Author: "Provinciali, L" / Topic: multiple sclerosis - Searchworks@Jio Institute Digital Library Search Results

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1. Persistence to oral disease-modifying therapies in multiple sclerosis patients.

Author: Lattanzi S, Danni M, Taffi R, Cerqua R, Carlini G, Pulcini A, Provinciali L, and Silvestrini M
Subjects: Adult, Crotonates therapeutic use, Dimethyl Fumarate therapeutic use, Female, Fingolimod Hydrochloride therapeutic use, Follow-Up Studies, Humans, Hydroxybutyrates, Male, Middle Aged, Nitriles, Retrospective Studies, Statistics, Nonparametric, Toluidines therapeutic use, Treatment Outcome, Immunosuppressive Agents therapeutic use, Multiple Sclerosis drug therapy
Abstract: Dimethyl fumarate (DMF), fingolimod (FTY) and teriflunomide (TFN) are oral disease-modifying therapies (DMTs) approved for relapsing-remitting multiple sclerosis (RRMS) whose efficacy and tolerability have been separately assessed in phase III trials. Conversely, little evidence exists about their head-to-head comparison. The aim of the study was to evaluate the 1-year persistence to DMF, FTY and TFN in patients with RRMS. Patients affected by RRMS who started treatment with DMF, FTY or TFN were identified. The study end-point was 12-month drug persistence as time to discontinuation and proportion of patients who discontinued medication within 1-year. A total of 307 patients were included (DMF = 114, FTY = 129, TFN = 64). The mean times to discontinuation were 144 (84), 189 (72) and 138 (120) days in the DMF, FTY and TFN cohorts (p = 0.036). At 12-month, the proportion of patients discontinuing medication was lower for subjects taking FTY (9.8%) compared with those starting DMF (21.9%) and TFN (23.6%) (p = 0.020). Compared to FTY cohort, DMF [ adj OR = 3.26 (1.38-7.70); p = 0.007] and TFN [ adj OR = 2.89 (1.10-7.63); p = 0.032] treated patients were more likely to have discontinued their drug at 1-year since initiation. In patients with RRMS, FTY was associated with a better persistence profile as compared to DMF and TFN.
Published: 2017
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2. Management of pregnancy-related issues in multiple sclerosis patients: the need for an interdisciplinary approach.

Author: Amato MP, Bertolotto A, Brunelli R, Cavalla P, Goretti B, Marrosu MG, Patti F, Pozzilli C, Provinciali L, Rizzo N, Strobelt N, Tedeschi G, Trojano M, and Comi G
Subjects: Animals, Disease Management, Female, Humans, Pregnancy, Multiple Sclerosis complications, Multiple Sclerosis therapy, Pregnancy Complications therapy
Abstract: Multiple sclerosis (MS) is a demyelinating and neurodegenerative disease of the central nervous system (CNS), most probably autoimmune in origin, usually occurring in young adults with a female/male prevalence of approximately 3:1. Women with MS in the reproductive age may face challenging issues in reconciling the desire for parenthood with their condition, owing to the possible influence both on the ongoing or planned treatment with the possible consequences on the disease course and on the potential negative effects of treatments on foetal and pregnancy outcomes. At MS diagnosis, timely counselling should promote informed parenthood, while disease evolution should be assessed before making therapeutic decisions. Current guidelines advise the discontinuation of any treatment during pregnancy, with possible exceptions for some treatments in patients with very active disease. Relapses decline during pregnancy but are more frequent during puerperium, when MS therapy should be promptly resumed in most of the cases. First-line immunomodulatory agents, such as interferon-β (IFN-β) and glatiramer acetate (GA), significantly reduce the post-partum risk of relapse. Due to substantial evidence of safety with the use of GA during pregnancy, a recent change in European marketing authorization removed the pregnancy contraindication for GA. This paper reports a consensus of Italian experts involved in MS management, including neurologists, gynaecologists and psychologists. This consensus, based on a review of the available scientific evidence, promoted an interdisciplinary approach to the management of pregnancy in MS women.
Published: 2017
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3. Oral and intravenous steroids for multiple sclerosis relapse: a systematic review and meta-analysis.

Author: Lattanzi S, Cagnetti C, Danni M, Provinciali L, and Silvestrini M
Subjects: Administration, Intravenous, Administration, Oral, Humans, Immunologic Factors administration & dosage, Randomized Controlled Trials as Topic, Glucocorticoids administration & dosage, Multiple Sclerosis drug therapy, Steroids administration & dosage
Abstract: Glucocorticoids are the standard of care for multiple sclerosis (MS) relapses, but the most desirable route of administration is still matter of debate. The aim of the study was to compare the efficacy and safety of oral versus intravenous steroids for treatment of acute relapses in patients with MS. Randomized or quasi-randomized, parallel group trials with direct comparison between oral and intravenous steroid treatment in MS patients with acute relapse were identified through a systematic literature search. Six trials were included involving 419 participants, 210 for oral, and 209 for intravenous groups, respectively. The weighted mean differences (WMDs) in the Kurtzke's Expanded Disability Status Scale (EDSS) score reduction between the oral and intravenous groups were 0.32 [(-0.09 to 0.73); p = 0.129] and 0.11 [(-0.12 to 0.33); p = 0.355] at 1 and 4 weeks after treatment, respectively. The risk ratios (RRs) for improvement by at least one EDSS point were 0.79 [(0.37-1.68); p = 0.539] at week 1 and 0.92 (0.76-1.12); p = 0.400] at week 4. There were no differences in the relapse rate and relapse freedom at 6 months between groups. The WMDs in the mean percentage reduction of Gadolinium-enhancing lesions between oral and intravenous arms were 0.14 (-0.02, 0.29); p = 0.083] and 0.04 (-0.19, 0.28); p = 0.705] at 1 and 4 weeks from treatment. Among the adverse events, insomnia was significantly associated with the oral route of steroid administration [RR 1.25 (1.07-1.46); p = 0.005]. In adult patients with acute MS relapse, there were no clear-cut differences in the efficacy and overall tolerability between oral and intravenous steroids.
Published: 2017
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4. Multiple sclerosis, solitary sclerosis or something else?

Author: Lattanzi S, Logullo F, Di Bella P, Silvestrini M, and Provinciali L
Subjects: Adult, Aged, Cohort Studies, Demyelinating Autoimmune Diseases, CNS pathology, Demyelinating Autoimmune Diseases, CNS physiopathology, Female, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis physiopathology, Myelitis, Transverse physiopathology, Spinal Cord physiopathology, Multiple Sclerosis pathology, Myelitis, Transverse pathology, Spinal Cord pathology
Abstract: Background: Inflammatory demyelinating diseases of the central nervous system represent a wide spectrum of entities and their classification cannot currently be regarded complete., Objective: Our aim is to describe a series of patients presenting with progressive myelopathy associated to a single demyelinating lesion of the spinal cord., Methods: We identified the patients affected by chronic progressive spinal cord dysfunction related to a single spinal cord lesion not satisfying the diagnostic criteria for any of the currently defined diseases., Results: Seven females and one male were included. The median age at onset of symptoms was 53 years (range 42-68) and the median follow-up was 8 years (range 5-12). Brain and spinal magnetic resonance imaging (MRI) scans detected only one single, circumscribed, T2 hyperintense, non-longitudinally extensive lesion at level of cervico-medullary junction or cervical cord, in the absence of Gadolinium enhancement or swelling. Cerebrospinal fluid (CSF) examination displayed neither oligoclonal bands nor raised IgG index. A response to immunosuppressive agents was observed in some of the patients. Serial control brain and spinal MRI did not reveal accumulation of new lesions., Conclusion: New entities or variants should be included among the inflammatory demyelinating diseases of the central nervous system, and their characterization may have relevant prognostic and treatment implications., (© The Author(s), 2014.)
Published: 2014
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5. MxA mRNA quantification and disability progression in interferon beta-treated multiple sclerosis patients.

Author: Serana F, Imberti L, Amato MP, Comi G, Gasperini C, Ghezzi A, Martinelli V, Provinciali L, Rottoli MR, Sotgiu S, Stecchi S, Vecchio M, Zaffaroni M, Cordioli C, and Capra R
Subjects: Adolescent, Adult, Antibodies, Neutralizing, Biomarkers metabolism, Female, Humans, Kinetics, Male, Middle Aged, Myxovirus Resistance Proteins metabolism, Patient Dropouts, Protein Isoforms genetics, Protein Isoforms metabolism, Protein Subunits genetics, Protein Subunits metabolism, RNA, Messenger genetics, RNA, Messenger metabolism, Receptor, Interferon alpha-beta metabolism, Young Adult, Disability Evaluation, Disease Progression, Interferon-beta therapeutic use, Multiple Sclerosis drug therapy, Multiple Sclerosis genetics, Myxovirus Resistance Proteins genetics
Abstract: Even though anti-interferon beta (IFNβ) antibodies are the main determinants of IFNβ bioactivity loss and Myxovirus-resistance protein A (MxA) is the most established marker of IFNβ biological activity in IFNβ-treated multiple sclerosis patients, their usefulness in the routine clinical practice is still debated. Therefore, 118 multiple sclerosis patients naïve for treatment were enrolled for a 3-year longitudinal observational study mimicking the conditions of a real-world setting. In order to evaluate the kinetics of bioactivity loss in blood samples obtained every 6 months after therapy initiation, MxA and interferon receptor isoform/subunit mRNA were quantified by real-time PCR, anti-IFNβ binding antibodies were detected by radioimmunoprecipitation, and neutralizing antibodies by cytopathic effect inhibition assay. Clinical measures of disease activity and disability progression were also obtained at all time points. We found that, at the individual-patient level, the response to IFNβ therapy was extremely heterogeneous, including patients with stable or transitory, early or late loss of IFNβ bioactivity, and patients with samples lacking MxA mRNA induction in spite of absence of antibodies. No interferon receptor isoform alterations that could explain these findings were found. At the group level, none of these biological features correlated with the measures of clinical disease activity or progression. However, when MxA mRNA was evaluated not at the single time point as a dichotomic marker (induced vs. non-induced), but as the mean of its values measured over the 6-to-24 month period, the increasing average MxA predicted a decreasing risk of short-term disability progression, independently from the presence of relapses. Therefore, a more bioactive treatment, even if unable to suppress relapses, reduces their severity by an amount that is proportional to MxA levels. Together with its feasibility in the routine laboratory setting, these data warrant the quantification of MxA mRNA as a primary tool for a routine monitoring of IFNβ therapy.
Published: 2014
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6. Percutaneous transluminal angioplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis: dichotomy between subjective and objective outcome scores.

Author: Zagaglia S, Balestrini S, Perticaroli E, Danni MC, Luzzi S, Silvestrini M, and Provinciali L
Subjects: Adult, Female, Humans, Male, Middle Aged, Multiple Sclerosis complications, Quality of Life, Treatment Outcome, Venous Insufficiency complications, Angioplasty, Brain blood supply, Multiple Sclerosis psychology, Multiple Sclerosis therapy, Spinal Cord blood supply, Venous Insufficiency psychology, Venous Insufficiency therapy
Abstract: Some multiple sclerosis (MS) patients reported an improvement after percutaneous transluminal angioplasty (PTA) for chronic cerebrospinal venous insufficiency (CCSVI), despite the lack of correspondence with objective outcome scores. The objective was to assess neurologic and quality of life scores before and after PTA for CCSVI in an observational study after a self-decided approach. 44 consecutive MS patients (21/23 M/F; median age 43 years, SD 9.8) who underwent PTA were evaluated before endovascular treatment for CCSVI and after 12 months. Neurologic outcome was assessed with EDSS, the annualized relapse rate (ARR) and frequency of new lesions at MRI after PTA. Quality of life was evaluated through the MSQoL-54 questionnaire. No modification in the ARR (p = 0.829), worsening of disability status (p = 0.002) and new lesions at MRI in 29.6 % of patients were found, in contrast to an improvement both in physical and mental domains of MSQoL-54 (p = 0.003). Multiple logistic regression showed EDSS score before PTA to be predictor of an increase of >10 points in MSQoL-54 mental domain (OR 0.52, 95 % CI, 0.31-0.89, p = 0.018). Spontaneously performed approach to CCSVI does not improve clinical and MRI parameters, despite frequent subjective perception of quality of life improvement.
Published: 2013
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7. Endovascular treatment of CCSVI in patients with multiple sclerosis: clinical outcome of 462 cases.

Author: Ghezzi A, Annovazzi P, Cocco E, Coarelli G, Lugaresi A, Rovaris M, Patti F, Capello E, Rodegher ME, Moiola L, Malucchi S, Salemi G, De Rossi N, Provinciali L, Perini P, Bergamaschi R, Scarpini E, Lus G, Gallo A, Tola MR, Amato MP, Rottoli MR, Bianchi A, and Comi G
Subjects: Adult, Cohort Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Sclerosis complications, Surveys and Questionnaires, Treatment Outcome, Venous Insufficiency complications, Brain blood supply, Endovascular Procedures adverse effects, Multiple Sclerosis surgery, Spinal Cord blood supply, Venous Insufficiency surgery
Abstract: Although it is still debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients underwent endovascular treatment (ET) of CCSVI. The objective of the study is to evaluate the outcome and safety of ET in Italian MS patients. Italian MS centers that are part of the Italian MS Study Group were all invited to participate to this retrospective study. A structured questionnaire was used to collect detailed clinical data before and after the ET. Data from 462 patients were collected in 33 centers. ET consisted of balloon dilatation (93 % of cases) or stent application. The mean follow-up duration after ET was 31 weeks. Mean EDSS remained unchanged after ET (5.2 vs. 4.9), 144 relapses occurred in 98/462 cases (21 %), mainly in RR-MS patients. Fifteen severe adverse events were recorded in 3.2 % of cases. Given the risk of severe adverse events and the lack of objective beneficial effects, our findings confirm that at present ET should not be recommended to patients with MS.
Published: 2013
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8. Three years of experience: the Italian registry and safety data update.

Author: Mancardi GL, Tedeschi G, Amato MP, D'Alessandro R, Drago F, Milanese C, Popoli P, Rossi P, Savettieri G, Tola MR, Comi G, Pozzilli C, Bertolotto A, Marrosu MG, Grimaldi LM, Laroni A, Vanacore N, Covezzoli A, De Rosa M, Piccinni C, Montanaro N, Periotto L, Iommelli R, Tomino C, and Provinciali L
Subjects: Adult, Antibodies, Monoclonal, Humanized adverse effects, Female, Humans, Italy epidemiology, Male, Multiple Sclerosis epidemiology, Natalizumab, Antibodies, Monoclonal, Humanized therapeutic use, Multiple Sclerosis drug therapy, Product Surveillance, Postmarketing trends, Registries statistics & numerical data
Abstract: At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability was documented.
Published: 2011
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9. The pharmacovigilance program on natalizumab in Italy: 2 years of experience.

Author: Tedeschi G, Amato MP, D'Alessandro R, Drago F, Milanese C, Popoli P, Rossi P, Savettieri G, Tola MR, Vanacore N, Covezzoli A, De Rosa M, Comi G, Pozzilli C, Bertolotto A, Marrosu MG, Grimaldi LM, Piccinni C, Montanaro N, Periotto L, Iommelli R, Addis A, Martini N, Provinciali L, and Mancardi GL
Subjects: Adult, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Databases, Factual, Female, Follow-Up Studies, Humans, Italy, Magnetic Resonance Imaging, Male, Natalizumab, Patient Dropouts, Antibodies, Monoclonal adverse effects, Multiple Sclerosis drug therapy, Product Surveillance, Postmarketing
Abstract: At the end of 2006 a country-based surveillance program on natalizumab therapy in multiple sclerosis was settled in Italy by a collaborative effort of the Italian Drug Agency (AIFA) and a group of experts and neurologists appointed by the National Society of Neurology (SIN). After 2 years, 1,818 patients are registered in the database. The majority of cases (88.6%) failed the therapy with beta interferon or glatiramer acetate and had relapses or accumulated disability during immunomodulating treatment, while 11.4% of patients enrolled in the surveillance study were not previously treated with immunomodulating therapies and had a rapidly evolving clinical course. Almost 10% of the patients treated with natalizumab interrupted, for various different reasons, the therapy. Treatment was well tolerated and side effects were similar to those reported in the registrative studies. The majority of treated cases are stable or ameliorated.
Published: 2009
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10. Natalizumab: a country-based surveillance program.

Author: Mancardi GL, Amato MP, D'Alessandro R, Drago F, Milanese C, Popoli P, Provinciali L, Rossi P, Savettieri G, Tedeschi G, Tola MR, Vanacore N, Covezzoli A, De Rosa M, Piccinni C, Montanaro N, Periotto L, Addis A, and Martini N
Subjects: Adult, Adverse Drug Reaction Reporting Systems, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Clinical Trials as Topic, Databases, Factual, Drug Resistance drug effects, Drug Resistance immunology, Drug-Related Side Effects and Adverse Reactions, Female, Follow-Up Studies, Humans, Immunologic Factors adverse effects, Immunologic Factors therapeutic use, Italy, Male, Multiple Sclerosis immunology, Natalizumab, National Health Programs standards, National Health Programs trends, Outcome Assessment, Health Care trends, Antibodies, Monoclonal pharmacology, Immunologic Factors pharmacology, Multiple Sclerosis drug therapy, Outcome Assessment, Health Care methods, Product Surveillance, Postmarketing
Abstract: Natalizumab is a humanized monoclonal antibody with a selective adhesion-molecule inhibitor effect, and a demonstrated efficacy in decreasing the frequency of relapses and progression of disability in relapsing-remitting multiple sclerosis (RR MS). After the approval of FDA and EMEA in MS cases unresponsive to immunomodulating therapy or in severe MS patients also not previously treated with interferons, and considering the concern on the possible side effects, an accurate program of surveillance was organized in our country by a combined effort of AIFA, Cineca, Department of Pharmacology of University of Bologna, and a group of neurologists appointed by the National Society of Neurology (SIN). After 15 months from the authorization of natalizumab therapy in MS, as of 31 March 2008, 908 cases have been treated with natalizumab and enrolled in this pharmaco-vigilance study. The mean age is 35 years, while the duration of disease is longer and disability is higher than that reported in the registrative study. Side effects are at the moment mild and similar to those previously described. At follow-up, the majority of treated cases are stable or ameliorated. The treatment was discontinued in 6% of patients.
Published: 2008
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11. Intracellular oxidative activity and respiratory burst of leukocytes isolated from multiple sclerosis patients.

Author: Ferretti G, Bacchetti T, DiLudovico F, Viti B, Angeleri VA, Danni M, and Provinciali L
Subjects: Adult, Case-Control Studies, Evoked Potentials, Visual, Female, Fluoresceins chemistry, Fluorescent Dyes chemistry, Humans, Leukocytes drug effects, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis metabolism, Multiple Sclerosis physiopathology, Respiratory Burst, Tetradecanoylphorbol Acetate pharmacology, Leukocytes metabolism, Multiple Sclerosis blood, Oxidative Stress
Abstract: Oxidative damage induced by free radicals and reactive oxygen species (ROS) have been suggested to play an important role in the development of autoimmune diseases such as multiple sclerosis (MS) disease and it has been hypothesised that oxidative injury could mediate demyelination and axonal injury in MS subjects. In our study, we compared intracellular oxidative activity and the respiratory burst activity in MS patients (n=20) and healthy controls (n=15) using leukocytes as cellular model. At this purpose, intracellular ROS levels were evaluated by fluorometric assay using the 2'-7'-dichlorodihydrofluorescin diacetate probe (H(2)DCFDA) in untreated or in leukocytes stimulated with phorbol-12-myristate-13-acetate (PMA). Our results demonstrate that the intracellular spontaneous ROS production in leukocytes from MS patients was higher with respect to cells from control subjects (p<0.001). PMA addition induced a higher formation of ROS both in leukocytes from MS patients and controls (p<0.001). The PMA-induced production of ROS was significantly higher in leukocytes from MS with respect to controls (p<0.001). Significant positive correlations were established between intracellular spontaneous or PMA-induced production of ROS in leukocytes isolated from MS patients and the clinical parameters used to evaluate disease disability such as expanded disability status scale (EDSS), brain lesions evaluated by MRI and visual evoked potential (VEP) (p<0.001). In conclusion, our results demonstrate higher levels of intracellular ROS in untreated or in PMA-treated leukocytes isolated from MS patients with respect to healthy subjects confirming the role of oxidative stress in multiple sclerosis.
Published: 2006
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12. Increased levels of lipid hydroperoxides in plasma of patients with multiple sclerosis: a relationship with paraoxonase activity.

Author: Ferretti G, Bacchetti T, Principi F, Di Ludovico F, Viti B, Angeleri VA, Danni M, and Provinciali L
Subjects: Adult, Biomarkers blood, Cholesterol Esters blood, Female, Humans, Lipids blood, Male, Multiple Sclerosis immunology, Neuritis immunology, Neuritis metabolism, Oxidative Stress, Aryldialkylphosphatase metabolism, Lipid Peroxidation, Lipid Peroxides blood, Multiple Sclerosis metabolism
Abstract: Paraoxonase, an enzyme associated with high density lipoproteins (HDL), plays an important role in the anti-oxidant and anti-inflammatory properties exerted by HDL. Increasing evidence supports a role of free radicals and oxidative stress in the inflammatory processes and in the pathogenesis of multiple sclerosis (MS). The aim of this study was to further investigate the relationship between oxidative damage and MS; therefore we compared the paraoxonase activity and levels of cholesteryl ester hydroperoxides (CE-OOH), as marker of lipid peroxidation, in plasma isolated from healthy subjects (n = 89) and from MS patients (n = 24) in the early stage disability (EDSS<3.5). Our results demonstrated for the first time that the activity of paraoxonase in the plasma of MS subjects was significantly lower with respect to controls (P <0.001). Moreover, our results showed a significant increase in the levels of CE-OOH in plasma from MS subjects (P<0.001). CE-OOH are biologically active substances derived from the oxidation of cholesteryl ester localized in the hydrophobic core of plasma lipoproteins (HDL, LDL). Therefore, our study demonstrates alterations of lipoprotein peroxidation in MS and provides further evidence that oxidative stress and impairment of the anti-oxidant system may play a role in MS.
Published: 2005
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13. A multidimensional assessment of multiple sclerosis: relationships between disability domains.

Author: Provinciali L, Ceravolo MG, Bartolini M, Logullo F, and Danni M
Subjects: Adolescent, Adult, Aged, Aged, 80 and over, Cognition, Depression etiology, Depression rehabilitation, Fatigue etiology, Fatigue rehabilitation, Female, Humans, Male, Middle Aged, Quality of Life, Disability Evaluation, Multiple Sclerosis psychology, Multiple Sclerosis rehabilitation
Abstract: Objective: To test the feasibility of a multidimensional assessment based on both task-related and self-evaluation questionnaire scores in patients with multiple sclerosis (MS); ii) to correlate the results from selective measures with the severity of illness in terms of the Expanded Disability Status Scale (EDSS) score; iii) to assess the relationships between different domains of MS-related disability and handicap., Patients and Methods: Eighty-three MS patients (M/F 31/52; age 43.26 +/- 10.9 years, range 21-72) underwent a standard clinical evaluation of motor abilities (by means of the Rivermead Mobility index, Timed Walking Test, Nine Hole Peg test and Hauser Ambulation Index) and cognitive performances (using Digit Symbol, Buschke-Fuld selective remind test, "FAS"-Word Fluency, Wisconsin Card Sorting test and Block design test). The Beck Depression inventory, MS Specific Fatigue Scale, Functional Assessment of MS and London Handicap Scale were applied to evaluate mood, fatigue, quality of life and handicap, respectively. Minimal Record of Disability measures - MRD (i.e. EDSS, Inability Status Scale and Environmental Status Scale) were also applied to test the criterion validity of the selected disability and handicap scales. The Kruskal-Wallis H-test for independent samples tested differences between subgroups with an increasing EDSS score (<3.5, 3.5-6.0, >6.0). The covariance and redundancy of measures included in the multidimensional assessment were evaluated through Factor Analysis. The Multiple Regression Analysis was used to detect the relative impact of either motor or cognitive disabilities and depression on handicap and quality of life., Results: The multimodal assessment took 70 min on average to be performed, being well accepted by patients. Motor abilities worsened as the EDSS score rose, unlike cognitive performances which proved to be similarly impaired at different severity levels. Measures of fatigue and depression were not related to EDSS values. The chosen measures were assigned by Factor Analysis to 4 domains corresponding to motor performance, executive performance, cognitive abilities and quality of life, respectively. Regression analysis showed how handicap and depression independently affect quality of life. While the handicap score is mostly influenced by motor ability, as measured by the Rivermead Mobility Index, the depression score grows independently of any physical or cognitive disability and seems to be related to fatigue self-assessment scores., Conclusions: A multidimensional approach to MS patient assessment allows a more detailed and sensitive evaluation of their disability profile and perceived difficulties, leading to a care programme tailored to the patient's needs.
Published: 1999
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14. Risk factors for unprovoked epileptic seizures in multiple sclerosis: a systematic review and meta-analysis

Author: Gasparini, Sara, Ferlazzo, Edoardo, Ascoli, Michele, Sueri, Chiara, Cianci, Vittoria, Russo, Concetta, Pisani, Laura Rosa, Striano, Pasquale, Elia, Maurizio, Beghi, Ettore, Colica, Carmela, Aguglia, Umberto, Belcastro, V., Bianchi, A., Calabrò, S., De Falco, F., De Maria, G., Galimberti, C. A., Gambardella, A., Iudice, A., Labate, A., La Neve, A., Le Piane, E., Monti, F., Mumoli, L., Paladin, F., Pisani, F., Pizza, V., Provinciali, L., Sofia, V., Specchio, L. M., Specchio, N., Striano, S., Villani, F., Zaccara, G., and On behalf of the Epilepsy Study Group of the Italian Neurological Society
Published: 2017
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15. Natalizumab therapy of multiple sclerosis: recommendations of the Multiple Sclerosis Study Group—Italian Neurological Society

Author: Ghezzi, A., Grimaldi, L. M. E., Marrosu, M. G., Pozzilli, C., Comi, G., Bertolotto, A., Trojano, M., Gallo, P., Capra, R., Centonze, D., Millefiorini, E., Sotgiu, S., Brescia Morra, V., Amato, M. P., Lugaresi, A., Mancardi, G., Caputo, D., Montanari, E., Provinciali, L., Durelli, L., Bergamaschi, R., Bellantonio, P., Tola, M. R., Cottone, S., Savettieri, G., Tedeschi, G., and MS-SIN Study Group
Published: 2011
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16. Natalizumab in pediatric multiple sclerosis: results of a cohort of 55 cases

Author: Ghezzi, A, Zaffaroni, M, Bianchi, A, Pozzilli, C, Prosperini, L, Borriello, G, Filippi, M, Moiola, L, Gerevini, S, Rocca, MA, Martinelli, V, Comi, G, Grimaldi, LM, Bucello, S, Lus, G, Rinaldi, F, Gallo, P, Trojano, M, Provinciali, L, Pucci, E, Bortolon, F, Capra, R, Coniglio, G, Gasperini, C, Lugaresi, A, Pietrolongo, E, Farina, D, Di Ioia, M, Milani, N, Rottoli, MR, Sarchielli, P., BRESCIA MORRA, VINCENZO, LANZILLO, ROBERTA, Ghezzi, A, Zaffaroni, M, Bianchi, A, Pozzilli, C, Prosperini, L, Borriello, G, Filippi, M, Moiola, L, Gerevini, S, Rocca, Ma, Martinelli, V, Comi, G, BRESCIA MORRA, Vincenzo, Lanzillo, Roberta, Grimaldi, Lm, Bucello, S, Lus, G, Rinaldi, F, Gallo, P, Trojano, M, Provinciali, L, Pucci, E, Bortolon, F, Capra, R, Coniglio, G, Gasperini, C, Lugaresi, A, Pietrolongo, E, Farina, D, Di Ioia, M, Milani, N, Rottoli, Mr, Sarchielli, P., Brescia Morra, V, Comi, Giancarlo, Filippi, Massimo, Italian MS Study, Group, Ghezzi A, Pozzilli C, Grimaldi L, Moiola L, Brescia-Morra V, Lugaresi A, Lus G, Rinaldi F, Rocca M, Trojano M, Bianchi A, Comi G, Filippi M, the Italian MS Study Group, and Lus, Giacomo
Subjects: Male, medicine.medical_specialty, Pediatrics, Adolescent, Antibodies, Monoclonal, Humanized, adolescence, childhood, Multiple sclerosis, natalizumab, Brain, Child, Cohort Studies, Female, Humans, Magnetic Resonance Imaging, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Neurology, Neurology (clinical), Female patient, Medicine, Multiple sclerosi, Cognitive skill, Expanded Disability Status Scale, medicine.diagnostic_test, business.industry, Magnetic resonance imaging, Mean age, medicine.disease, Surgery, Cohort, business, medicine.drug
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 ( pConclusions: 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

17. 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

18. 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

19. 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, MS SIN STUDY GROUP, TEDESCHI, Gioacchino, 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, Tedeschi, Gioacchino, MS SIN STUDY, Group, Comi, Giancarlo, Brescia Morra, V, Tedeschi, G, MS SIN Study, Group, 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, Tedeschi G, MS-SIN Study Group, BRESCIA MORRA, Vincenzo, Ghezzi,A, Grimaldi,LM, Marrosu,MG, Comi,G, Bertolotto,A, Centonze. D, Amato,MP, Tola, MR, and MS-SIN Study Group.
Subjects: medicine.medical_specialty, Pediatrics, pml, iris, multiple sclerosis, natalizumab, Multiple Sclerosis, Neurology, MEDLINE, Progressive Multifocal, Dermatology, Relapsing-Remitting, Antibodies, Monoclonal, Humanized, Antibodies, Leukoencephalopathy, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Monoclonal, medicine, Humans, Adverse effect, Humanized, Antibodies, therapeutic use, Humans, Leukoencephalopathy, chemically induced, Multiple Sclerosis, drug therapy, Humanized, Multiple sclerosis, Natalizumab, PML, IRIS, business.industry, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Leukoencephalopathy, Progressive Multifocal, Antibodies, Monoclonal, General Medicine, medicine.disease, Psychiatry and Mental health, therapeutic use, chemically induced, natalizumab, multiple sclerosis, treatment, guidelines, Physical therapy, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, business, medicine.drug
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

20. Clinical and Immunological Findings After Treatment with Thymostimulin in Multiple Sclerosis

Author: Giovagnoli, A. R., Provinciali, L., Bartocci, C., Montroni, M., Cazzullo, Carlo L., editor, Caputo, Domenico, editor, Ghezzi, Angelo, editor, and Zaffaroni, Mauro, editor
Published: 1988
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21. Natalizumab treatment in multiple sclerosis patients: a multicenter experience in clinical practice in Italy

Author: Totaro, R., Alessandra Lugaresi, Bellantonio, P., Danni, M., Costantino, G., Gasperini, C., Florio, C., Pucci, E., Maddestra, M., Spitaleri, D., Lus, G., Ardito, B., Farina, D., Rossi, M., Carmine, C. D. I., Altobelli, E., Maccarone, B., Casalena, A., Luca, G., Travaglini, D., Ioia, M. D. I., Tommaso, V. D. I., Fantozzi, R., Ruggieri, S., Provinciali, L., Riso, S., Mundi, C., Fuiani, A., Galgani, S., Maniscalco, G. T., Giuliani, G., Cartechini, E., Petretta, V., Fratta, M., Alfieri, G., Gatto, M., Carolei, A., Totaro, R, Lugaresi, A, Bellantonio, P, Danni, M, Costantino, G, Gasperini, C, Florio, C, Pucci, E, Maddestra, M, Spitaleri, D, Lus, Giacomo, Ardito, B, Farina, D, Rossi, M, Di Carmine, C, Altobelli, E, Maccarone, B, Casalena, A, De Luca, G, Travaglini, D, Di Ioia, M, Di Tommaso, V, Fantozzi, R, Ruggieri, S, Provinciali, L, De Riso, S, Mundi, C, Fuiani, A, Galgani, S, Maniscalco, Gt, Giuliani, G, Cartechini, E, Petretta, V, Fratta, M, Alfieri, G, Gatto, M, Carolei, A., and DIPARTIMENTO DI SCIENZE BIOMEDICHE E NEUROMOTORIE
Subjects: Adult, Male, medicine.medical_specialty, Time Factors, Antibodies, Monoclonal, Humanized, Disability Evaluation, Disease Progression, Disease-Free Survival, Female, Humans, Immunosuppressive Agents, Italy, Kaplan-Meier Estimate, Magnetic Resonance Imaging, Middle Aged, Multiple Sclerosis, Relapsing-Remitting, Natalizumab, Product Surveillance, Postmarketing, Treatment Outcome, Immunology, Relapsing-Remitting, multiple sclerosis, Antibodies, Internal medicine, Monoclonal, medicine, Immunology and Allergy, Humanized, Pharmacology, Expanded Disability Status Scale, medicine.diagnostic_test, treatment, business.industry, Multiple sclerosis, Disease progression, Magnetic resonance imaging, multi center, medicine.disease, Product Surveillance, Postmarketing, Clinical Practice, Physical therapy, Observational study, multiple sclerosis, treatment, natalizumab, multi center, Italy, business, medicine.drug
Abstract: none 39 no Articolo con dati scientifici originali pubblicato nella sezione "Editorial" della rivista We evaluated efficacy of natalizumab in relapsing-remitting multiple sclerosis patients in a clinical practice setting. We report data on the first consecutive 343 patients receiving natalizumab in 12 multiple sclerosis (MS) Italian centers enrolled between April 2007 and November 2010. The main efficacy endpoints were the proportion of patients free from relapses, disease progression, combined clinical activity, defined as presence of relapse or disease progression, from MRI activity, and from any disease activity defined as the absence of any single or combined activity. At the end of follow-up, the cumulative proportion of patients free from relapses was 68%; the proportion of patients free from Expanded Disability Status Scale (EDSS) progression was 93%; the proportion of patients free from combined clinical activity was 65%; the proportion of patients free from MRI activity was 77%; and the proportion of patients free from any disease activity was 53%. Natalizumab was effective in reducing clinical and neuroradiological disease activity. Its effectiveness in clinical practice is higher than that reported in pivotal trials and was maintained over time. none Totaro R; Lugaresi A; Bellantonio P; Danni M; Costantino G; Gasperini C; Florio C; Pucci E; Maddestra M; Spitaleri D; Lus G; Ardito B; Farina D; Rossi M; Di Carmine C; Altobelli E; Maccarone B; Casalena A; De Luca G; Travaglini D; Di Ioia M; Di Tommaso V; Fantozzi R; Ruggieri S; Provinciali L; De Riso S; Mundi C; Fuiani A; Galgani S; Ruggieri S; Maniscalco GT; Giuliani G; Cartechini E; Petretta V; Fratta M; Alfieri G; Gatto M; Carolei A; Natalizumab Long-Term Treatment Study group Totaro R; Lugaresi A; Bellantonio P; Danni M; Costantino G; Gasperini C; Florio C; Pucci E; Maddestra M; Spitaleri D; Lus G; Ardito B; Farina D; Rossi M; Di Carmine C; Altobelli E; Maccarone B; Casalena A; De Luca G; Travaglini D; Di Ioia M; Di Tommaso V; Fantozzi R; Ruggieri S; Provinciali L; De Riso S; Mundi C; Fuiani A; Galgani S; Ruggieri S; Maniscalco GT; Giuliani G; Cartechini E; Petretta V; Fratta M; Alfieri G; Gatto M; Carolei A; Natalizumab Long-Term Treatment Study group
Published: 2014

22. Phase III Dose-Comparison Study of Glatiramer Acetate for Multiple Sclerosis

Author: Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study Group, Rocc, Ma, Perego, E, Absinta, M, Mesaros, S, Vuotto, R, Misci, P, Petrolini, M, Coyle, P, Wolinsky, J, Antel, J, Zamvil, S, Feigin, P, Carra, Aj, Bettinelli, Rj, Luetic, Gg, Vrech, Ca, Dubois, Bd, Metz, L, Bar Or, A, Bhan, V, Myles, M, Havrdova, E, Ehler, E, Kanovsky, P, Talab, R, Zapletalova, O, Gross Paju, K, Taba, P, Elovaara, I, Erälinna, Jp, Kinnunen, E, Koivisto, K, Reunanen, M, Brochet, B, Camu, W, Damier, P, Defer, G, Tumani, H, Becker, E, Buettner, T, Diener, Hc, Franz, P, Haas, J, Heesen, C, Heidenreich, F, Koelmel, Hw, Reifschneider, G, Retzlaff, K, Thoemke, F, Ziemssen, T, Rozsa, C, Bartos, L, Csanyi, A, Deme, I, Komoly, S, Panczel, G, Simo, M, Achiron, A, Milo, R, Bergamaschi, R, Bertolotto, A, Capra, R, Caputo, D, Cavalla, P, Centonze, D, Cottone, S, DE STEFANO, Nicola, Gasperini, C, Mancardi, G, Provinciali, L, Ruggieri, S, Scarpini, E, Zaffaroni, M, Metra, M, Kizlaitiene, R, Vaitkus, A, Zwanikken, Cp, Hupperts, Rm, Jongen, Pj, Szczudlik, A, Fryze, W, Kazibutowska, Z, Pierzchaa, K, Pniewski, J, Podemski, R, Stepień, A, Bajenaru, O, Campeanu, A, Marginean, I, Popescu, Cd, Toldisan, I, Boiko, A, Gustov, A, Malkova, N, Perfilyev, S, Poverennova, I, Saykhunov, M, Shutov, A, Skoromets, A, Spirin, N, Stolyarov, I, Volkova, L, Rodriguez Antigüedad, A, Arbizu, T, Arroyo, R, Barcena, J, Casanova, B, Fernández, O, Montalban, X, Ramió, L, Saiz Hinarejos, A, Sharrack, B, Silber, E, Young, C, Agius, M, Birnbaum, G, Campagnolo, D, Chaudhary, K, Cohen, J, Ford, C, Fox, E, Goodman, A, Green, B, Gupta, A, Hughes, B, Javed, A, Jeffery, D, Kasper, L, Kaufman, M, Khan, O, Kresa Reahl, K, Leist, T, Lynch, S, Markowitz, C, Mattson, D, Moses, H, Parks, B, Parry, G, Phillips, T, Picone, M, Rammohan, K, Rizvi, S, Royal, W, Scarberry, S, Sheppard, C, Simnad, V, Thrower, B, Whitham, R, Wynn, D., Comi, G, Cohen, Ja, Arnold, Dl, Wynn, D, Filippi, M, FORTE Study, Group, Diener, Hans Christoph (Beitragende*r), Klinische Neurowetenschappen, and RS: MHeNs School for Mental Health and Neuroscience
Subjects: Male, Medizin, MULTICENTER, Relapsing-Remitting, Gastroenterology, law.invention, DOUBLE-BLIND, Randomized controlled trial, law, Recurrence, Drug Toxicity, Clinical endpoint, Secondary Prevention, administration /&/ dosage/adverse effects/therapeutic use, Middle Aged, drug therapy, Intention to Treat Analysis, Treatment Outcome, Neurology, Tolerability, Disease Progression, RELAPSE RATE, TRIAL, Female, Settore MED/26 - Neurologia, Drug, Immunosuppressive Agents, medicine.drug, Adult, medicine.medical_specialty, Multiple Sclerosis, Drug-Related Side Effects and Adverse Reactions, Adolescent, Endpoint Determination, DOUBLE-BLIND, RELAPSE RATE, FOLLOW-UP, DISABILITY, TRIAL, MULTICENTER, MS, Dose-Response Relationship, Multiple Sclerosis, Relapsing-Remitting, Adolescent, Adult, Disease Progression, Dose-Response Relationship, Drug, Drug Toxicity, Endpoint Determination, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects/therapeutic use, Intention to Treat Analysis, Male, Middle Aged, Multiple Sclerosis, drug therapy, Multiple Sclerosis, drug therapy, Peptides, administration /&/ dosage/adverse effects/therapeutic use, Recurrence, prevention /&/ control, Treatment Outcome, Internal medicine, medicine, Humans, Glatiramer acetate, Expanded Disability Status Scale, Intention-to-treat analysis, Peptides, Dose-Response Relationship, Drug, business.industry, DISABILITY, MS, Glatiramer Acetate, Confidence interval, Surgery, Relative risk, prevention /&/ control, Neurology (clinical), FOLLOW-UP, business
Abstract: Objective: To evaluate the safety, tolerability, and efficacy of glatiramer acetate (GA) 40mg compared to a 20mg dose. Methods: Patients with multiple sclerosis (MS) with ≥1 documented relapse in 12 months prior to screening, or ≥2 documented relapses in 24 months prior to screening, and Expanded Disability Status Scale (EDSS) score 0 to 5.5 were enrolled. Patients were evaluated at screening, baseline, and at months 1, 2, 3, 6, 9, and 12. Primary endpoint was rate of confirmed relapses observed during 12-month study. Analysis was by intent-to-treat. Results: A total of 1,155 patients randomized to GA 20mg (n = 586) or 40mg (n = 569). The groups were well-matched at baseline on demographic, clinical, and magnetic resonance imaging (MRI) characteristics. The primary endpoint was similar in both groups (relative risk [RR] = 1.07; 95% confidence interval [CI], 0.88–1.31; p = 0.486) with mean annualized relapse rates (ARRs) of 0.33 for the 20mg group, 0.35 for the 40mg group, and 0.27 for patients from both groups who completed the entire 1-year treatment. A total of 77% of patients remained relapse-free in both groups. Both groups showed a reduction in mean number of gadolinium-enhancing and new T2 lesions over time with trend for faster reduction in the first trimester with the 40mg dose compared with 20mg dose. Both doses were well-tolerated with a safety profile similar to that observed in previous studies of 20mg GA. Interpretation: In relapsing-remitting MS patients, both the currently-approved GA 20mg and 40mg doses were safe and well-tolerated, with no gain in efficacy for the higher dose. Ann Neurol 2011;69:75–82.
Published: 2011

23. 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

24. Efficacy of Natalizumab and Fingolimod in Relapsing Remitting Multiple Sclerosis in Real World Clinical Setting

Author: C. Carrocci, Serena Ruggieri, Danni M, Gianfranco Costantino, Antonio Carolei, Roberta Fantozzi, Aurora Fuiani, Paolo Bellantonio, Ciro Mundi, R. Cerqua, Rocco Totaro, Provinciali L, Caterina Di Carmine, and Carmine Marini
Subjects: medicine.medical_specialty, Expanded Disability Status Scale, medicine.diagnostic_test, business.industry, Multiple sclerosis, Magnetic resonance imaging, Pharmacology, medicine.disease, Fingolimod, Disease activity, Natalizumab, Relapsing remitting, Internal medicine, medicine, T2 lesions, business, medicine.drug
Abstract: Objective: The aim of this study was to compare the efficacy of natalizumab and fingolimod in relapsing-remitting multiple sclerosis patients in real-world clinical setting. Methods: We enrolled 391 patients starting either natalizumab or fingolimod for relapsing-remitting multiple sclerosis, referred to four multiple sclerosis centers between March 2007 and July 2013. Cumulative proportion of patients free from any disease activity, as defined by freedom from relapse, Expanded Disability Status Scale (EDSS) progression, new or newly enlarging T2 lesions, and gadolinium enhancing lesions at magnetic resonance imaging (MRI) was assessed at 12-month follow-up. Results: Out of 391 patients, 197 were treated with natalizumab and 194 with fingolimod. The cumulative proportion of patients free from any disease activity was 72.0% in the natalizumab and 59.1% in the fingolimod group (P=0.014). This proportion was lower in fingolimod patients with prior natalizumab exposure compared to those without (51.7% vs. 61.8%; P=0.008). Moreover, the cumulative proportion of patients free from new MRI lesions was 87.5% in the natalizumab vs. 70.0% in the fingolimod group (P
Published: 2015

25. 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

26. 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

27. 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

28. The Italian Surveillance Program on Natalizumab

Author: Mancardi G. L., Amato M. P., Drago F., Milanese C., Popoli P., Provinciali L., Rossi P., Savettieri G., Tedeschi G., Tola M. R., Vanacore N., Covezzoli A., De Rosa M., Periotto L., Addis A., Martini N., D'ALESSANDRO, ROBERTO, PICCINNI, CARLO, MONTANARO, NICOLA, Società Italiana di Neurologia, Mancardi G.L., Amato M.P., D'Alessandro R., Drago F., Milanese C., Popoli P., Provinciali L., Rossi P., Savettieri G., Tedeschi G., Tola M.R., Vanacore N., Covezzoli A., De Rosa M., Piccinni C., Montanaro N., Periotto L., Addis A., and Martini N.
Subjects: REGISTRY, MULTIPLE SCLEROSIS, NATALIZUMAB
Published: 2008

29. Three years of experience : the Italian registry and safety data update

Author: Giovanni Luigi Mancardi, Laura Periotto, Pier Giuseppe Rossi, M. De Rosa, R. Iommelli, Nicola Vanacore, Carlo Piccinni, Clara Milanese, Patrizia Popoli, Alice Laroni, Carlo Tomino, Roberto D’Alessandro, Maria Giovanna Marrosu, Filippo Drago, M. R. Tola, G. Comi, A. Covezzoli, Antonio Bertolotto, Giovanni Savettieri, Gioacchino Tedeschi, Nicola Montanaro, Maria Pia Amato, Carlo Pozzilli, L.M.E. Grimaldi, Leandro Provinciali, Mancardi, Gl, Tedeschi, G, Amato, Mp, D’Alessandro, R, Drago, F, Milanese, C, Popoli, P, Rossi, P, Savettieri, G, Tola, Mr, Comi, Giancarlo, Pozzilli, C, Bertolotto, A, Marrosu, Mg, Grimaldi, Lm, Laroni, A, Vanacore, N, Covezzoli, A, De Rosa, M, Piccinni, C, Montanaro, N, Pernotto, L, Iommelli, R, Tomino, C, Provinciali, L., Mancardi, GL, Amato,MP, D'Alessandro,R, Drago,F, Rossi,P, Tola, MR, Comi, G, Bertolotto,A, Marrosu,MG, Grimaldi, LM, Periotto, L, Tomino. C, Tedeschi, Gioacchino, D'Alessandro, R, DE ROSA, M, G.L. Mancardi, G. Tedeschi, M.P. Amato, R. D’Alessandro, F. Drago, C. Milanese, P. Popoli, P. Rossi, G. Savettieri, M.R. Tola, G. Comi, C. Pozzilli, A. Bertolotto, M.G. Marrosu, L.M.E. Grimaldi, A. Laroni, N. Vanacore, A. Covezzoli, M. De Rosa, C. Piccinni, N. Montanaro, L. Periotto, R. Iommelli, C. Tomino, and L. Provinciali
Subjects: Adult, Male, medicine.medical_specialty, Pediatrics, Multiple Sclerosis, Dermatology, Disease, Antibodies, Monoclonal, Humanized, Natalizumab, Pharmacovigilance, Product Surveillance, Postmarketing, medicine, Humans, Registries, Adverse effect, business.industry, Multiple sclerosis, General Medicine, medicine.disease, Psychiatry and Mental health, Italy, PHARMACOVIGILANCE, REGISTRY, surveillance program, pharmacovigilance, multiple sclerosis, natalizumab, Physical therapy, Female, Settore MED/26 - Neurologia, Neurology (clinical), Neurosurgery, business, Multiple sclerosis, Natalizumab,Surveillance program, Pharmacovigilance, medicine.drug
Abstract: At the end of 2006, a pharmacovigilance program on natalizumab was settled by the Italian Pharmaceutical Agency, and on January 2007, multiple sclerosis patients poorly responding to the immunomodulating therapies or with an aggressive clinical form of disease from onset initiated to be registered and to receive the medication. On February 2010, almost 3,000 cases have been treated with natalizumab. The drop-out rate is 10%. Almost 800 cases received cycles of natalizumab for more than 18 months. One case of PML was reported and other adverse events are similar to those described in phase III studies. The majority of cases remained stable, while in 25% of cases, an improvement of disability was documented.
Published: 2011

30. MxA mRNA Quantification and Disability Progression in Interferon Beta-Treated Multiple Sclerosis Patients

Author: Vittorio Martinelli, Ruggero Capra, Maria Pia Amato, Angelo Ghezzi, Stefano Sotgiu, Luisa Imberti, M. Rottoli, Giancarlo Comi, Claudio Gasperini, Sergio Stecchi, Leandro Provinciali, Mauro Zaffaroni, Cinzia Cordioli, Michele Vecchio, Federico Serana, Serana, F, Imberti, L, Amato, Mp, Comi, Giancarlo, Gasperini, C, Ghezzi, A, Martinelli, V, Provinciali, L, Rottoli, Mr, Sotgiu, S, Stecchi, S, Vecchio, M, Zaffaroni, M, Cordioli, C, and Capra, R.
Subjects: Male, Myxovirus Resistance Proteins, Epidemiology, lcsh:Medicine, Receptor, Interferon alpha-beta, Pathology and Laboratory Medicine, Biochemistry, Disability Evaluation, Medicine and Health Sciences, Protein Isoforms, lcsh:Science, Receptor, Cytopathic effect, Multidisciplinary, biology, Biological activity, Middle Aged, Neurology, Research Design, Genetic Epidemiology, Disease Progression, Female, Antibody, Research Article, Adult, Multiple Sclerosis, Patient Dropouts, Adolescent, Clinical Research Design, Immunology, Research and Analysis Methods, Autoimmune Diseases, MED/39 Neuropsichiatria infantile, Young Adult, Pharmacotherapy, Diagnostic Medicine, medicine, Humans, RNA, Messenger, Beta (finance), Population Biology, Multiple sclerosis, lcsh:R, Biology and Life Sciences, Interferon-beta, medicine.disease, Antibodies, Neutralizing, Demyelinating Disorders, Kinetics, Protein Subunits, Biomarker Epidemiology, biology.protein, lcsh:Q, Clinical Immunology, Protein A, Biomarkers, interferon beta-treated multiple sclerosis
Abstract: Even though anti-interferon beta (IFNβ) antibodies are the main determinants of IFNβ bioactivity loss and Myxovirus-resistance protein A (MxA) is the most established marker of IFNβ biological activity in IFNβ-treated multiple sclerosis patients, their usefulness in the routine clinical practice is still debated. Therefore, 118 multiple sclerosis patients naïve for treatment were enrolled for a 3-year longitudinal observational study mimicking the conditions of a real-world setting. In order to evaluate the kinetics of bioactivity loss in blood samples obtained every 6 months after therapy initiation, MxA and interferon receptor isoform/subunit mRNA were quantified by real-time PCR, anti-IFNβ binding antibodies were detected by radioimmunoprecipitation, and neutralizing antibodies by cytopathic effect inhibition assay. Clinical measures of disease activity and disability progression were also obtained at all time points. We found that, at the individual-patient level, the response to IFNβ therapy was extremely heterogeneous, including patients with stable or transitory, early or late loss of IFNβ bioactivity, and patients with samples lacking MxA mRNA induction in spite of absence of antibodies. No interferon receptor isoform alterations that could explain these findings were found. At the group level, none of these biological features correlated with the measures of clinical disease activity or progression. However, when MxA mRNA was evaluated not at the single time point as a dichotomic marker (induced vs. non-induced), but as the mean of its values measured over the 6-to-24 month period, the increasing average MxA predicted a decreasing risk of short-term disability progression, independently from the presence of relapses. Therefore, a more bioactive treatment, even if unable to suppress relapses, reduces their severity by an amount that is proportional to MxA levels. Together with its feasibility in the routine laboratory setting, these data warrant the quantification of MxA mRNA as a primary tool for a routine monitoring of IFNβ therapy.
Published: 2014

31. Immunity assessment in the early stages of amyotrophic lateral sclerosis: a study of virus antibodies and lymphocyte subsets

Author: C. Bartocci, Anna Rita Giovagnoli, M. Montroni, L. Vesprini, L. Provinciali, P. E. Varaldo, P. Bagnarelli, Massimo Clementi, M. A. Laurenzi, Provinciali, L, Laurenzi, Ma, Vesprini, L, Giovagnoli, Ar, Bartocci, C, Montroni, M, Bagnarelli, P, Clementi, Massimo, and Varaldo, P. E.
Subjects: Adult, Male, Cellular immunity, T-Lymphocytes, Antibodies, Viral, Virus, Immune system, Immunity, Medicine, Humans, Amyotrophic lateral sclerosis, biology, business.industry, Multiple sclerosis, Amyotrophic Lateral Sclerosis, General Medicine, Middle Aged, medicine.disease, Neurology, Immunology, Humoral immunity, biology.protein, Female, Neurology (clinical), Antibody, business
Abstract: Serum and CSF from 32 patients with idiopathic ALS, 30 agematched controls and 30 MS patients were investigated regarding immunoglobulin concentration and virus-specific antibodies, the lymphocytes in the peripheral blood and lymphocyte subsets were also investigated. ALS patients’ results were compared with findings in MS and controls. The ALS patients had significantly higher IgG concentration in serum than the controls, marked lymphopenia, reduction of CD2, CD8 and Leu 7 positive cells and increase of the CD4/CD8 ratio and of SIg-positive lymphocytes. Compared with the MS patients, the ALS patients showed similarity in T-subset distribution with a lower standard deviation. No HTLV-I and HIV antibodies were found in any group and no significant differences in antibody distribution to Toxoplasma G, herpes simples, cytomegalovirus, measles and mumps viruses were evident. All ALS patients were investigated at an early disease stage, therefore, our findings seem to support the conclusion that the immune alterations are related to the mechanisms of the disease and not to complications of its evolution.
Published: 1988

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31 results on '"Provinciali, L"'

1. Persistence to oral disease-modifying therapies in multiple sclerosis patients.

2. Management of pregnancy-related issues in multiple sclerosis patients: the need for an interdisciplinary approach.

3. Oral and intravenous steroids for multiple sclerosis relapse: a systematic review and meta-analysis.

4. Multiple sclerosis, solitary sclerosis or something else?

5. MxA mRNA quantification and disability progression in interferon beta-treated multiple sclerosis patients.

6. Percutaneous transluminal angioplasty for chronic cerebrospinal venous insufficiency in multiple sclerosis: dichotomy between subjective and objective outcome scores.

7. Endovascular treatment of CCSVI in patients with multiple sclerosis: clinical outcome of 462 cases.

8. Three years of experience: the Italian registry and safety data update.

9. The pharmacovigilance program on natalizumab in Italy: 2 years of experience.

10. Natalizumab: a country-based surveillance program.

11. Intracellular oxidative activity and respiratory burst of leukocytes isolated from multiple sclerosis patients.

12. Increased levels of lipid hydroperoxides in plasma of patients with multiple sclerosis: a relationship with paraoxonase activity.

13. A multidimensional assessment of multiple sclerosis: relationships between disability domains.

14. Risk factors for unprovoked epileptic seizures in multiple sclerosis: a systematic review and meta-analysis

15. Natalizumab therapy of multiple sclerosis: recommendations of the Multiple Sclerosis Study Group—Italian Neurological Society

16. Natalizumab in pediatric multiple sclerosis: results of a cohort of 55 cases

17. 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

18. Acute myeloid leukemia in Italian patients with multiple sclerosis treated with mitoxantrone

19. Natalizumab therapy of multiple sclerosis: recommendations of the Multiple Sclerosis Study Group-Italian Neurological Society

20. Clinical and Immunological Findings After Treatment with Thymostimulin in Multiple Sclerosis

21. Natalizumab treatment in multiple sclerosis patients: a multicenter experience in clinical practice in Italy

22. Phase III Dose-Comparison Study of Glatiramer Acetate for Multiple Sclerosis

23. Subcutaneous interferon β-1a may protect against cognitive impairment in patients with relapsing-remitting multiple sclerosis: 5-year follow-up of the COGIMUS study

24. Efficacy of Natalizumab and Fingolimod in Relapsing Remitting Multiple Sclerosis in Real World Clinical Setting

25. 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

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

27. 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

28. The Italian Surveillance Program on Natalizumab

29. Three years of experience : the Italian registry and safety data update

30. MxA mRNA Quantification and Disability Progression in Interferon Beta-Treated Multiple Sclerosis Patients

31. Immunity assessment in the early stages of amyotrophic lateral sclerosis: a study of virus antibodies and lymphocyte subsets

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31 results on '"Provinciali, L"'

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Select search scope, currently: Articles

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books, media & more in Jio Institute collections

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journal articles & other e-resources