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1. A Multicentric Prospective Incidence Study of Guillain-Barré Syndrome in Italy. The ITANG Study

Author

Benedetti, M, Pugliatti, M, Dalessandro, R, BEGHI, ETTORE, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Raschetti, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, AM, Borsato, C, Bortolotto, S, Bottacchi, EF, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, SI, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, AM, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, NA, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, FERRARESE, CARLO, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, DM, Passarella, B, Pavesi, G, Penza, MT, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, GM, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, MR, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., Benedetti, Md, Pugliatti, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Comi, Giancarlo, Raschetti, R, ITANG Study, Group, Giometto, B, Benedetti, M, Dalessandro, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, A, Borsato, C, Bortolotto, S, Bottacchi, E, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, S, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, A, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, N, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, D, Passarella, B, Pavesi, G, Penza, M, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, G, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, M, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, and Zoccolella, S

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Epidemiology, Population, Guillain-Barre Syndrome, Rate ratio, NO, Young Adult, Axonal and demyelinating GBS, Guillain-Barré syndrome, Incidence, Prospective study, Trend, Neurology (clinical), Aged, Aged, 80 and over, Female, Humans, Italy, Middle Aged, 80 and over, medicine, Young adult, education, Prospective cohort study, education.field_of_study, Guillain-Barre syndrome, business.industry, Medicine (all), Incidence (epidemiology), medicine.disease, Vaccination, Settore MED/26 - NEUROLOGIA, business, Human
Abstract

Background: To assess Guillain-Barré syndrome (GBS) incidence we relied on the Italian Network for the study of GBS (ITANG) established in 2010 in 7 Italian regions to analyse the association between influenza vaccination and GBS. Methods: All individuals aged ≥18 years, presenting with clinical manifestations that suggested GBS according to the universally accepted Asbury's diagnostic criteria (1990) were prospectively notified to a centralised database by ITANG neurologists over the period October 1, 2010-September 30, 2011. Through a telephone survey, 9 trained interviewers followed up the cases to diagnosis and then for 1 year since hospital discharge. Validation of case reporting was performed with the support of administrative data in 5 regions. Results: We found 365 cases fulfilling the definition for GBS or one of its variants over 19,846,068 population ≥18 years of age, yielding an annual incidence rate of 1.84 per 100,000 (95% CI 1.65-2.03), 2.30 (95% CI 1.99-2.60) in men and 1.41 (95% CI 1.18-1.64) in women. A highly significant peak of incidence was observed in February 2011 as compared to reference month (September 2011, rate ratio 3.3:1, p < 0.01). Conclusions: In Italy, GBS incidence was among the highest reported in Europe and higher than previously observed in Italian studies.

Published
2015

2. Physical activity and amyotrophic lateral sclerosis: A European population-based case-control study

Author

Pupillo, E, Messina, P, Giussani, G, Logroscino, G, Zoccolella, S, Chiò, A, Calvo, A, Corbo, M, Lunetta, C, Marin, B, Hardiman, O, Rooney, J, Stevic, Z, Bandettini Di Poggio, M, Filosto, M, Cotelli, M, Perini, M, Riva, N, Vitelli, E, Damiani, D, Beghi, E, Al Chalabi A, Chiò A, Hardiman O, Logroscino G, Ludolph A, Mitchell D, Preux PM, Swingler R, van den Berg L, Addison R, Alvisi E, Astegiano G, Bonito V, Bottacchi E, Buzzi P, Canosa A, Capozzo R, Caponnetto C, Cavallo R, Ceroni M, Chiveri L, Corti S, Couratier P, Delodovici L, Durelli L, Ferrarese C, Ferrero B, Fetoni V, Gallo S, Geda C, Ghiglione P, Gionco M, Guaita MC, Joyce G, Launaro N, Lynch C, Lorusso L, Maestri E, Magliola U, Marchet A, Mauro A, Mazzini L, Micheli A, Milicev M, Millul A, Montesano M, Padovani A, Palazzini E, Palermo M, Papurello D, Pastore I, Penza MT, Perrone P, Pisano F, Prelle A, Raineri M, Regio V, Rigamonti A, Sasanelli F, Secchi P, Smith J, Tavernelli F, Vergnano F, Villani A, Arbore G, Case N, Del Sordo N, Di Landro A, Leali N, Masini L, Matuonto V, Monticelli ML, Montini A, Palumbo M, Parati A, Pellegrino S, Sessa A, Severgnini E, Vertué G., TREMOLIZZO, LUCIO, Pupillo, E, Messina, P, Giussani, G, Logroscino, G, Zoccolella, S, Chiò, A, Calvo, A, Corbo, M, Lunetta, C, Marin, B, Hardiman, O, Rooney, J, Stevic, Z, Bandettini Di Poggio, M, Filosto, M, Cotelli, M, Perini, M, Riva, N, Tremolizzo, L, Vitelli, E, Damiani, D, Beghi, E, Al Chalabi, A, Ludolph, A, Mitchell, D, Preux, P, Swingler, R, van den Berg, L, Addison, R, Alvisi, E, Astegiano, G, Bonito, V, Bottacchi, E, Buzzi, P, Canosa, A, Capozzo, R, Caponnetto, C, Cavallo, R, Ceroni, M, Chiveri, L, Corti, S, Couratier, P, Delodovici, L, Durelli, L, Ferrarese, C, Ferrero, B, Fetoni, V, Gallo, S, Geda, C, Ghiglione, P, Gionco, M, Guaita, M, Joyce, G, Launaro, N, Lynch, C, Lorusso, L, Maestri, E, Magliola, U, Marchet, A, Mauro, A, Mazzini, L, Micheli, A, Milicev, M, Millul, A, Montesano, M, Padovani, A, Palazzini, E, Palermo, M, Papurello, D, Pastore, I, Penza, M, Perrone, P, Pisano, F, Prelle, A, Raineri, M, Regio, V, Rigamonti, A, Sasanelli, F, Secchi, P, Smith, J, Tavernelli, F, Vergnano, F, Villani, A, Arbore, G, Case, N, Del Sordo, N, Di Landro, A, Leali, N, Masini, L, Matuonto, V, Monticelli, M, Montini, A, Palumbo, M, Parati, A, Pellegrino, S, Sessa, A, Severgnini, E, and Vertué, G

Subjects
Adult, Aged, 80 and over, Male, MED/26 - NEUROLOGIA, Amyotrophic Lateral Sclerosis, Middle Aged, Motor Activity, Europe, Neurology, Case-Control Studies, Population Surveillance, Humans, Female, Neurology (clinical), Case-Control Studie, Exercise, Aged, Amyotrophic Lateral Sclerosi, Human
Abstract

Objective To assess whether physical activity is a risk factor for amyotrophic lateral sclerosis (ALS). Methods From February 2008 to April 2012, 652 patients with ALS from European population-based registries (France, Ireland, Italy, United Kingdom, Serbia) and 1,166 population controls (matched for age, sex, and residency) were assessed. Upon direct interview, data were collected on occupation and history of sport and leisure activities, physical activity, and accidental injuries. Physical exercise was defined as having spent time doing activities that caused an individual to breath hard at least once per month and was coded as none, job-related, and/or sport-related. Sport-related and work-related physical exercise were quantified using metabolic equivalents (METs). Risks were calculated using conditional logistic regression models (adjusting for age, country, trauma, and job-related physical activity) and expressed as odds ratios (ORs) and adjusted ORs (Adj ORs) with 95% confidence intervals (CIs). Results Overall physical activity was associated with reduced odds of having ALS (Adj OR = 0.65, 95% CI = 0.48-0.89) as were work-related physical activity (Adj OR = 0.56, 95% CI = 0.36-0.87) and organized sports (Adj OR = 0.49, 95% CI = 0.32-0.75). An inverse correlation was observed between ALS, the duration of physical activity (p = 0.0041), and the cumulative MET scores, which became significant for the highest exposure (Adj OR = 0.34, 95% CI = 0.21-0.54). An inverse correlation between ALS and sport was found in women but not in men, and in subjects with repeated traumatic events. Interpretation Physical activity is not a risk factor for ALS and may eventually be protective against the disease. © 2014 American Neurological Association

Published
2014

3. THE OPTIMIZATION OF INTERFERON FOR MS STUDY: 375 MICROG INTERFERON BETA-1B IN SUBOPTIMAL RESPONDERS

Author

Durelli L, Barbero P, Verdun E, Ferrero B, Clerico M, Ricci A, Cucci A, Contessa G, Rivoiro C, Ferrero C, Picco E, Ripellino P, Viglietti D, Bergui M, Zhong JJ, Versino E, Rottoli M, Moroni S, Teatini F, Schoenhuber R, Spissu A, Reggio A, Lo Fermo S, Liberto A, Perla F, Grasso E, Montanari E, Pesci I, Manneschi L, Ghezzi A, Zaffaroni M, Carolei A, Totaro R, Giuliani G, Pucci E, Cartechini E, Scarpini E, Clerici R, Protti A, Erminio C, Cotrufo R, Lus G, Bergamaschi R, Romani A, Bassano MA, Policreti A, Iudice A, Frittelli C, Motti L, Marcello N, Meola G, Robotti M, Cavallo R, Ravetti C, Deotto K., SAVETTIERI, Giovanni, SALEMI, Giuseppe, Durelli L, Barbero P, Verdun E, Ferrero B, Clerico M, Ricci A, Cucci A, Contessa G, Rivoiro C, Ferrero C, Picco E, Ripellino P, Viglietti D, Bergui M, Zhong JJ, Versino E, Rottoli M, Moroni S, Teatini F, Schoenhuber R, Spissu A, Reggio A, Lo Fermo S, Liberto A, Perla F, Grasso E, Montanari E, Pesci I, Manneschi L, Ghezzi A, Zaffaroni M, Carolei A, Totaro R, Giuliani G, Pucci E, Cartechini E, Scarpini E, Clerici R, Protti A, Erminio C, Cotrufo R, Lus G, Savettieri G, Salemi G, Bergamaschi R, Romani A, Bassano MA, Policreti A, Iudice A, Frittelli C, Motti L, Marcello N, Meola G, Robotti M, Cavallo R, Ravetti C, and Deotto K

Subjects
Adult, medicine.medical_specialty, Time Factors, Adolescent, Injections, Subcutaneous, suboptimal treatment response, Gastroenterology, Drug Administration Schedule, law.invention, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Randomized controlled trial, law, Internal medicine, medicine, Humans, Single-Blind Method, Prospective Studies, Adverse effect, Prospective cohort study, interferon beta (IFNβ), immunomodulatory drug, Subclinical infection, Dose-Response Relationship, Drug, business.industry, Interferon beta-1b, Interferon-beta, Middle Aged, Magnetic Resonance Imaging, Confidence interval, Surgery, Clinical trial, Treatment Outcome, Neurology, Relative risk, multiple sclerosi, MRI activity, Settore MED/26 - Neurologia, Neurology (clinical), business, Follow-Up Studies
Abstract

We aimed to evaluate the safety and MRI efficacy of interferon beta-1b (IFNbeta-1b) 375 microg (subcutaneously [sc] every other day [eod]) in relapsing-remitting multiple sclerosis (RRMS) patients with a suboptimal response to IFNbeta-1b 250 microg, i.e., with MRI activity or relapses. The OPTimization of Interferon for MS (OPTIMS) study was a prospective multicenter randomized phase 2 trial comprising a 6-month run-in phase (to identify suboptimal responders) and a 6-month randomized phase of open-label clinical and blinded MRI follow-up. During run-in all patients were treated with IFNbeta-1b 250 microg sc eod; during the study phase suboptimal treatment responders were randomized either to IFNbeta-1b 250 or 375 microg sc eod. Primary outcome was the proportion of patients without MRI activity during study Months 9-12 according to the intention-to-treat principle. 216 RRMS patients entered the study: 83 suboptimal responders were identified and randomized, 7 refused to continue treatment, 76 were included in the analysis. More patients treated with 375 microg had no MRI activity at Months 9-12 (30/36 vs.16/40; relative risk, 0.28; 95 % confidence interval, 0.08-0.47; p = 0.0001). Sensitivity analysis ("worst case scenario") confirmed the results. No new or unexpected adverse events were observed, but there was a trend towards more withdrawals in the 375 microg group. Increasing the dose of IFNbeta-1b from 250 microg to 375 microg is a successful strategy for reducing subclinical signs of disease activity in RRMS patients. Further studies are needed to show whether this dose may also improve clinical efficacy.

Published
2008

4. MRI activity and neutralising antibody as predictors of response to interferon beta treatment in multiple sclerosis

Author

DURELLI L, BARBERO P, BERGUI M, VERSINO E, BASSANO MA, VERDUN E, RIVOIRO C, FERRERO C, PICCO E, RIPELLINO P, GIULIANI G, MONTANARI E, CLERICO M, ITALIAN MULTIPLE SCLEROSIS STUDY GROUP DURELLI L, FERRERO B, PIPIERI A, RICCI A, CUCCI A, FESTA E, ROVERA A, TAVELLA A, CONTESSA G, DELFICO L, ZHONG JJ, ROTTOLI M, MORONI S, TEATINI F, SCHOENHUBER R, SPISSU A, REGGIO A, LO FERMO S, LIBERTO A, PERLA F, GRASSO E, PESCI I, MANNESCHI L, GHEZZI A, ZAFFARONI M, CAROLEI A, TOTARO R, PUCCI, Enzo, CARTECHINI E, SCARPINI E, CLERICI R, PROTTI A, ERMINIO C, COTRUFO R, LUS G, SAVETTIERI, Giovanni, SALEMI, Giuseppe, BERGAMASCHI R, ROMANI A, POLICRETI A, IUDICE A, FRITTELLI C, MOTTI L, MARCELLO N, MEOLA G, ROBOTTI M, CAVALLO R, RAVETTI C, DEOTTO L., DURELLI L, BARBERO P, BERGUI M, VERSINO E, BASSANO MA, VERDUN E, RIVOIRO C, FERRERO C, PICCO E, RIPELLINO P, GIULIANI G, MONTANARI E, CLERICO M, ITALIAN MULTIPLE SCLEROSIS STUDY GROUP DURELLI L, FERRERO B, PIPIERI A, RICCI A, CUCCI A, FESTA E, ROVERA A, TAVELLA A, CONTESSA G, DELFICO L, ZHONG JJ, ROTTOLI M, MORONI S, TEATINI F, SCHOENHUBER R, SPISSU A, REGGIO A, LO FERMO S, LIBERTO A, PERLA F, GRASSO E, PESCI I, MANNESCHI L, GHEZZI A, ZAFFARONI M, CAROLEI A, TOTARO R, PUCCI E, CARTECHINI E, SCARPINI E, CLERICI R, PROTTI A, ERMINIO C, COTRUFO R, LUS G, SAVETTIERI G, SALEMI G, BERGAMASCHI R, ROMANI A, POLICRETI A, IUDICE A, FRITTELLI C, MOTTI L, MARCELLO N, MEOLA G, ROBOTTI M, CAVALLO R, RAVETTI C, and DEOTTO L

Subjects
Male, Neutralising antibody, MULTICENTER, PLACEBO-CONTROLLED TRIAL, GUIDELINES, Gastroenterology, DOUBLE-BLIND, Interferon β, MAGNETIC-RESONANCE, Prospective Studies, Neurologic Examination, biology, Brain, IMPAIRMENT, Middle Aged, Predictive value, Magnetic Resonance Imaging, Recombinant Proteins, Psychiatry and Mental health, Treatment Outcome, Settore MED/26 - Neurologia, Female, Antibody, Interferon beta-1b, Adult, medicine.medical_specialty, DIAGNOSTIC-CRITERIA, Injections, Subcutaneous, Antibodies, Drug Administration Schedule, Disease activity, Multiple Sclerosis, Relapsing-Remitting, Adjuvants, Immunologic, Neutralization Tests, Internal medicine, medicine, Humans, Interferon beta, business.industry, Multiple sclerosis, DISABILITY, MS, Interferon-beta, medicine.disease, Confidence interval, Surgery, biology.protein, Neurology (clinical), business, Follow-Up Studies
Abstract

Objective: To prospectively validate MRI activity and neutralising anti-interferon antibody (NAb) during the first 6 months of interferon β treatment as response indicators in multiple sclerosis (MS). Methods: Patients with relapsing–remitting MS were followed during the first 2 years of treatment. Neurological assessments were performed every 3 months or when a relapse was suspected. MRI scans performed at baseline and at 3, 4, 5 and 6 months after the start of treatment were assessed centrally for disease activity: new T2 or gadolinium enhancing T1 lesions. NAb were assessed using the MxA protein assay; positivity was defined as two consecutive titres ⩾20 NU/ml. We evaluated the predictivity of an active scan, NAb positivity, or both, during the first 6 months of treatment, on the occurrence of clinical disease activity in the following 18 months. Results: 147 patients were assessed at 16 centres. Predictivity parameters (with confidence intervals) were as follows: active scan, sensitivity (SN) 52% (34–69%), specificity (SP) 80% (65–91%), negative predictive value (NPV) 73% (58–77%), positive predictive value (PPV) 62% (42–79%), p = 0.002; NAb positivity, SN 71% (45–88%), SP 66% (55–76%), NPV 92% (82–97%), PPV 29% (16–45%), p = 0.01; active scan and NAb positivity, SN 71% (38–91%), SP 86% (73–94%), NPV 94% (86–98%), PPV 50% (29–70%), p = 0.0003. Conclusions: MRI activity and NAb occurrence during the first 6 months of interferon β treatment were reliable predictors of long term clinical response, particularly when combined. Patients with negative predictors showed a less than 10% risk of developing clinical activity. Patients with positive predictors showed a 50% risk of further clinical activity. These patients need to be followed carefully with further MRI and NAb tests.

Published
2008

5. Neutralizing antibodies in multiple sclerosis patients treated with 375 μg interferon-β-1b

Author

Durelli, L, Barbero, P, Cucci, A, Ferrero, B, Ricci, A, Contessa, G, DE MERCANTI, S, Ripellino, P, Lapuma, D, Viglietta, E, Bergui, M, Versino, E, Clerico, M, FOR THE OPTIMS TRIAL SUB STUDY GROUP, and Carolei, Antonio

Subjects
Adult, Male, Treatment response, Adolescent, Clinical Biochemistry, multiple sclerosis, Neutralization, Drug Administration Schedule, 375 μg IFN-β-1b dose, IFN-β, neutralizing antibodies, OPTIMS study, treatment response, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Interferon, Neutralization Tests, Multicenter trial, Drug Discovery, medicine, Humans, Prospective Studies, Neutralizing antibody, Pharmacology, biology, business.industry, Multiple sclerosis, Interferon-beta, Middle Aged, medicine.disease, Antibodies, Neutralizing, Interferon β 1b, Cross-Sectional Studies, Immunology, biology.protein, Female, Antibody, business, medicine.drug, Follow-Up Studies, Interferon beta-1b
Abstract

Neutralizing antibodies (NAbs) to IFN-beta may have a detrimental effect on treatment response, but increasing IFN-beta dose could reduce their occurrence. The OPTimization of Interferon for MS (OPTIMS) study was a multicenter trial investigating clinical and MRI outcomes with the approved IFN-beta-1b dose (250 microg) and a higher dose (375 microg), s.c. every other day.To analyze the occurrence of NAbs and their effect on clinical and MRI response over a long-term (4-year) follow-up using cross-sectional and longitudinal statistical analysis.Relapses or disease progression was assessed open-label and MRI scans were performed serially during the first year of the study. Neutralizing antibodies were measured using the MxA protein production neutralization assay.A total of 145 patients with relapsing-remitting multiple sclerosis from 14 centers participated in the study. Neutralizing antibody frequency was negatively associated with MRI treatment response, but no detrimental effect of NAbs on the clinical response was observed. Results obtained using cross-sectional or longitudinal statistical approaches were similar. Over the 4-year period, NAb-positive patients treated with 375 microg had a significantly greater probability of NAb disappearance (hazard ratio: 3.41; 95% confidence interval: 1.78 - 6.43; p0.01).Use of an IFN-beta-1b dose higher than the currently approved 250-microg dose is associated with an increased probability of NAb disappearance. The OPTIMS study was registered at ClinicalTrials.gov: NCT00473213.

Published
2009

6. Autoantibodies in multiple sclerosis patients before and during IFN-beta 1b treatment: are they correlated with the occurrence of autoimmune diseases?

Author

Verdun, E, Giuliani, F, Salvi, F, Stecchi, S, Reggio, A, Reggio, E, Montanari, E, Negri, G, Ludovico, L, Ghezzi, A, Zaffaroni, M, Isoardo, G, Mancardi, GIOVANNI LUIGI, Inglese, MARIA MATILDE, Carolei, A, Totaro, R, Milanese, C, La Mantia, L, Caputo, D, Mini, M, Mendozzi, L, Cotrufo, R, Oggero, A, Lus, G, Cosi, V, Romani, A, Gallai, V, Sarchielli, P, Nocentini, U, Rizzato, B, Tonali, P. A, Massaro, A. R, Rosati, G, Ferrero, B, Sotgiu, S, Annunziata, P, Barbero, P, Pipieri, A, Ricci, A, Clerico, M, Bosio, A, Cucci, M. A, Aimo, G, Giorda, L, Bortolon, F, Stenta, G, Sormani, MARIA PIA, Ecari, U, Ciampini, M, Beckmann, K, Durelli, L, and Trojano, M.

Subjects
Adult, Male, Multiple Sclerosis, Adolescent, Adjuvants, Immunologic, Age of Onset, Autoantibodies, Autoimmune Diseases, Female, Follow-Up Studies, Humans, Interferon-beta, Liver Diseases, Longitudinal Studies, Middle Aged, Prospective Studies, Recombinant Proteins, Reference Values, Immunology, Virology, Cell Biology, medicine.disease_cause, Autoimmunity, Immunologic, medicine, Adjuvants, business.industry, Multiple sclerosis, Thyroid, Interferon beta-1b, Autoantibody, Interferon beta-1a, medicine.disease, medicine.anatomical_structure, Settore MED/26 - Neurologia, Liver function, Thyroid function, business, medicine.drug
Abstract

Autoimmune side effects, namely autoantibody (autoAb) occurrence and thyroid function alteration, have been described during interferon-beta (IFN-beta) treatment for multiple sclerosis (MS). AutoAb occurrence and autoimmune thyroid diseases are also frequently detected in MS patients free of any treatment. The aim of this study was to evaluate the relationship between IFN-beta 1b treatment, autoAb occurrence, and autoimmune diseases in MS. Thyroid and liver function and serum autoAb (antithyroid, antinuclear, anti-liver, anti-kidney microsomes, anti-smooth muscle and parietal cell antigens) occurrence were evaluated in 156 relapsing-remitting MS (RRMS) patients before and every 3 months after starting IFN-beta 1b treatment (8 MIU subcutaneously [s.c.] on alternate days). The probability of having liver or thyroid function alteration or autoAb occurrence was analyzed longitudinally with the generalized estimating equations (GEE) approach. At baseline, 16.1% of patients had autoAb. During treatment, autoAb occurred de novo in 7.2% of patients. GEE analysis showed that the probability of having autoAb at any time during IFN-beta 1b treatment did not change significantly compared with baseline. AutoAb occurring de novo rarely persisted during treatment and significantly less than those already present at baseline. Positivity for autoAb at baseline or during treatment was not correlated with the development of thyroid or liver function alteration during IFN-beta 1b treatment. Our study indicates that IFN-beta treatment is a safe treatment for MS patients, free of risk of autoimmunity and of associated liver or thyroid function alteration.

Published
2002

7. Liver and thyroid function and autoimmunity during interferon-beta 1b treatment for MS

Author

Durelli, L, Ferrero, B, Oggero, A, Verdun, E, Ghezzi, A, Montanari, E, Zaffaroni, M, and Nocentini, U

Subjects
Adult, Male, Multiple Sclerosis, Adolescent, Thyroid Gland, Thyrotropin, Interferon-beta, Thyroid Function Tests, Middle Aged, Hyperthyroidism, Humans, Adjuvants, Immunologic, Liver Function Tests, Longitudinal Studies, Prospective Studies, Autoantibodies, Liver, Hypothyroidism, Female, Immunologic, Settore MED/26 - Neurologia, Adjuvants
Published
2001

8. Thyroid function and autoimmunity during interferon beta-1b treatment. A multicenter prospective study

Author

Durelli, L, Ferrero, B, Oggero, A, Verdun, E, Ghezzi, A, Montanari, E, Zaffaroni, M, and Nocentini, U

Subjects
Adult, Male, Reference Values, Recombinant Proteins, Humans, Thyroid Function Tests, Interferon-beta, Aged, Triiodothyronine, Thyroid Gland, Liver Function Tests, Longitudinal Studies, Thyrotropin, Italy, Multiple Sclerosis, Autoantibodies, Aged, 80 and over, Thyroxine, Middle Aged, Adolescent, Time Factors, Thyroid Diseases, Female, 80 and over, Settore MED/26 - Neurologia
Published
2001

9. Liver and thyroid function and autoimmunity during interferon-b1b treatment for MS

Author

Durelli, L, Ferrero, B, Oggero, A, Verdun, E, Ghezzi, A, Montanari, E, Zaffaroni, M, AND THE BETAFERON SAFETY TRIAL BEST STUDY GROUP, and Carolei, Antonio

Subjects
Adult, Male, medicine.medical_specialty, Multiple Sclerosis, Adolescent, Adjuvants, Immunologic, Autoantibodies, Female, Humans, Hyperthyroidism, Hypothyroidism, Interferon-beta, Liver, Liver Function Tests, Longitudinal Studies, Middle Aged, Prospective Studies, Thyroid Function Tests, Thyroid Gland, Thyrotropin, Thyroid function tests, Gastroenterology, Immunologic, Internal medicine, medicine, Adjuvants, medicine.diagnostic_test, business.industry, Interferon beta-1b, Thyroid, Interferon beta-1a, medicine.anatomical_structure, Immunology, Neurology (clinical), Liver function, Thyroid function, Liver function tests, business, medicine.drug, Hormone
Abstract

The occurrence or recurrence of autoimmune diseases or of autoantibodies (autoAb) has been reported during type I interferon (IFN) treatment.To define the frequency of thyroid and liver dysfunction and of autoimmunity during IFN-beta 1b (IFNB) treatment of MS.Prospective 1-year multicenter follow-up of 156 patients with MS recruited by 18 centers was conducted. Thyroid-stimulating hormone and anti-thyroid autoAb were measured by an immunoradiometric method, thyroid hormones by chromatographic assay, and non-organ-specific autoAb by indirect immunofluorescence. Tests were repeated every 3 months. The probability of having liver, thyroid, or autoAb alterations was analyzed longitudinally with the generalized estimating equations (GEE) method.Thyroid dysfunction was observed in 5.3% of cases at baseline and 8.3% de novo during IFNB treatment. GEE analysis showed that the probability of having thyroid alteration did not change significantly during treatment compared with baseline. Liver alteration was observed in 4.6% of cases at baseline and 37.5% de novo during IFNB treatment (p0.0001). GEE analysis showed that the probability of having liver alteration was higher (p0.002) at months 3 and 6 compared with baseline, returning to values similar to baseline by month 9. AutoAb were detected in 16.1% of patients at baseline and in 20% during IFNB. GEE analysis showed that the probability of having autoAb did not change significantly during treatment compared with baseline. Thyroid or liver alteration or autoAb occurring de novo during IFNB were usually transient.Differently from the frequency of liver function alteration (which significantly increased during the first months of IFNB treatment, suggesting a probable causal relationship with IFNB), the frequency of thyroid dysfunction or of autoimmunity showed random and insignificant changes over time, probably not related to IFNB treatment.

Published
2001

10. Interferon alpha treatment of relapsing-remitting multiple sclerosis: long-term study of the correlations between clinical and magnetic resonance imaging results and effects on the immune function

Author

Durelli L, Bongioanni MR, Rossana CAVALLO, Ferrero B, Ferri R, Verdun E, Gb, Bradac, Riva A, Geuna M, and Bergamini L

Subjects
Adult, Male, Multiple Sclerosis, Adolescent, Tumor Necrosis Factor-alpha, Interferon-alpha, Antineoplastic Agents, Middle Aged, Magnetic Resonance Imaging, Interferon-gamma, Recurrence, Immune System, Humans, Female, Longitudinal Studies, Lymphocytes, Cells, Cultured
Abstract

Interferon gamma (IFN-gamma) and tumor necrosis factor alpha (TNF-alpha) are proinflammatory cytokines which may be involved in the pathogenesis of MS. IFN-alpha counteracts many of the proinflammatory actions of IFN-gamma and TNF-alpha. We treated 20 patients with relapsing-remitting (RR) MS with 9 MIU of recombinant IFN-alpha-2a (rIFN-alpha) (n = 12) or placebo (n = 8) intramuscularly every other day for 6 months. Clinical exacerbations or new or enlarging lesions at serial MRI occurred in 2/12 rIFN-alpha-treated and in 7/8 placebo-treated patients (P0.005). Only one new MRI lesion was detected in the rIFN-alpha group, while 27 new or enlarging lesions were detected in placebo group (P0.01). Baseline lymphocyte IFN-gamma (19.10 +/- 7.12 U ml-1) and TNF-alpha (18.05 +/- 5.34 pg ml-1) production significantly decreased to 3.03 +/- 0.66 (P0.04) (for IFN-gamma) and to 5.78 +/- 0.90 (P0.04) (for TNF-alpha) after rIFN-alpha treatment. IFN-gamma and TNF-alpha production was unchanged in the placebo group. rIFN-alpha was tolerated without drop-outs or serious side-effects, but fever, malaise, fatigue (interfering with daily activities in two patients) and leukopenia frequently occurred. High-dose chronic systemic rIFN-alpha might reduce clinical and MRI signs of disease activity in RRMS. The changes in cytokine production suggest that the effect is probably mediated by a down-regulation of proinflammatory cytokine.

Published
1995

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