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8. The agenda of the global patient reported outcomes for multiple sclerosis (PROMS) initiative: Progresses and open questions

Author

Zaratin, P, Vermersch, P, Amato, M, Brichetto, G, Coetzee, T, Cutter, G, Edan, G, Giovannoni, G, Gray, E, Hartung, H, Hobart, J, Helme, A, Hyde, R, Khan, U, Leocani, L, Mantovani, L, Mcburney, R, Montalban, X, Penner, I, Uitdehaag, B, Valentine, P, Weiland, H, Bertorello, D, Battaglia, M, Baneke, P, Comi, G, Zaratin P., Vermersch P., Amato M. P., Brichetto G., Coetzee T., Cutter G., Edan G., Giovannoni G., Gray E., Hartung H. P., Hobart J., Helme A., Hyde R., Khan U., Leocani L., Mantovani L. G., McBurney R., Montalban X., Penner I. -K., Uitdehaag B. M. J., Valentine P., Weiland H., Bertorello D., Battaglia M. A., Baneke P., Comi G., Zaratin, P, Vermersch, P, Amato, M, Brichetto, G, Coetzee, T, Cutter, G, Edan, G, Giovannoni, G, Gray, E, Hartung, H, Hobart, J, Helme, A, Hyde, R, Khan, U, Leocani, L, Mantovani, L, Mcburney, R, Montalban, X, Penner, I, Uitdehaag, B, Valentine, P, Weiland, H, Bertorello, D, Battaglia, M, Baneke, P, Comi, G, Zaratin P., Vermersch P., Amato M. P., Brichetto G., Coetzee T., Cutter G., Edan G., Giovannoni G., Gray E., Hartung H. P., Hobart J., Helme A., Hyde R., Khan U., Leocani L., Mantovani L. G., McBurney R., Montalban X., Penner I. -K., Uitdehaag B. M. J., Valentine P., Weiland H., Bertorello D., Battaglia M. A., Baneke P., and Comi G.

Abstract

On 12 September 2019, the global Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative was launched at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.

Published
2022

10. Did it hurt? COVID-19 vaccination experience in people with multiple sclerosis

Author

Allen-Philbey, K., primary, Stennett, A., additional, Begum, T., additional, Johnson, A.C., additional, MacDougall, A., additional, Green, S., additional, Dobson, R., additional, Giovannoni, G., additional, Gnanapavan, S., additional, Marta, M., additional, Smets, I., additional, Turner, B.P., additional, Baker, D., additional, Mathews, J., additional, and Schmierer, K., additional

Published
2022
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11. Incorporation of Other Biomarkers

Author

Gnanapavan, S., Giovannoni, G., Comi, Giancarlo, editor, Meldolesi, Jacopo, editor, Filippi, Massimo, editor, Leocani, Letizia, editor, Martino, Gianvito, editor, and Rovaris, Marco, editor

Published
2007
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15. Artificial intelligence extension of the OSCAR-IB criteria

Author

Petzold, A., Albrecht, P., Balcer, L., Bekkers, E., Brandt, A. U., Calabresi, P. A., Deborah, O. G., Graves, J. S., Green, A., Keane, P. A., Nij Bijvank, J. A., Sander, J. W., Paul, F., Saidha, S., Villoslada, P., Wagner, S. K., Yeh, E. A., Aktas, O., Antel, J., Asgari, N., Audo, I., Avasarala, J., Avril, D., Bagnato, F. R., Banwell, B., Bar-Or, A., Behbehani, R., Manterola, A. B., Bennett, J., Benson, L., Bernard, J., Bremond-Gignac, D., Britze, J., Burton, J., Calkwood, J., Carroll, W., Chandratheva, A., Cohen, J., Comi, G., Cordano, C., Costa, S., Costello, F., Courtney, A., Cruz-Herranz, A., Cutter, G., Crabb, D., Delott, L., De Seze, J., Diem, R., Dollfuss, H., El Ayoubi, N. K., Fasser, C., Finke, C., Fischer, D., Fitzgerald, K., Fonseca, P., Frederiksen, J. L., Frohman, E., Frohman, T., Fujihara, K., Cuellar, I. G., Galetta, S., Garcia-Martin, E., Giovannoni, G., Glebauskiene, B., Suarez, I. G., Jensen, G. P., Hamann, S., Hartung, H. -P., Havla, J., Hemmer, B., Huang, S. -C., Imitola, J., Jasinskas, V., Jiang, H., Kafieh, R., Kappos, L., Kardon, R., Keegan, D., Kildebeck, E., Kim, U. S., Klistorner, S., Knier, B., Kolbe, S., Korn, T., Krupp, L., Lagreze, W., Leocani, L., Levin, N., Liskova, P., Preiningerova, J. L., Lorenz, B., May, E., Miller, D., Mikolajczak, J., Said, S. M., Montalban, X., Morrow, M., Mowry, E., Murta, J., Navas, C., Nolan, R., Nowomiejska, K., Oertel, F. C., Oh, J., Oreja-Guevara, C., Orssaud, C., Osborne, B., Outteryck, O., Paiva, C., Palace, J., Papadopoulou, A., Patsopoulos, N., Pontikos, N., Preising, M., Prince, J., Reich, D., Rejdak, R., Ringelstein, M., Rodriguez de Antonio, L., Sahel, J. -A., Sanchez-Dalmau, B., Sastre-Garriga, J., Schippling, S., Schuman, J., Shindler, K., Shin, R., Shuey, N., Soelberg, K., Specovius, S., Suppiej, A., Thompson, A., Toosy, A., Torres, R., Touitou, V., Trauzettel-Klosinski, S., van der Walt, A., Vermersch, P., Vidal-Jordana, A., Waldman, A. T., Waters, C., Wheeler, R., White, O., Wilhelm, H., Winges, K. M., Wiegerinck, N., Wiehe, L., Wisnewski, T., Wong, S., Wurfel, J., Yaghi, S., You, Y., Yu, Z., Yu-Wai-Man, P., Zemaitien≐, R., Zimmermann, H., Albrecht P., Petzold A., Balcer, L., Bekkers, E., Brandt, A. U., Calabresi, P. A., Deborah, O. G., Graves, J. S., Green, A., Keane, P. A., Nij Bijvank, J. A., Sander, J. W., Paul, F., Saidha, S., Villoslada, P., Wagner, S. K., Yeh, E. A., Aktas, O., Antel, J., Asgari, N., Audo, I., Avasarala, J., Avril, D., Bagnato, F. R., Banwell, B., Bar-Or, A., Behbehani, R., Manterola, A. B., Bennett, J., Benson, L., Bernard, J., Bremond-Gignac, D., Britze, J., Burton, J., Calkwood, J., Carroll, W., Chandratheva, A., Cohen, J., Comi, G., Cordano, C., Costa, S., Costello, F., Courtney, A., Cruz-Herranz, A., Cutter, G., Crabb, D., Delott, L., De Seze, J., Diem, R., Dollfuss, H., El Ayoubi, N. K., Fasser, C., Finke, C., Fischer, D., Fitzgerald, K., Fonseca, P., Frederiksen, J. L., Frohman, E., Frohman, T., Fujihara, K., Cuellar, I. G., Galetta, S., Garcia-Martin, E., Giovannoni, G., Glebauskiene, B., Suarez, I. G., P. , Jensen, G., Hamann, S., Hartung, H. -P., Havla, J., Hemmer, B., Huang, S. -C., Imitola, J., Jasinskas, V., Jiang, H., Kafieh, R., Kappos, L., Kardon, R., Keegan, D., Kildebeck, E., Kim, U. S., Klistorner, S., Knier, B., Kolbe, S., Korn, T., Krupp, L., Lagreze, W., Leocani, L., Levin, N., Liskova, P., Preiningerova, J. L., Lorenz, B., May, E., Miller, D., Mikolajczak, J., Said, S. M., Montalban, X., Morrow, M., Mowry, E., Murta, J., Navas, C., Nolan, R., Nowomiejska, K., Oertel, F. C., Oh, J., Oreja-Guevara, C., Orssaud, C., Osborne, B., Outteryck, O., Paiva, C., Palace, J., Papadopoulou, A., Patsopoulos, N., Pontikos, N., Preising, M., Prince, J., Reich, D., Rejdak, R., Ringelstein, M., Rodriguez de Antonio, L., Sahel, J. -A., Sanchez-Dalmau, B., Sastre-Garriga, J., Schippling, S., Schuman, J., Shindler, K., Shin, R., Shuey, N., Soelberg, K., Specovius, S., Suppiej, A., Thompson, A., Toosy, A., Torres, R., Touitou, V., Trauzettel-Klosinski, S., van der Walt, A., Vermersch, P., Vidal-Jordana, A., Waldman, A. T., Waters, C., Wheeler, R., White, O., Wilhelm, H., Winges, K. M., Wiegerinck, N., Wiehe, L., Wisnewski, T., Wong, S., Wurfel, J., Yaghi, S., You, Y., Yu, Z., Yu-Wai-Man, P., Zemaitien≐, R., and Zimmermann, H.

Subjects
0301 basic medicine, Big Data, medicine.medical_specialty, Neurology, media_common.quotation_subject, Big data, MEDLINE, Reviews, Socio-culturale, Neurosciences. Biological psychiatry. Neuropsychiatry, Review, Public domain, Retina, Cohort Studies, 03 medical and health sciences, Annotation, 0302 clinical medicine, Artificial Intelligence, medicine, Humans, Quality (business), RC346-429, Tomography, media_common, Image pattern recognition, business.industry, General Neuroscience, Nervous System Diseases, Tomography, Optical Coherence, Algorithms, 030104 developmental biology, Optical Coherence, Imaging technology, RC0321, Neurology. Diseases of the nervous system, Neurology (clinical), Artificial intelligence, sense organs, business, 030217 neurology & neurosurgery, RC321-571
Abstract

Artificial intelligence (AI)‐based diagnostic algorithms have achieved ambitious aims through automated image pattern recognition. For neurological disorders, this includes neurodegeneration and inflammation. Scalable imaging technology for big data in neurology is optical coherence tomography (OCT). We highlight that OCT changes observed in the retina, as a window to the brain, are small, requiring rigorous quality control pipelines. There are existing tools for this purpose. Firstly, there are human‐led validated consensus quality control criteria (OSCAR‐IB) for OCT. Secondly, these criteria are embedded into OCT reporting guidelines (APOSTEL). The use of the described annotation of failed OCT scans advances machine learning. This is illustrated through the present review of the advantages and disadvantages of AI‐based applications to OCT data. The neurological conditions reviewed here for the use of big data include Alzheimer disease, stroke, multiple sclerosis (MS), Parkinson disease, and epilepsy. It is noted that while big data is relevant for AI, ownership is complex. For this reason, we also reached out to involve representatives from patient organizations and the public domain in addition to clinical and research centers. The evidence reviewed can be grouped in a five‐point expansion of the OSCAR‐IB criteria to embrace AI (OSCAR‐AI). The review concludes by specific recommendations on how this can be achieved practically and in compliance with existing guidelines.

Published
2021

16. Risk of requiring a wheelchair in primary progressive multiple sclerosis: Data from the ORATORIO trial and the MSBase registry

Author

Butzkueven, H, Spelman, T, Horakova, D, Hughes, S, Solaro, C, Izquierdo, G, Kubala Havrdova, E, Grand'Maison, F, Prat, A, Girard, M, Hupperts, R, Onofrj, M, Lugaresi, A, Taylor, B, Giovannoni, G, Kappos, L, Hauser, SL, Montalban, X, Craveiro, L, Freitas, R, Model, F, Overell, J, Muros-Le Rouzic, E, Sauter, A, Wang, Q, Wormser, D, Wolinsky, JS, Butzkueven, H, Spelman, T, Horakova, D, Hughes, S, Solaro, C, Izquierdo, G, Kubala Havrdova, E, Grand'Maison, F, Prat, A, Girard, M, Hupperts, R, Onofrj, M, Lugaresi, A, Taylor, B, Giovannoni, G, Kappos, L, Hauser, SL, Montalban, X, Craveiro, L, Freitas, R, Model, F, Overell, J, Muros-Le Rouzic, E, Sauter, A, Wang, Q, Wormser, D, and Wolinsky, JS

Abstract

BACKGROUND AND PURPOSE: Reaching Expanded Disability Status Scale (EDSS) ≥7.0 represents the requirement for a wheelchair. Here we (i) assess the effect of ocrelizumab on time to EDSS ≥7.0 over the ORATORIO (NCT01194570) double-blind and extended controlled periods (DBP+ECP), (ii) quantify likely long-term benefits by extrapolating results, and (iii) assess the plausibility of extrapolations using an independent real-world cohort (MSBase registry; ACTRN12605000455662). METHODS: Post hoc analyses assessing time to 24-week confirmed EDSS ≥7.0 in two cohorts of patients with primary progressive multiple sclerosis (baseline EDSS 3.0-6.5) were investigated in ORATORIO and MSBase. RESULTS: In the ORATORIO DBP+ECP, ocrelizumab reduced the risk of 24-week confirmed EDSS ≥7.0 (hazard ratio = 0.54, 95% confidence interval [CI]: 0.31-0.92; p = 0.022). Extrapolated median time to 24-week confirmed EDSS ≥7.0 was 12.1 and 19.2 years for placebo and ocrelizumab, respectively (7.1-year delay [95% CI: -4.3 to 18.4]). In MSBase, the median time to 24-week confirmed EDSS ≥7.0 was 12.4 years. CONCLUSIONS: Compared with placebo, ocrelizumab significantly delayed time to 24-week confirmed wheelchair requirement in ORATORIO. The plausibility of the extrapolated median time to reach this milestone in the placebo group was supported by observed real-world data from MSBase. Extrapolated benefits for ocrelizumab over placebo could represent a truly meaningful delay in loss of ambulation and independence.

Published
2022

17. Timely intervention, monitoring and education MATTERS in MS (TIME MATTERS in MS): Development of a globally applicable quality improvement tool.

Author

Hobart, J, Butzkueven, H, Haartsen, J, Ziemssen, T, Lane, T, Giovannoni, G, Hobart, J, Butzkueven, H, Haartsen, J, Ziemssen, T, Lane, T, and Giovannoni, G

Abstract

BACKGROUND: Previously, consensus MS care standards were defined by MS specialist neurologists from 19 countries. We developed, piloted and refined an Excel-based quality improvement tool to enable MS services to benchmark against these standards. Here, we examine the refined tool. OBJECTIVE: To determine the applicability of the quality improvement tool in different healthcare settings. METHODS: MS centres across the globe were invited to pilot the quality improvement tool by coding the medical records of 36 adults with MS. We invited feedback on user friendliness, quality improvement tool usefulness and relevance of data collected. RESULTS: Seventeen centres from 14 countries participated; 14 completed the post-service evaluation survey. Over 50% of responders rated the tool 'very easy' or 'easy' to use and 'very relevant' to their service. Almost 85% of responders (11/13) planned to introduce changes to their service, including improvements in documentation, communication, interactions with colleagues and referrals; 85% would use a future shorter version of the tool. CONCLUSIONS: The quality improvement tool can enable MS centres globally to benchmark their services. Widespread uptake of a shorter tool may help MS centres to work towards achieving consensus standards for brain health-focused care. Incorporation into routine clinical practice would drive adoption.

Published
2022

18. The Sylvia Lawry Centre for Multiple Sclerosis Research (SLCMSR)-- Critical review facing the 20 anniversary

Author

Heesen, C., Magyari, M., Stellmann, J. P., Lederer, C., Giovannoni, G., Scalfari, A., Daumer, M., Heesen, C., Magyari, M., Stellmann, J. P., Lederer, C., Giovannoni, G., Scalfari, A., and Daumer, M.

Abstract

The SLCMSR was formed as an international Multiple Sclerosis Trials, Research and Resource Center to identify clinical MRI and other predictors of the course of multiple sclerosis (MS) based on a large database of natural history and clinical trial data. Using an elaborate validation concept several key findings were published, challenging established outcome parameters and their assessment in MS such as disability ratings with Expanded Disability Status Scale (EDSS), relapses and MRI endpoints. Sustained increase of EDSS appeared to be an invalid outcome for 2-3 year clinical trials at least in patients with relapsing-remitting MS. The number of gadolinium-enhancing lesions and T2-lesion load on MRI were shown not to have a meaningful additional predictive value for the disease course. These issues risen some 15 years ago had triggered controversial discussions which have also been noticed by regulatory authorities and they all have not been resolved. In addition the SLCMSR contributed to the development of new outcomes such as real-world walking speed as an attractive, ecologically valid tool based on a wearable device. A so-called evidence-based-decision-support tool was constructed to provide individual prognostic estimates based on a matching algorithm to a given database. This paper con-densates the findings of 20 years of critical MS research.

Published
2022

19. Autologous haematopoietic stem cell transplantation for immunemediated neurological diseases: what, how, who and why?

Author

Brittain, Gavin, Coles, Alasdair J., Giovannoni, G., Muraro, Paolo Antonio, Palace, Jacqueline, Petrie, Jennifer, Roldan, Elisa, Scolding, N. J., Snowden, John A., and Sharrack, Basil

Subjects
NEUROLOGICAL disorders, MEDICAL care costs, COST control, TREATMENT effectiveness, IMMUNOLOGIC diseases, HEMATOPOIETIC stem cell transplantation
Abstract

In carefully selected patients, autologous haematopoietic stem cell transplantation (HSCT) is a safe, highly effective and cost-saving treatment modality for treatment-resistant, and potentially treatment-naïve, immune-mediated neurological disorders. Although the evidence base has been growing in the last decade, limited understanding has led to confusion, mistrust and increasing use of health tourism. In this article, we discuss what autologous HSCT is, which immune-mediated conditions can be treated with it, how to select patients, what are the expected outcomes and potential adverse effects, and how cost-effective this treatment is. [ABSTRACT FROM AUTHOR]

Published
2023
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29. Update on the management of multiple sclerosis during the COVID-19 pandemic and post pandemic: An international consensus statement

Author

Reyes, S, Cunningham, AL, Kalincik, T, Havrdova, EK, Isobe, N, Pakpoor, J, Airas, L, Bunyan, RF, van der Walt, A, Oh, J, Mathews, J, Mateen, FJ, Giovannoni, G, Reyes, S, Cunningham, AL, Kalincik, T, Havrdova, EK, Isobe, N, Pakpoor, J, Airas, L, Bunyan, RF, van der Walt, A, Oh, J, Mathews, J, Mateen, FJ, and Giovannoni, G

Abstract

In this consensus statement, we provide updated recommendations on multiple sclerosis (MS) management during the COVID-19 crisis and the post-pandemic period applicable to neurology services around the world. Statements/recommendations were generated based on available literature and the experience of 13 MS expert panelists using a modified Delphi approach online. The statements/recommendations give advice regarding implementation of telemedicine; use of disease-modifying therapies and management of MS relapses; management of people with MS at highest risk from COVID-19; management of radiological monitoring; use of remote pharmacovigilance; impact on MS research; implications for lowest income settings, and other key issues.

Published
2021

30. Ocrelizumab versus Placebo in Primary Progressive Multiple Sclerosis

Author

Montalban, X., Hauser, S. L., Kappos, L., Arnold, D. L., Bar‑or, A., Comi, G., de Seze, J., Giovannoni, G., Hartung, H. -P., Hemmer, B., Lublin, F., Rammohan, K. W., Selmaj, K., Traboulsee, A., Sauter, A., Masterman, D., Fontoura, P., Belachew, S., Garren, H., Mairon, N., Chin, P., Wolinsky, J. S., Uccelli, A, for the ORATORIO Clinical Investigators, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), Klinische Neurowetenschappen, Institut Català de la Salut, [Montalban X] Hospital Universitari Vall d’Hebron, Barcelona, Spain. [Hauser SL] University of California, San Francisco, United States. [Kappos L] University Hospital Basel, Basel, Switzerland. [Arnold DL, Bar-Or A] McGill University, Montreal, Canada. [Comi G] University Vita-Salute San Raffaele, Milan, Italy., Hospital Universitari Vall d'Hebron, CIC Strasbourg (Centre d’Investigation Clinique Plurithématique (CIC - P) ), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Strasbourg (UNISTRA)-Hôpital de Hautepierre [Strasbourg]-Nouvel Hôpital Civil de Strasbourg, CHU Strasbourg, Université de Strasbourg (UNISTRA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Nouvel Hôpital Civil de Strasbourg-Hôpital de Hautepierre [Strasbourg], Montalban, X., Hauser, S. L., Kappos, L., Arnold, D. L., Bar or, A., Comi, Giancarlo, De Seze, J., Giovannoni, G., Hartung, H. . P., Hemmer, B., Lublin, F., Rammohan, K. W., Selmaj, K., Traboulsee, A., Sauter, A., Masterman, D., Fontoura, P., Belachew, S., Garren, H., Mairon, N., Chin, P., and Wolinsky, J. S.

Subjects
Male, 0301 basic medicine, Intention to Treat Analysi, T-Lymphocytes, Esclerosi múltiple, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple::esclerosis múltiple crónica progresiva [ENFERMEDADES], Other subheadings::Other subheadings::/drug therapy [Other subheadings], DOUBLE-BLIND, chemistry.chemical_compound, 0302 clinical medicine, DEMYELINATION, Monoclonal, Clinical endpoint, aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales::anticuerpos monoclonales humanizados [COMPUESTOS QUÍMICOS Y DROGAS], Infusions, Intravenou, Other subheadings::/therapeutic use [Other subheadings], Otros calificadores::Otros calificadores::/inmunología [Otros calificadores], Humanized, Otros calificadores::Otros calificadores::/tratamiento farmacológico [Otros calificadores], MULTICENTER TRIAL, Enfermedades del Sistema Nervioso::Enfermedades Autoinmunes del Sistema Nervioso::Enfermedades Autoinmunes Desmielinizantes SNC::Esclerosis Múltiple::Esclerosis Múltiple Crónica Progresiva [ENFERMEDADES], DAMAGE, B-Lymphocytes, Medicine (all), Hazard ratio, B-Lymphocyte, Brain, General Medicine, Multiple Sclerosis, Chronic Progressive, Middle Aged, Magnetic Resonance Imaging, Intention to Treat Analysis, 3. Good health, Chronic Progressive, Disease Progression, Female, Intravenous, Human, medicine.drug, Adult, Infusions, medicine.medical_specialty, Multiple Sclerosis, Adolescent, CANCER-RISK, Antibodies, Monoclonal, Humanized, Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal::Antibodies, Monoclonal, Humanized [CHEMICALS AND DRUGS], Placebo, Antibodies, Young Adult, 03 medical and health sciences, Double-Blind Method, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis::Multiple Sclerosis, Chronic Progressive [DISEASES], Other subheadings::Other subheadings::/immunology [Other subheadings], Multicenter trial, Internal medicine, medicine, Humans, CD20, Lymphocyte Count, Antigens, Intention-to-treat analysis, Otros calificadores::/uso terapéutico [Otros calificadores], business.industry, Multiple sclerosis, Antigens, CD20, medicine.disease, Infusions, Intravenous, Surgery, PATHOLOGY, 030104 developmental biology, Siponimod, T-Lymphocyte, ANTIBODY, chemistry, Ocrelizumab, Medicaments immunosupressors, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery
Abstract

Ocrelizumab; Placebo; Multiple sclerosis Ocrelizumab; Placebo; Esclerosi múltiple Ocrelizumab; Placebo; Esclerosis múltiple BACKGROUND: An evolving understanding of the immunopathogenesis of multiple sclerosis suggests that depleting B cells could be useful for treatment. We studied ocrelizumab, a humanized monoclonal antibody that selectively depletes CD20-expressing B cells, in the primary progressive form of the disease. METHODS: In this phase 3 trial, we randomly assigned 732 patients with primary progressive multiple sclerosis in a 2:1 ratio to receive intravenous ocrelizumab (600 mg) or placebo every 24 weeks for at least 120 weeks and until a prespecified number of confirmed disability progression events had occurred. The primary end point was the percentage of patients with disability progression confirmed at 12 weeks in a time-to-event analysis. RESULTS: The percentage of patients with 12-week confirmed disability progression was 32.9% with ocrelizumab versus 39.3% with placebo (hazard ratio, 0.76; 95% confidence interval [CI], 0.59 to 0.98; P=0.03). The percentage of patients with 24-week confirmed disability progression was 29.6% with ocrelizumab versus 35.7% with placebo (hazard ratio, 0.75; 95% CI, 0.58 to 0.98; P=0.04). By week 120, performance on the timed 25-foot walk worsened by 38.9% with ocrelizumab versus 55.1% with placebo (P=0.04); the total volume of brain lesions on T2-weighted magnetic resonance imaging (MRI) decreased by 3.4% with ocrelizumab and increased by 7.4% with placebo (P

Published
2017

31. 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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39. The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL

Author

Hutchinson, M., Kappos, L., Calabresi, P. A., Confavreux, C., Giovannoni, G., Galetta, S. L., Havrdova, E., Lublin, F. D., Miller, D. H., O’Connor, P. W., Phillips, J. T., Polman, C. H., Radue, E.-W., Rudick, R. A., Stuart, W. H., Wajgt, A., Weinstock-Guttman, B., Wynn, D. R., Lynn, F., Panzara, M. A., and for the AFFIRM and SENTINEL Investigators

Published
2009
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47. Axonal damage accumulates in the progressive phase of multiple sclerosis: three year follow up study

Author

Petzold, A., Eikelenboom, M.J., Keir, G., Grant, D., Lazeron, R.H.C., Polman, C.H., Uitdehaag, B.M.J., Thompson, E.J., and Giovannoni, G.

Subjects
Multiple sclerosis -- Research, Multiple sclerosis -- Prognosis, Multiple sclerosis -- Physiological aspects, Multiple sclerosis -- Patient outcomes, Cytoplasmic filaments -- Research, Nervous system -- Degeneration, Nervous system -- Research, Nervous system -- Patient outcomes, Cerebrospinal fluid, Health, Psychology and mental health
Published
2005

48. Dyskinesias and associated psychiatric disorders following streptococcal infections

Author

Dale, R.C., Heyman, I., Surtees, R.A.H., Church, A.J., Giovannoni, G., Goodman, R., and Neville, B.B.R.

Subjects
Mental illness -- Research, Mental illness -- Analysis, Mental illness -- Care and treatment, Movement disorders -- Research, Movement disorders -- Care and treatment, Streptococcal infections -- Research, Streptococcal infections -- Analysis, Streptococcal infections -- Causes of
Published
2004

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