilli, G Salemi, A Lugaresi, and on behalf of Italian Multiple Sclerosis Database Network (MSDN) group
Subjects: Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Propensity score, Disease, gender, interferon beta, multiple sclerosis, observational study, propensity score, Lower risk, Severity of Illness Index, Multiple sclerosis, Interferon beta, Gender, Observational study, Propensity score, Cohort Studies, Disability Evaluation, Young Adult, Sex Factors, gender, multiple sclerosis, treatment, interferon, Double-Blind Method, Internal medicine, Observational study, medicine, Confidence Intervals, Odds Ratio, Product Surveillance, Postmarketing, Humans, Immunologic Factors, Multiple sclerosi, Proportional Hazards Models, Expanded Disability Status Scale, Proportional hazards model, business.industry, Multiple sclerosis, Drug Administration Routes, Interferon-beta, medicine.disease, Interferon beta, Surgery, Neurology, Italy, Cohort, Propensity score matching, Regression Analysis, Settore MED/26 - Neurologia, Female, Neurology (clinical), business
Abstract: Background: There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. Objective: To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFN beta) treatment response in a cohort of relapsing (RR) MS patients. Methods: A cohort of 2570 IFN beta-treated RRMS was prospectively followed for Lip to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by I point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. Results: The multivariate Cox Regression analyses showed that male patients had a significant (p = 0.0097) lower risk for 1st relapse and a trend (p = 0.0897) for a higher risk to reach I point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR = 0.86; 95% Cl = 0.76-0.98; p = 0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for I point EDSS progression (HR = 1.33; 95% Cl: 1.00-1.76; p
Published: 2009

45. post marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in intereron beta treatment

Author: TROJANO M, PELLEGRINI F, PAOLICELLI D, FUIANI A, ZIMATORE GB, TORTORELLA C, SIMONE IL, PATTI F, GHEZZI A, PORTACCIO E, ROSSI P, POZZILLI C, SALEMI G, LUGARESI A, BERGAMASCHI R, MILLEFIORINI E, CLERICO M, LUS G, VIANELLO M, AVOLIO C, CAVALLA P, IAFFALDANO P, DIRENZO V, D'ONGHIA M, LEPORE V, LIVREA P, AMATO MP, ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK GROUP, COMI , GIANCARLO, Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Portaccio, E, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, M, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Iaffaldano, P, Direnzo, V, D'Onghia, M, Lepore, V, Livrea, P, Comi, Giancarlo, Amato, Mp, and ITALIAN MULTIPLE SCLEROSIS DATABASE NETWORK, Group
Published: 2009

46. cognitive and psychosocial features of childhood and juvenile MS

Author: HUSSAIN H, USMAN A, RAZA Q, AMATO MP, GORETTI B, GHEZZI A, LORI S, ZIPOLI V, PORTACCIO E, MOIOLA L, FALAUTANO M, TROJANO M., COMI , GIANCARLO, Hussain, H, Usman, A, Raza, Q, Amato, Mp, Goretti, B, Ghezzi, A, Lori, S, Zipoli, V, Portaccio, E, Moiola, L, Falautano, M, Comi, Giancarlo, and Trojano, M.
Published: 2009

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

Author: BERGAMASCHI R, REZZANI C, MINGUZZI S, AMATO MP, PATTI F, MARROSU MG, S, GRASSO MG, GHEZZI A, ROTTOLI M, GASPERINI C, RESTIVO D, MAIMONE D, ROSSI P, STROMILLO ML, MONTOMOLI C, SOLARO C, GROUP D., BONAVITA, Simona, Bergamaschi, R, Rezzani, C, Minguzzi, S, Amato, Mp, Patti, F, Marrosu, Mg, Bonavita, Simona, S, Grasso, Mg, Ghezzi, A, Rottoli, M, Gasperini, C, Restivo, D, Maimone, D, Rossi, P, Stromillo, Ml, Montomoli, C, Solaro, C, and Group, D.
Published: 2009

48. rel-life impact of early interferon beta therapy in relapsing multiple sclerosis

Author: TROJANO M, PELLEGRINI F, PAOLICELLI D, FUIANI A, ZIMATORE GB, TORTORELLA C, SIMONE IL, PATTI F, GHEZZI A, ZIPOLI V, ROSSI P, POZZILLI C, SALEMI G, LUGARESI A, BERGAMASCHI R, MILLEFIORINI E, CLERICO M, LUS G, VIANELLO M, AVOLIO C, CAVALLA P, LEPORE V, LIVREA P, AMATO MP, ITALIAN MULTIPLE SCLEROISS DATABASE NETWORK MSDN GROUP, COMI , GIANCARLO, Trojano, M, Pellegrini, F, Paolicelli, D, Fuiani, A, Zimatore, Gb, Tortorella, C, Simone, Il, Patti, F, Ghezzi, A, Zipoli, V, Rossi, P, Pozzilli, C, Salemi, G, Lugaresi, A, Bergamaschi, R, Millefiorini, E, Clerico, M, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Lepore, V, Livrea, P, Comi, Giancarlo, Amato, Mp, and ITALIAN MULTIPLE SCLEROISS DATABASE NETWORK MSDN, Group
Published: 2009

49. A comparison of cognitive performances between multiple sclerosis patients with pediatric- versus adult onset disease

Author: Hakiki, B., Niccolai, C., Portaccio, E., Goretti, B., Giannini, M., Pasto’, L., Pecori, C., Stromillo, Ml, Giorgio, Antonio, Rossi, F., De Stefano, N., and Amato, Mp
Published: 2014

50. Neuropsychological features in childhood and juvenile multiple sclerosis: Five-year follow-up

Author: Amato, Mp, Goretti, B, Ghezzi, A, Hakiki, B, Niccolai, C, Lori, S, Moiola, L, Falautano, M, Viterbo, Rg, Patti, Francesco, Cilia, S, Pozzilli, C, Bianchi, V, Roscio, M, Martinelli, V, Comi, G, Portaccio, E, Trojano, M, and MS Study Group of the Italian Neurological Society
Subjects: Male, Pediatrics, medicine.medical_specialty, Multivariate analysis, Adolescent, Population, Neuropsychological Tests, Young Adult, Cognition, Multiple Sclerosis, Relapsing-Remitting, Sex Factors, Medicine, Juvenile, Humans, Longitudinal Studies, Prospective Studies, Age of Onset, education, education.field_of_study, business.industry, Multiple sclerosis, Five year follow up, Neuropsychology, Age Factors, medicine.disease, Cohort, Multivariate Analysis, Disease Progression, Educational Status, Cognition Disorders, Female, Follow-Up Studies, Neurology (clinical), business
Abstract: Objective: The aim of the study was to perform a third cognitive assessment in our pediatric-onset multiple sclerosis (MS) patient cohort and determine predictors of the individual cognitive outcome. Methods: After 4.7 ± 0.7 years from baseline evaluation, 48 of 63 patients in the original cohort were reassessed on an extensive neuropsychological battery and compared with 46 healthy controls. Two alternate versions of the tests were used at different assessment points. Cognitive impairment was defined as the failure of ≥3 tests; individual change in the cognitive impairment index was measured. Results: At year 5, 38% of the subjects with MS fulfilled our criterion for impairment. Between years 2 and 5, regarding individual cognitive impairment index change, 66.7% of the patients improved. However, comparing baseline and 5-year testing (when the same versions of the tests were used), cognitive impairment index deterioration was observed in 56% of the patients, improvement in 25%, and stability in 18.8%. A deteriorating performance was related to male sex, younger age and age at MS onset, and lower education. None of these variables, however, was retained in the multivariate analysis. Conclusions: Cognitive outcome in pediatric-onset MS can be heterogeneous. Progression of cognitive problems in a few subjects and potential for compensation and improvement in others call for systematic cognitive screening in this population and development of effective treatment strategies.
Published: 2014

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