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"no evidence of disease activity" AND "multiple sclerosis"

Jessica Frau, Giancarlo Coghe, Lorena Lorefice, Giuseppe Fenu, Luigina Musu, Eleonora Cocco
BACKGROUND: No postmarketing randomised clinical trials are available about alemtuzumab, and real-world data are limited. We aimed to analyse the efficacy and safety of alemtuzumab in a single-centre cohort of patients with relapsing-remitting MS. METHODS: Patients who took alemtuzumab were enrolled. We collected the following data: age, sex, MS history, expanded disability status scale (EDSS), relapses, magnetic resonance imaging (MRI) parameters after alemtuzumab, and adverse events...
March 12, 2019: Journal of Neurology
Bruce A C Cree, Jill A Hollenbach, Riley Bove, Gina Kirkish, Simone Sacco, Eduardo Caverzasi, Antje Bischof, Tristan Gundel, Alyssa H Zhu, Nico Papinutto, William A Stern, Carolyn Bevan, Andrew Romeo, Douglas S Goodin, Jeffrey M Gelfand, Jennifer Graves, Ari J Green, Michael R Wilson, Scott S Zamvil, Chao Zhao, Refujia Gomez, Nicholas R Ragan, Gillian Q Rush, Patrick Barba, Adam Santaniello, Sergio E Baranzini, Jorge R Oksenberg, Roland G Henry, Stephen L Hauser
OBJECTIVE: Rates of worsening and evolution to secondary progressive multiple sclerosis (MS) may be substantially lower in actively treated patients compared to natural history studies from the pre-treatment era. Nonetheless, in our recently reported prospective cohort more than half of patients with relapsing MS accumulated significant new disability by the 10th year of follow-up. Notably, "no evidence of disease activity" at 2-years did not predict long-term stability. Here, we determined to what extent clinical relapses and radiographic evidence of disease activity contribute to long-term disability accumulation...
March 9, 2019: Annals of Neurology
Hyunjin Kim, Eun-Jae Lee, Sung Keun Kim, Kwang-Kuk Kim, Young-Min Lim
BACKGROUND: Efficacy and safety profiles of alemtuzumab for relapsing-remitting multiple sclerosis (RRMS) mainly come from Western countries and have not been reported in Asian populations. The aim of this study was to report the efficacy and safety of alemtuzumab for RRMS patients in a Korean population. METHODS: We retrospectively reviewed RRMS patients treated with alemtuzumab. Study outcomes included annualized relapse rate (ARR), expanded disability status scale (EDSS) score, 6-month confirmed disability worsening (CDW), confirmed disability improvement (CDI), MRI lesion activity (new/enlarging T2 hyperintense and gadolinium-enhancing T1 lesions), no evidence of disease activity (NEDA), and adverse events...
March 2, 2019: Multiple Sclerosis and related Disorders
Lorena Lorefice, Federica Murgia, Giuseppe Fenu, Jessica Frau, Giancarlo Coghe, Maria Rita Murru, Stefania Tranquilli, Andrea Visconti, Maria Giovanna Marrosu, Luigi Atzori, Eleonora Cocco
Metabolomic research has emerged as a promising approach to identify potential biomarkers in multiple sclerosis (MS). The aim of the present study was to determine the effect of interferon beta (IFN ß) on the metabolome of MS patients to explore possible biomarkers of disease activity and therapeutic response. Twenty-one MS patients starting IFN ß therapy (Rebif® 44 μg; s.c. 3 times per week) were enrolled. Blood samples were obtained at baseline and after 6, 12, and 24 months of IFN ß treatment and were analyzed by high-resolution nuclear magnetic resonance spectroscopy...
February 28, 2019: Neurotherapeutics: the Journal of the American Society for Experimental NeuroTherapeutics
H N Beadnall, C Wang, W Van Hecke, A Ribbens, T Billiet, M H Barnett
Background: Whole brain atrophy (WBA) estimates in multiple sclerosis (MS) correlate more robustly with clinical disability than traditional, lesion-based metrics. We compare Structural Image Evaluation using Normalisation of Atrophy (SIENA) with the icobrain longitudinal pipeline (icobrain long), for assessment of longitudinal WBA in MS patients. Methods: Magnetic resonance imaging (MRI) scan pairs [1.05 (±0.15) year separation] from 102 MS patients were acquired on the same 3T scanner...
2019: Therapeutic Advances in Neurological Disorders
Carmen Alcalá, F Gascón, Francisco Pérez-Miralles, J A Domínguez, S Gil-Perotín, B Casanova
BACKGROUND: It has been described that treating relapsing-remitting multiple sclerosis (RRMS) patients with alemtuzumab following fingolimod could be less effective due to the different dynamics of lymphocyte repopulation. Effectiveness and safety of alemtuzumab compared to rituximab after fingolimod withdrawal were analyzed. PATIENTS AND METHODS: A follow-up of a cohort of RRMS patients treated with alemtuzumab or rituximab after fingolimod withdrawal was accomplished...
January 19, 2019: Journal of Neurology
Justin M Honce, Kavita V Nair, Stefan Sillau, Brooke Valdez, Augusto Miravalle, Enrique Alvarez, Teri Schreiner, John R Corboy, Timothy L Vollmer
OBJECTIVE: To examine whether rituximab induction followed by glatiramer acetate (GA) monotherapy is more effective than GA alone for the treatment of relapsing multiple sclerosis with active disease. METHODS: This was a single-center, double-blind, placebo-controlled study. Fifty-five participants were randomly assigned (1:1 ratio) to either rituximab (R-GA) or placebo (P-GA) induction, followed by GA therapy initiated in all participants. Participants were followed up to 3 years...
February 12, 2019: Neurology
Claudio Gasperini, Luca Prosperini, Mar Tintoré, Maria Pia Sormani, Massimo Filippi, Jordi Rio, Jacqueline Palace, Maria A Rocca, Olga Ciccarelli, Frederik Barkhof, Jaume Sastre-Garriga, Hugo Vrenken, Jette L Frederiksen, Tarek A Yousry, Christian Enzinger, Alex Rovira, Ludwig Kappos, Carlo Pozzilli, Xavier Montalban, Nicola De Stefano
Over the last few decades, the improved diagnostic criteria, the wide use of MRI, and the growing availability of effective pharmacologic treatments have led to substantial advances in the management of multiple sclerosis (MS). The importance of early diagnosis and treatment is now well-established, but there is still no consensus on how to define and monitor response to MS treatments. In particular, the clinical relevance of the detection of minimal MRI activity is controversial and recommendations on how to define and monitor treatment response are warranted...
January 22, 2019: Neurology
Dimitrios Papadopoulos, Dimos-Dimitrios D Mitsikostas
NEDA was evaluated as the proportion of patients free of relapses, 3-month confirmed disability progression, and free of new or newly enlarging T2 lesion and Gadolinium enhancing lesions.
December 20, 2018: CNS Drugs
Bassem I Yamout, Nabil K El-Ayoubi, Johny Nicolas, Yehya El Kouzi, Samia J Khoury, Maya M Zeineddine
Objective: To evaluate the efficacy and safety of rituximab in multiple sclerosis in a clinical practice setting. Methods: Clinical data for all adult patients with multiple sclerosis (MS) treated with off-label rituximab at a single MS center in Lebanon between March 2008 and April 2017 were retrospectively collected from medical charts. The main efficacy outcomes assessed were annualized relapse rate (ARR) and proportion of patients free from relapses, disability progression, or magnetic resonance imaging (MRI) activity...
2018: Journal of Immunology Research
Victor M Rivera
Multiple sclerosis (MS) has become a common neurological disorder involving populations previously considered to be infrequently affected. Genetic dissemination from high- to low-risk groups is a determining influence interacting with environmental and epigenetic factors, mostly unidentified. Disease modifying therapies (DMT) are effective in treating relapsing MS in variable degrees; one agent is approved for primary progressive disease, and several are in development. In the era of high-efficacy medications, complex molecules, and monoclonal antibodies (MAB), including anti-VLA4 (natalizumab), anti-CD52 (alemtuzumab), and anti-CD20 (ocrelizumab), obtaining NEDA (no evidence of disease activity) becomes an elusive accomplishment in areas of the world where access to MS therapies and care are generally limited...
November 30, 2018: Biomedicines
M Pisa, P Della Valle, A Coluccia, V Martinelli, G Comi, A D'Angelo, L Moiola
Alemtuzumab is a highly effective monoclonal antibody for the treatment of multiple sclerosis (MS). During the immune reconstitution following the use of this treatment severe secondary autoimmune diseases (SADs) can develop. We present the case of a patient affected by active MS who failed to achieve disease control with several disease-modifying drugs and was thereafter successfully treated with alemtuzumab, obtaining no evidence of disease activity and a high quality of life. Twenty months after the first infusion of alemtuzumab the patient developed acquired haemophilia A (AHA), a treatable but potentially lifethreatening condition that should be considered a possible SADs associated to this drug...
November 29, 2018: Multiple Sclerosis and related Disorders
Dimitrios Karussis, Panayiota Petrou
Immunotherapy of multiple sclerosis (MS) and other neuroimmune diseases is rapidly evolving. For the past 25 years, there has been an accelerating inclusion of new immunomodulating drugs. Based on their molecular construction and their basic mechanism of action, immunotherapeutic agents belong to the following categories: (1) cytotoxic drugs, (2) synthetic immunomodulators, (3) monoclonal antibodies, (4) vaccines (T cell vaccines, antigen vaccines), (5) oral tolerizing agents, (6) modalities that act as indirect immunosuppressants (plasmapheresis, intravenous immunoglobulins [IVIG]), and (7) cellular therapies...
November 16, 2018: Immunologic Research
J I Rojas, F Sanchez, F Caro, J Miguez, L Patrucco, J Funes, E Cristiano
The objective of our study was to evaluate the relationship of percentage of annualized brain volume loss (aBVL) and no evidence of disease activity (NEDA) in multiple sclerosis (MS) patients under interferon beta 1-a subcutaneous treatment (IFN-beta) during 3 years of follow up. Relapsing remitting MS (RRMS) patients, with less than three years from disease onset, expanded disability status scale (EDSS) ≤3 and in which IFN beta 1-a 44 mcg was indicated, were included. Demographic, clinical and structural parameters from the magnetic resonance (MR) during the 3 years of follow up were analyzed and compared between patients with and without NEDA (defined as the absence of: (a) three-month confirmed disability progression defined as an increase in EDSS score of 1...
November 3, 2018: Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia
Konstantin Huhn, Daniela Senger, Kathrin S Utz, Manuel Schmidt, Kilian Fröhlich, Anne Waschbisch, Frank Seifert, Arnd Dörfler, De-Hyung Lee, Ralf A Linker
BACKGROUND: Over the last decade, therapy of relapsing remitting multiple sclerosis (RRMS) has evolved with the approval of several new treatment concepts. Thus, treatment goals have become more ambitious aiming at "no evidence of disease activity" (NEDA). As NEDA-3, this concept comprises freedom of clinical disease progression and relapses as well as inflammatory MRI activity. So far, data on NEDA status mainly stem from post-hoc analyses of drug approval studies. Yet, less is known about the significance of NEDA in "real-world" clinical settings...
October 23, 2018: Multiple Sclerosis and related Disorders
Su Hyun Kim, Min Su Park, Woojun Kim, So Young Huh, Hyun June Shin, Jae Won Hyun, Ho Jin Kim
BACKGROUND AND PURPOSE: This study assessed the long-term outcomes of disease-modifying therapies (DMTs) in Korean multiple sclerosis (MS) patients treated in real-world clinical settings in Korea. METHODS: We retrospectively evaluated the medical records of 160 patients with an initial diagnosis of clinically isolated syndrome or relapsing-remitting MS who were treated for at least 2 years. A status of 3 for no evidence of disease activity (NEDA3) was defined as no relapse, disability progression, or active lesions in annual magnetic resonance imaging (MRI) evaluations...
October 26, 2018: Journal of Clinical Neurology
Luca Prosperini, Pietro Annovazzi, Laura Boffa, Maria Chiara Buscarinu, Antonio Gallo, Manuela Matta, Lucia Moiola, Luigina Musu, Paola Perini, Carlo Avolio, Valeria Barcella, Assunta Bianco, Deborah Farina, Elisabetta Ferraro, Simona Pontecorvo, Franco Granella, Luigi M E Grimaldi, Alice Laroni, Giacomo Lus, Francesco Patti, Eugenio Pucci, Matteo Pasca, Paola Sarchielli
In this retrospective, multicenter, real-world study we collected clinical and magnetic resonance imaging (MRI) data of all patients (n = 40) with relapsing-remitting multiple sclerosis (RRMS) treated with alemtuzumab according to a "free-of-charge" protocol available before the drug marketing approval in Italy. Almost all (39/40) started alemtuzumab after discontinuing multiple disease-modifying treatments (DMTs) because of either lack of response or safety concerns. We considered the proportion of alemtuzumab-treated patients who had no evidence of disease activity (NEDA-3) and disability improvement over a 36-month follow-up period...
December 2018: Journal of Neurology
Myintzu Min, Tim Spelman, Alessandra Lugaresi, Cavit Boz, Daniele LA Spitaleri, Eugenio Pucci, Francois Grand'Maison, Franco Granella, Guillermo Izquierdo, Helmut Butzkueven, Jose Luis Sanchez-Menoyo, Michael Barnett, Marc Girard, Maria Trojano, Pierre Grammond, Pierre Duquette, Patrizia Sola, Raed Alroughani, Raymond Hupperts, Steve Vucic, Tomas Kalincik, Vincent Van Pesch, Jeannette Lechner-Scott
BACKGROUND: The current best practice suggests yearly magnetic resonance imaging (MRI) to monitor treatment response in multiple sclerosis (MS) patients. OBJECTIVE: To evaluate the current practice of clinicians changing MS treatment based on subclinical new MRI lesions alone. METHODS: Using MSBase, an international MS patient registry with MRI data, we analysed the probability of treatment change among patients with clinically silent new MRI lesions...
October 2018: Multiple Sclerosis: Clinical and Laboratory Research
Anthony Traboulsee, David K B Li, Mark Cascione, Juanzhi Fang, Fernando Dangond, Aaron Miller
BACKGROUND: In the PRISMS study, interferon beta-1a subcutaneously (IFN β-1a SC) reduced clinical and radiological disease burden at 2 years in patients with relapsing-remitting multiple sclerosis. The study aimed to characterize efficacy of IFN β-1a SC 44 μg and 22 μg three times weekly (tiw) at Year 1. METHODS: Exploratory endpoints included annualized relapse rate (ARR), 3-month confirmed disability progression (1-point Expanded Disability Status Scale increase if baseline was < 6...
September 14, 2018: BMC Neurology
Douglas L Arnold, Shulian Shang, Qunming Dong, Matthias Meergans, Maria L Naylor
Background: No evidence of disease activity (NEDA) is a composite measurement, incorporating clinical and magnetic resonance imaging (MRI) elements of disease activity to sensitively evaluate the therapeutic efficacy of treatments for relapsing-remitting multiple sclerosis (RRMS). Objective: To assess the NEDA status of patients treated with peginterferon β-1a in the ADVANCE and ATTAIN studies and explore its predictive value on longer-term clinical outcomes. Methods: ATTAIN was a 2-year extension of the pivotal 2-year ADVANCE study of peginterferon β-1a for RRMS...
2018: Therapeutic Advances in Neurological Disorders
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