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1. Natalizumab is associated with early improvement of working ability in relapsing-remitting multiple sclerosis patients: WANT observational study results

Author

Capra, R., Morra, V. B., Mirabella, M., Gasperini, C., Scandellari, C., Totaro, R., De Rossi, N., Masera, S., Zipoli, V., Patti, F., Mirabella M. (ORCID:0000-0002-7783-114X), Capra, R., Morra, V. B., Mirabella, M., Gasperini, C., Scandellari, C., Totaro, R., De Rossi, N., Masera, S., Zipoli, V., Patti, F., and Mirabella M. (ORCID:0000-0002-7783-114X)

Abstract

Background: The Work Ability in Natalizumab-Treated MS Patients (WANT) study assessed work ability, quality of life, and cognitive processing speed during natalizumab treatment. Methods: WANT was a 1-year, prospective, multicenter observational study conducted in Italy. Inclusion criteria included relapsing-remitting multiple sclerosis (MS), natalizumab treatment, full-time worker status, and loss of working hours due to MS as measured by the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS). The primary endpoint was change in WPAI:MS domain scores after 1 year on natalizumab. Secondary endpoints included change in annualized relapse rate (ARR), Multiple Sclerosis Impact Scale (MSIS-29) score, and Symbol Digit Modalities Test (SDMT) score. Results: At enrollment, the 91 patients had a mean age of 38.3 (standard deviation [SD], 9.0) years and a mean ARR of 1.5 (SD, 0.8). After 1 year, improvements were observed in all WPAI:MS domains, with significant reductions in Absenteeism (−4.2 [SD, 26.0], p = 0.0190) and Work Productivity Loss (−7.2 [SD, 28.6]; p = 0.0456). These changes were accompanied by a low ARR (0.1), and 87.9% of patients were relapse free. Significant improvement was observed in MSIS-29 physical and psychological domains (reductions of 2.8 [SD, 11.6; p = 0.0295] and 6.3 [SD, 15.6; p = 0.0007], respectively) and SDMT score (increase of 2.4 [SD, 7.9; p = 0.0006]). Adverse events were reported in 32 of 104 patients (30.8%). Conclusions: The reductions in Absenteeism and Work Productivity Loss and the improved physical and psychological functioning reported after 1 year of natalizumab treatment in real-world settings extend our understanding of natalizumab’s effects on patient-centric and health economics outcomes.

Published
2020

2. Quality of life, depression and fatigue in mildly disabled patients with relapsing–remitting multiple sclerosis receiving subcutaneous interferon beta-1a: 3-year results from the COGIMUS (COGnitive Impairment in MUltiple Sclerosis) study

Author

Patti, F., Lo Fermo, S., Maimone, D., Messina, S., D'Amico, E., Cimino, V., Gasperini, C., Galgani, S., Orefice, V., Brescia Morra, V., Florio, C., Amato, M., 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, G., Giuliani, G., Pucci, S., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Bell'Antonio, P., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., De Caro, M., Ghezzi, A., Zaffaroni, M., Zolo, P., Zorzon, M., Signorino, M., Scarpini, E., Durelli, L., Carolei, A., Todaro, M., Todaro, R., Spitaleri, D., Tartaglione, A., Patti, F, Amato, Mp, Trojano, M, Bastianello, S, Tola, Mr, Picconi, O, Cilia, S, Cottone, S, Centonze, D, Gasperini, C, BRESCIA MORRA, Vincenzo, Lo Fermo, S, Maimone, D, Messina, S, D'Amico, E, Cimino, V, Galgani, S, Orefice, V, Brescia Morra, V, Florio, C, Amato, MP, Goretti, B, Portaccio, E, Zipoli, V, Bertolotto, A, Bramanti, P, Sessa, E, Salemi, G, Falcini, M, Gallo, P, Perini, P, Gigli, GL, Giuliani, G, Pucci, S, Grimaldi, LM, Murri, L, Lugaresi, A, Monaco, F, Montanari, E, Motti, L, Neri, S, Paciello, M, Provinciali, L, Ragno, M, Rosati, G, Ruggieri, S, Bell'antonio, P, Tola, MR, Caniatti, L, Tonali, P, Batocchi, AP, Di Monte, E, De Caro, MF, Ghezzi, A, Zaffaroni, M, Zolo, P, Zorzon, M, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Todaro, M, Todaro, R, Spitaleri, D, Tartaglione, A, Patti F, Amato MP, Trojano M, Bastianello S, Tola MR, Picconi O, Cilia S, Cottone S, Centonze D, Gasperini C, COGIMUS Study Group, and Lugaresi A

Subjects
Adult, Male, Quality of life, Longitudinal study, medicine.medical_specialty, Injections, Subcutaneous, multiple sclerosis, Relapsing-Remitting Multiple Sclerosis, Interferon beta 1a, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Internal medicine, medicine, Humans, Young adult, Fatigue, Depression (differential diagnoses), Aged, Depression, business.industry, Cognitive function, Multiple sclerosis, Cognitive disorder, Interferon beta-1a, Interferon-beta, Middle Aged, medicine.disease, Clinical trial, Neurology, Physical therapy, multiple sclerosis, cognition, interferon beta, Female, Settore MED/26 - Neurologia, Neurology (clinical), Cognition Disorders, business, medicine.drug
Abstract

Background: The precise relationships among quality of life, depression, fatigue and cognitive impairment in multiple sclerosis (MS) are complex and poorly understood. Objective: To assess the effects of subcutaneous interferon beta-1a on quality of life, depression and fatigue over 3 years in the COGIMUS study, and to examine the relationship between these outcomes and baseline cognitive status. Methods: COGIMUS was an observational 3-year trial assessing cognitive function in 459 patients with relapsing–remitting MS treated with subcutaneous interferon beta-1a. Results: In total, 331 patients completed the study (168 received interferon beta-1a, 44 µg subcutaneously three times weekly, and 163 received interferon beta-1a, 22 µg subcutaneously three times weekly). Mean MS Quality of Life-54 (MSQoL-54) composite scores did not change over time. There were no significant differences between groups in MSQoL-54 composite scores when patients were grouped by treatment dose and baseline cognitive status. Mean (standard deviation) Hamilton Depression Rating Scale score decreased from 6.8 (4.9) at baseline to 5.8 (5.9) at year 3. Mean total Fatigue Impact Scale scores were low ( Conclusion: Quality of life, depression and fatigue remained largely stable over 3 years; no effects of treatment dose or baseline cognitive status were found.

Published
2011

3. 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

4. Real-life impact of early interferon beta therapy in relapsing multiple sclerosis

Author

Trojano, M., Pellegrini, F., Paolicelli, D., Fuiani, A., Zimatore, G., Tortorella, C., Simone, I., 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, G., Amato, M., Di Monte, E., Iaffaldano, P., Direnzo, V., D'Onghia, M., Lo Fermo, S., Messina, S., D'Amico, E., Rizzo, A., Zaffaroni, M., Portaccio, E., Martinelli, V., Prosperini, L., Onesti, E., Aridon, P., D'Amelio, M., Ragonese, P., De Luca, G., Farina, D., Di Tommaso, V., Tavazzi, E., Bargiggia, V., Crivelli, P., Cortese, A., Di Rezze, S., Durastanti, V., Alfieri, G., Rosellini, I., Modesto, M., Notariello, M., Tortorella, P., 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 G, Amato MP, Di Monte E, Iaffaldano P, Direnzo V, D'Onghia M, Lo Fermo S, Messina S, D'Amico E, Rizzo A, Zaffaroni M, Portaccio E, Martinelli V, Prosperini L, Onesti E, Aridon P, D'Amelio M, Ragonese P, De Luca G, Farina D, Di Tommaso V, Tavazzi E, Bargiggia V, Crivelli P, Cortese A, Di Rezze S, Durastanti V, Alfieri G, Rosellini I, Modesto M, Notariello M, Tortorella P, 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, Alessandra, Bergamaschi, R, Millefiorini, E, Clerico, M, Lus, G, Vianello, M, Avolio, C, Cavalla, P, Lepore, V, Livrea, P, Comi, G, and Amato, Mp

Subjects
Adult, Male, Time Factors, Multiple Sclerosis, Interferon beta, Interferon-beta, Cohort Studies, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Treatment Outcome, observational study, multiple sclerosis, interferon, treatment, early, Sickness Impact Profile, Multiple Sclerosi, Quality of Life, Humans, Female, Settore MED/26 - Neurologia, Prospective Studies, Follow-Up Studies
Abstract

OBJECTIVE: Recent findings support greater efficacy of early vs. delayed interferon beta (IFNbeta) treatment in patients with a first clinical event suggestive of multiple sclerosis (MS). We aimed to evaluate the effectiveness of early IFNbeta treatment in definite relapsing-remitting MS (RRMS) and to assess the optimal time to initiate IFNbeta treatment with regard to the greatest benefits on disability progression. METHODS: A cohort of 2,570 IFNbeta-treated RRMS patients was prospectively followed for up to 7 years in 15 Italian MS Centers. A Cox proportional hazards regression model adjusted for propensity score (PS) quintiles was used to assess differences between groups of patients with early vs. delayed IFNbeta treatment on risk of reaching a 1-point progression in the Expanded Disability Status Scale (EDSS) score, and the EDSS 4.0 and 6.0 milestones. A set of PS-adjusted Cox hazards regression models were calculated according to different times of treatment initiation (within 1 year up to within 5 years from disease onset). A sensitivity analysis was performed to assess the robustness of findings. RESULTS: The lowest hazard ratios (HRs) for the three PS quintiles-adjusted models were obtained by a cutoff of treatment initiation within 1 year from disease onset. Early treatment significantly reduced the risk of reaching a 1-point progression in EDSS score (HR = 0.63; 95% CI = 0.48-0.85; p < 0.002), and the EDSS 4.0 milestone (HR = 0.56; 95% CI = 0.36-0.90; p = 0.015). Sensitivity analysis showed the bound of significance for unmeasured confounders. INTERPRETATION: Greater benefits on disability progression may be obtained by an early IFNbeta treatment in RRMS.

Published
2009

5. 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

6. Changes in magnetic resonance imaging disease measures over 3 years in mildly disabled patients with relapsing-remitting multiple sclerosis receiving interferon β-1a in the COGnitive Impairment in MUltiple Sclerosis (COGIMUS) study

Author

Patti, F., Lo Fermo, S., Vecchio, R., Maimone, D., Messina, S., Gasperini, C., Orefice, V., Brecia Morra, V., Florio, C., Amato, M., 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, G., Giuliani, G., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., De Caro, M., Ghezzi, A., Zaffaroni, M., Zolo, P., Zorzon, M., Signorino, M., Scarpini, E., Durelli, L., Carolei, A., Totaro, R., Spitaleri, D., Tartaglione, A., Patti F, Lo Fermo S, Vecchio R, Maimone D, Messina S, Gasperini C, Orefice V, Brecia 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, S, 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, Signorino, M, Scarpini, E, Durelli, L, Carolei, A, Totaro, R, Spitaleri, D, and Tartaglione, A

Subjects
Male, Pathology, Neurology, Disease, Relapsing-Remitting, Neuropsychological Tests, lcsh:RC346-429, 0302 clinical medicine, Relapsing-Remitting Multiple Sclerosi, 030212 general & internal medicine, 10. No inequality, medicine.diagnostic_test, Brain, General Medicine, Magnetic Resonance Imaging, 3. Good health, Female, Settore MED/26 - Neurologia, Radiology, Neurosurgery, Neuroimaging, Immunologic Factors, Dose-Response Relationship, Drug, Humans, Interferon-beta, Quality of Life, Multiple Sclerosis, Relapsing-Remitting, Cognition Disorders, Adult, Drug, Interferon beta-1a, Research Article, medicine.medical_specialty, Multiple Sclerosis, Clinical Neurology, Dose-Response Relationship, 03 medical and health sciences, medicine, Neurochemistry, lcsh:Neurology. Diseases of the nervous system, business.industry, Multiple sclerosis, Magnetic resonance imaging, Brain Magnetic Resonance Imaging, medicine.disease, Clinical trial, Relapsing-Remitting Multiple Sclerosis, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background Conventional magnetic resonance imaging (MRI) has improved the diagnosis and monitoring of multiple sclerosis (MS). In clinical trials, MRI has been found to detect treatment effects with greater sensitivity than clinical measures; however, clinical and MRI outcomes tend to correlate poorly. Methods In this observational study, patients (n = 550; 18-50 years; relapsing-remitting MS [Expanded Disability Status Scale score ≤4.0]) receiving interferon (IFN) β-1a therapy (44 or 22 µg subcutaneously [sc] three times weekly [tiw]) underwent standardized MRI, neuropsychological and quality-of-life (QoL) assessments over 3 years. In this post hoc analysis, MRI outcomes and correlations between MRI parameters and clinical and functional outcomes were analysed. Results MRI data over 3 years were available for 164 patients. T2 lesion and T1 gadolinium-enhancing (Gd+) lesion volumes, but not black hole (BH) volumes, decreased significantly from baseline to Year 3 (P < 0.0001). Percentage decreases (baseline to Year 3) were greater with the 44 μg dose than with the 22 μg dose for T2 lesion volume (-10.2% vs -4.5%, P = 0.025) and T1 BH volumes (-7.8% vs +10.3%, P = 0.002). A decrease in T2 lesion volume over 3 years predicted stable QoL over the same time period. Treatment with IFN β-1a, 44 μg sc tiw, predicted an absence of cognitive impairment at Year 3. Conclusion Subcutaneous IFN β-1a significantly decreased MRI measures of disease, with a significant benefit shown for the 44 µg over the 22 µg dose; higher-dose treatment also predicted better cognitive outcomes over 3 years.

Published
2011

7. 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

8. Psychococial issue in children and adolescents with multiple sclerosis

Author

GORETTI B, GHEZZI A. PORTACCIO E, LORI S, ZIPOLI V, RAZZOLINI L, MOIOLA L, FALAUTANO M, DE CARRO MF, STUDY GROUP OF THE ITALIAN NEUROLOGICAL SOCIETY, COMI , GIANCARLO, Goretti, B, GHEZZI A., PORTACCIO E, Lori, S, Zipoli, V, Razzolini, L, Moiola, L, Falautano, M, Comi, Giancarlo, DE CARRO, Mf, and STUDY GROUP OF THE ITALIAN NEUROLOGICAL, Society

Published
2010

9. 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

10. Pregnancy and fetal outcomes after interferon-β exposure in multiple sclerosis

Author

Amato, M. P., Portaccio, E., Ghezzi, A., Hakiki, B., Zipoli, V., Martinelli, V., Moiola, L., Patti, F., La Mantia, L., Mancardi, G. L., Solaro, C., Tola, M. R., Pozzilli, C., De Giglio, L., Totaro, R., Lugaresi, A., Di Tommaso, V., Paolicelli, D., Marrosu, M. G., Comi, G., Pellegrini, F., Trojano, M., Siracusa, G., Rizzo, A., Zaffaroni, M., Radaelli, M., Milanese, C., Protti, A., Spreafico, C., Marazzi, R., Cavalla, P., Masera, S., Bergamaschi, R., Capello, E., Molinari, F., Caniatti, L., Granella, F., Immovilli, P., Annunziata, P., De Santi, L., Plewnia, K., Guidi, L., Bartolozzi, M. L., Mazzoni, M., De Luca, Giovanna, Carrozzo, A., D'Onghia, M., Musu, L., Cavallaro, T., Amato, M. P., Portaccio, E., Ghezzi, A., Hakiki, B., Zipoli, V., Martinelli, V., Moiola, L., Patti, F., La Mantia, L., Mancardi, G. L., Solaro, C., Tola, M. R., Pozzilli, C., De Giglio, L., Totaro, R., Lugaresi, A., Di Tommaso, V., Paolicelli, D., Marrosu, M. G., Comi, G., Pellegrini, F., Trojano, M., Siracusa, G., Rizzo, A., Zaffaroni, M., Radaelli, M., Milanese, C., Protti, A., Spreafico, C., Marazzi, R., Cavalla, P., Masera, S., Bergamaschi, R., Capello, E., Molinari, F., Caniatti, L., Granella, F., Immovilli, P., Annunziata, P., De Santi, L., Plewnia, K., Guidi, L., Bartolozzi, M. L., Mazzoni, M., De Luca, Giovanna, Carrozzo, A., D'Onghia, M., Musu, L., Cavallaro, T., and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Fetal Disease, Abortion, Follow-Up Studie, Cohort Studies, Pregnancy, Multiple Sclerosi, medicine, Abortion, Spontaneou, Humans, Prospective Studies, Fetus, treatment, business.industry, Obstetrics, multiple sclerosis, treatment, pregnancy, interferon, Infant, Newborn, Pregnancy Outcome, interferon, Odds ratio, Interferon-beta, medicine.disease, Confidence interval, Surgery, Abortion, Spontaneous, Fetal Diseases, Prospective Studie, Fetal Weight, In utero, Propensity score matching, Female, Neurology (clinical), Cohort Studie, business, Cohort study, Follow-Up Studies, Human
Abstract

none 23 no Objective: To assess pregnancy and fetal outcomes after in utero exposure to interferon-beta (IFN beta) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus on the risk of spontaneous abortion. Methods: In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFN beta less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS). Results: We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 +/- 5.8 weeks). IFN beta exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio [OR] 1.08, 95% confidence interval [CI] 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted beta -113.8, p < 0.0001) and length (PS-adjusted beta -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFN beta exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years. Conclusions: Our findings point to the relative safety of IFN beta exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan. Neurology (R) 2010;75:1794-1802 none Amato MP; Portaccio 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; Totaro R; Lugaresi A; Di Tommaso V; Paolicelli D; Marrosu MG; Comi G; Pellegrini F; Trojano M MS Study Group of the Italian Neurological Society; De Luca G Amato MP; Portaccio 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; Totaro R; Lugaresi A; Di Tommaso V; Paolicelli D; Marrosu MG; Comi G; Pellegrini F; Trojano M MS Study Group of the Italian Neurological Society; De Luca G

Published
2010

11. Effects of immunomodulatory treatment with subcutaneous interferon beta-1a on cognitive decline in mildly disabled patients with relapsing-remitting multiple sclerosis

Author

Patti, F., Lo Fermo, S., Vecchio, R., Maimone, D., Messina, S., Gasperini, C., Orefice, V., Morra, V., Florio, C., Amato, M., 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, G., Giuliani, G., Grimaldi, L., Murri, L., Lugaresi, A., Monaco, F., Montanari, E., Motti, L., Neri, S., Paciello, M., Provinciali, L., Ragno, M., Rosati, G., Ruggieri, S., Tola, M., Caniatti, L., Tonali, P., Batocchi, A., Trojano, M., Di Monte, E., 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, Bastianello S, Caniatti L, Di Monte E, Ferrazza P, Goretti B, Gallo P, Morra VB, Lo Fermo S, Picconi O, Tola MR, Trojano M, COGIMUS Study Group, Lugaresi A, Vecchio R, Maimone D, Messina S, Gasperini C, Orefice V, Florio C, Portaccio E, Zipoli V, Bertolotto A, Bramanti P, Sessa E, Centonze D, Cottone S, Salemi G, Falcini M, Perini P, Gigli GL, Giuliani G, Grimaldi LM, Murri L, 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, and Tartaglione A

Subjects
Male, interferon beta-1a, Kaplan-Meier Estimate, Relapsing-Remitting, Neuropsychological Tests, Cohort Studies, Disability Evaluation, Medicine, Adolescent, Young Adult, Middle Aged, Cognition Disorders, Survival Analysis, Female, Dose-Response Relationship, Drug, Humans, Multiple Sclerosis, Relapsing-Remitting, Prospective Studies, Disease Progression, Interferon-beta, Injections, Subcutaneous, Adult, Immunologic Factors, Endpoint Determination, Prospective cohort study, interferon beta, multiple sclerosis, cognitive impairment, Subcutaneous, Cognitive disorder, Hazard ratio, Settore MED/26 - NEUROLOGIA, Neurology, Settore MED/26 - Neurologia, Drug, medicine.drug, medicine.medical_specialty, Multiple Sclerosis, Lower risk, Injections, Dose-Response Relationship, Internal medicine, cognitive function, cognitive impairment, Expanded Disability Status Scale, business.industry, Interferon beta-1a, McDonald criteria, Odds ratio, medicine.disease, Surgery, disability, Neurology (clinical), business, disease progression, multiple sclerosis
Abstract

The objective of this study was to assess the effects of subcutaneous (sc) interferon beta-1a (IFNβ-1a) on cognition in mildly disabled patients with relapsing—remitting multiple sclerosis (RRMS). Patients aged 18—50 years with RRMS (McDonald criteria; Expanded Disability Status Scale score ≤4.0) were assigned IFNβ therapy at the physician’s discretion and underwent standardized magnetic resonance imaging, neurological examination and neuropsychological testing at the baseline and regular intervals for up to three years. This analysis included 459 patients who received sc IFNβ-1a (44 mcg: n = 236; 22 mcg: n = 223; three-year follow up was available for 318 patients). The hazard ratio for cognitive impairment over three years (44 mcg versus 22 mcg) was 0.68 (95% confidence interval [CI]: 0.480—0.972), suggesting a 32% lower risk with the higher dose treatment. At year 3, the proportion of patients who were cognitively impaired increased slightly from 23.5% at the baseline to 24.8% in the IFNβ-1a 22 mcg treatment group, but remained stable at 15.2% in the IFNβ-1a 44 mcg treatment group. The proportion of patients with cognitive impairment at year 3 was significantly higher in the 22 mcg group than in the 44 mcg group (P = 0.03), although a trend was also seen at the baseline (P = 0.058). Multivariate logistic regression (corrected for baseline cognitive deficits) indicated that treatment with the higher dose of IFNβ-1a was predictive of lower cognitive impairment at three years (odds ratio: 0.51, 95% CI: 0.26—0.99) compared with the lower dose of IFNβ-1a. These findings suggest that sc IFNβ-1a may have dose-dependent cognitive benefits in mildly disabled patients with RRMS, and may support early initiation of high-dose IFNβ-1a treatment.

Published
2010

12. 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

13. The brief neuropsychological battery for children: a screening tool for cognitive impairment in childhood and juvenile multiple sclerosis

Author

Portaccio, E., Goretti, B., Lori, S., Zipoli, V., Centorrino, S., Ghezzi, A., Patti, F., Bianchi, V., Comi, G., Trojano, M., Amato, M. P., Falcini, M., Moiola, L., Falautano, M., De Caro, M. F., Lopez, M., Vecchio, R., Grossi, P., Bertootto, A., Giam-paolo, S., Pozzilli, C., Manca, I., Masia, C., Bergamaschi, R., Veggiotti, P., Roscio, M., Contri, V., Gallo, P., Portaccio, E, Goretti, B, Lori, S, Zipoli, V, Centorrino, S, Ghezzi, A, Patti, F, Bianchi, V, Comi, Giancarlo, Trojano, M, Amato, Mp, and MULTIPLE SCLEROSIS STUDY GROUP OF THE ITALIAN NEUROLOGICAL, Society

Subjects
Male, medicine.medical_specialty, Adolescent, Trail Making Test, Neuropsychological Tests, Audiology, Developmental psychology, Multiple Sclerosis, Relapsing-Remitting, medicine, Humans, Mass Screening, Neuropsychological assessment, Age of Onset, Child, Wechsler Intelligence Scale for Children, medicine.diagnostic_test, Childhood and juvenile multiple sclerosis, Cognitive impairment, Screening battery, Cognition Disorders, Female, Reproducibility of Results, Neurology, Neurology (clinical), Cognitive disorder, Neuropsychology, Cognition, medicine.disease, Test (assessment), Age of onset, Psychology
Abstract

Background A critical problem with neuropsychological assessment in children and adolescents with multiple sclerosis (MS) is the absence of a standardized, well-validated neuropsychological battery specifically tailored for detecting disease-related cognitive problems in this age range. Objective To develop a Brief Neuropsychological Battery for Children (BNBC) with MS. Methods We assessed cognitive functions in 61 patients with childhood and juvenile MS and 58 demographically matched healthy controls through an extensive neuropsychological battery. Results In MS patients, we found a proportion of cognitive impairment of 41%. In the BNBC, we included the tests with higher discriminating ability (the Selective Reminding Test, the Symbol Digit Modalities Test, the Trail Making Test, and the Vocabulary test from the Wechsler Intelligence Scale for children). The BNBC yielded a sensitivity of 96% and a specificity of 76%. Conclusion Our findings provide preliminary evidence of the usefulness of the BNBC as a screening tool for detecting cognitive impairment in childhood and juvenile MS cases.

Published
2009

14. 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

15. 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

16. The glycopeptide CSF114(Glc) detects serum antibodies in multiple sclerosis

Author

Lolli, F, Mazzanti, B, Pazzagli, M, Peroni, E, Alcaro, Mc, Sabatino, G, Lanzillo, R, Morra, Vb, Santoro, L, Gasperini, C, Galgani, S, D'Elios, Mm, Zipoli, V, Sotgiu, S, Pugliatti, Maura, Rovero, P, Chelli, M, Papini, Am, RI Lolli Francesco/C 6439 2008, Lolli, F, Mazzanti, B, Pazzagli, M, Peroni, E, Alcaro, Mc, Sabatino, G, Lanzillo, Roberta, BRESCIA MORRA, Vincenzo, Santoro, L, Gasperini, C, Galgani, S, D'Elios, Mm, Zipoli, V, Sotgiu, S, Pugliatti, M, Rovero, P, Chelli, M, and Papini, Am

Subjects
Adult, Male, Multiple Sclerosis, Anti-nuclear antibody, Adolescent, diagnosis, Immunology, Enzyme-Linked Immunosorbent Assay, myelin autoantibodies, medicine.disease_cause, multiple sclerosis, glycosylated antigen, B cell, autoimmunity, Aged, Analysis of Variance, Antibodies, Female, Flow Cytometry, Humans, Middle Aged, ROC Curve, Sensitivity and Specificity, Glycopeptides, Subclass, Autoimmunity, medicine, Immunology and Allergy, biology, business.industry, Multiple sclerosis, medicine.disease, Glycopeptide, Neurology, biology.protein, Neurology (clinical), Antibody, business, Meningitis, Encephalitis
Abstract

Synthetic glycopeptides have the potential to detect antibodies in multiple sclerosis (MS). In the present study, we analyzed the antibodies (IgM class, IgG class and IgG subclasses) to the synthetic glycopeptide CSF114(Glc) in the serum of 186 MS patients, 166 blood donors (BDs), 25 patients affected by meningitis/encephalitis, 41 affected by systemic lupus erythematosus (SLE) and 49 affected by rheumatoid arthritis (RA). The IgM antibody level to CSF114(Glc) was significantly increased in MS patients versus BDs (p

Published
2005

17. Recommendations for the management of urinary disorders in multiple sclerosis: a consensus of the Italian Multiple Sclerosis Study Group

Author

Ghezzi, A, Carone, R, Del Popolo, G, Amato, Mp, Bertolotto, A, Comola, M, Del Carro, U, Di Benedetto, P, Giannantoni, A, Lopes de Carvalho ML, Montanari, E, Patti, Francesco, Protti, A, Rasia, S, Salonia, A, Scandellari, C, Sperli, F, Spinelli, M, Solaro, C, Uccelli, A, Zaffaroni, M, Zipoli, V, Multiple Sclerosis Study Group, and Italian Society of Neurology

Subjects
Pediatrics, medicine.medical_specialty, Consensus, Multiple Sclerosis, Neurology, Urinary system, Urinary incontinence, Dermatology, Disease, Asymptomatic, Quality of life, Humans, Medicine, business.industry, Multiple sclerosis, Urinary Bladder Diseases, Disease Management, General Medicine, voiding dysfunction, medicine.disease, Psychiatry and Mental health, Italy, Physical therapy, Neurology (clinical), Neurosurgery, medicine.symptom, business
Abstract

Urinary disorders are uncommon in the initial phases of multiple sclerosis, but increase in frequency as the disease progresses, with a negative impact on quality of life. The goal of this study was to propose a protocol for the diagnosis and treatment of urinary disorders in multiple sclerosis, based on data from the scientific literature and the experience of Italian clinical centres. In particular, the following clinical aspects were considered: what to do with patients with asymptomatic multiple sclerosis; what to do with symptomatic patients; how and when to perform a second-level diagnostic evaluation; and how to treat urinary disorders. A diagnostic-therapeutic algorithm is proposed, that can be applied in Italian clinical centres.

Published
2011

18. Breastfeeding and post-partum relapses in multiple sclerosis patients

Author

Portaccio, E, Ghezzi, A, Hakiki, B, Zipoli, V, Razzolini, L, Martinelli, V, Moiola, L, Patti, Francesco, LA MANTIA, L, Mancardi, G, Solaro, C, Tola, M, Pozzilli, C, DE GIGLIO, L, Totaro, R, Lugaresi, A, DI TOMMASO, V, Paolicelli, D, Marrosu, M, Comi, G, Trojano, M, Amato, M, and FOR THE MULTIPLE SCLEROSIS STUDY GROUP OF THE ITALIAN NEUROLOGICAL SOCIETY

Published
2010

19. Psychosocial issue in children and adolescents with multiple sclerosis

Author

Amato, Mp, Goretti, B, Zipoli, V, Portaccio, E, Razzolini, L, Centorrino, S, Contri, V, Lori, S, Falcini, M, Comi, G, Moiola, L, Falautano, M, Trojano, M, De Caro MF, Viterbo, R, Patti, F, Vecchio, R, Gallo, Paolo, Grossi, P, Bertolotto, A, Borghi, M, Pozzilli, C, Bianchi, V, Manca, I, Masia, C, Bergamaschi, R, Veggiotti, P, Ghezzi, A, Trojano, Roscio M., and Amato, M. P.

Subjects
Male, medicine.medical_specialty, Activities of daily living, Adolescent, psychosocial features, Dermatology, Disease, children and adolescent, multiple sclerosis, Education, Cohort Studies, Interview, Psychological, medicine, Humans, Age of Onset, Psychiatry, Child, Depression (differential diagnoses), Fatigue, Psychiatric Status Rating Scales, Depression, Mental Disorders, General Medicine, Psychiatry and Mental health, Italy, Cohort, Disease Progression, Female, Neurology (clinical), Psychiatric interview, Age of onset, Psychology, Psychosocial, Clinical psychology, Cohort study
Abstract

In adult-onset multiple sclerosis (MS) cases, major depression, fatigue and psychological distress are common, whereas there is little information on these issues in children with the disease. The aim of this study was to assess psychosocial disorders in an Italian cohort of children and adolescent with MS. We evaluated 56 patients through self-assessment scales of depression (Children Depression Inventory) and fatigue (Fatigue Severity Scale), a psychiatric interview [Kiddie-SADS-Present and Lifetime Version (K-SADS-PL)] and an interview on school and everyday activities. Significant fatigue was found in 11 patients (20%). Twelve of the 39 patients who underwent the K-SADS-PL received a formal diagnosis of an affective disorder. Moreover, MS affected school activities in 28% of cases, daily living activities in 41% and social relationships in 28%. Our study confirms the critical role of psychosocial difficulties in children and adolescents with MS and provides a few cues to clinical management.

Published
2010

22. Interferon beta therapy and pregnancy outcomes in patients with multiple sclerosis

Author

Portaccio, E, Ghezzi, A, Rizzo, A, Zipoli, V, Hakiki, B, Pellegrini, F, DE GIGLIO, L, Pozzilli, C, Fuiani, A, Trojano, M, Musu, L, Marrosu, Mg, Cavallaro, T, Patti, Francesco, Milanese, C, LA MANTIA, L, Capello, E, Mancardi, Gl, Protti, A, Tola, M, DI TOMMASO, V, Lugaresi, A, Martinelli, V, Comi, G, Amato, Mp, and FOR THE MS STUDY GROUP OF THE ITALIAN NEUROLOGICAL SOCIETY

Published
2008

23. Cognitive and psychosocial features of childhood and juvenile MS

Author

Amato, Mp, Goretti, B, Ghezzi, A, Lori, S, Zipoli, V, Portaccio, E, Moiola, L, Falautano, M, DE CARO MF, Lopez, M, Patti, Francesco, Vecchio, R, Pozzilli, C, Bianchi, V, Roscio, M, Comi, G, Trojano, M, and FOR THE MULTIPLE SCLEROSIS STUDY GROUP OF THE ITALIAN NEUROLOGICAL SOCIETY

Subjects
Male, medicine.medical_specialty, Multiple Sclerosis, Activities of daily living, Adolescent, Neuropsychological Tests, Cohort Studies, Activities of Daily Living, medicine, Humans, Psychology, Attention, Child, Social Behavior, Psychiatry, Cognition Disorders, Depression, Fatigue, Female, Intelligence Tests, Linguistics, Regression Analysis, Neurology (clinical), Depression (differential diagnoses), Intelligence quotient, Cognition, Executive functions, El Niño, Psychosocial, Cohort study
Abstract

To assess the impact of multiple sclerosis (MS) on cognitive and psychosocial functioning in childhood and juvenile cases.We used an extensive neuropsychological battery assessing IQ, memory, attention/concentration, executive functions, and language. Fatigue and depression were also measured. An interview on school and daily living activities was obtained from the parents. Performance of cases was compared with that of demographically matched healthy controls.Sixty-three patients and 57 healthy controls were assessed. Five patients (8%) exhibited a particularly low IQ (70). Criteria for cognitive impairment (failure on at least three tests) were fulfilled in 19 patients (31%), whereas 32 patients (53%) failed at least two tests. Beyond deficits in memory, complex attention, and executive functions, the profile of deficits was characterized by involvement of linguistic abilities. In the regression analysis, the only significant predictor of cognitive impairment was an IQ score lower than 90 (odds ratio [OR] 18.2, 95% CI 4.6-71.7, p0.001). Considering the IQ score as a dependent variable, the only significant predictor was represented by younger age at onset (OR 0.7, 95% CI 0.5-0.9, p = 0.009). Depressive symptoms were reported by 6% of the cases, and fatigue was reported by 73% of the cases. MS negatively affected school and everyday activities in 56% of the subjects.In childhood and juvenile cases, multiple sclerosis (MS) is associated with cognitive impairment and low IQ scores, the latter related to younger age at onset. These aspects are of critical importance in helping children and adolescents with MS to manage their difficulties and psychosocial challenges.

Published
2008

25. Cognitive functioning in childhood and juvenile multiple sclerosis

Author

Amato, Mp, Goretti, B, Lori, S, Zipoli, V, Portaccio, E, Centorrino, S, Trojano, M, De Caro MF, Lopez, M, Martinelli, V, Falautano, M, Comi, G, Patti, Francesco, Vecchio, R, Roscio, M, Grezzi, A, and for the MS Study Group ot the Italian Neurological Society

Published
2006

26. 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, DE CARO MF, Lopez, M, Patti, Francesco, Vecchio, R, Pozzilli, C, Bianchi, V, Roscio, M, Comi, G, and Trojano, M.

Subjects
Neurology (clinical)
Published
2009

27. Early prediction of the long term evolution of multiple sclerosis: the Bayesian Risk Estimate for Multiple Sclerosis (BREMS) score

Author

Bergamaschi, R., primary, Quaglini, S., additional, Trojano, M., additional, Amato, M. P., additional, Tavazzi, E., additional, Paolicelli, D., additional, Zipoli, V., additional, Romani, A., additional, Fuiani, A., additional, Portaccio, E., additional, Berzuini, C., additional, Montomoli, C., additional, Bastianello, S., additional, and Cosi, V., additional

Published
2006
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28. Early prediction of the long term evolution of multiple sclerosis: the Bayesian Risk Estimate for Multiple Sclerosis (BREMS) score.

Author

Bergamaschi R, Quaglini S, Trojano M, Amato MP, Tavazzi E, Paolicelli D, Zipoli V, Romani A, Fuiani A, Portaccio E, Berzuini C, Montomoli C, Bastianello S, Cosi V, Bergamaschi, Roberto, Quaglini, Silvana, Trojano, Maria, Amato, Maria Pia, Tavazzi, Eleonora, and Paolicelli, Damiano

Abstract

Aim: To propose a simple tool for early prediction of unfavourable long term evolution of multiple sclerosis (MS).Methods: A Bayesian model allowed us to calculate, within the first year of disease and for each patient, the Bayesian Risk Estimate for MS (BREMS) score that represents the risk of reaching secondary progression (SP).Results: The median BREMS scores were higher in 158 patients who reached SP within 10 years compared with 1087 progression free patients (0.69 vs 0.30; p<0.0001). The BREMS value was related to SP risk in the whole cohort (p<0.0001) and in the subgroup of 535 patients who had never been treated with immune therapies, thus reasonably representing the natural history of the disease (p<0.000001).Conclusions: The BREMS score may be useful both to identify patients who are candidates for early or for more aggressive therapies and to improve the design and analysis of clinical therapeutic trials and of observational studies. [ABSTRACT FROM AUTHOR]

Published
2007

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

Author

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

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

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

30. Neopterin production and tryptophan degradation during 24-months therapy with interferon beta-1a in multiple sclerosis patients

Author

Sessa Edoardo, Solda' Annalisa, Locatelli Laura, Fantozzi Roberta, Picconi Orietta, De Luca Giovanna, Bellantonio Paolo, Amato Mariapia, Bramanti Placido, Lugaresi Alessandra, Durastanti Valentina, Totaro Rocco, Marino Silvia, Zipoli Valentina, Zorzon Marino, and Millefiorini Enrico

Subjects
Medicine
Abstract

Background Increased synthesis of neopterin and degradation of tryptophan to kynurenine, measured as kynurenine/tryptophan ratio (kyn/trp ratio), are considered in vitro markers of interferon beta-1a (IFNβ-1a) activity. The aim of the study was to investigate the dynamic profile of neopterin and kyn/trp ratio in patients with relapsing remitting multiple sclerosis (RRMS) treated with two different doses of IFNβ-1a over a period of 24 months. Methods RRMS patients (n = 101) received open-label IFNβ-1a 22 mcg (low dose, LD) or 44 mcg (high dose, HD) subcutaneously (sc), three times weekly for 24 months. Serum measurements of neopterin, kyn/trp ratio and neutralizing antibodies (NAbs) were obtained before treatment (i.e., at baseline) and 48 hours post-injection every 3 months thereafter. Clinical assessments were performed at baseline and every 6 months. Changes in biomarkers over time were compared between LD- and HD-group as well as between patients with/without relapses and with/without NAbs using Analysis of Variance and Mann-Whitney tests. Results Neopterin (p < 0.001) and kyn/trp ratio (p = 0.0013) values increased over time vs baseline in both treatment groups. Neopterin values were higher (p = 0.046) in the HD-compared to the LD-group at every time point with the exclusion of months 21 and 24 of therapy. Conversely, there were no differences between the two doses groups in the kyn/trp ratio with the exclusion of month 6 of therapy (p < 0.05). Neopterin levels were significantly reduced in NAb-positive patients starting from month 9 of therapy (p < 0.05); the same result was observed for kyn/trp ratio but only at month 9 (p = 0.02). Clinical status did not significantly affect neopterin production and tryptophan degradation. Conclusions Although differences in serum markers concentration were found following IFNβ administration the clinical relevance of these findings needs to be confirmed with more detailed studies.

Published
2011
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31. A cross-sectional, multicentre study of the therapeutic management of multiple sclerosis relapses in Italy

Author

Giovanni Frisullo, Simona Malucchi, Paolo Ragonese, Giovanna De Luca, Eleonora Cocco, Benedetta Bodini, Cinzia Cordioli, Damiano Paolicelli, Claudio Gasperini, Ilaria Pesci, Luca Roccatagliata, Mariaemma Rodegher, Antonio Gallo, Marta Radaelli, Massimiliano Calabrese, Valentina Tomassini, Valentina Zipoli, Carla Tortorella, Marco Vercellino, Claudio Solaro, Pietro Annovazzi, Laura Boffa, Annovazzi, P, Tomassini, V, Bodini, B, Boffa, L, Calabrese, M, Cocco, E, Cordioli, C, De Luca, G, Frisullo, G, Gallo, Antonio, Malucchi, S, Paolicelli, D, Pesci, I, Radaelli, M, Ragonese, P, Roccatagliata, L, Tortorella, C, Vercellino, M, Zipoli, V, Gasperini, C, Rodegher, M, Solaro, C., Annovazzi, Pietro, Tomassini, Valentina, Bodini, Benedetta, Boffa, Laura, Calabrese, Massimiliano, Cocco, Eleonora, Cordioli, Cinzia, De Luca, Giovanna, Frisullo, Giovanni, Malucchi, Simona, Paolicelli, Damiano, Pesci, Ilaria, Radaelli, Marta, Ragonese, Paolo, Roccatagliata, Luca, Tortorella, Carla, Vercellino, Marco, Zipoli, Valentina, Gasperini, Claudio, Rodegher, Mariaemma, Solaro, Claudio, Gallo, A, and Solaro, C

Subjects
Male, Pediatrics, Neurology, Cross-sectional study, multi center study, Adrenal Cortex Hormone, Adrenal Cortex Hormones, Recurrence, Surveys and Questionnaires, Multiple Sclerosi, Corticosteroid, Surveys and Questionnaire, Relapse, Survey, Neuroradiology, General Medicine, Middle Aged, Management, Psychiatry and Mental health, Methylprednisolone, Italy, Psychiatry and Mental Health, multiple sclerosi, Settore MED/26 - Neurologia, Female, Neurosurgery, medicine.drug, Human, Adult, medicine.medical_specialty, Multiple Sclerosis, Dermatology, medicine, Humans, Medical prescription, Cross-Sectional Studie, therapy, business.industry, Multiple sclerosis, medicine.disease, Management of multiple sclerosis, Cross-Sectional Studies, Health Care Survey, Health Care Surveys, Physical therapy, Neurology (clinical), business
Abstract

Despite the existence of therapeutic guidelines, management of multiple sclerosis relapse remains heterogeneous. Optimisation of relapse outcome demands an improved understanding of the neurologist's therapeutic attitude towards relapse management, which is the aim of this study. Neurologists from 13 multiple sclerosis centres completed a questionnaire every time they assessed multiple sclerosis relapses. The questionnaire requested a guided description of the relapse's clinical characteristics and an indication of the prescribed therapy, supported with up to 3 out of 20 suggested reasons. Over 3 months, 368 questionnaires were collected. Median percentage (%) of 21 relapses resulting in a prescription was 88.9%. Corticosteroids represented the most frequent prescription. A short-course of high-dose intravenous methylprednisolone was the most used corticosteroid (73.7%). Treatment was administrated mainly in day case unit (80.0%) and at home (13.6%). A tapered therapy was prescribed to 28.8% of patients. Neurologists' therapeutic decisions were driven mainly by relapse severity (45.3%) and symptom evolution (24.2%). Our study confirms the therapeutic attitude of multiple sclerosis specialists in treating relapses with high-dose intravenous corticosteroids in a day hospital setting, with a tapering in a proportion of cases. The main reasons for prescription are relapse severity and symptom evolution. © 2012 Springer-Verlag.

Published
2013

32. Impact of treatment with dimethyl fumarate on sleep quality in patients with relapsing-remitting multiple sclerosis: A multicentre Italian wearable tracker study.

Author

Comi G, Leocani L, Ferini-Strambi L, Radaelli M, Costa GD, Lanzillo R, Lus G, Bianchi V, Traccis S, Capone F, Grimaldi LM, Salemi G, Cardillo A, and Zipoli V

Abstract

Background: Sleep disorders are common in patients with multiple sclerosis and have a bidirectional interplay with fatigue and depression., Objective: To evaluate the effect of treatment with oral dimethyl fumarate on the quality of sleep in relapsing-remitting multiple sclerosis., Methods: This was a multicentre observational study with 223 relapsing-remitting multiple sclerosis subjects starting treatment with dimethyl fumarate ( n =177) or beta interferon ( n =46). All patients underwent subjective (Pittsburgh Sleep Quality Index) and objective (wearable tracker) measurements of quality of sleep. Fatigue, depression, and quality of life were also investigated and physical activity was monitored., Results: Patients treated with dimethyl fumarate had significant improvement in the quality of sleep as measured with the Pittsburgh Sleep Quality Index ( p <0.001). At all-time points, no significant changes in Pittsburgh Sleep Quality Index score were observed in the interferon group. Total and deep sleep measured by wearable tracker decreased at week 12 with both treatments, then remained stable for the total study duration. Depression significantly improved in patients treated with dimethyl fumarate. No significant changes were observed in mobility, fatigue and quality of life., Conclusion: In patients with relapsing-remitting multiple sclerosis, the treatment with dimethyl fumarate was associated with improvements in patient-reported quality of sleep. Further randomised clinical trials are needed to confirm the benefits of long-term treatment with dimethyl fumarate., (© The Author(s), 2023.)

Published
2023
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33. Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Peg IFN Beta-1a (Pre-filled Pen) in Subjects With Relapsing-Remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM Study).

Author

Centonze D, Fantozzi R, Buttari F, Grimaldi LME, Totaro R, Corea F, Marrosu MG, Confalonieri P, Cottone S, Trojano M, and Zipoli V

Abstract

Subcutaneous (SC) interferons beta (IFN-beta) are effective therapies for the treatment of relapsing-remitting multiple sclerosis (RRMS). Factors such as dosing schedule, needle intolerance/fatigue, and side effects may impact patient satisfaction with treatment. Improvement of patient satisfaction may increase the adherence to treatment and the patient quality of life. This study was aimed at evaluating the impact of switching to "Peginterferon beta-1a (Peg-IFN beta-1a)" in patients with RRMS unsatisfied with other SC interferons. The multicenter, open-label, phase IV PLATINUM study was conducted in 32 Italian centers. The primary endpoint was changes from baseline in the score of a convenience satisfaction domain of the TSQM-9 questionnaire at 12 weeks. The secondary endpoints were patients' global satisfaction, short-term adherence to treatment, satisfaction with the injection system, effect on fatigue, disease activity, and patient inability score. A total of 193 patients were enrolled and 166 (86%) completed the study, receiving Peg-IFN beta-1a for 24 weeks. Patients switching to Peg-IFN beta-1a from other SC interferons reported a significant improvement ( p < 0.001) of Convenience Score and all other scores of the TSQM-9 questionnaire at 12 and 24 weeks ( p < 0.001). Peg IFN beta-1a attained very high adherence to the treatment (92 and 86% at 12 and 24 weeks, respectively) with a stable annualized relapse rate (ARR). At 24 weeks, 94% of the participants were relapse free. Adverse events (AEs), recorded on 82 patients (42%), were mild or moderate. The most common AE was flu-like syndrome (29.2%). Patients switching from SC IFN beta therapy to Peg IFN beta-1a showed high treatment satisfaction with a positive safety profile, comparable with that of other currently approved first-line injectable SC interferons. This study suggests that Peg IFN beta-1a might represent a treatment choice to improve adherence in RRMS patients unsatisfied with other SC interferons., Competing Interests: VZ was employed by the company Biogen Italy. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Biogen Italia. The funder had the following involvement with the study: study design, data analysis, and revision of the manuscript., (Copyright © 2021 Centonze, Fantozzi, Buttari, Grimaldi, Totaro, Corea, Marrosu, Confalonieri, Cottone, Trojano and Zipoli.)

Published
2021
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34. Neopterin production and tryptophan degradation during 24-months therapy with interferon beta-1a in multiple sclerosis patients.

Author

Durastanti V, Lugaresi A, Bramanti P, Amato M, Bellantonio P, De Luca G, Picconi O, Fantozzi R, Locatelli L, Solda' A, Sessa E, Totaro R, Marino S, Zipoli V, Zorzon M, and Millefiorini E

Subjects
Adult, Antibodies, Neutralizing immunology, Biomarkers blood, Demography, Dose-Response Relationship, Drug, Female, Humans, Interferon beta-1a, Kynurenine blood, Male, Multiple Sclerosis blood, Multiple Sclerosis immunology, Neopterin blood, Time Factors, Tryptophan blood, Interferon-beta therapeutic use, Multiple Sclerosis drug therapy, Neopterin biosynthesis, Tryptophan metabolism
Abstract

Background: Increased synthesis of neopterin and degradation of tryptophan to kynurenine, measured as kynurenine/tryptophan ratio (kyn/trp ratio), are considered in vitro markers of interferon beta-1a (IFNβ-1a) activity. The aim of the study was to investigate the dynamic profile of neopterin and kyn/trp ratio in patients with relapsing remitting multiple sclerosis (RRMS) treated with two different doses of IFNβ-1a over a period of 24 months., Methods: RRMS patients (n = 101) received open-label IFNβ-1a 22 mcg (low dose, LD) or 44 mcg (high dose, HD) subcutaneously (sc), three times weekly for 24 months. Serum measurements of neopterin, kyn/trp ratio and neutralizing antibodies (NAbs) were obtained before treatment (i.e., at baseline) and 48 hours post-injection every 3 months thereafter. Clinical assessments were performed at baseline and every 6 months. Changes in biomarkers over time were compared between LD- and HD-group as well as between patients with/without relapses and with/without NAbs using Analysis of Variance and Mann-Whitney tests., Results: Neopterin (p < 0.001) and kyn/trp ratio (p = 0.0013) values increased over time vs baseline in both treatment groups. Neopterin values were higher (p = 0.046) in the HD-compared to the LD-group at every time point with the exclusion of months 21 and 24 of therapy. Conversely, there were no differences between the two doses groups in the kyn/trp ratio with the exclusion of month 6 of therapy (p < 0.05). Neopterin levels were significantly reduced in NAb-positive patients starting from month 9 of therapy (p < 0.05); the same result was observed for kyn/trp ratio but only at month 9 (p = 0.02). Clinical status did not significantly affect neopterin production and tryptophan degradation., Conclusions: Although differences in serum markers concentration were found following IFNβ administration the clinical relevance of these findings needs to be confirmed with more detailed studies.

Published
2011
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35. Cognitive changes in multiple sclerosis.

Author

Amato MP, Zipoli V, and Portaccio E

Subjects
Cognition Disorders complications, Humans, Multiple Sclerosis complications, Brain pathology, Clinical Trials as Topic trends, Cognition Disorders diagnosis, Cognition Disorders prevention & control, Magnetic Resonance Imaging, Multiple Sclerosis diagnosis, Multiple Sclerosis therapy
Abstract

Cognitive dysfunction (CD) affects 40-65% of multiple sclerosis (MS) patients and can have a great functional impact. It can be detected in all the disease phenotypes from the early stages of the disease and tends to progress over time. Memory, complex attention, information processing speed and executive functions are most commonly involved. The relationship between cognitive changes and MRI findings may involve changes in different areas, including white matter lesions, normal appearing brain tissue on conventional MRI, cortical and deep gray matter. The search for effective therapeutic strategies is a major undertaking. Evidence of a possible effect of anticholinesterasics and cognitive rehabilitation is still preliminary. In this article, we review the current knowledge on CD in MS and highlight areas of special importance for future research in the field.

Published
2008
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36. Brain damage as detected by magnetization transfer imaging is less pronounced in benign than in early relapsing multiple sclerosis.

Author

De Stefano N, Battaglini M, Stromillo ML, Zipoli V, Bartolozzi ML, Guidi L, Siracusa G, Portaccio E, Giorgio A, Sorbi S, Federico A, and Amato MP

Subjects
Adult, Age Factors, Aged, Diagnosis, Differential, Female, Humans, Image Processing, Computer-Assisted methods, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting pathology, Brain pathology, Multiple Sclerosis pathology
Abstract

The trend to start disease-modifying therapy early in the course of multiple sclerosis makes it important to establish whether the benign form is a real entity. In previous studies, measures of magnetization transfer (MT) ratio (MTr) have been shown to provide good estimates of the amount of tissue damage occurring in multiple sclerosis brains. Thus, with the hypothesis that if benign multiple sclerosis patients were really benign, sensitive measures of subtle tissue damage would be less pronounced in these patients than in very early relapsing-remitting (RR) multiple sclerosis patients. We carried out conventional MRI and MT imaging in 50 patients with benign multiple sclerosis [defined as having Kurtzke Expanded Disability Status Score (EDSS) <3 and disease duration >15 years] and in 50 early RR patients selected to have similar disability (EDSS <3) and short disease duration (<3 years). Data were compared with those of 32 demographically-matched normal controls. We used a fully automated procedure to measure lesional-MTr, perilesional-MTr, normal-appearing white matter (NAWM) MTr and cortical-MTr. We found that, after correction for common effects of age, lesional-MTr and perilesional-MTr of benign patients were significantly (P < 0.0001) lower than WM of normal controls, but significantly (P < 0.0001) higher than corresponding tissues of RR patients. In NAWM and cortex, MTr values of benign patients were similar to those of normal controls (P > 0.5) and significantly higher than those of the RR patients (P < 0.0001 and P < 0.01, respectively). Similar differences in MTr measures between benign and RR patients were found when patient groups were selected to have no disability (EDSS < or = 2) and, for benign multiple sclerosis, very long disease duration (>20 years) or when both groups were matched for high lesion load (T2-weighted lesion volume >10 cm3). We conclude that lesional and non-lesional MTr values can be significantly less pronounced in benign multiple sclerosis than in a cohort of RR patients at their earliest disease stages, suggesting that brain tissue damage is milder in benign multiple sclerosis than in early RR disease. This can be due to an extraordinary beneficial response to demyelination of benign patients and may represent the evidence that benign multiple sclerosis truly exists and might be differentiated from other forms of this illness.

Published
2006
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37. Cognitive dysfunction in multiple sclerosis: current approaches to clinical management.

Author

Amato MP and Zipoli V

Abstract

In the last two decades clinicians have become increasingly aware of the frequency, importance and functional impact of cognitive dysfunction in multiple sclerosis. There is, however, a dearth of research in this area. In order to further progress in the field of neuropsychological diagnosis it is essential to validate sensitive, cost-effective and reliable screening instruments that can be used in clinical settings to identify patients appropriate for extensive neuropsychological assessment. As for the therapeutic approach, there is preliminary evidence that treatment with both disease-modifying and symptomatic agents may influence positively also the cognitive outcome of the patient. Few studies have assessed the efficacy of cognitive rehabilitation programs using an experimental design. Therefore, further research is clearly needed in this field: in particular, there is a need for tailor-made rehabilitation techniques for multiple sclerosis subjects, which take into account the course and stage of the disease, as well as the psychosocial problems of the individual patient.

Published
2002
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