title: Neuromyelitis optica spectrum disorders: long-term safety and efficacy of rituximab in Caucasian patients.
abstract: OBJECTIVE
  To assess the long-term benefit-risk profile of repeated courses of rituximab in Caucasian patients affected by neuromyelitis optica (NMO) and related disorders, in everyday clinical practice.
  
  
  METHODS
  This is a prospective observational study performed at San Raffaele Hospital, Milan, Italy. From February 2006, we recruited 21 patients affected by NMO and NMO spectrum of disorders (NMOSD) whom underwent at least one cycle of intravenous (i.v.) rituximab and then were followed for at least 2 years.
  
  
  RESULTS
  At a mean follow-up time of 48 months, we observed a significant reduction of the annualized relapse rate (ARR), from 2.0 to 0.16 (p < 0.01); and of the median Expanded Disability Status Scale (EDSS), from 5.5 to 4.0 (p < 0.013). There were 12 patients (57%) who remained disease free during the follow-up period. Five patients (24%) reported mild hematological adverse events. Serious infectious adverse events were reported by another four patients: These were all wheelchair bound at the beginning of their rituximab treatment.
  
  
  CONCLUSIONS
  A fixed treatment scheme of rituximab, with re-treatment every 6 months, was efficacious for NMO and NMOSD, with a good safety profile; however, to obtain an even better benefit-risk ratio, close monitoring of CD19(+) B cells should be performed before the re-treatment of patients with high-level disability, concomitant leukopenia and hypogammaglobulinemia.
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy radaelli.marta@hsr.it.
authors.forename: M
authors.initials: M
authors.lastname: Radaelli
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Moiola
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Sangalli
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Esposito
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Barcella
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: L
authors.initials: L
authors.lastname: Ferrè
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Rodegher
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Colombo
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Fazio
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Martinelli
authors.affiliation: Department of Neurology, San Raffaele Scientific Institute, Milan, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Comi
mesh_terms: D000328:Adult; D000368:Aged; D004185:Disability Evaluation; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007558:Italy / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D009471:Neuromyelitis Optica / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology / Q000276:immunology; D011446:Prospective Studies; D020127:Recovery of Function; D012074:Remission Induction; D000069283:Rituximab / Q000008:administration & dosage* / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D044465:White People; D055815:Young Adult
chemical_list: D007166:Immunosuppressive Agents; D000069283:Rituximab
keywords: Adverse effects; antibody levels; disability; efficacy; infections; neuromyelitis optica; optic neuritis; recurrent transverse myelitis; risk profile; rituximab; safety