title: Safety and Clinical Outcomes of Rituximab Treatment in Patients with Multiple Sclerosis and Neuromyelitis Optica: Experience from a National Online Registry (GRAID).
abstract: BACKGROUND
  Multiple sclerosis (MS) is an immune-mediated disease. Over the last decades therapeutic options have broadened tremendously. Nevertheless, various therapeutic agents, e.g., rituximab, are currently used in the treatment of MS off label. Disease or health registries are useful methods to collect information about off-label treatments. The German registry for autoimmune disease (GRAID) is a multicenter, retrospective, non-interventional database of patients with various autoimmune diseases.
  
  
  OBJECTIVE
  The aim of this observational analysis is to present safety data of rituximab in the treatment of MS and neuromyelitis optica (NMO) in a real life clinical setting based on the available registry data.
  
  
  RESULTS
  Data were collected nationwide in patients who received rituximab. 56 patients were treated with rituximab for MS or NMO. Average observation period was 9.6 months (SD 7.6, ranging from 6 to 29.7 months). Interval between treatments cycles differed tremendously (ranging from 0 to 21 months, median 10 months). Number of infusions ranged from 1 up to more than 8. The analysis provides experience on almost 50 patient years. Infusion related reactions were most common and reported in four patients; infections were seen in three patients (two of them were hospitalized for urinary tract infection and urosepsis). All patients recovered from infection. Full treatment response was attested in a quarter of the patients; two thirds benefited partially from treatment.
  
  
  CONCLUSIONS
  Safety data of almost 50 patient years of treatment with rituximab show that rituximab is tolerated well in MS/NMO patients. Infections and infusion reactions are the most common adverse events. Our data may help the individual physician to balance efficacy of rituximab against the risk. • Data on rituximab in MS and NMO are provided for almost 50 patientyears • Rituximab was tolerated well • No unexpected side effects were seen • Almost 80% of the patients benefited at least partially from treatment.
authors.affiliation: Department of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany. paulus.rommer@meduniwien.ac.at.|Department of Neurology, Medical University of Vienna, Vienna, Austria. paulus.rommer@meduniwien.ac.at.
authors.forename: P S
authors.initials: PS
authors.lastname: Rommer
authors.affiliation: Department of Medicine/Rheumatology and Clinical Immunology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Dörner
authors.affiliation: Analytica GmbH, Lörrach, Germany.
authors.forename: K
authors.initials: K
authors.lastname: Freivogel
authors.affiliation: Department of Neurology, Jewish Hospital Berlin, Berlin, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Haas
authors.affiliation: Department of Neurology, Medical Faculty, Heinrich Heine-University, Düsseldorf, Germany.
authors.forename: B C
authors.initials: BC
authors.lastname: Kieseier
authors.affiliation: Institute of Clinical Neuroimmunology, Ludwig-Maximilians-University, Munich, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Kümpfel
authors.affiliation: NeuroCure Clinical Research Center, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Paul
authors.affiliation: Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Proft
authors.affiliation: Division of Rheumatology and Clinical Immunology, Department of Internal Medicine IV, University of Munich, Munich, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Schulze-Koops
authors.affiliation: Analytica GmbH, Lörrach, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Schmidt
authors.affiliation: Department of Neurology, University of Muenster, Muenster, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Wiendl
authors.affiliation: Department of Neurology & Stroke, Hertie Institute for Clinical Brain Research, Eberhard-Karls-University, Tübingen, Germany.|Department of Neurology, Goethe University Frankfurt, Frankfurt/Main, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Ziemann
authors.affiliation: Department of Neurology, Neuroimmunological Section, University of Rostock, Rostock, Germany.
authors.forename: U K
authors.initials: UK
authors.lastname: Zettl
mesh_terms: D000328:Adult; D005260:Female; D005858:Germany; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D009471:Neuromyelitis Optica / Q000188:drug therapy*; D012042:Registries; D012189:Retrospective Studies; D000069283:Rituximab / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007155:Immunologic Factors; D000069283:Rituximab
keywords: Multiple sclerosis; Neuromyelitis optica; Rituximab; Treatment