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1. Serum Neurofilament Levels and PML Risk in Patients With Multiple Sclerosis Treated With Natalizumab

Author

Fissolo, Nicolás, Pignolet, Beatrice, Rio, Jordi, Vermersch, Patrick, Ruet, Aurélie, deSèze, Jerome, Labauge, Pierre, Vukusic, Sandra, Papeix, Caroline, Martinez-Almoyna, Laurent, Tourbah, Ayman, Clavelou, Pierre, Moreau, Thibault, Pelletier, Jean, Lebrun-Frenay, Christine, Bourre, Bertrand, Defer, Gilles, Montalban, Xavier, Brassat, David, Comabella, Manuel, Universitat Autònoma de Barcelona, Universitat Autònoma de Barcelona (UAB), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Vall d'Hebron University Hospital [Barcelona], Lille Neurosciences & Cognition - U 1172 (LilNCog (ex-JPARC)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Physiopathologie de la Plasticité Neuronale (Neurocentre Magendie - U1215 Inserm), Université de Bordeaux (UB)-Institut François Magendie-Institut National de la Santé et de la Recherche Médicale (INSERM), Nouvel Hôpital Civil de Strasbourg, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Département de Neuroradiologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL), Service de Neurologie [CHU Pitié-Salpêtrière], IFR70-CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Service de Neurologie [Aix-en-Provence], Centre Hospitalier du Pays d'Aix, Centre Hospitalier Universitaire de Reims (CHU Reims), Laboratoire de Psychopathologie et Neuropsychologie (LPN), Université Paris 8 Vincennes-Saint-Denis (UP8), CHU Clermont-Ferrand, CHU Dijon, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Universitaire de Nice (CHU Nice), Unité de Recherche Clinique de la Côte d’Azur [Nice] (URRIS UR2CA), Université Côte d'Azur (UCA), CHU Rouen, Normandie Université (NU), CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre d'Esclerosi Múltiple de Catalunya (CemCat), Vall d’Hebron Research Institute (VHIR), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Lille Neurosciences & Cognition - U 1172 (LilNCog), Neurocentre Magendie : Physiopathologie de la Plasticité Neuronale (U1215 Inserm - UB), CHU Bordeaux [Bordeaux], Service de Neurologie [Strasbourg], CHU Strasbourg-Hopital Civil, Département de neurologie [Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Service de Neurologie [Lyon], CHU Lyon, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de neurologie [Reims], Service de Neurologie [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], Service de Neurologie générale, vasculaire et dégénérative (CHU de Dijon), Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Service de Neurologie [CHU Nice], Hôpital Pasteur [Nice] (CHU)-Centre Hospitalier Universitaire de Nice (CHU Nice), Service de neurologie [Rouen], Normandie Université (NU)-Normandie Université (NU), Service de Neurologie [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), HAL-SU, Gestionnaire, Institut Català de la Salut, [Fissolo N, Comabella M] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Institut de Recerca (VHIR), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. [Pignolet B] CRC-SEP Neurosciences Centre Hospitalier Universitaire Toulouse, CPTP INSERM UMR 1043 CNRS UMR 5282 et Université de Toulouse III, UPS, France. [Rio J, Montalban X] Servei de Neurologia-Neuroimmunologia, Centre d’Esclerosi Múltiple de Catalunya (CEMCAT), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Vermersch P] Univ. Lille, Inserm U1172, CHU Lille, FHU Imminent, France. [Ruet A] CHU de Bordeaux, INSERM-CHU CIC-P 0005, Service de Neurologie, Bordeaux F-33076, France. Université de Bordeaux, Bordeaux F-33076, France. [deSèze J] Department of Neurology, Hôpital Civil, Strasbourg, Vall d'Hebron Barcelona Hospital Campus, Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)

Subjects
Male, Oncology, Macromolecular Substances::Polymers::Biopolymers::Intermediate Filament Proteins::Neurofilament Proteins [CHEMICALS AND DRUGS], viruses, Other subheadings::Other subheadings::/drug therapy [Other subheadings], MESH: Multiple Sclerosis, Relapsing-Remitting / blood, 0302 clinical medicine, Natalizumab, Neurofilament Proteins, 030212 general & internal medicine, Prospective cohort study, MESH: Middle Aged, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Progressive multifocal leukoencephalopathy, Leukoencephalopathy, Progressive Multifocal, Nervous System Diseases::Autoimmune Diseases of the Nervous System::Demyelinating Autoimmune Diseases, CNS::Multiple Sclerosis [DISEASES], MESH: Multiple Sclerosis / diagnosis, virus diseases, MESH: Follow-Up Studies, Middle Aged, Prognosis, Clinical Practice, MESH: Immunologic Factors / administration & dosage, Neurology, MESH: Young Adult, enfermedades del sistema nervioso::enfermedades autoinmunitarias del sistema nervioso::enfermedades autoinmunes desmielinizantes del SNC::esclerosis múltiple [ENFERMEDADES], Cohort, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, MESH: Multiple Sclerosis / drug therapy, [SDV.NEU]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], Otros calificadores::Otros calificadores::Otros calificadores::/sangre [Otros calificadores], medicine.drug, Adult, medicine.medical_specialty, Neurofilament, MESH: Multiple Sclerosis, Relapsing-Remitting / diagnosis, [SDV.IMM] Life Sciences [q-bio]/Immunology, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Filaments citoplasmàtics, sustancias macromoleculares::polímeros::biopolímeros::proteínas de filamentos intermedios::proteínas de neurofilamentos [COMPUESTOS QUÍMICOS Y DROGAS], Sensitivity and Specificity, Article, MESH: Prognosis, Multiple sclerosis, Young Adult, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, parasitic diseases, MESH: Leukoencephalopathy, Progressive Multifocal / blood, medicine, Humans, Immunologic Factors, Other subheadings::Other subheadings::/blood [Other subheadings], In patient, [SDV.NEU] Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC], MESH: Leukoencephalopathy, Progressive Multifocal / diagnosis, MESH: Humans, business.industry, MESH: Multiple Sclerosis / blood, MESH: Adult, medicine.disease, MESH: Sensitivity and Specificity, MESH: Male, Class I, Avaluació de resultats (Assistència sanitària), MESH: Multiple Sclerosis, Relapsing-Remitting / drug therapy, Neurology (clinical), business, Esclerosi múltiple - Tractament, MESH: Female, MESH: Natalizumab / administration & dosage, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, 030217 neurology & neurosurgery, Follow-Up Studies, MESH: Neurofilament Proteins / blood
Abstract

ObjectivesThe study aimed to assess the potential for serum neurofilament light chain (NFL) levels to predict the risk of progressive multifocal leukoencephalopathy (PML) in natalizumab (NTZ)-treated patients with multiple sclerosis (MS) and to discriminate PML from MS relapses.MethodsNFL levels were measured with single molecule array (Simoa) in 4 cohorts: (1) a prospective cohort of patients with MS who developed PML under NTZ therapy (pre-PML) and non-PML NTZ-treated patients (NTZ-ctr); (2) a cohort of patients whose blood was collected during PML; (3) an independent cohort of non-PML NTZ-treated patients with serum NFL determinations at 2 years (replication cohort); and (4) a cohort of patients whose blood was collected during exacerbations.ResultsSerum NFL levels were significantly increased after 2 years of NTZ treatment in pre-PML patients compared with NTZ-ctr. The prognostic performance of serum NFL levels to predict PML development at 2 years was similar in the NTZ-ctr group and replication cohort. Serum NFL levels also distinguished PML from MS relapses and were 8-fold higher during PML compared with relapses.ConclusionsThese results support the use of serum NFL levels in clinical practice to identify patients with relapsing-remitting MS at higher PML risk and to differentiate PML from clinical relapses in NTZ-treated patients.Classification of EvidenceThis study provides Class I evidence that serum NFL levels can identify NTZ-treated patients with MS who will develop PML with a sensitivity of 67% and specificity of 80%.

Published
2021

2. Treatment with synthetic lipophilic tyrosyl ester controls Leishmania major infection by reducing parasite load in BALB/c mice

Author

Fatma Z. Guerfali, Hanène Attia, Youssef Gargouri, Pablo A. Leon Martinez, Ghada Mkannez, Aymen Bali, Dhafer Laouini, Imen Aissa, Rabiaa M. Sghaier, Laboratoire de Transmission, Contrôle et Immunobiologie des Infections - Laboratory of Transmission, Control and Immunobiology of Infection (LR11IPT02), Institut Pasteur de Tunis, Réseau International des Instituts Pasteur (RIIP)-Réseau International des Instituts Pasteur (RIIP), Université de Tunis El Manar (UTM), École Nationale d'Ingénieurs de Sfax | National School of Engineers of Sfax (ENIS), This work received financial support from the Tunisian Ministry of Higher Education and Scientific Research to the Transmission, Control and Immunobiology of Infections Laboratory (LR11IPT02, D. Laouini)., and We thank Mr A. Marouani and Dr Z. Ben Lasfer (Animal Facilities of the Institut Pasteur de Tunis) for their help conducting this study. We are also grateful to Ms S. Amouri for her help and thankful to Dr K. Ben-Aissa (Washignton, USA) and Dr S. Gritli (Department of Oto-Rhino-Laryngology, Charles Nicolle Hospital, Tunis, Tunisia) for their critical reading and grammar corrections

Subjects
0301 basic medicine, [SDV]Life Sciences [q-bio], Pharmacology, Parasite load, Mice, parasite load, 0302 clinical medicine, MESH: Animals, Leishmania major, MESH: Th1 Cells/immunology, Mice, Inbred BALB C, MESH: Leishmaniasis, Cutaneous/drug therapy, MESH: Tyrosine/analogs & derivatives, 3. Good health, [SDV.MP]Life Sciences [q-bio]/Microbiology and Parasitology, Infectious Diseases, 030220 oncology & carcinogenesis, Cytokines, Leishmania infantum, Injections, Subcutaneous, lipophilic tyrosyl ester, Antiprotozoal Agents, MESH: Mice, Inbred BALB C, Leishmaniasis, Cutaneous, MESH: Antiprotozoal Agents/administration & dosage, MESH: Leishmania major/drug effects, Biology, BALB/c, 03 medical and health sciences, Cutaneous leishmaniasis, In vivo, MESH: Tyrosine/pharmacology, medicine, Animals, Immunologic Factors, MESH: Mice, anti-leishmanial activity, MESH: Injections, Subcutaneous, Th1 Cells, biology.organism_classification, medicine.disease, Leishmania, In vitro, MESH: Parasite Load, MESH: Immunologic Factors/administration & dosage, Disease Models, Animal, 030104 developmental biology, Immunology, Tyrosine, Animal Science and Zoology, Parasitology, MESH: Cytokines/metabolism, MESH: Disease Models, Animal
Abstract

SUMMARYSynthesized lipophilic tyrosyl ester derivatives with increasing lipophilicity were effective against Leishmania (L.) major and Leishmania infantum species in vitro. These findings prompted us to test in vivo leishmanicidal properties of these molecules and their potential effect on the modulation of immune responses. The experimental BALB/c model of cutaneous leishmaniasis was used in this study. Mice were infected with L. major parasites and treated with three in vitro active tyrosyl esters derivatives.Among these tested tyrosylcaprate (TyC) compounds, only TyC10 exhibited an in vivo anti-leishmanial activity, when injected sub-cutaneously (s.c.). TyC10 treatment of L. major-infected BALB/c mice resulted in a decrease of lesion development and parasite load. TyC10 s.c. treatment of non-infected mice induced an imbalance in interferon γ/interleukin 4 (IFN-γ/IL-4) ratio cytokines towards a Th1 response. Our results indicate that TyC10 s.c. treatment improves lesions’ healing and parasite clearance and may act on the cytokine balance towards a Th1 protective response by decreasing IL-4 and increasing IFN-γ transcripts. TyC10 is worthy of further investigation to uncover its mechanism of action that could lead to consider this molecule as a potential drug candidate.

Published
2016

3. Efficacy of rituximab in refractory RRMS

Author

Clarisse Carra-Dalliere, Pierre Durozard, Marc Debouverie, Audrey Rico Lamy, Bruno Brochet, C. Giannesini, Olivier Gout, Aurélie Ruet, Jean Pelletier, Sandra Vukusic, Adil Maarouf, Bertrand Audoin, Jonathan Ciron, Caroline Papeix, Clemence Boutiere, David Brassat, Catherine Lubetzki, C. Bensa, Bruno Stankoff, Elisabeth Maillart, Pierre Labauge, Guillaume Mathey, Aix-Marseille Université - Faculté de médecine (AMU MED), Aix Marseille Université (AMU), 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), Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - AP-HM] (CEMEREM), Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)-Assistance Publique - Hôpitaux de Marseille (APHM)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS)- Hôpital de la Timone [CHU - APHM] (TIMONE), Centre National de la Recherche Scientifique (CNRS), Service de neurologie [Bordeaux], CHU Bordeaux [Bordeaux]-Groupe hospitalier Pellegrin, Département de neurologie [Montpellier], Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [Montpellier]-Université de Montpellier (UM), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Service de neurologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Service de neurologie 1 [CHU Pitié-Salpétrière], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Service de Neurologie [CHU Pitié-Salpêtrière], IFR70-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service de Neurologie [CHU Nice], Hôpital Pasteur [Nice] (CHU)-Centre Hospitalier Universitaire de Nice (CHU Nice), Department of Neurology, Fondation A de Rothschild, Institut du Cerveau et de la Moëlle Epinière = Brain and Spine Institute (ICM), Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Centre d'Exploration Métabolique par Résonance Magnétique [Hôpital de la Timone - APHM] (CEMEREM), Hôpital de la Timone [CHU - APHM] (TIMONE)-Centre de résonance magnétique biologique et médicale (CRMBM), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS)-Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Centre National de la Recherche Scientifique (CNRS), Université de Bordeaux (UB), Hospices Civils de Lyon, Departement de Neurologie (HCL), Fondation Eugène Devic EDMUS, Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Gui de Chauliac [CHU Montpellier], Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université de Montpellier (UM), Fondation Ophtalmologique Adolphe de Rothschild [Paris], CHU Saint-Antoine [AP-HP], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), and Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
Oncology, Male, [SDV]Life Sciences [q-bio], 0302 clinical medicine, Outcome Assessment, Health Care, 030212 general & internal medicine, disease-modifying therapies, relapsing/remitting, ComputingMilieux_MISCELLANEOUS, MESH: Middle Aged, medicine.diagnostic_test, Middle Aged, 3. Good health, MESH: Immunologic Factors / administration & dosage, Neurology, MESH: Young Adult, Disease Progression, MESH: Disease Progression, Rituximab, Female, medicine.drug, Adult, medicine.medical_specialty, Treatment response, MESH: Rituximab / pharmacology, Multiple sclerosis, MESH: Rituximab / administration & dosage, 03 medical and health sciences, Young Adult, Multiple Sclerosis, Relapsing-Remitting, Refractory, Rescue therapy, Internal medicine, medicine, [SDV.MHEP.AHA]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Immunologic Factors, In patient, MESH: Outcome Assessment, Health Care, Retrospective Studies, MESH: Humans, business.industry, treatment response, MESH: Adult, MESH: Retrospective Studies, Magnetic resonance imaging, medicine.disease, MESH: Male, Persistent Disease, MESH: Immunologic Factors / pharmacology, second-line treatment, MESH: Multiple Sclerosis, Relapsing-Remitting / drug therapy, Neurology (clinical), business, MESH: Female, 030217 neurology & neurosurgery
Abstract

Objective: To investigate the efficacy of rituximab as rescue therapy in patients with relapsing-remitting multiple sclerosis (RRMS) and persistent disease activity confirmed by magnetic resonance imaging (MRI) despite immunosuppressive disease-modifying therapy (DMT). Methods: In this observational nationwide retrospective multicenter study, we first identified 351 off-label rituximab-treated patients through a cohort of 15,984 RRMS patients. In this group, we identified patients with disease activity prior to rituximab confirmed by MRI (one or more new T2 lesion and/or gadolinium-enhancing lesion) despite immunosuppressive DMT (fingolimod, natalizumab, or mitoxantrone) with a follow-up after rituximab initiation longer than 6 months. Outcome data were collected from the French Observatory of Multiple Sclerosis (OFSEP) register and medical charts. Results: A total of 50 patients were identified. Median rituximab treatment duration was 1.1 (0.5–6.4) year. Mean annualized relapse rate significantly decreased from 0.8 during last immunosuppressive DMT to 0.18 after rituximab ( p Conclusion: This study provides level IV evidence that rituximab reduces clinical and MRI disease activity in patients with active RRMS despite immunosuppressive DMT.

Published
2018

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