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1. Multiple sclerosis registries in Europe – An updated mapping survey

Author

Glaser, A., Stahmann, A., Meissner, T., Flachenecker, P., Horáková, D., Zaratin, P., Brichetto, G., Pugliatti, M., Rienhoff, O., Vukusic, S., de Giacomoni, A.C., Battaglia, M.A., Brola, W., Butzkueven, H., Casey, R., Drulovic, J., Eichstädt, K., Hellwig, K., Iaffaldano, P., Ioannidou, E., Kuhle, J., Lycke, K., Magyari, M., Malbaša, T., Middleton, R., Myhr, K.M., Notas, K., Orologas, A., Otero-Romero, S., Pekmezovic, T., Sastre-Garriga, J., Seeldrayers, P., Soilu-Hänninen, M., Stawiarz, L., Trojano, M., Ziemssen, T., Hillert, J., and Thalheim, C.

Published
2019
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3. Kappa free light chains is a valid tool in the diagnostics of MS: A large multicenter study

Author

Leurs, CE, Twaalfhoven, HAM, Lissenberg-Witte, BI, van Pesch, V, Dujmovic, I, Drulovic, J, Castellazzi, M, Bellini, T, Pugliatti, M, Kuhle, J, Villar, LM, Alvarez-Cermeño, JC, Alvarez-Lafuente, R, Hegen, H, Deisenhammer, F, Walchhofer, LM, Thouvenot, E, Comabella, M, Montalban, X, Vécsei, L, Rajda, C, Galimberti, D, Scarpini, E, Altintas, A, Rejdak, K, Frederiksen, JL, Pihl-Jensen, G, Jensen, PEH, Khalil, M, Voortman, MM, Fazekas, F, Saiz, Albert, La Puma, D, Vercammen, M, Vanopdenbosch, L, Uitdehaag, BMJ, Killestein, J, Bridel, C, Teunissen, Charlotte E, Universitat Autònoma de Barcelona, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie, Basic (bio-) Medical Sciences, Ayşe, Altıntaş, Leurs, C.E., Twaalfhoven, H.A.M., Lissenberg-Witte, B.I., van Pesch, V., Dujmovic, I., Drulovic, J., Castellazzi, M., Bellini, T., Pugliatti, M., Kuhle, J., Villar, L.M., Alvarez-Cermeño, J.C., Alvarez-Lafuente, R., Hegen, H., Deisenhammer, F., Walchhofer, L.M., Thouvenot, E., Comabella, M., Montalban, X., Vécsei, L., Rajda, C., Galimberti, D., Scarpini, E., Rejdak, K., Frederiksen, J.L., Pihl-Jensen, G., Jensen, P.E.H., Khalil, M., Voortman, M.M., Fazekas, F., Saiz, A., La Puma, D., Vercammen, M., Vanopdenbosch, L., Uitdehaag, B.M.J., Killestein, J., Bridel, C., Teunissen, C., School of Medicine, Department of Neurology, Neurology, Laboratory Medicine, Epidemiology and Data Science, APH - Methodology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA), Department of Anatomy and Neurosciences [Amsterdam, The Netherlands] (Amsterdam Neuroscience), Section Clinical Neuroanatomy [Amsterdam, The Netherlands], VU University Medical Center [Amsterdam]-VU University Medical Center [Amsterdam], Vrije Universiteit Medical Centre (VUMC), Vrije Universiteit Amsterdam [Amsterdam] (VU), Cliniques Universitaires Saint-Luc [Bruxelles], Clinical Centre of Serbia, Università degli Studi di Ferrara (UniFE), University Hospital Basel [Basel], Hospital Universitario Ramón y Cajal [Madrid], Universidad de Alcalá - University of Alcalá (UAH), Red Española de Esclerosis Múltiple (REEM), Instituto de Investigación Sanitaria del Hospital Clínico San Carlos [Madrid, Spain] (IdISSC), Department of Neurology, Medical University of Innsbruck, Service de Neurologie [CHU Nimes] (Pôle NIRR), Hôpital Universitaire Carémeau [Nîmes] (CHU Nîmes), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Centre d'Esclerosi Múltiple de Catalunya (CemCat), Vall d'Hebron University Hospital [Barcelona], Centre de résonance magnétique biologique et médicale (CRMBM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), University of Szeged [Szeged], Centro Dino Ferrari [Milano], Università degli Studi di Milano [Milano] (UNIMI)-Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Koç University, Medical University of Lublin, Rigshospitalet [Copenhagen], Copenhagen University Hospital, Danish Multiple Sclerosis Research Centre, Copenhagen University Hospital-Copenhagen University Hospital, Department of Neurology, Clinical Division of Neurogeriatrics, Medical University Graz, Graz 8010, Austria, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona (UB), Department of Neurology, AZ Sint Jan Brugge Oostende, Neuroscience Amsterdam, VU University Medical Centre, 1081HV 1117, Amsterdam, Amsterdam Neuroscience [Pays-Bas], and Vrije Universiteit Amsterdam [Amsterdam] (VU)-University of Amsterdam [Amsterdam] (UvA)-VU University Medical Center [Amsterdam]

Subjects
KFLC (kappa free light chain), Adult, Male, Multiple Sclerosis, Clinical Neurology, Esclerosi múltiple, CSF, CSF (cerebrospinal fluid), Immunoglobulin light chain, Sensitivity and Specificity, NO, Multiple sclerosis, Immunoglobulin kappa-Chains, 03 medical and health sciences, 0302 clinical medicine, Nuclear magnetic resonance, Immunoglobulin lambda-Chains, Humans, Medicine, Diagnostic biomarker, biomarkers, KFLC, OCB, 030304 developmental biology, 0303 health sciences, business.industry, Biochemical markers, Oligoclonal Bands, Reproducibility of Results, Middle Aged, OCB (oligoclonal IgG band), Free Light Chain, Biomarkers, Neurology, Multicenter study, Marcadors bioquímics, [SDV.IMM]Life Sciences [q-bio]/Immunology, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Female, Neurology (clinical), business, Original Research Papers, 030217 neurology & neurosurgery, Kappa
Abstract

Objective: to validate kappa free light chain (KFLC) and lambda free light chain (LFLC) indices as a diagnostic biomarker in multiple sclerosis (MS). Methods: we performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes. Results: the cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2–138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5–22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85–0.90) was higher than OCB (0.82; 95%CI = 0.79–0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78–0.88) was lower (OCB = 0.92; 95% CI = 0.89–0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB. Conclusion: compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS., NA

Published
2020
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4. The Multiple Sclerosis Data Alliance Catalogue: Enabling Web-Based Discovery of Metadata from Real-World Multiple Sclerosis Data Sources.

Author

Geys, L, Parciak, T, Pirmani, A, McBurney, R, Schmidt, H, Malbaša, T, Ziemssen, T, Bergmann, A, Rojas, JI, Cristiano, E, García-Merino, JA, Fernández, Ó, Kuhle, J, Gobbi, C, Delmas, A, Simpson-Yap, S, Nag, N, Yamout, B, Steinemann, N, Seeldrayers, P, Dubois, B, van der Mei, I, Stahmann, A, Drulovic, J, Pekmezovic, T, Brola, W, Tintore, M, Kalkers, N, Ivanov, R, Zakaria, M, Naseer, MA, Van Hecke, W, Grigoriadis, N, Boziki, M, Carra, A, Pawlak, MA, Dobson, R, Hellwig, K, Gallagher, A, Leocani, L, Dalla Costa, G, de Carvalho Sousa, NA, Van Wijmeersch, B, Peeters, LM, Geys, L, Parciak, T, Pirmani, A, McBurney, R, Schmidt, H, Malbaša, T, Ziemssen, T, Bergmann, A, Rojas, JI, Cristiano, E, García-Merino, JA, Fernández, Ó, Kuhle, J, Gobbi, C, Delmas, A, Simpson-Yap, S, Nag, N, Yamout, B, Steinemann, N, Seeldrayers, P, Dubois, B, van der Mei, I, Stahmann, A, Drulovic, J, Pekmezovic, T, Brola, W, Tintore, M, Kalkers, N, Ivanov, R, Zakaria, M, Naseer, MA, Van Hecke, W, Grigoriadis, N, Boziki, M, Carra, A, Pawlak, MA, Dobson, R, Hellwig, K, Gallagher, A, Leocani, L, Dalla Costa, G, de Carvalho Sousa, NA, Van Wijmeersch, B, and Peeters, LM

Abstract

BACKGROUND: One of the major objectives of the Multiple Sclerosis Data Alliance (MSDA) is to enable better discovery of multiple sclerosis (MS) real-world data (RWD). METHODS: We implemented the MSDA Catalogue, which is available worldwide. The current version of the MSDA Catalogue collects descriptive information on governance, purpose, inclusion criteria, procedures for data quality control, and how and which data are collected, including the use of e-health technologies and data on collection of COVID-19 variables. The current cataloguing procedure is performed in several manual steps, securing an effective catalogue. RESULTS: Herein we summarize the status of the MSDA Catalogue as of January 6, 2021. To date, 38 data sources across five continents are included in the MSDA Catalogue. These data sources differ in purpose, maturity, and variables collected, but this landscaping effort shows that there is substantial alignment on some domains. The MSDA Catalogue shows that personal data and basic disease data are the most collected categories of variables, whereas data on fatigue measurements and cognition scales are the least collected in MS registries/cohorts. CONCLUSIONS: The Web-based MSDA Catalogue provides strategic overview and allows authorized end users to browse metadata profiles of data cohorts and data sources. There are many existing and arising RWD sources in MS. Detailed cataloguing of MS RWD is a first and useful step toward reducing the time needed to discover MS RWD sets and promoting collaboration.

Published
2021

5. Placebo-controlled trial of oral laquinimod in multiple sclerosis: MRI evidence of an effect on brain tissue damage

Author

Filippi, Massimo, Rocca, Maria A, Pagani, Elisabetta, De Stefano, Nicola, Jeffery, Douglas, Kappos, Ludwig, Montalban, Xavier, Boyko, Alexei N, Comi, Giancarlo, Filippi, M, Rocca, MA, Absinta, M, Longoni, G, Galantucci, S., Pagani, E, DallʼOcchio, L., Misci, P., Petrolini, M., Sala, S., Vuotto, R., Comi, G, Boyko, A, Filippi, M, Jeffery, D, Kappos, L, Montalban, x, McFarland, H, Bauer, K, Galay, N, Weber, J, Franta, C, Lampi, C, Shotekov, P, Bozhinov, S, Deleva, N, Haralanov, L, Ivanova Hristova, S, Petrov, I, Milanov, I, Kremenchutzky, M, Rabinovitch, H, Ayotte, C, GrandMaison, F, Lamontagne, A, Leckey, R, Lee, L, Hradilek, P, Kanovsky, P, Gross-Paju, K, Taba, P, Vermersch, P, Rumbach, L, Clavelou, P, Confavreux, C, Pelletier, J, Edan, G, Shakarishvili, R, Tsiskaridze, A, Becker, E, Chan, A, Eggers, J, Haas, J, Heesen, C, Heidenreich, F, Koehler, J., Koelmel, H W, Linker, R, Oschmann, P, Rauer, S, Maschke, M, Mueller, M, Reifschneider, G, Wildemann, B, Steinbrecher, A, Tumani, H, Ziebold, U, Ziemssen, T, Kanya, J, Jakab, G, Valikovics, A, Bartos, L, Karussis, D, Rawashdeh, H, Karni, A, Chapman, J, Comi, G, Caputo, D, Centonze, D, Cottone, S, Ghezzi, A, Maimone, D, Montanari, E, Plewnia, K, Scarpini, E, Metra, M, Rastenyte, D, Sceponaviciute, S, De Jong, B, Frequin, S, Visser, L, Zwanikken, C., Selmaj, K, Blaszczyk, B., Wajgt, A, Nowak, R, Jasinska, E, Brola, W, Sobkowiak-Osinska, M, Kapustecki, J, Zaborski, J, Panea, CA, Simu, M, Bulboaca, AC, Balasa, RI, Carciumaru, N, Boyko, A, Skoromets, A, Stolyarov, I, Perfilyev, S, Odinak, M, Amelina, O, Malkova, N, Gustov, A, Volkova, L, Shutov, A, Drulovic, J, Vojinovic, S, Montalban, Arroyo, R, Saiz Hinarejos, A, Brieva, L, Ramio, L, Meca Lallana, J, Amigo Jorrin, MdC, Prieto, JM, Munoz Gracia, D, Aladro, Y, Coret, F, Escartin, A, Diez Tejedor, E, Hillert, J, Olddon, T, Martin, C, Idiman, E, Sharrack, B, Giovannoni, G, Young, C, Nehrych, T, Moskovko, S, Kobys, T, AIpatov, Loganovskyi, K, AbouZeid, N, Jeffery, D, Dihenia, B, Carpenter, A, Flitman, S, Gazda, S, Goodman, A, Green, B, Gupta, A, Herbert, J, Hughes, B, Jacobs, A, Khatri, B, Lynch, S, Miller, T, Markowitz, C, Murray, R, Pardo, G, Parry, G, Gottschalk, G, Rossman, H, Scaberry, S, Thomas, F, Turel, A, Anderson, G, CTwyman, and Wyn, D

Published
2014
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6. Kappa free light chains is a valid tool in the diagnostics of MS: A large multicenter study

Author

UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie, Leurs, CE, Twaalfhoven, HAM, Lissenberg-Witte, BI, Van Pesch, Vincent, Dujmovic, I, Drulovic, J, Castellazzi, M, Bellini, T, Pugliatti, M, Kuhle, J, Villar, LM, Alvarez-Cermeño, JC, Alvarez-Lafuente, R, Hegen, H, Deisenhammer, F, Walchhofer, LM, Thouvenot, E, Comabella, M, Montalban, X, Vécsei, L, Rajda, C, Galimberti, D, Scarpini, E, Altintas, A, Rejdak, K, Frederiksen, JL, Pihl-Jensen, G, Jensen, PEH, Khalil, M, Voortman, MM, Fazekas, F, Saiz, A, La Puma, D, Vercammen, M, Vanopdenbosch, L, Uitdehaag, BMJ, Killestein, J, Bridel, C, Teunissen, C, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - (SLuc) Service de neurologie, Leurs, CE, Twaalfhoven, HAM, Lissenberg-Witte, BI, Van Pesch, Vincent, Dujmovic, I, Drulovic, J, Castellazzi, M, Bellini, T, Pugliatti, M, Kuhle, J, Villar, LM, Alvarez-Cermeño, JC, Alvarez-Lafuente, R, Hegen, H, Deisenhammer, F, Walchhofer, LM, Thouvenot, E, Comabella, M, Montalban, X, Vécsei, L, Rajda, C, Galimberti, D, Scarpini, E, Altintas, A, Rejdak, K, Frederiksen, JL, Pihl-Jensen, G, Jensen, PEH, Khalil, M, Voortman, MM, Fazekas, F, Saiz, A, La Puma, D, Vercammen, M, Vanopdenbosch, L, Uitdehaag, BMJ, Killestein, J, Bridel, C, and Teunissen, C

Abstract

OBJECTIVE: To validate kappa free light chain (KFLC) and lambda free light chain (LFLC) indices as a diagnostic biomarker in multiple sclerosis (MS). METHODS: We performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes. RESULTS: The cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2-138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5-22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85-0.90) was higher than OCB (0.82; 95%CI = 0.79-0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78-0.88) was lower (OCB = 0.92; 95% CI = 0.89-0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB. CONCLUSION: Compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS.

Published
2020

7. EAN guideline on palliative care of people with severe, progressive multiple sclerosis

Author

Solari, A., Giordano, A., Sastre-Garriga, J., Kopke, S., Rahn, A. C., Kleiter, I, Aleksovska, K., Battaglia, M. A., Bay, J., Copetti, M., Drulovic, J., Kooij, L., Mens, J., Meza Murillo, E. R., Milanov, I, Milo, R., Pekmezovic, T., Vosburgh, J., Silber, E., Veronese, S., Patti, F., Voltz, R., Oliver, D., Solari, A., Giordano, A., Sastre-Garriga, J., Kopke, S., Rahn, A. C., Kleiter, I, Aleksovska, K., Battaglia, M. A., Bay, J., Copetti, M., Drulovic, J., Kooij, L., Mens, J., Meza Murillo, E. R., Milanov, I, Milo, R., Pekmezovic, T., Vosburgh, J., Silber, E., Veronese, S., Patti, F., Voltz, R., and Oliver, D.

Abstract

Background and purpose Patients with severe, progressive multiple sclerosis (MS) have complex physical and psychosocial needs, typically over several years. Few treatment options are available to prevent or delay further clinical worsening in this population. The objective was to develop an evidence-based clinical practice guideline for the palliative care of patients with severe, progressive MS. Methods This guideline was developed using the Grading of Recommendations Assessment, Development and Evaluation methodology. Formulation of the clinical questions was performed in the Patients-Intervention-Comparator-Outcome format, involving patients, carers and healthcare professionals (HPs). No uniform definition of severe MS exists: in this guideline, constant bilateral support required to walk 20 m without resting (Expanded Disability Status Scale score > 6.0) or higher disability is referred to. When evidence was lacking for this population, recommendations were formulated using indirect evidence or good practice statements were devised. Results Ten clinical questions were formulated. They encompassed general and specialist palliative care, advance care planning, discussing with HPs the patient's wish to hasten death, symptom management, multidisciplinary rehabilitation, interventions for caregivers and interventions for HPs. A total of 34 recommendations (33 weak, 1 strong) and seven good practice statements were devised. Conclusions The provision of home-based palliative care (either general or specialist) is recommended with weak strength for patients with severe, progressive MS. Further research on the integration of palliative care and MS care is needed. Areas that currently lack evidence of efficacy in this population include advance care planning, the management of symptoms such as fatigue and mood problems, and interventions for caregivers and HPs.

Published
2020

8. EAN guideline on palliative care of people with severe, progressive multiple sclerosis

Author

Solari, Alessandra, Giordano, Andrea, Sastre‐Garriga, J., Köpke, Sascha, Rahn, Anne Christin, Kleiter, I., Aleksovska, K., Battaglia, M. A., Bay, J., Copetti, M., Drulovic, J., Kooij, L., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Pekmezovic, T., Vosburgh, J., Silber, E., Veronese, Simone, Patti, Francesco, Voltz, Raymond, Oliver, David, Solari, Alessandra, Giordano, Andrea, Sastre‐Garriga, J., Köpke, Sascha, Rahn, Anne Christin, Kleiter, I., Aleksovska, K., Battaglia, M. A., Bay, J., Copetti, M., Drulovic, J., Kooij, L., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Pekmezovic, T., Vosburgh, J., Silber, E., Veronese, Simone, Patti, Francesco, Voltz, Raymond, and Oliver, David

Published
2020

9. Kappa free light chains is a valid tool in the diagnostics of MS:A large multicenter study

Author

Leurs, C. E., Twaalfhoven, H. A. M., Lissenberg-Witte, B. I., van Pesch, V., Dujmovic, I., Drulovic, J., Castellazzi, M., Bellini, T., Pugliatti, M., Kuhle, J., Villar, L. M., Alvarez-Cermeño, J. C., Alvarez-Lafuente, R., Hegen, H., Deisenhammer, F., Walchhofer, L. M., Thouvenot, E., Comabella, M., Montalban, X., Vécsei, L., Rajda, C., Galimberti, D., Scarpini, E., Altintas, A., Rejdak, K., Frederiksen, J. L., Pihl-Jensen, G., Jensen, P. E. H., Khalil, M., Voortman, M. M., Fazekas, F., Saiz, A., La Puma, D., Vercammen, M., Vanopdenbosch, L., Uitdehaag, B. M. J., Killestein, J., Bridel, C., Teunissen, C., Leurs, C. E., Twaalfhoven, H. A. M., Lissenberg-Witte, B. I., van Pesch, V., Dujmovic, I., Drulovic, J., Castellazzi, M., Bellini, T., Pugliatti, M., Kuhle, J., Villar, L. M., Alvarez-Cermeño, J. C., Alvarez-Lafuente, R., Hegen, H., Deisenhammer, F., Walchhofer, L. M., Thouvenot, E., Comabella, M., Montalban, X., Vécsei, L., Rajda, C., Galimberti, D., Scarpini, E., Altintas, A., Rejdak, K., Frederiksen, J. L., Pihl-Jensen, G., Jensen, P. E. H., Khalil, M., Voortman, M. M., Fazekas, F., Saiz, A., La Puma, D., Vercammen, M., Vanopdenbosch, L., Uitdehaag, B. M. J., Killestein, J., Bridel, C., and Teunissen, C.

Abstract

Objective: To validate kappa free light chain (KFLC) and lambda free light chain (LFLC) indices as a diagnostic biomarker in multiple sclerosis (MS). Methods: We performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes. Results: The cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2–138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5–22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85–0.90) was higher than OCB (0.82; 95%CI = 0.79–0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78–0.88) was lower (OCB = 0.92; 95% CI = 0.89–0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB. Conclusion: Compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS.

Published
2020

14. International consensus on quality standards for brain health-focused care in multiple sclerosis.

Author

Hobart, J, Bowen, A, Pepper, G, Crofts, H, Eberhard, L, Berger, T, Boyko, A, Boz, C, Butzkueven, H, Celius, EG, Drulovic, J, Flores, J, Horáková, D, Lebrun-Frénay, C, Marrie, RA, Overell, J, Piehl, F, Rasmussen, PV, Sá, MJ, Sîrbu, C-A, Skromne, E, Torkildsen, Ø, van Pesch, V, Vollmer, T, Zakaria, M, Ziemssen, T, Giovannoni, G, Hobart, J, Bowen, A, Pepper, G, Crofts, H, Eberhard, L, Berger, T, Boyko, A, Boz, C, Butzkueven, H, Celius, EG, Drulovic, J, Flores, J, Horáková, D, Lebrun-Frénay, C, Marrie, RA, Overell, J, Piehl, F, Rasmussen, PV, Sá, MJ, Sîrbu, C-A, Skromne, E, Torkildsen, Ø, van Pesch, V, Vollmer, T, Zakaria, M, Ziemssen, T, and Giovannoni, G

Abstract

BACKGROUND: Time matters in multiple sclerosis (MS). Irreversible neural damage and cell loss occur from disease onset. The MS community has endorsed a management strategy of prompt diagnosis, timely intervention and regular proactive monitoring of treatment effectiveness and disease activity to improve outcomes in people with MS. OBJECTIVES: We sought to develop internationally applicable quality standards for timely, brain health-focused MS care. METHODS: A panel of MS specialist neurologists participated in an iterative, online, modified Delphi process to define 'core', 'achievable' and 'aspirational' time frames reflecting minimum, good and high care standards, respectively. A multidisciplinary Reviewing Group (MS nurses, people with MS, allied healthcare professionals) provided insights ensuring recommendations reflected perspectives from multiple stakeholders. RESULTS: Twenty-one MS neurologists from 19 countries reached consensus on most core (25/27), achievable (25/27) and aspirational (22/27) time frames at the end of five rounds. Agreed standards cover six aspects of the care pathway: symptom onset, referral and diagnosis, treatment decisions, lifestyle, disease monitoring and managing new symptoms. CONCLUSION: These quality standards for core, achievable and aspirational care provide MS teams with a three-level framework for service evaluation, benchmarking and improvement. They have the potential to produce a profound change in the care of people with MS.

Published
2019

15. Patient and caregiver involvement in the formulation of guideline questions: findings from the European Academy of Neurology guideline on palliative care of people with severe multiple sclerosis

Author

Köpke, Sascha, Giordano, Andrea, Veronese, Simone, Rahn, Anne Christin, Kleiter, Ingo, Basedow‐Rajwich, Birgit, Fornari, Arianna, Battaglia, M. A., Drulovic, J., Kooij, L., Koops, J., Mensah, J., Meza Murillo, Edwin Roger, Milanov, Ivan, Milo, Ron, Patti, Francesco, Pekmezovic, Tatiana, Sastre‐Garriga, J., Vosburgh, J., Voltz, Raymond, Bayry, J., Oliver, David, Solari, Alessandra, Köpke, Sascha, Giordano, Andrea, Veronese, Simone, Rahn, Anne Christin, Kleiter, Ingo, Basedow‐Rajwich, Birgit, Fornari, Arianna, Battaglia, M. A., Drulovic, J., Kooij, L., Koops, J., Mensah, J., Meza Murillo, Edwin Roger, Milanov, Ivan, Milo, Ron, Patti, Francesco, Pekmezovic, Tatiana, Sastre‐Garriga, J., Vosburgh, J., Voltz, Raymond, Bayry, J., Oliver, David, and Solari, Alessandra

Published
2019

16. Kappa free light chains is a valid tool in the diagnostics of MS: a large multicenter study

Author

Ayşe, Altıntaş, Leurs, C.E.; Twaalfhoven, H.A.M.; Lissenberg-Witte, B.I.; van Pesch, V.; Dujmovic, I.; Drulovic, J.; Castellazzi, M.; Bellini, T.; Pugliatti, M.; Kuhle, J.; Villar, L.M.; Alvarez-Cermeño, J.C.; Alvarez-Lafuente, R.; Hegen, H.; Deisenhammer, F.; Walchhofer, L.M.; Thouvenot, E.; Comabella, M.; Montalban, X.; Vécsei, L.; Rajda, C.; Galimberti, D.; Scarpini, E.; Rejdak, K.; Frederiksen, J.L.; Pihl-Jensen, G.; Jensen, P.E.H.; Khalil, M.; Voortman, M.M.; Fazekas, F.; Saiz, A.; La Puma, D.; Vercammen, M.; Vanopdenbosch, L.; Uitdehaag, B.M.J.; Killestein, J.; Bridel, C.; Teunissen, C., School of Medicine, Department of Neurology, Ayşe, Altıntaş, Leurs, C.E.; Twaalfhoven, H.A.M.; Lissenberg-Witte, B.I.; van Pesch, V.; Dujmovic, I.; Drulovic, J.; Castellazzi, M.; Bellini, T.; Pugliatti, M.; Kuhle, J.; Villar, L.M.; Alvarez-Cermeño, J.C.; Alvarez-Lafuente, R.; Hegen, H.; Deisenhammer, F.; Walchhofer, L.M.; Thouvenot, E.; Comabella, M.; Montalban, X.; Vécsei, L.; Rajda, C.; Galimberti, D.; Scarpini, E.; Rejdak, K.; Frederiksen, J.L.; Pihl-Jensen, G.; Jensen, P.E.H.; Khalil, M.; Voortman, M.M.; Fazekas, F.; Saiz, A.; La Puma, D.; Vercammen, M.; Vanopdenbosch, L.; Uitdehaag, B.M.J.; Killestein, J.; Bridel, C.; Teunissen, C., School of Medicine, and Department of Neurology

Abstract

Objective: to validate kappa free light chain (KFLC) and lambda free light chain (LFLC) indices as a diagnostic biomarker in multiple sclerosis (MS). Methods: we performed a multicenter study including 745 patients from 18 centers (219 controls and 526 clinically isolated syndrome (CIS)/MS patients) with a known oligoclonal IgG band (OCB) status. KFLC and LFLC were measured in paired cerebrospinal fluid (CSF) and serum samples. Gaussian mixture modeling was used to define a cut-off for KFLC and LFLC indexes. Results: the cut-off for the KFLC index was 6.6 (95% confidence interval (CI) = 5.2–138.1). The cut-off for the LFLC index was 6.9 (95% CI = 4.5–22.2). For CIS/MS patients, sensitivity of the KFLC index (0.88; 95% CI = 0.85–0.90) was higher than OCB (0.82; 95%CI = 0.79–0.85; p < 0.001), but specificity (0.83; 95% CI = 0.78–0.88) was lower (OCB = 0.92; 95% CI = 0.89–0.96; p < 0.001). Both sensitivity and specificity for the LFLC index were lower than OCB. Conclusion: compared with OCB, the KFLC index is more sensitive but less specific for diagnosing CIS/MS. Lacking an elevated KFLC index is more powerful for excluding MS compared with OCB but the latter is more important for ruling in a diagnosis of CIS/MS., NA

Published
2019

20. Serum neurofilament light chain levels are increased in patients with a clinically isolated syndrome

Author

Disanto, G1, Adiutori, R2, Dobson, R2, Martinelli, V3, Dalla Costa G3, Runia, T4, Evdoshenko, E5, Thouvenot, E6, Trojano, M7, Norgren, N8, Teunissen, C9, Kappos, L10, Giovannoni, G2, Kuhle, J, Bianchi, L, Topping, J, Bestwick, Jp, Meier, Uc, Lazareva, N, Iaffaldano, P, Direnzo, V, Khademi, M, Piehl, F, Comabella, M, Sombekke, M, Killestein, J, Hegen, H, Rauch, S, D'Alfonso, S, Alvarez-Cermeño, Jc, Kleinová, P, Horáková, D, Roesler, R, Lauda, F, Llufriu, S, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Menge, T, Rajda, C, Bergamaschi, R, Moll, N, Khalil, M, Marignier, R, Dujmovic, I, Larsson, H, Malmestrom, C, Scarpini, E, Fenoglio, C, Wergeland, S, Laroni, A, Annibali, V, Romano, S, Martínez, Ad, Carra, A, Salvetti, M, Uccelli, A, Torkildsen, Ø, Myhr, Km, Galimberti, D, Rejdak, K, Lycke, J, Frederiksen, Jl, Drulovic, J, Confavreux, C, Brassat, D, Enzinger, C, Fuchs, S, Bosca, I, Pelletier, J, Picard, C, Colombo, E, Franciotta, D, Derfuss, T, Lindberg, Rl, Yaldizli, Ö, Vécsei, L, Kieseier, Bc, Hartung, Hp, Villoslada, P, Siva, A, Saiz, A, Tumani, H, Havrdová, E, Villar, Lm, Leone, M, Barizzone, N, Deisenhammer, F, Montalban, X, Tintoré, M, Olsson, T, Lehmann, S, Castelnovo, G, Lapin, S, Hintzen, R, Furlan, R, Comi, G, Ramagopalan, Sv., Institut de Génomique Fonctionnelle (IGF), Université de Montpellier (UM)-Université Montpellier 1 (UM1)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Montpellier 2 - Sciences et Techniques (UM2)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), Laboratory Medicine, Amsterdam Neuroscience - Neuroinfection & -inflammation, Disanto, G., Adiutori, R., Dobson, R., Martinelli, V., Dalla Costa, G., Runia, T., Evdoshenko, E., Thouvenot, E., Trojano, M., Norgren, N., Teunissen, C., Kappos, L., Giovannoni, G., Kuhle, J., on behalf of the International ClinicallyIsolated Syndrome Study, Group, and Neurology

Subjects
Male, Pathology, Future studies, Gastroenterology, 0302 clinical medicine, Neurofilament Proteins, Multiple Sclerosi, 0303 health sciences, Clinically isolated syndrome, medicine.diagnostic_test, Medicine (all), Neurofilament Protein, Demyelinating Disease, Magnetic Resonance Imaging, Psychiatry and Mental Health, Predictive value of tests, Disease Progression, Biomarker (medicine), [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Female, Human, Adult, medicine.medical_specialty, Multiple Sclerosis, Neurofilament light, multiple sclerosis, adult, axons, biomarkers, demyelinating diseases, disease progression, female, follow-up studies, humans, magnetic resonance imaging, male, neurofilament proteins, predictive value of tests, neurology (clinical), psychiatry and mental health, surgery, arts and humanities (miscellaneous), medicine (all), [SDV.MHEP.CHI]Life Sciences [q-bio]/Human health and pathology/Surgery, Axon, Follow-Up Studie, 03 medical and health sciences, Arts and Humanities (miscellaneous), Predictive Value of Tests, Internal medicine, medicine, Humans, In patient, MULTIPLE SCLEROSIS, 030304 developmental biology, business.industry, Multiple sclerosis, Magnetic resonance imaging, Biomarker, medicine.disease, Axons, [SDV.MHEP.PSM]Life Sciences [q-bio]/Human health and pathology/Psychiatrics and mental health, Surgery, Neurology (clinical), business, 030217 neurology & neurosurgery, Biomarkers, Demyelinating Diseases, Follow-Up Studies
Abstract

International audience; BACKGROUND:Neurofilament light chain (NfL) represents a promising biomarker for axonal injury. We present the first exploratory study on serum NfL in patients with a clinically isolated syndrome (CIS) and healthy controls.METHODS:We investigated serum NfL levels in 100 patients with CIS with a short conversion interval to clinically definite multiple sclerosis (MS) (fast converters (FC), median (IQR) conversion time: 110 days (79-139)); 98 patients with non-converting CIS (non-converters (NC), follow-up: 6.5 years (5.3-7.9)); and 92 healthy controls.RESULTS:NfL levels were higher in FC (24.1 pg/mL (13.5-51.8)) and NC (19.3 pg/mL (13.6-35.2)) than in healthy controls (7.9 pg/mL (5.6-17.2)) (OR=5.85; 95% CI 2.63 to 13.02; p = 1.5 × 10(-5) and OR = 7.03; 95% CI 2.85 to 17.34; p = 2.3 × 10(-5), respectively). When grouping FC and NC, increased serum NfL concentration was also associated with increasing numbers of T2 hyperintense MRI lesions (OR = 2.36; 95% CI 1.21 to 4.59; p = 0.011), gadolinium-enhancing lesions (OR = 2.69; 95% CI 1.13 to 6.41; p=0.026) and higher disability scores (OR = 2.54; 95% CI 1.21 to 5.31; p = 0.013) at CIS diagnosis.CONCLUSIONS:If replicated in future studies, serum NfL may represent a reliable and easily accessible biomarker of early axonal damage in CIS and MS.

Published
2016
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24. phenotypic and genetic heterogeneity of adult patients with hereditary spastic paraplegia from Serbia

Author

Peric, S., primary, Markovic, V., additional, De Vriendt, E., additional, Estrada-Cuzcano, A., additional, Svetel, M., additional, Stojanovic, V. Rakocevic, additional, Dragasevic-Miskovic, N., additional, Stevic, Z., additional, Bozovic, I., additional, Mijajlovic, M., additional, Mesaros, S., additional, Drulovic, J., additional, Novakovic, I., additional, Kostic, V.S., additional, and Jordanova, A., additional

Published
2019
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25. Kappa free light chains is a valid tool in the diagnostics of MS: A large multicenter study

Author

Leurs, CE, primary, Twaalfhoven, HAM, additional, Lissenberg-Witte, BI, additional, van Pesch, V, additional, Dujmovic, I, additional, Drulovic, J, additional, Castellazzi, M, additional, Bellini, T, additional, Pugliatti, M, additional, Kuhle, J, additional, Villar, LM, additional, Alvarez-Cermeño, JC, additional, Alvarez-Lafuente, R, additional, Hegen, H, additional, Deisenhammer, F, additional, Walchhofer, LM, additional, Thouvenot, E, additional, Comabella, M, additional, Montalban, X, additional, Vécsei, L, additional, Rajda, C, additional, Galimberti, D, additional, Scarpini, E, additional, Altintas, A, additional, Rejdak, K, additional, Frederiksen, JL, additional, Pihl-Jensen, G, additional, Jensen, PEH, additional, Khalil, M, additional, Voortman, MM, additional, Fazekas, F, additional, Saiz, A, additional, La Puma, D, additional, Vercammen, M, additional, Vanopdenbosch, L, additional, Uitdehaag, BMJ, additional, Killestein, J, additional, Bridel, C, additional, and Teunissen, C, additional

Published
2019
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27. Consumer involvement in formulation of the questions to be answered: findings from the EAN Guideline on Palliative Care of People with severe Multiple Sclerosis

Author

Koepke, S., Giordano, A., Veronese, S., Rahn, A. C., Kleiter, I., Basedow-Rajwich, B., Fornari, A., Battaglia, M., Drulovic, J., Kooij, L., Koops, J., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Patti, F., Pekmezovic, T., Sastre-Garriga, J., Silber, E., Vosburgh, J., Voltz, R., Bay, J., Oliver, D., Solari, A., Koepke, S., Giordano, A., Veronese, S., Rahn, A. C., Kleiter, I., Basedow-Rajwich, B., Fornari, A., Battaglia, M., Drulovic, J., Kooij, L., Koops, J., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Patti, F., Pekmezovic, T., Sastre-Garriga, J., Silber, E., Vosburgh, J., Voltz, R., Bay, J., Oliver, D., and Solari, A.

Published
2018

28. Patient and caregiver involvement in formulation of guideline questions: findings from the EAN guideline on palliative care of people with severe multiple sclerosis

Author

Solari, A., Koepke, S., Giordano, A., Veronese, S., Rahn, A., Kleiter, I., Basedow-Rajwich, B., Fornari, A., Battaglia, M. A., Drulovic, J., Kooij, L., Koops, J., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Patti, F., Pekmezovic, T., Sastre-Garriga, J., Vosburgh, J., Voltz, R., Bay, J., Oliver, D. J., Solari, A., Koepke, S., Giordano, A., Veronese, S., Rahn, A., Kleiter, I., Basedow-Rajwich, B., Fornari, A., Battaglia, M. A., Drulovic, J., Kooij, L., Koops, J., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Patti, F., Pekmezovic, T., Sastre-Garriga, J., Vosburgh, J., Voltz, R., Bay, J., and Oliver, D. J.

Published
2018

29. Epstein-Barr-negative MS: a true phenomenon?

Author

Dobson, Ruth, Kuhle, Jens, Middeldorp, Jaap, Giovannoni, Gavin, on behalf of the international CIS study investigators including Dalla Costa, G, Furlan, R, Martinelli, V, Comi, G, Runia, T, Hintzen, R, Evdoshenko, E, Lazareva, N, Lapin, S, Thouvenot, E, Lehmann, S, Castelnovo, G, Iaffaldano, P, Direnzo, V, Trojano, M, Khademi, . M, Piehl, F, Olsson, T, Comabella, M, Montalban, X, Tintoré, M, Sombekke, M, Killestein, J, Teunissen, C, Hegen, H, Deisenhammer, F, Rauch, S, D'Alfonso, S, Barizzone, N, Alvarez Cermeño, Jc, Villar, Lm, Kleinová, P, Horáková, D, Havrdová, E, Roesler, R, Lauda, F, Tumani, H, Llufriu, S, Villoslada, P, Saiz, A, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Siva, A, Menge, T, Kieseier, Bc, Hartung, Hp, Rajda, C, Vécsei, L, Bergamaschi, R, Colombo, E, Franciotta, D, Moll, N, Pelletier, J, Picard, C, Khalil, M, Enzinger, C, Fuchs, S, Marignier, R, Confavreux, C, Dujmovic, I, Drulovic, J, Larsson, H, Malmestrom, C, Lycke, J, Scarpini, E, C. Fenoglio, C, Galimberti, D, Wergeland, S, Torkildsen, Ø, Myhr, Km, Laroni, Alice, Uccelli, Antonio, Annibali, V, Romano, S, Salvetti, M, Martínez, Ad, Carra, A, Rejdak, K, Frederiksen, Jl, Brassat, D, Bosca, I, Casanova, B, Derfuss, T, Lindberg, R, Yaldizli, Ö, Kappos, L, Leone, M., and Pathology

Subjects
0301 basic medicine, business.industry, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, Neurology, Epstein barr, Phenomenon, Medicine, Neurology (clinical), business, Competence (human resources), Social psychology, Clinical/Scientific Notes, 030217 neurology & neurosurgery
Abstract

This work was supported by institutional funding and in part by the BMBF grant KKNMS (Competence Net Multiple Sclerosis) to H Tumani.

Published
2017
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30. Patient and caregiver involvement in the formulation of guideline questions: findings from the European Academy of Neurology guideline on palliative care of people with severe multiple sclerosis

Author

Köpke, S., primary, Giordano, A., additional, Veronese, S., additional, Rahn, A. C., additional, Kleiter, I., additional, Basedow‐Rajwich, B., additional, Fornari, A., additional, Battaglia, M. A., additional, Drulovic, J., additional, Kooij, L., additional, Koops, J., additional, Mens, J., additional, Meza Murillo, E. R., additional, Milanov, I., additional, Milo, R., additional, Patti, F., additional, Pekmezovic, T., additional, Sastre‐Garriga, J., additional, Vosburgh, J., additional, Voltz, R., additional, Bay, J., additional, Oliver, D. J., additional, and Solari, A., additional

Published
2018
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31. A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis

Author

Giovannoni, G, Comi, G, Cook, S, Rammohan, K, Rieckmann, P, Soelberg Sørensen, P, Vermersch, P, Sandberg Wollheim, M, Cuzick, J, Juliusson, G, Reingold, S, King, J, Pollard, J, Sedal, L, Aichner, F, Eggers, C, Dive, D, Medaer, R, Ferreira, M, Manchev, I, Milanov, I, Haralanov, L, Deleva, N, Petrova, N, Bozhinov, P, Zahariev, Z, Stamenov, B, Shotekov, P, Petrov, I, Moskov, R, Emond, F, Freedman, M, Grand'Maison, F, Jacques, F, Vorobeychik, G, Demarin, V, Kovacicek, M, Lusic, I, Perhat Bucevic, T, Havrdova, E, Talab, R, Kanovsky, P, Petersen, T, Gross Paju, K, Kalbe, I, Toomsoo, T, Elovaara, I, Eralinna, Jp, Reunanen, M, Clavelou, P, Damier, P, Debouverie, M, Edan, G, Gout, O, Labauge, P, Laplaud, D, Wiertlewski, S, Heidenreich, F, Mäurer, M, Kieseier, B, Limmroth, V, Oschmann, P, Schimrigk, S, Steinbrecher, A, Zettl, U, Ziemann, U, Karageorgiou, K, Kyritsis, A, Papadimitriou, A, Amato, Mp, Bernardi, G, Morra, Vb, Galgani, S, Gallo, Paolo, Patti, F, Marrosu, M, Pozzilli, C, Trojano, M, Mancardi, Gl, Gebeily, S, Koussa, S, Wehbe, M, Yamout, B, Vaitkus, A, Metra, M, Messouak, O, Mossaddaq, R, Slassi, I, Yahyaoui, M, Hupperts, Rm, Czlonkowska, A, Kozubski, W, Nyka, W, Selmaj, K, Szczudlik, A, Figueiredo, J, Pedrosa, R, Alifirova, V, Balyazin, V, Barbarash, O, Belova, A, Boyko, A, Gusev, E, Elchaninov, A, Jacoupov, E, Julev, N, Kotov, S, Kudryavtsev, A, Laskov, V, Lesnyak, O, Odinak, M, Pasechnik, E, Poverennonva, I, Skoromets, A, Spirin, N, Stolyarov, I, Vorobieva, O, Voskresenskaya, O, Zaslavskiy, L, Zonova, E, Bohlega, S, El Jumah, M, Drulovic, J, Nadj, C, Goebels, N, Schluep, M, Ayed Frih, M, Hentati, F, Mhiri, C, Mrabet, A, Mrissa, R, Idiman, E, Karabudak, R, Turan, Of, Ahmed, F, Constantinescu, C, Hawkins, C, Palace, J, Sharrack, B, Loganovsky, K, Moskovko, S, Nehrych, T, Voloshyna, Np, Carlini, W, English, J, Garmany, G, Glyman, S, Huddlestone, J, Hurwitz, B, Kresa Reahl, K, Mikol, D, Pardo, G, Rao, H, Reif, M, Thrower, B, Royal, W, Webb, R, Wynn, D, Naga, C, Allen, N, Lin, K, Stefoski, D, Balabanov, R., Klinische Neurowetenschappen, RS: MHeNs School for Mental Health and Neuroscience, G., Giovannoni, G., Comi, S., Cook, K., Rammohan, P., Rieckmann, P. S., Sorensen, P., Vermersch, P., Chang, A., Hamlett, B., Musch, S. J., Greenberg, Altri, and BRESCIA MORRA, Vincenzo

Subjects
Male, Medizin, Placebo-controlled study, Administration, Oral, Relapsing-Remitting, drug therapy/pathology, Gastroenterology, Disability Evaluation, Cladribine, Hazard ratio, Brain, General Medicine, Middle Aged, Administration, Oral, Adolescent, Adult, Aged, Analysis of Variance, Brain, pathology, Cladribine, adverse effects/therapeutic use, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Herpes Zoster, etiology, Humans, Immunosuppressive Agents, adverse effects/therapeutic use, Intention to Treat Analysis, Lymphopenia, chemically induced, Magnetic Resonance Imaging, Male, Middle Aged, Multiple Sclerosis, drug therapy/pathology, Young Adult, Magnetic Resonance Imaging, Intention to Treat Analysis, adverse effects/therapeutic use, Disease Progression, chemically induced, Female, Immunosuppressive Agents, medicine.drug, Oral, Adult, medicine.medical_specialty, Multiple Sclerosis, Adolescent, etiology, cladribine, immunomodulation, multiple sclerosis, trial, Lower risk, Placebo, DIAGNOSIS, Herpes Zoster, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Double-Blind Method, Lymphopenia, Internal medicine, medicine, Humans, Adverse effect, Aged, Analysis of Variance, business.industry, MS, medicine.disease, Confidence interval, Surgery, CELLS, pathology, Lymphocytopenia, business
Abstract

Cladribine provides immunomodulation through selective targeting of lymphocyte subtypes. We report the results of a 96-week phase 3 trial of a short-course oral tablet therapy in patients with relapsing–remitting multiple sclerosis. We randomly assigned 1326 patients in an approximate 1:1:1 ratio to receive one of two cumulative doses of cladribine tablets (either 3.5 mg or 5.25 mg per kilogram of body weight) or matching placebo, given in two or four short courses for the first 48 weeks, then in two short courses starting at week 48 and week 52 (for a total of 8 to 20 days per year). The primary end point was the rate of relapse at 96 weeks. Among patients who received cladribine tablets (either 3.5 mg or 5.25 mg per kilogram), there was a significantly lower annualized rate of relapse than in the placebo group (0.14 and 0.15, respectively, vs. 0.33 ; P

Published
2010
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33. Patient and caregiver involvement in the formulation of guideline questions: findings from the European Academy of Neurology guideline on palliative care of people with severe multiple sclerosis.

Author

Köpke, S., Giordano, A., Veronese, S., Christin Rahn, A., Kleiter, I., Basedow‐Rajwich, B., Fornari, A., Battaglia, M. A., Drulovic, J., Kooij, L., Koops, J., Mens, J., Meza Murillo, E. R., Milanov, I., Milo, R., Patti, F., Pekmezovic, T., Sastre‐Garriga, J., Vosburgh, J., and Voltz, R.

Subjects
MULTIPLE sclerosis, PALLIATIVE treatment, MEDICAL rehabilitation, CAREGIVERS, INTERNET surveys
Abstract

Background and purpose: Patient and public involvement in clinical practice guideline development is recommended to increase guideline trustworthiness and relevance. The aim was to engage multiple sclerosis (MS) patients and caregivers in the definition of the key questions to be answered in the European Academy of Neurology guideline on palliative care of people with severe MS. Methods: A mixed methods approach was used: an international online survey launched by the national MS societies of eight countries, after pilot testing/debriefing on 20 MS patients and 18 caregivers, focus group meetings of Italian and German MS patients and caregivers. Results: Of 1199 participants, 951 (79%) completed the whole online survey and 934 from seven countries were analysed: 751 (80%) were MS patients (74% women, mean age 46.1) and 183 (20%) were caregivers (36% spouses/partners, 72% women, mean age 47.4). Participants agreed/strongly agreed on inclusion of the nine pre‐specified topics (from 89% for 'advance care planning' to 98% for 'multidisciplinary rehabilitation'), and <5% replied 'I prefer not to answer' to any topic. There were 569 free comments: 182 (32%) on the pre‐specified topics, 227 (40%) on additional topics (16 guideline‐pertinent) and 160 (28%) on outcomes. Five focus group meetings (three of MS patients, two of caregivers, and overall 35 participants) corroborated the survey findings. In addition, they allowed an explanation of the guideline production process and the exploration of patient‐important outcomes and of taxing issues. Conclusions: Multiple sclerosis patient and caregiver involvement was resource and time intensive, but rewarding. It was the key for the formulation of the 10 guideline questions and for the identification of patient‐important outcomes. [ABSTRACT FROM AUTHOR]

Published
2019
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36. Atrophy of the whole cervical cord differs among the major multiple sclerosis clinical phenotypes and is associated with disability: a multicenter study

Author

Sala S, Rocca MA, Drulovic J, Martinelli V, Caputo D, Horsfield MA, Rodegher M, Copetti M, Stosic-Opincal T, Absinta M, Agosta F, Mesaros S, Comi G, Filippi M, Sala, S, Rocca, Ma, Drulovic, J, Martinelli, V, Caputo, D, Horsfield, Ma, Rodegher, M, Copetti, M, Stosic-Opincal, T, Absinta, M, Agosta, F, Mesaros, S, Comi, G, and Filippi, M

Published
2010

37. Conversion from clinically isolated syndrome to multiple sclerosis:A large multicentre study

Author

Kuhle, J, Disanto, G, Dobson, R, Adiutori, R, Bianchi, L, Topping, J, Bestwick, J P, Meier, U-C, Marta, M, Dalla Costa, G, Runia, T, Evdoshenko, E, Lazareva, N, Thouvenot, E, Iaffaldano, P, Direnzo, V, Khademi, M, Piehl, F, Comabella, M, Sombekke, M, Killestein, J, Hegen, H, Rauch, S, D'Alfonso, S, Alvarez-Cermeño, J C, Kleinová, P, Horáková, D, Roesler, R, Lauda, F, Llufriu, S, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Menge, T, Rajda, C, Bergamaschi, R, Moll, N, Khalil, M, Marignier, R, Dujmovic, I, Larsson, H, Malmestrom, C, Scarpini, E, Fenoglio, C, Wergeland, S, Laroni, A, Annibali, V, Romano, S, Martínez, A D, Carra, A, Salvetti, M, Uccelli, A, Torkildsen, Ø, Myhr, K M, Galimberti, D, Rejdak, K, Lycke, J, Fredriksen, Jette Lautrup, Drulovic, J, Confavreux, C, Brassat, D, Enzinger, C, Fuchs, S, Bosca, I, Pelletier, J, Picard, C, Colombo, E, Franciotta, D, Derfuss, T, Lindberg, Rlp, Yaldizli, Ö, Vécsei, L, Kieseier, B C, Hartung, H P, Villoslada, P, Siva, A, Saiz, A, Tumani, H, Havrdová, E, Villar, L M, Leone, M, Barizzone, N, Deisenhammer, F, Teunissen, C, Montalban, X, Tintoré, M, Olsson, T, Trojano, M, Lehmann, S, Castelnovo, G, Lapin, S, Hintzen, R, Kappos, L, Furlan, R, Martinelli, V, Comi, G, Ramagopalan, S V, Giovannoni, G, Kuhle, J, Disanto, G, Dobson, R, Adiutori, R, Bianchi, L, Topping, J, Bestwick, J P, Meier, U-C, Marta, M, Dalla Costa, G, Runia, T, Evdoshenko, E, Lazareva, N, Thouvenot, E, Iaffaldano, P, Direnzo, V, Khademi, M, Piehl, F, Comabella, M, Sombekke, M, Killestein, J, Hegen, H, Rauch, S, D'Alfonso, S, Alvarez-Cermeño, J C, Kleinová, P, Horáková, D, Roesler, R, Lauda, F, Llufriu, S, Avsar, T, Uygunoglu, U, Altintas, A, Saip, S, Menge, T, Rajda, C, Bergamaschi, R, Moll, N, Khalil, M, Marignier, R, Dujmovic, I, Larsson, H, Malmestrom, C, Scarpini, E, Fenoglio, C, Wergeland, S, Laroni, A, Annibali, V, Romano, S, Martínez, A D, Carra, A, Salvetti, M, Uccelli, A, Torkildsen, Ø, Myhr, K M, Galimberti, D, Rejdak, K, Lycke, J, Fredriksen, Jette Lautrup, Drulovic, J, Confavreux, C, Brassat, D, Enzinger, C, Fuchs, S, Bosca, I, Pelletier, J, Picard, C, Colombo, E, Franciotta, D, Derfuss, T, Lindberg, Rlp, Yaldizli, Ö, Vécsei, L, Kieseier, B C, Hartung, H P, Villoslada, P, Siva, A, Saiz, A, Tumani, H, Havrdová, E, Villar, L M, Leone, M, Barizzone, N, Deisenhammer, F, Teunissen, C, Montalban, X, Tintoré, M, Olsson, T, Trojano, M, Lehmann, S, Castelnovo, G, Lapin, S, Hintzen, R, Kappos, L, Furlan, R, Martinelli, V, Comi, G, Ramagopalan, S V, and Giovannoni, G

Abstract

BACKGROUND AND OBJECTIVE: We explored which clinical and biochemical variables predict conversion from clinically isolated syndrome (CIS) to clinically definite multiple sclerosis (CDMS) in a large international cohort.METHODS: Thirty-three centres provided serum samples from 1047 CIS cases with at least two years' follow-up. Age, sex, clinical presentation, T2-hyperintense lesions, cerebrospinal fluid (CSF) oligoclonal bands (OCBs), CSF IgG index, CSF cell count, serum 25-hydroxyvitamin D3 (25-OH-D), cotinine and IgG titres against Epstein-Barr nuclear antigen 1 (EBNA-1) and cytomegalovirus were tested for association with risk of CDMS.RESULTS: At median follow-up of 4.31 years, 623 CIS cases converted to CDMS. Predictors of conversion in multivariable analyses were OCB (HR = 2.18, 95% CI = 1.71-2.77, p < 0.001), number of T2 lesions (two to nine lesions vs 0/1 lesions: HR = 1.97, 95% CI = 1.52-2.55, p < 0.001; >9 lesions vs 0/1 lesions: HR = 2.74, 95% CI = 2.04-3.68, p < 0.001) and age at CIS (HR per year inversely increase = 0.98, 95% CI = 0.98-0.99, p < 0.001). Lower 25-OH-D levels were associated with CDMS in univariable analysis, but this was attenuated in the multivariable model. OCB positivity was associated with higher EBNA-1 IgG titres.CONCLUSIONS: We validated MRI lesion load, OCB and age at CIS as the strongest independent predictors of conversion to CDMS in this multicentre setting. A role for vitamin D is suggested but requires further investigation.

Published
2015

44. Conversion from clinically isolated syndrome to multiple sclerosis: A large multicentre study

Author

Kuhle, J, primary, Disanto, G, additional, Dobson, R, additional, Adiutori, R, additional, Bianchi, L, additional, Topping, J, additional, Bestwick, JP, additional, Meier, U-C, additional, Marta, M, additional, Costa, G Dalla, additional, Runia, T, additional, Evdoshenko, E, additional, Lazareva, N, additional, Thouvenot, E, additional, Iaffaldano, P, additional, Direnzo, V, additional, Khademi, M, additional, Piehl, F, additional, Comabella, M, additional, Sombekke, M, additional, Killestein, J, additional, Hegen, H, additional, Rauch, S, additional, D’Alfonso, S, additional, Alvarez-Cermeño, JC, additional, Kleinová, P, additional, Horáková, D, additional, Roesler, R, additional, Lauda, F, additional, Llufriu, S, additional, Avsar, T, additional, Uygunoglu, U, additional, Altintas, A, additional, Saip, S, additional, Menge, T, additional, Rajda, C, additional, Bergamaschi, R, additional, Moll, N, additional, Khalil, M, additional, Marignier, R, additional, Dujmovic, I, additional, Larsson, H, additional, Malmestrom, C, additional, Scarpini, E, additional, Fenoglio, C, additional, Wergeland, S, additional, Laroni, A, additional, Annibali, V, additional, Romano, S, additional, Martínez, AD, additional, Carra, A, additional, Salvetti, M, additional, Uccelli, A, additional, Torkildsen, Ø, additional, Myhr, KM, additional, Galimberti, D, additional, Rejdak, K, additional, Lycke, J, additional, Frederiksen, JL, additional, Drulovic, J, additional, Confavreux, C, additional, Brassat, D, additional, Enzinger, C, additional, Fuchs, S, additional, Bosca, I, additional, Pelletier, J, additional, Picard, C, additional, Colombo, E, additional, Franciotta, D, additional, Derfuss, T, additional, Lindberg, RLP, additional, Yaldizli, Ö, additional, Vécsei, L, additional, Kieseier, BC, additional, Hartung, HP, additional, Villoslada, P, additional, Siva, A, additional, Saiz, A, additional, Tumani, H, additional, Havrdová, E, additional, Villar, LM, additional, Leone, M, additional, Barizzone, N, additional, Deisenhammer, F, additional, Teunissen, C, additional, Montalban, X, additional, Tintoré, M, additional, Olsson, T, additional, Trojano, M, additional, Lehmann, S, additional, Castelnovo, G, additional, Lapin, S, additional, Hintzen, R, additional, Kappos, L, additional, Furlan, R, additional, Martinelli, V, additional, Comi, G, additional, Ramagopalan, SV, additional, and Giovannoni, G, additional

Published
2015
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46. IL28B polymorphisms are not associated with the response to interferon-beta in multiple sclerosis

Author

Malhotra, S., Morcillo-Suárez, C., Brassat, D., Goertsches, R., Lechner-Scott, J., Urcelay, E., Fernández, O., Drulovic, J., García-Merino, A., Martinelli Boneschi, F., Chan, A., Vandenbroeck, K., Navarro, A., Bustamante, M.F., Río, J., Akkad, D.A., Giacalone, G., Sánchez, A.J., Leyva, L., Alvarez-Lafuente, R., Zettl, U.K., Oksenberg, J., Montalban, X., and Comabella, M.

Published
2011
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