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Your search keyword '"Grimaldi, L. M. E."' showing total 5 results
Start Over Author "Grimaldi, L. M. E." Topic immunosuppressive agents
5 results on '"Grimaldi, L. M. E."'

1. 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 We also assessed the time to discontinuation and reasons of therapy withdrawn.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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2. 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

3. Safety of the first dose of fingolimod for multiple sclerosis: results of an open-label clinical trial

Author

Laroni A., Brogi D., Morra V. B., Guidi L., Pozzilli C., Comi G., Lugaresi A., Turrini R., Raimondi D., Uccelli A., Mancardi G. L., Amato M. P., Appendino L., Ardito B., Avolio C., Bandini F., Batocchi A. P., Bellantonio P., Benedetti M. D., Bergamaschi R., Bortolon F., Bosco A., Buccafusca M., Cargnelutti D., Cavalla P., Cavallo R., Centonze D., Coniglio M. G., Costantino G., Cottone S., Danni M. C., De Robertis F., Deotto L., Dotta M., Di Battista G., Filippi M. M., Florio C., Francia A., Galgani S., Gallo P., Ghezzi A., Giometto B., Giuliani G., Grimaldi L. M. E., Guidotti M., Iudice A., Lenzi G. L., Lorusso L., Lus G., Maimone D., Malentacchi G. M., Mantegazza R. E., Massacesi L., Melato M., Millefiorini E., Montanari E., Patti F., Perrone P. S. M., Protti A., Provera P., Quattrone A., Rasi F., Rosati G., Rovaris M., Sacca F., Salemi G., Sarchielli P., Scarpini E. A., Schoenhuber R., Serrati C., Sinisi L., Sola P., Spitaleri D. L. A., Tedeschi G., Tezzon F., Tinebra Asti M. C., Tola M. R., Totaro R., Trojano M., Ulivelli M., Vecchio M. M., Zimatore G. B., Alice Laroni, Davide Brogi, Vincenzo Brescia Morra, Leonello Guidi, Carlo Pozzilli, Giancarlo Comi, Alessandra Lugaresi, Renato Turrini, Debora Raimondi, Antonio Uccelli, Giovanni Mancardi, EAP Investigators, Laroni, A, Brogi, D, BRESCIA MORRA, Vincenzo, Guidi, L, Pozzilli, C, Comi, G, Lugaresi, A, Turrini, R, Raimondi, D, Uccelli, A, Macardi, G., Laroni A, Brogi D, Morra VB, Guidi L, Pozzilli C, Comi G, Lugaresi A, Turrini R, Raimondi D, Uccelli A, Mancardi GL, Amato MP, Appendino L, Ardito B, Avolio C, Bandini F, Batocchi AP, Bellantonio P, Benedetti MD, Bergamaschi R, Bortolon F, Bosco A, Buccafusca M, Cargnelutti D, Cavalla P, Cavallo R, Centonze D, Coniglio MG, Costantino G, Cottone S, Danni MC, De Robertis F, Deotto L, Dotta M, Di Battista G, Filippi MM, Florio C, Francia A, Galgani S, Gallo P, Ghezzi A, Giometto B, Giuliani G Grimaldi LME, Guidotti M, Iudice A, Lenzi GL, Lorusso L, Lus G, Maimone D, Malentacchi GM, Mantegazza RE, Massacesi L, Melato M, Millefiorini E, Montanari E, Patti F, Perrone PSM, Protti A, Provera P, Quattrone A, Rasi F, Rosati G, Rovaris M, Saccà F, Salemi G, Sarchielli P, Scarpini EA, Schoenhuber R, Serrati C, Sinisi L, Sola P, Spitaleri DLA, Tedeschi G, Tezzon F, Tinebra Asti MC, Tola MR, Totaro R, Trojano M, Ulivelli M, Vecchio MM, Zimatore GB, Laroni, A., Brogi, D., Morra, V. B., Guidi, L., Pozzilli, C., Comi, G., Lugaresi, A., Turrini, R., Raimondi, D., Uccelli, A., Mancardi, G. L., Amato, M. P., Appendino, L., Ardito, B., Avolio, C., Bandini, F., Batocchi, A. P., Bellantonio, P., Benedetti, M. D., Bergamaschi, R., Bortolon, F., Bosco, A., Buccafusca, M., Cargnelutti, D., Cavalla, P., Cavallo, R., Centonze, D., Coniglio, M. G., Costantino, G., Cottone, S., Danni, M. C., De Robertis, F., Deotto, L., Dotta, M., Di Battista, G., Filippi, M. M., Florio, C., Francia, A., Galgani, S., Gallo, P., Ghezzi, A., Giometto, B., Giuliani, G., Grimaldi, L. M. E., Guidotti, M., Iudice, A., Lenzi, G. L., Lorusso, L., Lus, G., Maimone, D., Malentacchi, G. M., Mantegazza, R. E., Massacesi, L., Melato, M., Millefiorini, E., Montanari, E., Patti, F., Perrone, P. S. M., Protti, A., Provera, P., Quattrone, A., Rasi, F., Rosati, G., Rovaris, M., Sacca, F., Salemi, G., Sarchielli, P., Scarpini, E. A., Schoenhuber, R., Serrati, C., Sinisi, L., Sola, P., Spitaleri, D. L. A., Tedeschi, G., Tezzon, F., Tinebra Asti, M. C., Tola, M. R., Totaro, R., Trojano, M., Ulivelli, M., Vecchio, M. M., Zimatore, G. B., Mancardi, Gl, Brescia Morra, V, on behalf of the EAP, Investigator, and Giometto, B

Subjects
Oncology, Male, Neurology, fingolimod, multiple sclerosis, treatment, first dose, safety, administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use, Immunosuppressive Agent, Sphingosine, Multiple Sclerosi, Atrioventricular Block, administration /&/ dosage/adverse effects/therapeutic use, General Medicine, Middle Aged, Tolerability, Propylene Glycol, Fingolimod, drug therapy, Anesthesia, Cohort, Adolescent, Adult, Atrioventricular Block, chemically induced/epidemiology, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects/therapeutic use, Male, Middle Aged, Multiple Sclerosis, drug therapy, Propylene Glycols, administration /&/ dosage/adverse effects/therapeutic use, Sphingosine, administration /&/ dosage/adverse effects/analogs /&/ derivatives/therapeutic use, Young Adult, Combination, Drug Therapy, Combination, Settore MED/26 - Neurologia, Female, Atrioventricular block, Bradycardia, Multiple sclerosis, Safety, Adolescent, Adult, Fingolimod Hydrochloride, Humans, Immunosuppressive Agents, Multiple Sclerosis, Propylene Glycols, Young Adult, Neurology (clinical), Atrioventricular block, Bradicardia, Multiple sclerosis, Fingolimod, Safety Tolerability, Research Article, Human, medicine.drug, medicine.medical_specialty, Clinical Neurology, Internal medicine, medicine, Neurochemistry, business.industry, medicine.disease, Clinical trial, Atrioventricular block, Bradycardia, Multiple sclerosis, Fingolimod, Safety, Tolerability, chemically induced/epidemiology, business
Abstract

BACKGROUND: In patients with relapsing-remitting MS (RRMS) fingolimod prevents disease relapses and delays disability progression. First dose administration of fingolimod is associated with a transient, dose-dependent decrease in heart rate (HR) in the 6 hours after drug intake.The aim of the study is to to assess safety and tolerability of the first dose of fingolimod in a cohort of Italian patients with RRMS without alternative therapeutic options. METHODS: Open-label, single arm, multicentre study. After the first dose of fingolimod, patients were observed for 6 hours and had their vital signs monitored hourly. Extended on-site monitoring was provided when required. RESULTS: Of the 906 patients enrolled in the study, most (95.2%) did not experience any adverse event (AE) following fingolimod administration. Cardiovascular AEs occurred in 18 patients and included bradycardia (1.3%), first-and second-degree atrioventricular block (0.1% and 0.2%), palpitations (0.1%), sinus arrhythmia (0.1%) and ventricular premature beats (0.1%). All events were self-limiting and did not require any intervention. Extended monitoring was required in 34 patients. CONCLUSIONS: These results, in a population who better resembled real-world clinical practice in terms of concomitant diseases and medications, are consistent with previous clinical trials and confirmed that the first dose administration of fingolimod is generally safe and well tolerated. TRIAL REGISTRATION: EudraCT 2011-000770-60.

Published
2014

4. Disease-Modifying Therapies and Coronavirus Disease 2019 Severity in Multiple Sclerosis

Author

Sormani, Maria P., Nicola De Rossi, Irene, Schiavetti, Luca, Carmisciano, Cinzia, Cordioli, Lucia, Moiola, Marta, Radaelli, Paolo, Immovilli, Marco, Capobianco, Maria, Trojano, Paola, Zaratin, Gioacchino, Tedeschi, Giancarlo, Comi, Battaglia, Mario A., Francesco, Patti, Marco, Salvetti, Agostino, Nozzolillo, Alessandra, Bellacosa, Alessandra, Protti, Alessia Di Sapio, Alessio, Signori, Alfredo, Petrone, Alvino, Bisecco, Aniello, Iovino, Anna, Dutto, Anna Maria Repice, Antonella, Conte, Antonio, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Arianna, Sartori, Bruno, Giometto, Carla, Tortorella, Carlo, Antozzi, Carlo, Pozzilli, Chiara Rosa Mancinelli, Chiara, Zanetta, Christian, Cordano, Cinzia, Scandellari, Clara, Guaschino, Claudio, Gasperini, Claudio, Solaro, Cristina, Fioretti, Daiana, Bezzini, Damiano, Marastoni, Damiano, Paolicelli, Domizia, Vecchio, Doriana, Landi, Elisabetta, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elvira, Sbragia, Emanuela Laura Susani, Erica, Curti, Eva, Milano, Fabiana, Marinelli, Federico, Camilli, Filippo Martinelli Boneschi, Flora, Govone, Francesca, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesco, Corea, Francesco, Crescenzo, Francesco, Teatini, Giulietta, Tabiadon, Franco, Granella, Giacomo, Boffa, Giacomo, Lus, Giampaolo, Brichetto, Giorgia Teresa Maniscalco, Giovanna, Borriello, Giovanna De Luca, Giovanna, Konrad, Giovanna, Vaula, Girolama Alessandra Marfia, Giulia, Mallucci, Giuseppe, Liberatore, Giuseppe, Salemi, Giuseppina, Miele, Grazia, Sibilia, Ilaria, Pesci, Laura, Brambilla, Leonardo, Lopiano, Leonardo, Sinisi, Pasquali, Livia, Lorenzo, Saraceno, Luca, Chiveri, Luca, Mancinelli, Grimaldi, Luigi M. E., Luisa Maria Caniatti, Marco Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Margherita Monti Bragadin, Maria, Buccafusca, Maria Chiara Buscarinu, Maria Grazia Celani, Maria Grazia Grasso, Maria Laura Stromillo, Maria, Petracca, Maria Pia Amato, Maria Pia Sormani, Maria Rita L'Episcopo, Maria, Sessa, Maria Teresa Ferrò, Maria Vittoria Ercolani, Mariangela, Bianco, Marianna Lo Re, Marika, Vianello, Marinella, Clerico, Mario Alberto Battaglia, Mario di Napoli, Marta, Ponzano, Marta Zaffira Conti, Massimiliano, Calabrese, Massimiliano, Mirabella, Massimo, Filippi, Matilde, Inglese, Matteo, Lucchini, Matteo, Pozzato, Maura Chiara Danni, Mauro, Zaffaroni, Mauro, Zampolini, Michela, Ponzio, Milena De Riz, Nicola De Stefano, Paola, Cavalla, Paola De Mitri, Paola, Grossi, Paolo, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Patrizia, Sola, Pietro, Annovazzi, Pietro, Iaffaldano, Raffaele, Nardone, Raffaella, Cerqua, Raffaella, Clerici, Roberta, Lanzillo, Roberta, Motta, Roberto, Balgera, Roberto, Bergamaschi, Rocco, Totaro, Rosa, Iodice, Ruggero, Capra, Sabrina, Marangoni, Sabrina, Realmuto, Salvatore, Cottone, Sara, Montepietra, Sarah, Rasia, Sebastiano, Arena, Sebastiano, Bucello, Silvia, Banfi, Simona, Bonavita, Simona, Malucchi, Simone, Tonietti, Stefano, Vollaro, Susanna, Cordera, Umberto, Aguglia, Valentina Torri Clerici, Valeria, Barcella, Valeria, Bergamaschi, Vincenzo Brescia Morra, Vincenzo, Dattola, and Vittorio Mantero, Sormani, M. P., De Rossi, N., Schiavetti, I., Carmisciano, L., Cordioli, C., Moiola, L., Radaelli, M., Immovilli, P., Capobianco, M., Trojano, M., Zaratin, P., Tedeschi, G., Comi, G., Battaglia, M. A., Patti, F., Salvetti, M., P Sormani, Maria, De Rossi, Nicola, Schiavetti, Irene, Carmisciano, Luca, Cordioli, Cinzia, Moiola, Lucia, Radaelli, Marta, Immovilli, Paolo, Capobianco, Marco, Trojano, Maria, Zaratin, Paola, Tedeschi, Gioacchino, Comi, Giancarlo, A Battaglia, Mario, Patti, Francesco, Salvetti, Marco, Nozzolillo, Agostino, Bellacosa, Alessandra, Protti, Alessandra, Di Sapio, Alessia, Signori, Alessio, Petrone, Alfredo, Bisecco, Alvino, Iovino, Aniello, Dutto, Anna, Maria Repice, Anna, Conte, Antonella, Bertolotto, Antonio, Bosco, Antonio, Gallo, Antonio, Zito, Antonio, Sartori, Arianna, Giometto, Bruno, Tortorella, Carla, Antozzi, Carlo, Pozzilli, Carlo, Rosa Mancinelli, Chiara, Zanetta, Chiara, Cordano, Christian, Scandellari, Cinzia, Guaschino, Clara, Gasperini, Claudio, Solaro, Claudio, Fioretti, Cristina, Bezzini, Daiana, Marastoni, Damiano, Paolicelli, Damiano, Vecchio, Domizia, Landi, Doriana, Bucciantini, Elisabetta, Pedrazzoli, Elisabetta, Signoriello, Elisabetta, Sbragia, Elvira, Laura Susani, Emanuela, Curti, Erica, Milano, Eva, Marinelli, Fabiana, Camilli, Federico, Martinelli Boneschi, Filippo, Govone, Flora, Bovis, Francesca, Calabria, Francesca, Caleri, Francesca, Rinaldi, Francesca, Vitetta, Francesca, Corea, Francesco, Crescenzo, Francesco, Teatini, Francesco, Tabiadon, Giulietta, Granella, Franco, Boffa, Giacomo, Lus, Giacomo, Brichetto, Giampaolo, Teresa Maniscalco, Giorgia, Borriello, Giovanna, De Luca, Giovanna, Konrad, Giovanna, Vaula, Giovanna, Alessandra Marfia, Girolama, Mallucci, Giulia, Liberatore, Giuseppe, Salemi, Giuseppe, Miele, Giuseppina, Sibilia, Grazia, Pesci, Ilaria, Brambilla, Laura, Lopiano, Leonardo, Sinisi, Leonardo, Pasquali, Livia, Saraceno, Lorenzo, Chiveri, Luca, Mancinelli, Luca, E Grimaldi, Luigi M, Maria Caniatti, Luisa, Della Cava, Marco, Onofrj, Marco, Rovaris, Marco, Vercellino, Marco, Monti Bragadin, Margherita, Buccafusca, Maria, Chiara Buscarinu, Maria, Grazia Celani, Maria, Grazia Grasso, Maria, Laura Stromillo, Maria, Petracca, Maria, Pia Amato, Maria, Pia Sormani, Maria, Rita L'Episcopo, Maria, Sessa, Maria, Teresa Ferrò, Maria, Vittoria Ercolani, Maria, Bianco, Mariangela, Lo Re, Marianna, Vianello, Marika, Clerico, Marinella, Alberto Battaglia, Mario, di Napoli, Mario, Ponzano, Marta, Zaffira Conti, Marta, Calabrese, Massimiliano, Mirabella, Massimiliano, Filippi, Massimo, Inglese, Matilde, Lucchini, Matteo, Pozzato, Matteo, Chiara Danni, Maura, Zaffaroni, Mauro, Zampolini, Mauro, Ponzio, Michela, De Riz, Milena, De Stefano, Nicola, Cavalla, Paola, De Mitri, Paola, Grossi, Paola, Confalonieri, Paolo, Gallo, Paolo, Ragonese, Paolo, Sola, Patrizia, Annovazzi, Pietro, Iaffaldano, Pietro, Nardone, Raffaele, Cerqua, Raffaella, Clerici, Raffaella, Lanzillo, Roberta, Motta, Roberta, Balgera, Roberto, Bergamaschi, Roberto, Totaro, Rocco, Iodice, Rosa, Capra, Ruggero, Marangoni, Sabrina, Realmuto, Sabrina, Cottone, Salvatore, Montepietra, Sara, Rasia, Sarah, Arena, Sebastiano, Bucello, Sebastiano, Banfi, Silvia, Bonavita, Simona, Malucchi, Simona, Tonietti, Simone, Vollaro, Stefano, Cordera, Susanna, Aguglia, Umberto, Torri Clerici, Valentina, Barcella, Valeria, Bergamaschi, Valeria, Brescia Morra, Vincenzo, Dattola, Vincenzo, Mantero, Vittorio, Mp, Sormani, N, De Rossi, I, Schiavetti, L, Carmisciano, C, Cordioli, L, Moiola, M, Radaelli, P, Immovilli, M, Capobianco, M, Trojano, P, Zaratin, G, Tedeschi, G, Comi, Ma, Battaglia, F, Patti, M, Salvetti, Study Group Agostino Nozzolillo, Musc-19, Grimaldi, Luigi M. E., Vittorio Mantero, And, Nozzolillo, A., Bellacosa, A., Protti, A., Di Sapio, A., Signori, A., Petrone, A., Bisecco, A., Iovino, A., Dutto, A., Repice, A. M., Conte, A., Bertolotto, A., Bosco, A., Gallo, A., Zito, A., Sartori, A., Giometto, B., Tortorella, C., Antozzi, C., Pozzilli, C., Mancinelli, C. R., Zanetta, C., Cordano, C., Scandellari, C., Guaschino, C., Gasperini, C., Solaro, C., Fioretti, C., Bezzini, D., Marastoni, D., Paolicelli, D., Vecchio, D., Landi, D., Bucciantini, E., Pedrazzoli, E., Signoriello, E., Sbragia, E., Susani, E. L., Curti, E., Milano, E., Marinelli, F., Camilli, F., Boneschi, F. M., Govone, F., Bovis, F., Calabria, F., Caleri, F., Rinaldi, F., Vitetta, F., Corea, F., Crescenzo, F., Teatini, F., Tabiadon, G., Granella, F., Boffa, G., Lus, G., Brichetto, G., Maniscalco, G. T., Borriello, G., De Luca, G., Konrad, G., Vaula, G., Marfia, G. A., Mallucci, G., Liberatore, G., Salemi, G., Miele, G., Sibilia, G., Pesci, I., Brambilla, L., Lopiano, L., Sinisi, L., Pasquali, L., Saraceno, L., Chiveri, L., Mancinelli, L., Grimaldi, L. M. E., Caniatti, L. M., Cava, M. D., Onofrj, M., Rovaris, M., Vercellino, M., Bragadin, M. M., Buccafusca, M., Buscarinu, M. C., Celani, M. G., Grasso, M. G., Stromillo, M. L., Petracca, M., Amato, M. P., L'Episcopo, M. R., Sessa, M., Ferro, M. T., Ercolani, M. V., Bianco, M., Re, M. L., Vianello, M., Clerico, M., di Napoli, M., Ponzano, M., Conti, M. Z., Calabrese, M., Mirabella, M., Filippi, M., Inglese, M., Lucchini, M., Pozzato, M., Danni, M. C., Zaffaroni, M., Zampolini, M., Ponzio, M., De Riz, M., De Stefano, N., Cavalla, P., De Mitri, P., Grossi, P., Confalonieri, P., Gallo, P., Ragonese, P., Sola, P., Annovazzi, P., Iaffaldano, P., Nardone, R., Cerqua, R., Clerici, R., Lanzillo, R., Motta, R., Balgera, R., Bergamaschi, R., Totaro, R., Iodice, R., Capra, R., Marangoni, S., Realmuto, S., Cottone, S., Montepietra, S., Rasia, S., Arena, S., Bucello, S., Banfi, S., Bonavita, S., Malucchi, S., Tonietti, S., Vollaro, S., Cordera, S., Aguglia, U., Clerici, V. T., Barcella, V., Bergamaschi, V., Morra, V. B., Dattola, V., Mantero, V., Sormani M.P., De Rossi N., Schiavetti I., Carmisciano L., Cordioli C., Moiola L., Radaelli M., Immovilli P., Capobianco M., Trojano M., Zaratin P., Tedeschi G., Comi G., Battaglia M.A., Patti F., Salvetti M., Nozzolillo A., Bellacosa A., Protti A., Di Sapio A., Signori A., Petrone A., Bisecco A., Iovino A., Dutto A., Repice A.M., Conte A., Bertolotto A., Bosco A., Gallo A., Zito A., Sartori A., Giometto B., Tortorella C., Antozzi C., Pozzilli C., Mancinelli C.R., Zanetta C., Cordano C., Scandellari C., Guaschino C., Gasperini C., Solaro C., Fioretti C., Bezzini D., Marastoni D., Paolicelli D., Vecchio D., Landi D., Bucciantini E., Pedrazzoli E., Signoriello E., Sbragia E., Susani E.L., Curti E., Milano E., Marinelli F., Camilli F., Boneschi F.M., Govone F., Bovis F., Calabria F., Caleri F., Rinaldi F., Vitetta F., Corea F., Crescenzo F., Teatini F., Tabiadon G., Granella F., Boffa G., Lus G., Brichetto G., Maniscalco G.T., Borriello G., De Luca G., Konrad G., Vaula G., Marfia G.A., Mallucci G., Liberatore G., Salemi G., Miele G., Sibilia G., Pesci I., Brambilla L., Lopiano L., Sinisi L., Pasquali L., Saraceno L., Chiveri L., Mancinelli L., Grimaldi L.M.E., Caniatti L.M., Cava M.D., Onofrj M., Rovaris M., Vercellino M., Bragadin M.M., Buccafusca M., Buscarinu M.C., Celani M.G., Grasso M.G., Stromillo M.L., Petracca M., Amato M.P., L'Episcopo M.R., Sessa M., Ferro M.T., Ercolani M.V., Bianco M., Re M.L., Vianello M., Clerico M., di Napoli M., Ponzano M., Conti M.Z., Calabrese M., Mirabella M., Filippi M., Inglese M., Lucchini M., Pozzato M., Danni M.C., Zaffaroni M., Zampolini M., Ponzio M., De Riz M., De Stefano N., Cavalla P., De Mitri P., Grossi P., Confalonieri P., Gallo P., Ragonese P., Sola P., Annovazzi P., Iaffaldano P., Nardone R., Cerqua R., Clerici R., Lanzillo R., Motta R., Balgera R., Bergamaschi R., Totaro R., Iodice R., Capra R., Marangoni S., Realmuto S., Cottone S., Montepietra S., Rasia S., Arena S., Bucello S., Banfi S., Bonavita S., Malucchi S., Tonietti S., Vollaro S., Cordera S., Aguglia U., Clerici V.T., Barcella V., Bergamaschi V., Morra V.B., Dattola V., and Mantero V.

Subjects
Male, 0301 basic medicine, Dimethyl Fumarate, Neurodegenerative, multiple sclerosis, coronavirus, pneumonia, Severity of Illness Index, law.invention, Immunosuppressive Agent, Immunologic Factor, 0302 clinical medicine, Natalizumab, law, Monoclonal, Multiple Sclerosi, 80 and over, Lung, Humanized, Research Articles, Aged, 80 and over, Middle Aged, Intensive care unit, Hospitalization, Settore MED/26 - NEUROLOGIA, Intensive Care Units, Neurology, Methylprednisolone, Neurological, Pneumonia & Influenza, Interferon, Female, Immunosuppressive Agents, Research Article, Human, medicine.drug, Adult, medicine.medical_specialty, Musc-19 Study Group, Multiple Sclerosis, Adolescent, Clinical Sciences, Intensive Care Unit, Clinical Neurology, Settore MED/26, Antibodies, Monoclonal, Humanized, Autoimmune Disease, Antibodies, Young Adult, 03 medical and health sciences, Clinical Research, Internal medicine, Severity of illness, medicine, Humans, Immunologic Factors, Mortality, Aged, COVID-19, Fingolimod Hydrochloride, Interferons, SARS-CoV-2, Neurology & Neurosurgery, Expanded Disability Status Scale, business.industry, Multiple sclerosis, Neurosciences, Pneumonia, Odds ratio, medicine.disease, Brain Disorders, Good Health and Well Being, 030104 developmental biology, Ocrelizumab, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Objective: This study was undertaken to assess the impact of immunosuppressive and immunomodulatory therapies on the severity of coronavirus disease 2019 (COVID-19) in people with multiple sclerosis (PwMS). Methods: We retrospectively collected data of PwMS with suspected or confirmed COVID-19. All the patients had complete follow-up to death or recovery. Severe COVID-19 was defined by a 3-level variable: mild disease not requiring hospitalization versus pneumonia or hospitalization versus intensive care unit (ICU) admission or death. We evaluated baseline characteristics and MS therapies associated with severe COVID-19 by multivariate and propensity score (PS)-weighted ordinal logistic models. Sensitivity analyses were run to confirm the results. Results: Of 844 PwMS with suspected (n = 565) or confirmed (n = 279) COVID-19, 13 (1.54%) died; 11 of them were in a progressive MS phase, and 8 were without any therapy. Thirty-eight (4.5%) were admitted to an ICU; 99 (11.7%) had radiologically documented pneumonia; 96 (11.4%) were hospitalized. After adjusting for region, age, sex, progressive MS course, Expanded Disability Status Scale, disease duration, body mass index, comorbidities, and recent methylprednisolone use, therapy with an anti-CD20 agent (ocrelizumab or rituximab) was significantly associated (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.18–4.74, p = 0.015) with increased risk of severe COVID-19. Recent use (

Published
2021

5. 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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