Rituximab in the treatment of Neuromyelitis optica: a multicentre Italian observational study.
Rituximab (RTX) efficacy in NMO is suggested by several case series. No consensus exists on optimal dosing strategies. At present the treatment schedules more frequently used are 375 mg/m2/week iv for 4 weeks (RTX-A) and 1000 mg iv twice, 2 weeks apart (RTX-B). Aim of this study is to confirm RTX efficacy and safety in the treatment of NMO and to evaluate whether a most favourable dosage regimen exists. Data on RTX-treated NMO patients were collected from 13 Italian Hospitals. 73 patients (64 F), were enlisted. RTX-A was administered in 42/73 patients, RTX-B in 31/73. Median follow-up was 27 months (range 7-106). Mean relapse rate in the previous year before RTX start was 2.2 ± 1.3 for RTX-A and 2.3 ± 1.2 for RTX-B. ARR in the first year of treatment was 0.8 ± 0.9 for RTX-A and 0.2 ± 0.4 for RTX-B, in the second year of treatment was 0.9 ± 1.5 for RTX-A and 0.4 ± 0.8 for RTX-B patients (p = 0.001 for the first year, ns (0.09) for the second year). RTX-B was more effective in delaying the occurrence of a relapse (HR 2.2 (95 % IC 1.08-4.53) p = 0.02). Adverse events were described in 19/73 patients (mainly urinary tract and respiratory infections, and infusion reactions). Two deaths were reported in severely disabled patients. Though with the limitations of an observational study, our data support RTX efficacy in NMO and suggest that high dose pulses might be more effective than a more fractioned dose.
Multiple Sclerosis Study Center, ASST Valle Olona, PO di Gallarate (VA), Italy. pietro.annovazzi@gmail.com.
Pietro
P
Annovazzi
Regional MS Center, University Hospital S. Luigi Gonzaga, Orbassano (TO), Italy.
M
M
Capobianco
Department of Neurology, Scientific Institute H. San Raffaele, University Vita-Salute, Milan, Italy.
L
L
Moiola
Multiple Sclerosis Center, University of Catania, Catania, Italy.
F
F
Patti
Multiple Sclerosis Center, University of Catania, Catania, Italy.
J
J
Frau
Department of Neurosciences Ophtalmology and Genetics, University of Genoa, Genoa, Italy.
A
A
Uccelli
Department of Neurology I and neurorehabilitation, IRCCS Neuromed, Pozzilli (IS), Italy.|Department of Systems Medicine, University of Tor Vergata, Rome, Italy.
D
D
Centonze
Department of Neurology, AO University of Padova, Padua, Italy.
P
P
Perini
Departments of Neurological and Psychiatric Sciences, University of Bari, Bari, Italy.
C
C
Tortorella
Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
L
L
Prosperini
Department of Neurological Sciences, School of Medicine, Second University of Naples, Policlinico Federico II, Naples, Italy.
G
G
Lus
Department of Neurosciences, Multiple Sclerosis Unit, General Hospital, "OORR", Foggia, Italy.
A
A
Fuiani
Multiple Sclerosis Center, Ospedale Misericordia e Dolce, Prato, Italy.
M
M
Falcini
Department of Neurology, Scientific Institute H. San Raffaele, University Vita-Salute, Milan, Italy.
V
V
Martinelli
Multiple Sclerosis Study Center, ASST Valle Olona, PO di Gallarate (VA), Italy.|Department of Neurology, Scientific Institute H. San Raffaele, University Vita-Salute, Milan, Italy.
G
G
Comi
Multiple Sclerosis Study Center, ASST Valle Olona, PO di Gallarate (VA), Italy.
A
A
Ghezzi
D004185:Disability Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009471:Neuromyelitis Optica / Q000188:drug therapy* / Q000401:mortality; D012189:Retrospective Studies; D000069283:Rituximab / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D007155:Immunologic Factors; D000069283:Rituximab
Devic’s syndrome; Dosing regimen; Neuromyelitis optica; Rituximab