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Start Over Author "Grimaldi, L. M. E." Topic multiple sclerosis, relapsing-remitting
9 results on '"Grimaldi, L. M. E."'

1. Do patients' and referral centers' characteristics influence multiple sclerosis phenotypes? Results from the Italian multiple sclerosis and related disorders register.

Author

Bergamaschi R, Beghi E, Bosetti C, Ponzio M, Santucci C, Lepore V, Mosconi P, Aguglia U, Amato MP, Ancona AL, Ardito B, Avolio C, Balgera R, Banfi P, Barcella V, Barone P, Bellantonio P, Berardinelli A, Bergamaschi R, Bertora P, Bianchi M, Bramanti P, Morra VB, Brichetto G, Brioschi AM, Buccafusca M, Bucello S, Busillo V, Calchetti B, Cantello R, Capobianco M, Capone F, Capone L, Cargnelutti D, Carrozzi M, Cartechini E, Cavaletti G, Cavalla P, Celani MG, Clerici R, Clerico M, Cocco E, Confalonieri P, Coniglio MG, Conte A, Corea F, Cottone S, Crociani P, D'Andrea F, Danni MC, De Luca G, de Pascalis D, De Riz M, De Robertis F, De Rosa G, De Stefano N, Corte MD, Di Sapio A, Docimo R, Falcini M, Falcone N, Fermi S, Ferraro E, Ferrò MT, Fortunato M, Foschi M, Gajofatto A, Gallo A, Gallo P, Gatto M, Gazzola P, Giordano A, Granella F, Grasso MF, Grasso MG, Grimaldi LME, Iaffaldano P, Imperiale D, Inglese M, Iodice R, Leva S, Luezzi V, Lugaresi A, Lus G, Maimone D, Mancinelli L, Maniscalco GT, Marfia GA, Marini B, Marson A, Mascoli N, Massacesi L, Melani F, Merello M, Meucci G, Mirabella M, Montepietra S, Nasuelli D, Nicolao P, Passantino F, Patti F, Peresson M, Pesci I, Piantadosi C, Piras ML, Pizzorno M, Plewnia K, Pozzilli C, Protti A, Quatrale R, Realmuto S, Ribizzi G, Rinalduzzi S, Rini A, Romano S, Romeo M, Ronzoni M, Rossi P, Rovaris M, Salemi G, Santangelo G, Santangelo M, Santuccio G, Sarchielli P, Sinisi L, Sola P, Solaro C, Spitaleri D, Strumia S, Tassinari T, Tonietti S, Tortorella C, Totaro R, Tozzo A, Trivelli G, Ulivelli M, Valentino P, Venturi S, Vianello M, Zaffaroni M, Zarbo R, Trojano M, Battaglia MA, Capobianco M, Pugliatti M, Ulivelli M, Mosconi P, Gasperini C, Patti F, Amato MP, Bergamaschi R, and Comi G

Subjects
Female, Humans, Phenotype, Recurrence, Referral and Consultation, Multiple Sclerosis complications, Multiple Sclerosis, Chronic Progressive complications, Multiple Sclerosis, Chronic Progressive epidemiology, Multiple Sclerosis, Relapsing-Remitting complications, Multiple Sclerosis, Relapsing-Remitting epidemiology
Abstract

Background: Multiple sclerosis (MS) is characterized by phenotypical heterogeneity, partly resulting from demographic and environmental risk factors. Socio-economic factors and the characteristics of local MS facilities might also play a part., Methods: This study included patients with a confirmed MS diagnosis enrolled in the Italian MS and Related Disorders Register in 2000-2021. Patients at first visit were classified as having a clinically isolated syndrome (CIS), relapsing-remitting (RR), primary progressive (PP), progressive-relapsing (PR), or secondary progressive MS (SP). Demographic and clinical characteristics were analyzed, with centers' characteristics, geographic macro-areas, and Deprivation Index. We computed the odds ratios (OR) for CIS, PP/PR, and SP phenotypes, compared to the RR, using multivariate, multinomial, mixed effects logistic regression models., Results: In all 35,243 patients from 106 centers were included. The OR of presenting more advanced MS phenotypes than the RR phenotype at first visit significantly diminished in relation to calendar period. Females were at a significantly lower risk of a PP/PR or SP phenotype. Older age was associated with CIS, PP/PR, and SP. The risk of a longer interval between disease onset and first visit was lower for the CIS phenotype, but higher for PP/PR and SP. The probability of SP at first visit was greater in the South of Italy., Discussion: Differences in the phenotype of MS patients first seen in Italian centers can be only partly explained by differences in the centers' characteristics. The demographic and socio-economic characteristics of MS patients seem to be the main determinants of the phenotypes at first referral., (© 2022. The Author(s).)

Published
2022
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2. Discontinuation of teriflunomide and dimethyl fumarate in a large Italian multicentre population: a 24-month real-world experience.

Author

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

Subjects
Adult, Follow-Up Studies, Humans, Hydroxybutyrates, Italy, Middle Aged, Nitriles, Retrospective Studies, Time Factors, Crotonates administration & dosage, Dimethyl Fumarate administration & dosage, Immunosuppressive Agents administration & dosage, Multiple Sclerosis, Relapsing-Remitting drug therapy, Toluidines administration & dosage
Abstract

Background: Teriflunomide (TRF) and Dimethyl fumarate (DMF) are licensed drugs for relapsing-remitting Multiple Sclerosis (RRMS)., Objectives: We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF., Materials and Methods: A retrospective study on prospectively collected data was performed in nine tertiary MS centers, in Italy. The 24-month discontinuation rate in the two cohorts was the primary study outcome. We also assessed the time to discontinuation and reasons of therapy withdrawn. Discontinuation of TRF and DMF was defined as a gap of treatment ≥ 60 days., Results: A cohort of 903 pwRRMS (316 on TRF and 587 on DMF) was analyzed. During 24 months of follow-up, pwRRMS on TRF and DMF showed similar discontinuation rates. The analysis of predictors with Cox regression model showed differences between the two groups (p for log-rank test = 0.007); male gender [HR 2.21 (1.00-4.90); p = 0.01] and the number of previous switches [HR 1.47 (1.16-1.86); p = 0.01] were associated with higher hazard of discontinuation in the DMF group., Conclusions: In a real-world setting, pwRRMS on TRF and DMF had similar discontinuation rates over 24 months. Male pwRRMS on DMF with a previous history of therapeutic failure are at more risk of discontinuation therapy.

Published
2019
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3. Natalizumab in pediatric multiple sclerosis: results of a cohort of 55 cases.

Author

Ghezzi A, Pozzilli C, Grimaldi LM, Moiola L, Brescia-Morra V, Lugaresi A, Lus G, Rinaldi F, Rocca MA, Trojano M, Bianchi A, Comi G, and Filippi M

Subjects
Adolescent, Brain pathology, Child, Cohort Studies, Female, Humans, Magnetic Resonance Imaging, Male, Multiple Sclerosis, Relapsing-Remitting pathology, Natalizumab, Antibodies, Monoclonal, Humanized therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Background: Limited information is available on the use of natalizumab (NA) in pediatric multiple sclerosis (ped-MS) patients., Objective: The purpose of this study was to describe the long-term effects of NA in a large cohort of active ped-MS patients., Methods: Patients with definite ped-MS were treated with NA if in the previous year they had experienced at least two relapses or a severe relapse with incomplete recovery while on immunomodulating treatment, or at least two relapses and new magnetic resonance imaging (MRI) lesions regardless of any prior treatment., Results: The study included 55 patients (mean age: 14.4 years, mean number of relapses: 4.4, pre-treatment mean disease duration: 25.5 months). They received a median number of 26 infusions. Three relapses occurred during the follow-up, one female patient continued to deteriorate in cognitive functioning. Mean Expanded Disability Status Scale (EDSS) scores decreased from 2.7 to 1.9 at the last visit (p<0.001). During the follow-up the majority of patients remained free from MRI activity. Transient and mild clinical adverse events occurred in 20 patients. Mild hematological abnormalities occurred in seven patients. Anti-JCV antibodies were detected in 20/51 tested patients., Conclusions: NA was well tolerated in all patients. A strong suppression of disease activity was observed in the majority of patients during the follow-up.

Published
2013
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4. 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, and Tedeschi G

Subjects
Antibodies, Monoclonal, Humanized, Humans, Leukoencephalopathy, Progressive Multifocal chemically induced, Natalizumab, Antibodies, Monoclonal therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy
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
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5. Efficacy and tolerability of natalizumab in relapsing-remitting multiple sclerosis patients: a post-marketing observational study.

Author

Sangalli F, Moiola L, Bucello S, Annovazzi P, Rizzo A, Radaelli M, Vitello G, Grimaldi LM, Ghezzi A, Martinelli V, and Comi G

Subjects
Adult, Cohort Studies, Drug Hypersensitivity etiology, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting physiopathology, Natalizumab, Treatment Outcome, Young Adult, Antibodies, Monoclonal, Humanized adverse effects, Antibodies, Monoclonal, Humanized therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy, Product Surveillance, Postmarketing trends
Abstract

To evaluate the efficacy and safety of natalizumab in patients with active relapsing-remitting multiple sclerosis (MS). We included 285 MS patients receiving natalizumab. Clinical, neuroradiological and safety data were registered every 6 months. Neutralizing antibodies (NABs) were tested after 6 months of treatment. After 1 year, the annualized relapse rate decreased to 0.26, with a significant reduction compared to the previous year (2.13). At 24 months the proportion of "relapse free" patients was 78% while that of "MRI free" patients was 69%. Considering clinical and MRI cumulative activity, "disease free" patients were 63% at 24 months. A total of 18 patients showed NABs positivity. We reported 34 cases of treatment interruptions. In conclusion, our data confirm the remarkable efficacy of natalizumab in a group of patients with higher disease activity than that of pivotal studies.

Published
2011
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6. An MRI study of Chlamydia pneumoniae infection in Italian multiple sclerosis patients.

Author

Grimaldi LM, Pincherle A, Martinelli-Boneschi F, Filippi M, Patti F, Reggio A, Franciotta D, Allegra L, Comi G, and Blasi F

Subjects
Adolescent, Adult, Aged, Chlamydophila Infections blood, Chlamydophila Infections cerebrospinal fluid, Chlamydophila pneumoniae genetics, DNA, Bacterial blood, DNA, Bacterial cerebrospinal fluid, Female, Humans, Italy, Male, Middle Aged, Multiple Sclerosis, Chronic Progressive blood, Multiple Sclerosis, Chronic Progressive cerebrospinal fluid, Multiple Sclerosis, Relapsing-Remitting blood, Multiple Sclerosis, Relapsing-Remitting cerebrospinal fluid, Chlamydophila Infections complications, Chlamydophila pneumoniae isolation & purification, Magnetic Resonance Imaging, Multiple Sclerosis, Chronic Progressive microbiology, Multiple Sclerosis, Relapsing-Remitting microbiology
Abstract

We amplified sequences of the Chlamydia pneumoniae (CP) major-outer membrane protein in the cerebrospinal fluid (CSF) from 23 of 107 (21.5%) relapsing-remitting or secondary progressive multiple sclerosis (MS) patients and two of 77 (2.6%) patients with other neurological diseases (OND) (P = 0.00022). CP+ patients showed magnetic resonance imaging (MRI) evidence of more active disease (P = 0.02) compared to CP- MS patients and tended to have an anticipation of age at disease onset (32.3 +/- 12 versus 28.5 +/- 10 years; P = ns) causing a longer disease duration (7.5 +/- 5 versus 4.4 +/- 4 years; P = 0.016) at the time of clinical evaluation. These findings, although indirectly, suggest that CP infection of the central nervous system (CNS) might affect disease course in a subgroup of MS patients.

Published
2003
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7. Do patients' and referral centers' characteristics influence multiple sclerosis phenotypes? Results from the Italian multiple sclerosis and related disorders register

Author

Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Aguglia, U, Amato, M P, Ancona, A L, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bergamaschi, R, Bertora, P, Bianchi, M, Bramanti, P, Morra, V Brescia, Brichetto, G, Brioschi, A M, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M G, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M G, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M C, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M Della, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M T, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M F, Grasso, M G, Grimaldi, L M E, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G T, Marfia, G A, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M L, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, Comi, Giancarlo, Bergamaschi, R, Beghi, E, Bosetti, C, Ponzio, M, Santucci, C, Lepore, V, Mosconi, P, Aguglia, U, Amato, M, Ancona, A, Ardito, B, Avolio, C, Balgera, R, Banfi, P, Barcella, V, Barone, P, Bellantonio, P, Berardinelli, A, Bertora, P, Bianchi, M, Bramanti, P, Morra, V, Brichetto, G, Brioschi, A, Buccafusca, M, Bucello, S, Busillo, V, Calchetti, B, Cantello, R, Capobianco, M, Capone, F, Capone, L, Cargnelutti, D, Carrozzi, M, Cartechini, E, Cavaletti, G, Cavalla, P, Celani, M, Clerici, R, Clerico, M, Cocco, E, Confalonieri, P, Coniglio, M, Conte, A, Corea, F, Cottone, S, Crociani, P, D'Andrea, F, Danni, M, De Luca, G, de Pascalis, D, De Riz, M, De Robertis, F, De Rosa, G, De Stefano, N, Corte, M, Di Sapio, A, Docimo, R, Falcini, M, Falcone, N, Fermi, S, Ferraro, E, Ferrò, M, Fortunato, M, Foschi, M, Gajofatto, A, Gallo, A, Gallo, P, Gatto, M, Gazzola, P, Giordano, A, Granella, F, Grasso, M, Grimaldi, L, Iaffaldano, P, Imperiale, D, Inglese, M, Iodice, R, Leva, S, Luezzi, V, Lugaresi, A, Lus, G, Maimone, D, Mancinelli, L, Maniscalco, G, Marfia, G, Marini, B, Marson, A, Mascoli, N, Massacesi, L, Melani, F, Merello, M, Meucci, G, Mirabella, M, Montepietra, S, Nasuelli, D, Nicolao, P, Passantino, F, Patti, F, Peresson, M, Pesci, I, Piantadosi, C, Piras, M, Pizzorno, M, Plewnia, K, Pozzilli, C, Protti, A, Quatrale, R, Realmuto, S, Ribizzi, G, Rinalduzzi, S, Rini, A, Romano, S, Romeo, M, Ronzoni, M, Rossi, P, Rovaris, M, Salemi, G, Santangelo, G, Santangelo, M, Santuccio, G, Sarchielli, P, Sinisi, L, Sola, P, Solaro, C, Spitaleri, D, Strumia, S, Tassinari, T, Tonietti, S, Tortorella, C, Totaro, R, Tozzo, A, Trivelli, G, Ulivelli, M, Valentino, P, Venturi, S, Vianello, M, Zaffaroni, M, Zarbo, R, Trojano, M, Battaglia, M, Pugliatti, M, Gasperini, C, Comi, G, Bergamaschi, Roberto, Beghi, Ettore, Bosetti, Cristina, Ponzio, Michela, Santucci, Claudia, Lepore, Vito, Mosconi, Paola, Amato, M P, Ancona, A L, Morra, V Brescia, Brioschi, A M, Celani, M G, Coniglio, M G, Danni, M C, Corte, M Della, Ferrò, M T, Grasso, M F, Grasso, M G, Grimaldi, L M E, Maniscalco, G T, Marfia, G A, Piras, M L, Trojano, Maria, Battaglia, Mario Alberto, Capobianco, Marco, Pugliatti, Maura, Ulivelli, Monica, Gasperini, Claudio, Patti, Francesco, Amato, Maria Pia, and Comi, Giancarlo

Subjects
Multiple Sclerosis, Centers’ characteristics, Italian Multiple Sclerosis Register, Multiple sclerosis phenotypes, Real-world data, Settore MED/42 - Igiene Generale e Applicata, Dermatology, General Medicine, Multiple Sclerosis, Chronic Progressive, Settore MED/26, Settore SECS-S/04 - Demografia, Multiple sclerosis phenotype, Settore MED/01 - Statistica Medica, Psychiatry and Mental health, Multiple Sclerosis, Relapsing-Remitting, Phenotype, Recurrence, Humans, Female, Settore MED/26 - Neurologia, Neurology (clinical), Centers’ characteristic, Referral and Consultation
Abstract

Background Multiple sclerosis (MS) is characterized by phenotypical heterogeneity, partly resulting from demographic and environmental risk factors. Socio-economic factors and the characteristics of local MS facilities might also play a part. Methods This study included patients with a confirmed MS diagnosis enrolled in the Italian MS and Related Disorders Register in 2000–2021. Patients at first visit were classified as having a clinically isolated syndrome (CIS), relapsing–remitting (RR), primary progressive (PP), progressive-relapsing (PR), or secondary progressive MS (SP). Demographic and clinical characteristics were analyzed, with centers’ characteristics, geographic macro-areas, and Deprivation Index. We computed the odds ratios (OR) for CIS, PP/PR, and SP phenotypes, compared to the RR, using multivariate, multinomial, mixed effects logistic regression models. Results In all 35,243 patients from 106 centers were included. The OR of presenting more advanced MS phenotypes than the RR phenotype at first visit significantly diminished in relation to calendar period. Females were at a significantly lower risk of a PP/PR or SP phenotype. Older age was associated with CIS, PP/PR, and SP. The risk of a longer interval between disease onset and first visit was lower for the CIS phenotype, but higher for PP/PR and SP. The probability of SP at first visit was greater in the South of Italy. Discussion Differences in the phenotype of MS patients first seen in Italian centers can be only partly explained by differences in the centers’ characteristics. The demographic and socio-economic characteristics of MS patients seem to be the main determinants of the phenotypes at first referral.

Published
2022

8. Dimethyl fumarate vs Teriflunomide: an Italian time-to-event data analysis

Author

D'Amico E., Zanghi A., Sciandra M., Lanzillo R., Callari G., Cortese A., Lus G., Lucchini M., Buccafusca M., Bonavita S., Gallo A., Curti E., Gajofatto A., Signoriello E., Bisecco A., Gobbin F., Ferro M. T., Ferrazzano G., Sparaco M., Valentino P., Mirabella M., Granella F., Bresciamorra V., Grimaldi L. M. E., Patti F., Borriello G., Grossi P., Carotenuto A., Siena E., Tsantes E., Giugno A., Abbadessa G. M., Chisari C. G., D'Amico, Emanuele, Zanghì, Aurora, Sciandra, Mariangela, Lanzillo, Roberta, Callari, Graziella, Cortese, Antonio, Lus, Giacomo, Lucchini, Matteo, Buccafusca, Maria, Bonavita, Simona, Gallo, Antonio, Curti, Erica, Gajofatto, Alberto, Signoriello, Elisabetta, Bisecco, Alvino, Gobbin, Francesca, Ferrò, Maria Teresa, Ferrazzano, Gina, Sparaco, Maddalena, Valentino, Paola, Mirabella, Massimiliano, Granella, Franco, Brescia Morra, Vincenzo, Grimaldi, Luigi Maria Edoardo, Patti, Francesco, D'Amico, E., Zanghi, A., Sciandra, M., Lanzillo, R., Callari, G., Cortese, A., Lus, G., Lucchini, M., Buccafusca, M., Bonavita, S., Gallo, A., Curti, E., Gajofatto, A., Signoriello, E., Bisecco, A., Gobbin, F., Ferro, M. T., Ferrazzano, G., Sparaco, M., Valentino, P., Mirabella, M., Granella, F., Bresciamorra, V., Grimaldi, L. M. E., Patti, F., Borriello, G., Grossi, P., Carotenuto, A., Siena, E., Tsantes, E., Giugno, A., Abbadessa, G. M., and Chisari, C. G.

Subjects
Adult, Data Analysis, Male, medicine.medical_specialty, Neurology, Efficacy, Toluidines, Dimethyl Fumarate, Hydroxybutyrates, Relapsing-Remitting, Multiple sclerosis, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, Teriflunomide, Nitriles, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, Neuroradiology, Dimethyl fumarate, Proportional hazards model, business.industry, Safety, Female, Italy, Middle Aged, Crotonates, Immunosuppressive Agents, medicine.disease, Settore MED/26 - NEUROLOGIA, Event data, chemistry, Cohort, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background: The introduction of oral disease-modifying therapies (DMTs) for relapsing–remitting multiple sclerosis (RRMS) changed algorithms of RRMS treatment. Objectives: To compare the effectiveness of treatment with dimethyl fumarate (DMF) and teriflunomide (TRF) in a large multicentre Italian cohort of RRMS patients. Materials and Methods: Patients with RRMS who received treatment with DMF and TRF between January 1st, 2012 and December 31st, 2018 from twelve MS centers were identified. The events investigated were “time-to-first-relapse”, “time-to-Magnetic-Resonance-Imaging (MRI)-activity” and “time-to-disability-progression”. Results: 1445 patients were enrolled (1039 on DMF, 406 on TRF) and followed for a median of 34months. Patients on TRF were older (43.5 ± 8.6 vs 38.8 ± 9.2years), with a predominance of men and higher level of disability (p < 0.001 for all). Patients on DMF had a higher number of relapses and radiological activity (p 38DMF = 3.83, CI = 1.11 to 13.23, p = 0.033). Both DMTs controlled similarly MRI activity and disability progression. Conclusions: Patients on DMF had higher relapse-free survival time than TRF group after the first 38 months ontherapy.

Published
2020

9. Discontinuation of teriflunomide and dimethyl fumarate in a large Italian multicentre population: a 24-month real-world experience

Author

Mario Zappia, Giuseppe Salemi, Graziella Callari, Mariangela Sciandra, L.M.E. Grimaldi, G. Tedeschi, Antonio Gallo, Carlo Pozzilli, Roberto Bruno Bossio, Salvatore Cottone, Giovanna Borriello, Francesco Patti, Aurora Zanghì, Emanuele D'Amico, Maria Buccafusca, Paola Valentino, D'Amico E., Zanghì A., Sciandra M., Borriello G., Callari G., Gallo A., Salemi G., Cottone S., Buccafusca M., Valentino P., Bossio RB., Grimaldi LME., Pozzilli C., Tedeschi G., Zappia M., Patti F., D'Amico, E, Zanghì, A, Sciandra, M, Borriello, G, Callari, G, Gallo, A, Salemi, G, Cottone, S, Buccafusca, M, Valentino, P, Bossio, R B, Grimaldi, L M E, Pozzilli, C, Tedeschi, G, Zappia, M, and Patti, F

Subjects
Adult, medicine.medical_specialty, Discontinuation rate, Time Factors, Toluidines, Population, Hydroxybutyrates, Relapsing-Remitting, Dimethyl fumarate, Multiple sclerosis, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, Teriflunomide, Nitriles, medicine, Humans, Multiple sclerosi, 030212 general & internal medicine, education, Retrospective Studies, education.field_of_study, business.industry, Proportional hazards model, Real-life, Neurology, Neurology (clinical), Retrospective cohort study, Middle Aged, medicine.disease, Discontinuation, chemistry, Italy, Crotonates, Cohort, Dimethyl Fumarate, Follow-Up Studies, Immunosuppressive Agents, business, 030217 neurology & neurosurgery
Abstract

Teriflunomide (TRF) and Dimethyl fumarate (DMF) are licensed drugs for relapsing-remitting Multiple Sclerosis (RRMS). We aimed to compare the rate and the time to discontinuation among persons with RRMS (pwRRMS), newly treated with TRF and DMF. A retrospective study on prospectively collected data was performed in nine tertiary MS centers, in Italy. The 24-month discontinuation rate in the two cohorts was the primary study outcome. We also assessed the time to discontinuation and reasons of therapy withdrawn. Discontinuation of TRF and DMF was defined as a gap of treatment ≥ 60 days. A cohort of 903 pwRRMS (316 on TRF and 587 on DMF) was analyzed. During 24 months of follow-up, pwRRMS on TRF and DMF showed similar discontinuation rates. The analysis of predictors with Cox regression model showed differences between the two groups (p for log-rank test = 0.007); male gender [HR 2.21 (1.00–4.90); p = 0.01] and the number of previous switches [HR 1.47 (1.16–1.86); p = 0.01] were associated with higher hazard of discontinuation in the DMF group. In a real-world setting, pwRRMS on TRF and DMF had similar discontinuation rates over 24 months. Male pwRRMS on DMF with a previous history of therapeutic failure are at more risk of discontinuation therapy.

Published
2019

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