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Start Over Author "BOFFA, L" Journal journal of neurology
4 results on '"BOFFA, L"'

1. No evidence of disease activity (NEDA-3) and disability improvement after alemtuzumab treatment for multiple sclerosis: a 36-month real-world study

Author

Prosperini, L, Annovazzi, P, Boffa, L, Buscarinu, Mc, Gallo, A, Matta, M, Moiola, L, Musu, L, Perini, P, Avolio, C, Barcella, V, Bianco, A, Farina, D, Ferraro, E, Pontecorvo, S, Granella, F, Grimaldi, Lme, Laroni, A, Lus, G, Patti, F, Pucci, E, Pasca, M, Sarchielli, P, Ghezzi, A, Zaffaroni, M, Baroncini, D, Buttari, F, Centonze, D, Fornasiero, A, Salvetti, M, Docimo, R, Signoriello, E, Tedeschi, G, Bertolotto, A, Capobianco, M, Comi, G, Cocco, E, Gallo, P, Puthenparampil, M, Grasso, R, Di Francescantonio, V, Rottoli, Mr, Mirabella, M, Lugaresi, A, De Luca, G, Di Ioia, M, Di Tommaso, V, Mancinelli, L, Di Battista, G, Francia, A, Ruggieri, S, Pozzilli, C, Curti, E, Tsantes, E, Palmeri, B, Lapucci, C, Mancardi, Gl, Uccelli, A, Chisari, C, D'Amico, E, Cartechini, E, Repice, Am, Magnani, E, Massaccesi, L, Calabresi, P, Di Filippo, M, Di Gregorio, M, Italian Alemtuzumab Study, Group., Prosperini, Luca, Annovazzi, Pietro, Boffa, Laura, Buscarinu, Maria Chiara, Gallo, Antonio, Matta, Manuela, Moiola, Lucia, Musu, Luigina, Perini, Paola, Avolio, Carlo, Barcella, Valeria, Bianco, Assunta, Farina, Deborah, Ferraro, Elisabetta, Pontecorvo, Simona, Granella, Franco, Grimaldi, Luigi M E, Laroni, Alice, Lus, Giacomo, Patti, Francesco, Pucci, Eugenio, Pasca, Matteo, and Sarchielli, Paola

Subjects
Adult, Male, medicine.medical_specialty, Neurology, Outcome measurement, Relapsing-Remitting, Follow-Up Studie, Multiple sclerosis, 03 medical and health sciences, Immunologic Factor, 0302 clinical medicine, Multiple Sclerosis, Relapsing-Remitting, Alemtuzumab, Multiple sclerosis, Outcome measurement, Retrospective Studie, Alemtuzumab, Internal medicine, Medicine, Humans, Immunologic Factors, Multiple sclerosi, 030212 general & internal medicine, Female, Follow-Up Studies, Magnetic Resonance Imaging, Retrospective Studies, Treatment Outcome, Neurology (clinical), Expanded Disability Status Scale, medicine.diagnostic_test, business.industry, Retrospective cohort study, Magnetic resonance imaging, Odds ratio, medicine.disease, alemtuzumab, multiple sclerosis, outcome measurement, neurology, Clinical trial, Settore MED/26 - NEUROLOGIA, business, 030217 neurology & neurosurgery, Human, medicine.drug
Abstract

In this retrospective, multicenter, real-world study we collected clinical and magnetic resonance imaging (MRI) data of all patients (n = 40) with relapsing-remitting multiple sclerosis (RRMS) treated with alemtuzumab according to a "free-of-charge" protocol available before the drug marketing approval in Italy. Almost all (39/40) started alemtuzumab after discontinuing multiple disease-modifying treatments (DMTs) because of either lack of response or safety concerns. We considered the proportion of alemtuzumab-treated patients who had no evidence of disease activity (NEDA-3) and disability improvement over a 36-month follow-up period. NEDA-3 was defined as absence of relapses, disability worsening, and MRI activity. Disability improvement was defined as a sustained reduction of ≥ 1-point in Expanded Disability Status Scale (EDSS) score. At follow-up, 18 (45%) patients achieved NEDA-3, 30 (75%) were relapse-free, 33 (82.5%) were EDSS worsening-free, and 25 (62.5%) were MRI activity-free. Eleven (27.5%) patients had a sustained disability improvement. We found no predictor for the NEDA-3 status, while the interaction of higher EDSS score by higher number of pre-alemtuzumab relapses was associated with a greater chance of disability improvement (odds ratio 1.10, p = 0.049). Our study provides real-world evidence that alemtuzumab can promote clinical and MRI disease remission, as well as disability improvement, in a significant proportion of patients with RRMS despite prior multiple DMT failures. The drug safety profile was consistent with data available from clinical trials.

Published
2018

2. A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study

Author

Massimiliano Calabrese, Eleonora Cocco, Roberta Fantozzi, Viviana Nociti, Antonio Gallo, Laura Boffa, Alice Laroni, Claudio Solaro, Valentina Torri Clerici, Giancarlo Coghe, Simona Malucchi, Massimiliano Di Filippo, Valentina Tomassini, Marcello Moccia, Pietro Annovazzi, Federica Pinardi, Carla Tortorella, Paola Cavalla, Ilaria Pesci, Luca Prosperini, Giorgia Teresa Maniscalco, Alberto Gajofatto, Claudio Gasperini, Roberta Lanzillo, Fabio Buttari, Paolo Ragonese, Marta Radaelli, Maria Chiara Buscarinu, Lanzillo, Roberta, Prosperini, Luca, Gasperini, Claudio, Moccia, Marcello, Fantozzi, Roberta, Tortorella, Carla, Nociti, Viviana, Annovazzi, Pietro, Cavalla, Paola, Radaelli, Marta, Malucchi, Simona, Clerici, Valentina Torri, Boffa, Laura, Buttari, Fabio, Ragonese, Paolo, Maniscalco, Giorgia Teresa, Di Filippo, Massimiliano, Buscarinu, Maria Chiara, Pinardi, Federica, Gallo, Antonio, Coghe, Giancarlo, Pesci, Ilaria, Laroni, Alice, Gajofatto, Alberto, Calabrese, Massimiliano, Tomassini, Valentina, Cocco, Eleonora, Solaro, Claudio, Lanzillo R., Prosperini L., Gasperini C., Moccia M., Fantozzi R., Tortorella C., Nociti V., Annovazzi P., Cavalla P., Radaelli M., Malucchi S., Clerici V.T., Boffa L., Buttari F., Ragonese P., Maniscalco G.T., Di Filippo M., Buscarinu M.C., Pinardi F., Gallo A., Coghe G., Pesci I., Laroni A., Gajofatto A., Calabrese M., Tomassini V., Cocco E., and Solaro C.

Subjects
Male, Injection, Time Factors, Patient Dropout, disease-modifying therapies, multiple sclerosis, outcome measurement, persistence to treatment, quality of life, Administration, Oral, Self Administration, Sex Factor, Kaplan-Meier Estimate, Relapsing-Remitting, Immunologic Factor, 0302 clinical medicine, Quality of life, Retrospective Studie, Risk Factors, Medicine, 030212 general & internal medicine, Disease-modifying therapie, Disease-modifying therapies, Multiple sclerosis, Outcome measurement, Persistence to treatment, Quality of life, Administration, Oral, Adult, Female, Follow-Up Studies, Humans, Immunologic Factors, Injections, Kaplan-Meier Estimate,Male, Multiple Sclerosis, Relapsing-Remitting, Patient Dropouts, Prognosis, Proportional Hazards Models, Retrospective Studies, Risk Factors, Self Administration, Sex Factors, Time Factors, Hazard ratio, Prognosis, Neurology, Tolerability, Administration, Settore MED/26 - Neurologia, Female, Human, Oral, Adult, medicine.medical_specialty, Patient Dropouts, Time Factor, Prognosi, Follow-Up Studie, Injections, 03 medical and health sciences, Route of administration, Multiple Sclerosis, Relapsing-Remitting, Sex Factors, Internal medicine, Humans, Immunologic Factors, Multiple sclerosi, Adverse effect, Proportional Hazards Models, Retrospective Studies, business.industry, Proportional hazards model, Risk Factor, Retrospective cohort study, Discontinuation, Disease-modifying therapies, Multiple sclerosis, Outcome measurement, Persistence to treatment, Follow-Up Studies, Proportional Hazards Model, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

In this independent, multicenter, retrospective study, we investigated the short-term persistence to treatment with first-line self-injectable or oral disease-modifying treatments (DMTs) in patients with relapsing–remitting multiple sclerosis. Data of patients regularly attending 21 Italian MS Centres who started a self-injectable or an oral DMT in 2015 were collected to: (1) estimate the proportion of patients discontinuing the treatment; (3) explore reasons for discontinuation; (3) identify baseline predictors of treatment discontinuation over a follow-up period of 12months. We analyzed data of 1832 consecutive patients (1289 women, 543 men); 374 (20.4%) of them discontinued the prescribed DMT after a median time of 6 months (range 3days to 11.5months) due to poor tolerability (n = 163; 43.6%), disease activity (n = 95; 25.4%), adverse events (n = 64; 17.1%), convenience (i.e. availability of new drug formulations) and pregnancy planning (n = 21; 1.1%). Although the proportion of discontinuers was higher with self-injectable (n = 107; 22.9%) than with oral DMT (n = 215; 16.4%), the Cox regression model revealed no significant between-group difference (p = 0.12). Female sex [hazard ratio (HR) = 1.39, p = 0.01] and previous exposure to ≥ 3 DMTs (HR = 1.71, p = 0.009) were two independent risk factors for treatment discontinuation, regardless of prescribed DMTs. Our study confirms that persistence to treatment represents a clinical challenge, irrespective of the route of administration.

Published
2018

3. Exit strategies for "needle fatigue" in multiple sclerosis: a propensity score-matched comparison study.

Author

Prosperini L, Cortese A, Lucchini M, Boffa L, Borriello G, Buscarinu MC, Capone F, Centonze D, De Fino C, De Pascalis D, Fantozzi R, Ferraro E, Filippi M, Galgani S, Gasperini C, Haggiag S, Landi D, Marfia G, Mataluni G, Millefiorini E, Mirabella M, Monteleone F, Nociti V, Pontecorvo S, Romano S, Ruggieri S, Salvetti M, Tortorella C, Zannino S, and Di Battista G

Subjects
Administration, Oral, Adult, Crotonates administration & dosage, Dimethyl Fumarate administration & dosage, Female, Humans, Hydroxybutyrates, Injections, Subcutaneous, Interferon alpha-2 administration & dosage, Interferon-alpha administration & dosage, Male, Middle Aged, Nitriles, Polyethylene Glycols administration & dosage, Product Surveillance, Postmarketing, Propensity Score, Recombinant Proteins administration & dosage, Retrospective Studies, Toluidines administration & dosage, Young Adult, Drug Substitution, Immunosuppressive Agents administration & dosage, Medication Adherence, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

Patients with multiple sclerosis on long-term injectable therapies may suffer from the so-called "needle fatigue", i.e., a waning commitment to continue with the prescribed injectable treatment. Therefore, alternative treatment strategies to enhance patients' adherence are warranted. In this independent, multicentre post-marketing study, we sought to directly compare switching to either teriflunomide (TFN), dimethyl fumarate (DMF), or pegylated interferon (PEG) on treatment persistence and time to first relapse over a 12-month follow-up. We analyzed a total of 621 patients who were free of relapses and gadolinium-enhancing lesions in the year prior to switching to DMF (n = 265), TFN (n = 160), or PEG (n = 196). Time to discontinuation and time to first relapse were explored in the whole population by Cox regression models adjusted for baseline variables and after a 1:1:1 ratio propensity score (PS)-based matching procedure. Treatment discontinuation was more frequent after switching to PEG (28.6%) than DMF (14.7%; hazard ratio [HR] = 0.25, p < 0.001) and TFN (16.9%; HR = 0.27, p < 0.001). We found similar results even in the re-sampled cohort of 222 patients (74 per group) derived by the PS-based matching procedure. The highest discontinuation rate observed in PEG recipient was mainly due to poor tolerability (p = 0.005) and pregnancy planning (p = 0.04). The low number of patients who relapsed over the 12-month follow-up (25 out of 621, approximately 4%) prevented any analysis on the short-term risk of relapse. This real-world study suggests that oral drugs are a better switching option than low-frequency interferon for promoting the short-term treatment persistence in stable patients who do not tolerate injectable drugs.

Published
2020
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4. A multicentRE observational analysiS of PErsistenCe to Treatment in the new multiple sclerosis era: the RESPECT study.

Author

Lanzillo R, Prosperini L, Gasperini C, Moccia M, Fantozzi R, Tortorella C, Nociti V, Annovazzi P, Cavalla P, Radaelli M, Malucchi S, Clerici VT, Boffa L, Buttari F, Ragonese P, Maniscalco GT, Di Filippo M, Buscarinu MC, Pinardi F, Gallo A, Coghe G, Pesci I, Laroni A, Gajofatto A, Calabrese M, Tomassini V, Cocco E, and Solaro C

Subjects
Administration, Oral, Adult, Female, Follow-Up Studies, Humans, Immunologic Factors adverse effects, Injections, Kaplan-Meier Estimate, Male, Multiple Sclerosis, Relapsing-Remitting diagnosis, Patient Dropouts, Prognosis, Proportional Hazards Models, Retrospective Studies, Risk Factors, Self Administration, Sex Factors, Time Factors, Immunologic Factors administration & dosage, Multiple Sclerosis, Relapsing-Remitting drug therapy
Abstract

In this independent, multicenter, retrospective study, we investigated the short-term persistence to treatment with first-line self-injectable or oral disease-modifying treatments (DMTs) in patients with relapsing-remitting multiple sclerosis. Data of patients regularly attending 21 Italian MS Centres who started a self-injectable or an oral DMT in 2015 were collected to: (1) estimate the proportion of patients discontinuing the treatment; (3) explore reasons for discontinuation; (3) identify baseline predictors of treatment discontinuation over a follow-up period of 12 months. We analyzed data of 1832 consecutive patients (1289 women, 543 men); 374 (20.4%) of them discontinued the prescribed DMT after a median time of 6 months (range 3 days to 11.5 months) due to poor tolerability (n = 163; 43.6%), disease activity (n = 95; 25.4%), adverse events (n = 64; 17.1%), convenience (i.e. availability of new drug formulations) and pregnancy planning (n = 21; 1.1%). Although the proportion of discontinuers was higher with self-injectable (n = 107; 22.9%) than with oral DMT (n = 215; 16.4%), the Cox regression model revealed no significant between-group difference (p = 0.12). Female sex [hazard ratio (HR) = 1.39, p = 0.01] and previous exposure to ≥ 3 DMTs (HR = 1.71, p = 0.009) were two independent risk factors for treatment discontinuation, regardless of prescribed DMTs. Our study confirms that persistence to treatment represents a clinical challenge, irrespective of the route of administration.

Published
2018
Full Text
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