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  1. Article ; Online: Important role of oxidative stress biomarkers in Huntington's disease.

    Túnez, Isaac / Sánchez-López, Fernando / Agüera, Eduardo / Fernández-Bolaños, Ricardo / Sánchez, Francisco Manuel / Tasset-Cuevas, Inmaculada

    Journal of medicinal chemistry

    2011  Volume 54, Issue 15, Page(s) 5602–5606

    Abstract: This study examined global oxidative stress (GOS) and antioxidant system and their correlation with disease stage in 19 patients with HD. The results revealed an increase in oxidative stress biomarkers and a reduction in antioxidant systems in HD ... ...

    Abstract This study examined global oxidative stress (GOS) and antioxidant system and their correlation with disease stage in 19 patients with HD. The results revealed an increase in oxidative stress biomarkers and a reduction in antioxidant systems in HD patients. The effects were more intense in HD1 than in HD2 patients. Additionally, carbonylated proteins and GOS were correlated with disease stage. These findings suggest that oxidative stress plays an important role in the pathogenesis of HD.
    MeSH term(s) Adult ; Antioxidants/metabolism ; Biomarkers/metabolism ; Female ; Humans ; Huntington Disease/metabolism ; Huntington Disease/pathology ; Male ; Middle Aged ; Oxidative Stress ; Protein Carbonylation
    Chemical Substances Antioxidants ; Biomarkers
    Language English
    Publishing date 2011-08-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 218133-2
    ISSN 1520-4804 ; 0022-2623
    ISSN (online) 1520-4804
    ISSN 0022-2623
    DOI 10.1021/jm200605a
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  2. Article ; Online: NGF and nitrosative stress in patients with Huntington's disease.

    Tasset, Inmaculada / Sánchez-López, Fernando / Agüera, Eduardo / Fernández-Bolaños, Ricardo / Sánchez, Francisco Manuel / Cruz-Guerrero, Antonio / Gascón-Luna, Felix / Túnez, Isaac

    Journal of the neurological sciences

    2012  Volume 315, Issue 1-2, Page(s) 133–136

    Abstract: Introduction: Huntington's disease (HD) is a neurodegenerative genetic disorder caused by expansion of polyglutamine repeats in the huntingtin gene and characterised by the loss of striatal and cortical neurons. Few studies to date have focussed on ... ...

    Abstract Introduction: Huntington's disease (HD) is a neurodegenerative genetic disorder caused by expansion of polyglutamine repeats in the huntingtin gene and characterised by the loss of striatal and cortical neurons. Few studies to date have focussed on peripheral neurotrophic-factor levels in patients with HD.
    Objective: To measure plasma NGF levels in Huntington's disease and investigate their correlation with disease intensity.
    Materials and methods: Nineteen patients with HD and nineteen age- and sex-matched healthy subjects took part in this cross-sectional study. Plasma levels of NGF, BDNF, GDNF, nitrotyrosine, and myeloperoxidase (MPO) were measured; lactate dehydrogenase (LDH) levels were determined and white blood cell (WBC) counts were evaluated.
    Results: NGF levels were significantly lower, nitrotyrosine levels were higher and LDH activity was greater in HD patients than in healthy subjects. There was no significant difference in MPO levels or WBC counts, whereas the MPO/WBC ratio was considerably higher in HD patients. The data obtained suggested that biochemical and haematological changes correlated with disease severity.
    Conclusion: NGF levels are lower in HD patients than in healthy subjects. However, further research is required to confirm the role of NGF in HD.
    MeSH term(s) Adult ; Biomarkers/blood ; Female ; Humans ; Huntington Disease/blood ; Huntington Disease/diagnosis ; Male ; Middle Aged ; Nerve Growth Factor/blood ; Nitrosation/physiology ; Severity of Illness Index ; Tyrosine/analogs & derivatives ; Tyrosine/blood ; Young Adult
    Chemical Substances Biomarkers ; NGF protein, human ; 3-nitrotyrosine (3604-79-3) ; Tyrosine (42HK56048U) ; Nerve Growth Factor (9061-61-4)
    Language English
    Publishing date 2012-04-15
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 80160-4
    ISSN 1878-5883 ; 0022-510X ; 0374-8642
    ISSN (online) 1878-5883
    ISSN 0022-510X ; 0374-8642
    DOI 10.1016/j.jns.2011.12.014
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  3. Article ; Online: Oxidative stress and inflammation biomarkers in the blood of patients with Huntington's disease.

    Sánchez-López, Fernando / Tasset, Inmaculada / Agüera, Eduardo / Feijóo, Montserrat / Fernández-Bolaños, Ricardo / Sánchez, Francisco M / Ruiz, María C / Cruz, Antonio H / Gascón, Félix / Túnez, Isaac

    Neurological research

    2012  Volume 34, Issue 7, Page(s) 721–724

    Abstract: Objectives: Huntington's disease (HD) is a neurodegenerative disorder for which there is no effective treatment. Oxidative stress and inflammation are known to be involved in HD, but the precise relationship between the two remains unclear. The aim of ... ...

    Abstract Objectives: Huntington's disease (HD) is a neurodegenerative disorder for which there is no effective treatment. Oxidative stress and inflammation are known to be involved in HD, but the precise relationship between the two remains unclear. The aim of this study was to analyze oxidative stress and inflammation biomarkers in blood of patients with HD with a view to identifying potential links between them.
    Methods: Blood samples were collected from 13 patients with HD and from 10 age- and sex-matched controls, and the following were measured: C-reactive proteins, myeloperoxidase (MPO)/white blood cell (WBC) ratio, interleukin-6 (IL-6), thioredoxin reductase-1 (TrRd-1), thioredoxin-1 (Trx-1), total nitrites (NOx), nitric oxide synthase (NOS) and nitrotyrosine.
    Results: Results showed that HD is associated to a reduction of TrRd-1 and Trx-1 levels in plasma and erythrocytes, and with an increase in the MPO/WBC ratio. A positive correlation was observed between global oxidative stress (GOS) and MPO/WBC. No changes were found in NOS and Nox levels with respect to controls.
    Conclusion: Oxidative damage may be linked to the inflammatory response in HD, via a peripheral immune response.
    MeSH term(s) Adult ; Biomarkers/blood ; Female ; Humans ; Huntington Disease/blood ; Huntington Disease/pathology ; Huntington Disease/physiopathology ; Inflammation/blood ; Inflammation/diagnosis ; Inflammation/pathology ; Inflammation/physiopathology ; Inflammation Mediators/blood ; Male ; Middle Aged ; Oxidative Stress/physiology
    Chemical Substances Biomarkers ; Inflammation Mediators
    Language English
    Publishing date 2012-09
    Publishing country England
    Document type Journal Article ; Multicenter Study
    ZDB-ID 424428-x
    ISSN 1743-1328 ; 0161-6412
    ISSN (online) 1743-1328
    ISSN 0161-6412
    DOI 10.1179/1743132812Y.0000000073
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  4. Article: Electrolytes disturbances and seizures.

    Castilla-Guerra, Luis / del Carmen Fernández-Moreno, María / López-Chozas, José Manuel / Fernández-Bolaños, Ricardo

    Epilepsia

    2006  Volume 47, Issue 12, Page(s) 1990–1998

    MeSH term(s) Anticonvulsants/pharmacology ; Anticonvulsants/therapeutic use ; Brain/physiopathology ; Electroencephalography/statistics & numerical data ; Electrolytes/blood ; Humans ; Hypercalcemia/blood ; Hypercalcemia/drug therapy ; Hypercalcemia/physiopathology ; Hypernatremia/blood ; Hypernatremia/drug therapy ; Hypernatremia/physiopathology ; Hypocalcemia/blood ; Hypocalcemia/drug therapy ; Hypocalcemia/physiopathology ; Hyponatremia/blood ; Hyponatremia/drug therapy ; Hyponatremia/physiopathology ; Magnesium/blood ; Magnesium/physiology ; Male ; Middle Aged ; Potassium/blood ; Potassium/physiology ; Seizures/blood ; Seizures/diagnosis ; Seizures/physiopathology ; Water-Electrolyte Balance/drug effects ; Water-Electrolyte Balance/physiology ; Water-Electrolyte Imbalance/blood ; Water-Electrolyte Imbalance/drug therapy ; Water-Electrolyte Imbalance/physiopathology
    Chemical Substances Anticonvulsants ; Electrolytes ; Magnesium (I38ZP9992A) ; Potassium (RWP5GA015D)
    Language English
    Publishing date 2006-12
    Publishing country United States
    Document type Case Reports ; Journal Article ; Review
    ZDB-ID 216382-2
    ISSN 1528-1167 ; 0013-9580
    ISSN (online) 1528-1167
    ISSN 0013-9580
    DOI 10.1111/j.1528-1167.2006.00861.x
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    Zs.MO 475: Show issues

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  5. Article ; Online: Prognostic indicators in pediatric clinically isolated syndrome.

    Iaffaldano, Pietro / Simone, Marta / Lucisano, Giuseppe / Ghezzi, Angelo / Coniglio, Gabriella / Brescia Morra, Vincenzo / Salemi, Giuseppe / Patti, Francesco / Lugaresi, Alessandra / Izquierdo, Guillermo / Bergamaschi, Roberto / Cabrera-Gomez, Jose Antonio / Pozzilli, Carlo / Millefiorini, Enrico / Alroughani, Raed / Boz, Cavit / Pucci, Eugenio / Zimatore, Giovanni Bosco / Sola, Patrizia /
    Lus, Giacomo / Maimone, Davide / Avolio, Carlo / Cocco, Eleonora / Sajedi, Seyed Aidin / Costantino, Gianfranco / Duquette, Pierre / Shaygannejad, Vahid / Petersen, Thor / Fernández Bolaños, Ricardo / Paolicelli, Damiano / Tortorella, Carla / Spelman, Tim / Margari, Lucia / Amato, Maria Pia / Comi, Giancarlo / Butzkueven, Helmut / Trojano, Maria

    Annals of neurology

    2017  Volume 81, Issue 5, Page(s) 729–739

    Abstract: Objective: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients.: Methods: A cohort of 770 pCIS patients was ... ...

    Abstract Objective: To assess prognostic factors for a second clinical attack and a first disability-worsening event in pediatric clinically isolated syndrome (pCIS) suggestive of multiple sclerosis (MS) patients.
    Methods: A cohort of 770 pCIS patients was followed up for at least 10 years. Cox proportional hazard models and Recursive Partitioning and Amalgamation (RECPAM) tree-regression were used to analyze data.
    Results: In pCIS, female sex and a multifocal onset were risk factors for a second clinical attack (hazard ratio [HR], 95% confidence interval [CI] = 1.28, 1.06-1.55; 1.42, 1.10-1.84, respectively), whereas disease-modifying drug (DMD) exposure reduced this risk (HR, 95% CI = 0.75, 0.60-0.95). After pediatric onset MS (POMS) diagnosis, age at onset younger than 15 years and DMD exposure decreased the risk of a first Expanded Disability Status Scale (EDSS)-worsening event (HR, 95% CI = 0.59, 0.42-0.83; 0.75, 0.71-0.80, respectively), whereas the occurrence of relapse increased this risk (HR, 95% CI = 5.08, 3.46-7.46). An exploratory RECPAM analysis highlighted a significantly higher incidence of a first EDSS-worsening event in patients with multifocal or isolated spinal cord or optic neuritis involvement at onset in comparison to those with an isolated supratentorial or brainstem syndrome. A Cox regression model including RECPAM classes confirmed DMD exposure as the most protective factor against EDSS-worsening events and relapses as the most important risk factor for attaining EDSS worsening.
    Interpretation: This work represents a step forward in identifying predictors of unfavorable course in pCIS and POMS and supports a protective effect of early DMD treatment in preventing MS development and disability accumulation in this population. Ann Neurol 2017;81:729-739.
    MeSH term(s) Adolescent ; Age of Onset ; Child ; Demyelinating Diseases/diagnosis ; Demyelinating Diseases/diagnostic imaging ; Demyelinating Diseases/physiopathology ; Disease Progression ; Female ; Follow-Up Studies ; Humans ; Male ; Multiple Sclerosis/diagnosis ; Multiple Sclerosis/diagnostic imaging ; Multiple Sclerosis/physiopathology ; Prognosis ; Registries ; Retrospective Studies ; Risk Factors
    Language English
    Publishing date 2017-05
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Observational Study
    ZDB-ID 80362-5
    ISSN 1531-8249 ; 0364-5134
    ISSN (online) 1531-8249
    ISSN 0364-5134
    DOI 10.1002/ana.24938
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  6. Article ; Online: Comparison of switch to fingolimod or interferon beta/glatiramer acetate in active multiple sclerosis.

    He, Anna / Spelman, Tim / Jokubaitis, Vilija / Havrdova, Eva / Horakova, Dana / Trojano, Maria / Lugaresi, Alessandra / Izquierdo, Guillermo / Grammond, Pierre / Duquette, Pierre / Girard, Marc / Pucci, Eugenio / Iuliano, Gerardo / Alroughani, Raed / Oreja-Guevara, Celia / Fernandez-Bolaños, Ricardo / Grand'Maison, Francois / Sola, Patrizia / Spitaleri, Daniele /
    Granella, Franco / Terzi, Murat / Lechner-Scott, Jeannette / Van Pesch, Vincent / Hupperts, Raymond / Sánchez-Menoyo, José Luis / Hodgkinson, Suzanne / Rozsa, Csilla / Verheul, Freek / Butzkueven, Helmut / Kalincik, Tomas

    JAMA neurology

    2015  Volume 72, Issue 4, Page(s) 405–413

    Abstract: Importance: After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch decisions is often uncertain.: Objective: ...

    Abstract Importance: After multiple sclerosis (MS) relapse while a patient is receiving an injectable disease-modifying drug, many physicians advocate therapy switch, but the relative effectiveness of different switch decisions is often uncertain.
    Objective: To compare the effect of the oral immunomodulator fingolimod with that of all injectable immunomodulators (interferons or glatiramer acetate) on relapse rate, disability, and treatment persistence in patients with active MS.
    Design, setting, and participants: Matched retrospective analysis of data collected prospectively from MSBase, an international, observational cohort study. The MSBase cohort represents a population of patients with MS monitored at large MS centers. The analyzed data were collected between July 1996 and April 2014. Participants included patients with relapsing-remitting MS who were switching therapy to fingolimod or injectable immunomodulators up to 12 months after on-treatment clinical disease activity (relapse or progression of disability), matched on demographic and clinical variables. Median follow-up duration was 13.1 months (range, 3-80). Indication and attrition bias were controlled with propensity score matching and pairwise censoring, respectively. Head-to-head analyses of relapse and disability outcomes used paired, weighted, negative binomial models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity analyses were conducted.
    Exposures: Patients had received fingolimod, interferon beta, or glatiramer acetate for a minimum of 3 months following a switch of immunomodulatory therapy.
    Main outcomes and measures: Annualized relapse rate and proportion of relapse-free patients, as well as the proportion of patients without sustained disability progression.
    Results: Overall, 379 patients in the injectable group were matched to 148 patients in the fingolimod group. The fingolimod group had a lower mean annualized relapse rate (0.31 vs 0.42; 95% CI, 0.02-0.19; P=.009), lower hazard of first on-treatment relapse (hazard ratio [HR], 0.74; 95% CI, 0.56-0.98; P=.04), lower hazard of disability progression (HR, 0.53; 95% CI, 0.31-0.91; P=.02), higher rate of disability regression (HR, 2.0; 95% CI, 1.2-3.3; P=.005), and lower hazard of treatment discontinuation (HR, 0.55; P=.04) compared with the injectable group.
    Conclusions and relevance: Switching from injectable immunomodulators to fingolimod is associated with fewer relapses, more favorable disability outcomes, and greater treatment persistence compared with switching to another injectable preparation following on-treatment activity of MS.
    MeSH term(s) Adult ; Cohort Studies ; Female ; Fingolimod Hydrochloride ; Humans ; Immunologic Factors/administration & dosage ; Immunologic Factors/therapeutic use ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/therapeutic use ; Interferon-beta/administration & dosage ; Interferon-beta/therapeutic use ; Magnetic Resonance Imaging/methods ; Male ; Multiple Sclerosis/drug therapy ; Propylene Glycols/administration & dosage ; Propylene Glycols/therapeutic use ; Retrospective Studies ; Sphingosine/administration & dosage ; Sphingosine/analogs & derivatives ; Sphingosine/therapeutic use ; Treatment Outcome
    Chemical Substances Immunologic Factors ; Immunosuppressive Agents ; Propylene Glycols ; Interferon-beta (77238-31-4) ; Fingolimod Hydrochloride (G926EC510T) ; Sphingosine (NGZ37HRE42)
    Language English
    Publishing date 2015-04
    Publishing country United States
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2702023-X
    ISSN 2168-6157 ; 2168-6149
    ISSN (online) 2168-6157
    ISSN 2168-6149
    DOI 10.1001/jamaneurol.2014.4147
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  7. Article ; Online: Comparative effectiveness of glatiramer acetate and interferon beta formulations in relapsing-remitting multiple sclerosis.

    Kalincik, Tomas / Jokubaitis, Vilija / Izquierdo, Guillermo / Duquette, Pierre / Girard, Marc / Grammond, Pierre / Lugaresi, Alessandra / Oreja-Guevara, Celia / Bergamaschi, Roberto / Hupperts, Raymond / Grand'Maison, Francois / Pucci, Eugenio / Van Pesch, Vincent / Boz, Cavit / Iuliano, Gerardo / Fernandez-Bolanos, Ricardo / Flechter, Shlomo / Spitaleri, Daniele / Cristiano, Edgardo /
    Verheul, Freek / Lechner-Scott, Jeannette / Amato, Maria Pia / Cabrera-Gomez, Jose Antonio / Saladino, Maria Laura / Slee, Mark / Moore, Fraser / Gray, Orla / Paine, Mark / Barnett, Michael / Havrdova, Eva / Horakova, Dana / Spelman, Timothy / Trojano, Maria / Butzkueven, Helmut

    Multiple sclerosis (Houndmills, Basingstoke, England)

    2015  Volume 21, Issue 9, Page(s) 1159–1171

    Abstract: Background: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed.: Objective: We aimed to compare, in a real- ... ...

    Abstract Background: The results of head-to-head comparisons of injectable immunomodulators (interferon β, glatiramer acetate) have been inconclusive and a comprehensive analysis of their effectiveness is needed.
    Objective: We aimed to compare, in a real-world setting, relapse and disability outcomes among patients with multiple sclerosis (MS) treated with injectable immunomodulators.
    Methods: Pairwise analysis of the international MSBase registry data was conducted using propensity-score matching. The four injectable immunomodulators were compared in six head-to-head analyses of relapse and disability outcomes using paired mixed models or frailty proportional hazards models adjusted for magnetic resonance imaging variables. Sensitivity and power analyses were conducted.
    Results: Of the 3326 included patients, 345-1199 patients per therapy were matched (median pairwise-censored follow-up was 3.7 years). Propensity matching eliminated >95% of the identified indication bias. Slightly lower relapse incidence was found among patients treated with glatiramer acetate or subcutaneous interferon β-1a relative to intramuscular interferon β-1a and interferon β-1b (p≤0.001). No differences in 12-month confirmed progression of disability were observed.
    Conclusion: Small but statistically significant differences in relapse outcomes exist among the injectable immunomodulators. MSBase is sufficiently powered to identify these differences and reflects practice in tertiary MS centres. While the present study controlled indication, selection and attrition bias, centre-dependent variance in data quality was likely.
    MeSH term(s) Glatiramer Acetate/therapeutic use ; Humans ; Immunologic Factors/therapeutic use ; Interferon-beta/therapeutic use ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Registries ; Treatment Outcome
    Chemical Substances Immunologic Factors ; Glatiramer Acetate (5M691HL4BO) ; Interferon-beta (77238-31-4)
    Language English
    Publishing date 2015-08
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1290669-4
    ISSN 1477-0970 ; 1352-4585
    ISSN (online) 1477-0970
    ISSN 1352-4585
    DOI 10.1177/1352458514559865
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  8. Article: Predictors of disability worsening in clinically isolated syndrome.

    Jokubaitis, Vilija G / Spelman, Tim / Kalincik, Tomas / Izquierdo, Guillermo / Grand'Maison, François / Duquette, Pierre / Girard, Marc / Lugaresi, Alessandra / Grammond, Pierre / Hupperts, Raymond / Cabrera-Gomez, José / Oreja-Guevara, Celia / Boz, Cavit / Giuliani, Giorgio / Fernández-Bolaños, Ricardo / Iuliano, Gerardo / Lechner-Scott, Jeannette / Verheul, Freek / van Pesch, Vincent /
    Petkovska-Boskova, Tatjana / Fiol, Marcela / Moore, Fraser / Cristiano, Edgardo / Alroughani, Raed / Bergamaschi, Roberto / Barnett, Michael / Slee, Mark / Vella, Norbert / Herbert, Joseph / Shaw, Cameron / Saladino, Maria Laura / Amato, Maria Pia / Liew, Danny / Paolicelli, Damiano / Butzkueven, Helmut / Trojano, Maria

    Annals of clinical and translational neurology

    2015  Volume 2, Issue 5, Page(s) 479–491

    Abstract: Objective: To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS).: Methods: We ... ...

    Abstract Objective: To assess demographic, clinical, magnetic resonance imaging, and treatment exposure predictors of time to 3 or 12-month confirmed disability worsening in clinically isolated syndrome (CIS) and early multiple sclerosis (MS).
    Methods: We utilized the MSBase Incident Study (MSBasis), a prospective cohort study of outcome after CIS. Predictors of time to first 3 and 12-month confirmed expanded disability status scale worsening were analyzed using Cox proportional hazards regression.
    Results: About 1989 patients were analyzed, the largest seen-from-onset cohort reported to-date. A total of 391 patients had a first 3-month confirmed disability worsening event, of which 307 were sustained for 12 months. Older age at CIS onset (adjusted hazard ratio: aHR 1.17, 95% 1.06, 1.30), pyramidal (aHR 1.45, 95% CI 1.13, 1.89) and ambulation (HR 1.60, 95% CI 1.09, 2.34) system dysfunction, annualized relapse rate (aHR 1.20, 95% CI 1.18, 1.22), and lower proportion of observation time on treatment were associated with 3-month confirmed worsening. Predictors of time to 12-month sustained worsening included pyramidal system dysfunction (Hazard ratio: aHR 1.38, 95% CI 1.05, 1.83), and older age at CIS onset (aHR 1.17, 95% CI 1.04, 1.31). Greater proportion of follow-up time exposed to treatment was associated with greater reductions in the rate of worsening.
    Interpretation: This study provides class IV evidence for a strong protective effect of disease-modifying treatment to reduce disability worsening events in patients with CIS and early MS, and confirms age and pyramidal dysfunction at onset as risk factors.
    Language English
    Publishing date 2015-05
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2740696-9
    ISSN 2328-9503
    ISSN 2328-9503
    DOI 10.1002/acn3.187
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  9. Article ; Online: Defining reliable disability outcomes in multiple sclerosis.

    Kalincik, Tomas / Cutter, Gary / Spelman, Tim / Jokubaitis, Vilija / Havrdova, Eva / Horakova, Dana / Trojano, Maria / Izquierdo, Guillermo / Girard, Marc / Duquette, Pierre / Prat, Alexandre / Lugaresi, Alessandra / Grand'Maison, Francois / Grammond, Pierre / Hupperts, Raymond / Oreja-Guevara, Celia / Boz, Cavit / Pucci, Eugenio / Bergamaschi, Roberto /
    Lechner-Scott, Jeannette / Alroughani, Raed / Van Pesch, Vincent / Iuliano, Gerardo / Fernandez-Bolaños, Ricardo / Ramo, Cristina / Terzi, Murat / Slee, Mark / Spitaleri, Daniele / Verheul, Freek / Cristiano, Edgardo / Sánchez-Menoyo, José Luis / Fiol, Marcela / Gray, Orla / Cabrera-Gomez, Jose Antonio / Barnett, Michael / Butzkueven, Helmut

    Brain : a journal of neurology

    2015  Volume 138, Issue Pt 11, Page(s) 3287–3298

    Abstract: Prevention of irreversible disability is currently the most important goal of disease modifying therapy for multiple sclerosis. The disability outcomes used in most clinical trials rely on progression of Expanded Disability Status Scale score confirmed ... ...

    Abstract Prevention of irreversible disability is currently the most important goal of disease modifying therapy for multiple sclerosis. The disability outcomes used in most clinical trials rely on progression of Expanded Disability Status Scale score confirmed over 3 or 6 months. However, sensitivity and stability of this metric has not been extensively evaluated. Using the global MSBase cohort study, we evaluated 48 criteria of disability progression, testing three definitions of baseline disability, two definitions of progression magnitude, two definitions of long-term irreversibility and four definitions of event confirmation period. The study outcomes comprised the rates of detected progression events per 10 years and the proportions of the recorded events persistent at later time points. To evaluate the ratio of progression frequency and stability for each criterion, we calculated the proportion of events persistent over the five subsequent years once progression was achieved. Finally, we evaluated the clinical and demographic determinants characterising progression events and, for those that regressed back to baseline, determinants of their subsequent regression. The study population consisted of 16 636 patients with the minimum of three recorded disability scores, totalling 112 584 patient-years. The progression rates varied between 0.41 and 1.14 events per 10 years, with the length of required confirmation interval as the most important determinant of the observed variance. The concordance among all tested progression criteria was only 17.3%. Regression of disability occurred in 11-34% of the progression events over the five subsequent years. The most important determinant of progression stability was the length of the confirmation period. For the most accurate set of the progression criteria, the proportions of 3-, 6-, 12- or 24-month confirmed events persistent over 5 years reached 70%, 74%, 80% and 89%, respectively. Regression post progression was more common in younger patients, relapsing-remitting disease course, and after a smaller change in disability, and was inflated by higher visit frequency. These results suggest that the disability outcomes based on 3-6-month confirmed disability progression overestimate the accumulation of permanent disability by up to 30%. This could lead to spurious results in short-term clinical trials, and the issue may be magnified further in cohorts consisting predominantly of younger patients and patients with relapsing-remitting disease. Extension of the required confirmation period increases the persistence of progression events.
    MeSH term(s) Adult ; Age Factors ; Cohort Studies ; Disability Evaluation ; Disease Progression ; Female ; Humans ; Longitudinal Studies ; Male ; Middle Aged ; Multiple Sclerosis, Chronic Progressive/physiopathology ; Multiple Sclerosis, Relapsing-Remitting/physiopathology ; Outcome Assessment (Health Care) ; Registries
    Language English
    Publishing date 2015-11
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 80072-7
    ISSN 1460-2156 ; 0006-8950
    ISSN (online) 1460-2156
    ISSN 0006-8950
    DOI 10.1093/brain/awv258
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis.

    Kalincik, Tomas / Horakova, Dana / Spelman, Tim / Jokubaitis, Vilija / Trojano, Maria / Lugaresi, Alessandra / Izquierdo, Guillermo / Rozsa, Csilla / Grammond, Pierre / Alroughani, Raed / Duquette, Pierre / Girard, Marc / Pucci, Eugenio / Lechner-Scott, Jeannette / Slee, Mark / Fernandez-Bolanos, Ricardo / Grand'Maison, Francois / Hupperts, Raymond / Verheul, Freek /
    Hodgkinson, Suzanne / Oreja-Guevara, Celia / Spitaleri, Daniele / Barnett, Michael / Terzi, Murat / Bergamaschi, Roberto / McCombe, Pamela / Sanchez-Menoyo, Jose / Simo, Magdolna / Csepany, Tunde / Rum, Gabor / Boz, Cavit / Havrdova, Eva / Butzkueven, Helmut

    Annals of neurology

    2015  Volume 77, Issue 3, Page(s) 425–435

    Abstract: Objective: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of ... ...

    Abstract Objective: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents.
    Methods: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses.
    Results: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p < 0.001). No difference in the rate of sustained disability progression events was observed between the groups. The change in overall disability burden (quantified as area under the disability-time curve) differed between natalizumab and fingolimod (-0.12 vs 0.04 per year, respectively, p < 0.001).
    Interpretation: This study suggests that in active multiple sclerosis during treatment with injectable disease-modifying therapies, switching to natalizumab is more effective than switching to fingolimod in reducing relapse rate and short-term disability burden.
    MeSH term(s) Adult ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/pharmacology ; Disability Evaluation ; Disease Progression ; Female ; Fingolimod Hydrochloride ; Humans ; Immunosuppressive Agents/administration & dosage ; Immunosuppressive Agents/pharmacology ; Male ; Middle Aged ; Multiple Sclerosis, Relapsing-Remitting/drug therapy ; Natalizumab ; Propylene Glycols/administration & dosage ; Propylene Glycols/pharmacology ; Recurrence ; Registries ; Severity of Illness Index ; Sphingosine/administration & dosage ; Sphingosine/analogs & derivatives ; Sphingosine/pharmacology ; Treatment Outcome
    Chemical Substances Antibodies, Monoclonal, Humanized ; Immunosuppressive Agents ; Natalizumab ; Propylene Glycols ; Fingolimod Hydrochloride (G926EC510T) ; Sphingosine (NGZ37HRE42)
    Language English
    Publishing date 2015-03
    Publishing country United States
    Document type Comparative Study ; Controlled Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 80362-5
    ISSN 1531-8249 ; 0364-5134
    ISSN (online) 1531-8249
    ISSN 0364-5134
    DOI 10.1002/ana.24339
    Database MEDical Literature Analysis and Retrieval System OnLINE

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