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Your search keyword '"Comi, Giancarlo"' showing total 190 results
Start Over Author "Comi, Giancarlo" Publisher elsevier b.v.
190 results on '"Comi, Giancarlo"'

1. The utility of wearable devices in assessing ambulatory impairments of people with multiple sclerosis in free-living conditions

Author

Sun, Shaoxiong, Folarin, Amos A, Zhang, Yuezhou, Cummins, Nicholas, Liu, Shuo, Stewart, Callum, Ranjan, Yatharth, Rashid, Zulqarnain, Conde, Pauline, Laiou, Petroula, Sankesara, Heet, Dalla Costa, Gloria, Leocani, Letizia, Sørensen, Per Soelberg, Magyari, Melinda, Guerrero, Ana Isabel, Zabalza, Ana, Vairavan, Srinivasan, Bailon, Raquel, Simblett, Sara, Myin-Germeys, Inez, Rintala, Aki, Wykes, Til, Narayan, Vaibhav A, Hotopf, Matthew, Comi, Giancarlo, and Dobson, Richard JB

Published
2022
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15. Severity of COVID19 infection among patients with multiple sclerosis treated with interferon-β

Author

Simpson-Yap, Steve, Pirmani, Ashkan, De Brouwer, Edward, Peeters, Liesbet M., Geys, Lotte, Parciak, Tina, Helme, Anne, Hillert, Jan, Moreau, Yves, Edan, Gilles, Spelman, Tim, Sharmin, Sifat, McBurney, Robert, Schmidt, Hollie, Bergmann, Arnfin, Braune, Stefan, Stahmann, Alexander, Middleton, Rodden, Salter, Amber, Bebo, Bruce, van der Walt, Anneke, Butzkueven, Helmut, Ozakbas, Serkan, Karabudak, Rana, Boz, Cavit, Alroughani, Raed, Rojas, Juan I, van der Mei, Ingrid, Sciascia do Olival, Guilherme, Magyari, Melinda, Alonso, Ricardo, Nicholas, Richard, Chertcoff, Anibal, Zabalza, Ana, Arrambide, Georgina, Nag, Nupur, Descamps, Annabel, Costers, Lars, Dobson, Ruth, Miller, Aleisha, Rodrigues, Paulo, Prčkovska, Vesna, Comi, Giancarlo, and Kalincik, Tomas

Published
2022
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22. Comparative effectiveness of early intensive or escalation treatment strategies on long term disability trajectories in relapsing multiple sclerosis patients

Author

Iaffaldano, Pietro, Lucisano, Giuseppe, Caputo, Francesca, Paolicelli, Damiano, Patti, Francesco, Zaffaroni, Mauro, Morra, Vincenzo Brescia, Pozzilli, Carlo, De Luca, Giovanna, Inglese, Matilde, Salemi, Giuseppe, Maniscalco, Giorgia, Cocco, Eleonora, Sola, Patrizia, Lus, Giacomo, Conte, Antonella, Amato, Maria Pia, Granella, Franco, Gasperini, Claudio, Bellantonio, Paolo, Totaro, Rocco, Rovaris, Marco, Salvetti, Marco, Clerici, Valentina Torri, Bergamaschi, Roberto, Mainome, Davide, Capobianco, Marco, Comi, Giancarlo, Filippi, Massimo, and Trojano, Maria

Published
2021
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38. A whole genome screen for linkage disequilibrium in multiple sclerosis performed in a continental Italian population

Author

Liguori, Maria, Sawcer, Stephen, Setakis, Efrosini, Compston, Alastair, Giordano, Mara, D'Alfonso, Sandra, Mellai, Marta, Malferrari, Giulia, Trojano, Maria, Livrea, Paolo, De Robertis, Francesca, Massacesi, Luca, Repice, Anna, Ballerini, Clara, Biagioli, Tiziana, Bomprezzi, Roberto, Cannoni, Stefania, Ristori, Giovanni, Salvetti, Marco, Grimaldi, Luigi M.E., Biunno, Ida, Comi, Giancarlo, Leone, Maurizio, Ferro, Isabella, Naldi, Paola, Milanese, Clara, Gellera, Cinzia, Loredana, La Mantia, Savettieri, Giovanni, Salemi, Giuseppe, Aridon, Paolo, Caputo, Domenico, Rosa Guerini, Franca, Ferrante, Pasquale, and Momigliano-Richiardi, Patricia

Published
2003
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43. Effects of Natalizumab and Fingolimod on Clinical, Cognitive, and Magnetic Resonance Imaging Measures in Multiple Sclerosis.

Author

Preziosa, Paolo, Rocca, Maria A., Riccitelli, Gianna C., Moiola, Lucia, Storelli, Loredana, Rodegher, Mariaemma, Comi, Giancarlo, Signori, Alessio, Falini, Andrea, and Filippi, Massimo

Subjects
MENTAL health, MULTIPLE sclerosis diagnosis, MULTIPLE sclerosis, BRAIN, DISEASE progression, CLINICAL trials, MAGNETIC resonance imaging, TREATMENT effectiveness, IMMUNOLOGICAL adjuvants, IMMUNOSUPPRESSIVE agents, LONGITUDINAL method
Abstract

Studies comparing the effects of natalizumab and fingolimod in relapsing-remitting multiple sclerosis (RRMS) are limited. We aimed to compare natalizumab and fingolimod effects on clinical, neuropsychological, and MRI measures in RRMS patients after 2 years of treatment. RRMS patients starting natalizumab (n = 30) or fingolimod (n = 25) underwent neurologic, neuropsychological, and brain MRI assessments at baseline, month (M) 6, M12, and M24. Volumes of lesions, brain, gray matter (GM), white matter (WM), and deep GM were measured. Fifteen healthy controls (HC) were also scanned at baseline and M24. Treatment groups were matched for baseline variables. At M24 versus baseline, both drugs reduced the relapse rate (p value < 0.001), stabilized disability, and improved cognitive function (fingolimod: p value = 0.03; natalizumab: p value = 0.01), without between-group differences. The natalizumab group had a higher proportion of freedom from MRI activity (67% vs 36%, p value = 0.02) and no evidence of disease activity-3 (NEDA-3) (57% vs 28%, p value = 0.04). At M24 vs M6, brain (- 0.35%, p value = 0.002 [fingolimod]; - 0.42%, p value < 0.001 [natalizumab]), GM (- 0.62%, p value < 0.001 [fingolimod]; - 0.64%, p value < 0.001 [natalizumab]), and WM (- 0.98%, p value < 0.001 [fingolimod]; - 0.99%, p value < 0.001 [natalizumab]) atrophy progressed at higher rates than in HC, but similarly between treatment groups, whereas only the natalizumab group showed deep GM atrophy (- 0.79%, p value = 0.02) (p value vs fingolimod not significant). In both groups, atrophy progression was correlated with lesion accumulation (r from - 0.49 to - 0.36, p values from 0.013 to 0.05), whereas no correlation was found between clinical and MRI changes. Natalizumab and fingolimod reduce disease activity and improve cognition in RRMS. Natalizumab seems superior to limit lesion accumulation, whereas both drugs similarly modify atrophy progression. [ABSTRACT FROM AUTHOR]

Published
2020
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44. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (SUNBEAM): a multicentre, randomised, minimum 12-month, phase 3 trial.

Author

Comi, Giancarlo, Kappos, Ludwig, Selmaj, Krzysztof W, Bar-Or, Amit, Arnold, Douglas L, Steinman, Lawrence, Hartung, Hans-Peter, Montalban, Xavier, Kubala Havrdová, Eva, Cree, Bruce A C, Sheffield, James K, Minton, Neil, Raghupathi, Kartik, Ding, Ning, Cohen, Jeffrey A, and SUNBEAM Study Investigators

Subjects
*INTERFERONS, *MULTIPLE sclerosis, *OPPORTUNISTIC infections, *BRADYCARDIA, *SUBSTANCE abuse relapse
Abstract

Background: Ozanimod, a sphingosine 1-phosphate receptor modulator, selectively binds to receptor subtypes 1 and 5 with high affinity. The RADIANCE phase 2 study showed that ozanimod had better efficacy than placebo on MRI measures, with a favourable safety profile, in participants with relapsing multiple sclerosis. The SUNBEAM study aimed to assess the safety and efficacy of ozanimod versus intramuscular interferon beta-1a in participants with relapsing multiple sclerosis.Methods: SUNBEAM was a randomised, double-blind, double-dummy, active-controlled phase 3 trial done at 152 academic medical centres and clinical practices in 20 countries. We enrolled participants aged 18-55 years with relapsing multiple sclerosis, baseline expanded disability status scale (EDSS) score of 0·0-5·0, and either at least one relapse within the 12 months before screening or at least one relapse within 24 months plus at least one gadolinium-enhancing lesion within 12 months before screening. Participants were randomly assigned 1:1:1 by a blocked algorithm stratified by country and baseline EDSS score to at least 12 months treatment of either once-daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment assignment. The primary endpoint was annualised relapse rate (ARR) during the treatment period and was assessed in the intention-to-treat population. Safety was assessed in all participants according to the highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, number NCT02294058 and EudraCT, number 2014-002320-27.Findings: Between Dec 18, 2014, and Nov 12, 2015, 1346 participants were enrolled and randomly assigned to ozanimod 1·0 mg (n=447), ozanimod 0·5 mg (n=451), or interferon beta-1a (n=448). 91 (6·8%) participants discontinued the study drug (29 in the ozanimod 1·0 mg group; 26 in the ozanimod 0·5 mg group; and 36 in the interferon beta-1a group). Adjusted ARRs were 0·35 (0·28-0·44) for interferon beta-1a, 0·18 (95% CI 0·14-0·24) for ozanimod 1·0 mg (rate ratio [RR] of 0·52 [0·41-0·66] vs interferon beta-1a; p<0·0001), and 0·24 (0·19-0·31) for ozanimod 0·5 mg (RR 0·69 [0·55-0·86] vs interferon beta-1a; p=0·0013). Few ozanimod-treated participants discontinued treatment because of adverse events (13 [2·9%] who received ozanimod 1·0 mg; seven [1·5%] who received ozanimod 0·5 mg; and 16 [3·6%] who received interferon beta-1a). No first-dose, clinically significant bradycardia or second-degree or third-degree atrioventricular block was reported. The incidence of serious adverse events was low and similar across treatment groups (13 [2·9%] participants who received ozanimod 1·0 mg; 16 [3·5%] who received ozanimod 0·5 mg; and 11 [2·5%] who received interferon beta-1a). No serious opportunistic infections occurred in ozanimod-treated participants.Interpretation: In participants with relapsing multiple sclerosis treated for at least 12 months, ozanimod was well tolerated and demonstrated a significantly lower relapse rate than interferon beta-1a. These findings provide support for ozanimod as an oral therapy for individuals with relapsing multiple sclerosis.Funding: Celgene International II. [ABSTRACT FROM AUTHOR]

Published
2019
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45. Safety and efficacy of ozanimod versus interferon beta-1a in relapsing multiple sclerosis (RADIANCE): a multicentre, randomised, 24-month, phase 3 trial.

Author

Cohen, Jeffrey A, Comi, Giancarlo, Selmaj, Krzysztof W, Bar-Or, Amit, Arnold, Douglas L, Steinman, Lawrence, Hartung, Hans-Peter, Montalban, Xavier, Kubala Havrdová, Eva, Cree, Bruce A C, Sheffield, James K, Minton, Neil, Raghupathi, Kartik, Huang, Vivian, Kappos, Ludwig, and RADIANCE Trial Investigators

Subjects
*INTERACTIVE voice response (Telecommunication), *MULTIPLE sclerosis, *INTERFERONS, *RADIANCE, *SUBSTANCE abuse relapse, *TERMINATION of treatment
Abstract

Background: Ozanimod is a sphingosine 1-phosphate receptor modulator, which selectively binds to sphingosine 1-phosphate receptor subtypes 1 and 5 with high affinity. In the RADIANCE phase 2 study in participants with relapsing multiple sclerosis, ozanimod was associated with better efficacy than placebo on MRI measures and was well tolerated. The RADIANCE phase 3 study aimed to confirm the safety and efficacy of ozanimod versus interferon beta-1a in individuals with relapsing multiple sclerosis.Methods: We did a 24-month, multicentre, double-blind, double-dummy phase 3 trial in participants with relapsing multiple sclerosis at 147 medical centres and clinical practices in 21 countries. Participants were aged 18-55 years, had multiple sclerosis according to 2010 McDonald criteria, a relapsing clinical course, brain MRI lesions consistent with multiple sclerosis, an expanded disability status scale score of 0·0-5·0, and either at least one relapse within 12 months before screening or at least one relapse within 24 months before screening plus at least one gadolinium-enhancing lesion within the 12 months before randomisation. Participants were randomly assigned (1:1:1) via an interactive voice response system to daily oral ozanimod 1·0 mg or 0·5 mg or weekly intramuscular interferon beta-1a 30 μg. Participants, investigators, and study staff were masked to treatment allocation. The primary endpoint was annualised relapse rate (ARR) over 24 months. The primary analysis was done in the intention-to-treat population of all participants who received study drug and safety was assessed in all randomly assigned participants who received study drug, grouped by highest dose of ozanimod received. This trial is registered at ClinicalTrials.gov, NCT02047734, and EudraCT, 2012-002714-40.Findings: Between Dec 27, 2013, and March 31, 2015, we screened 1695 participants, of which 375 did not meet inclusion criteria. 1320 participants were enrolled and randomly assigned to a group, of whom 1313 received study drug (433 assigned to ozanimod 1·0 mg, 439 assigned to ozanimod 0·5 mg, and 441 assigned to interferon beta-1a) and 1138 (86·7%) completed 24 months of treatment. Adjusted ARRs were 0·17 (95% CI 0·14-0·21) with ozanimod 1·0 mg, 0·22 (0·18-0·26) with ozanimod 0·5 mg, and 0·28 (0·23-0·32) with interferon beta-1a, with rate ratios versus interferon beta-1a of 0·62 (95% CI 0·51-0·77; p<0·0001) for ozanimod 1·0 mg and 0·79 (0·65 to 0·96; p=0·0167) for ozanimod 0·5 mg. The incidence of treatment-emergent adverse events was higher in the interferon beta-1a group (365 [83·0%] of 440 participants) than in the ozanimod 1·0 mg group (324 [74·7%] of 434) or the ozanimod 0·5 mg group (326 [74·3%] of 439). More participants in the interferon beta-1a group had treatment-emergent adverse events leading to treatment discontinuation than in the ozanimod groups. Incidences of infections and serious treatment-emergent adverse events were similar across treatment groups. No cases of ozanimod-related symptomatic reduction in heart rate and no second-degree or third-degree cases of atrioventricular block were reported.Interpretation: In this 24-month phase 3 study in participants with relapsing multiple sclerosis, ozanimod was well tolerated and associated with a significantly lower rate of clinical relapses than intramuscular interferon beta-1a. These findings show the potential of ozanimod as an effective oral therapy for individuals with relapsing multiple sclerosis.Funding: Celgene International II. [ABSTRACT FROM AUTHOR]

Published
2019
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