Contributions
Abstract: P844
Type: Poster
Abstract Category: Clinical aspects of MS - 2 MS Variants
Introduction: Neuromyelitis Optica Spectrum Disorders (NMOSD) is a severe demyelinating disease antibody-mediated with no approved treatment. Rituximab (RTX) has been proposed as a first-line therapy, but few comparative studies have been published so far. We retrospectively evaluated the effect of RTX treatment respect to cyclophosphamide (CFX) which is one of the main alternative therapy used in these patients.
Methods: Overall among the 70 NMOSD patients followed at our centre, 42 patients received at least one cycle of RTX and 25 patients received at least two cycles of CFX.
Results: No differences in disease severity and clinical characteristics between the two cohorts were observed (table 1). The median treatment duration was 33 and 11 months for the RTX and CFX group respectively. Overall the proportion of relapse free patients was significantly higher in the RTX group (57% vs 20% p< 0.0001). The reduction of the mean ARR was significantly higher in the group of patients receiving RTX (81 vs 43% p< 0,05). In both groups the EDSS was stable or improved in the majority of patients (83% in the group treated with RTX and 72% in the group receiving CFX). Since fourteen patients were treated with RTX after the failure of CFX, subgroup analysis confirming the results were performed.
Conclusion: Our study demonstrated a more efficacy of RTX in NMO patients respect to CFX. Despite the several limitations of the study, our results justify an earlier use of the monoclonal antibody and confirm that RTX can be considered the best treatment option in NMO SD patients. However as the CFX was used at the standard dosage of 800 mg/m2 we cannot exclude a possible better outcome with higher dose of the immunosuppressive drug. More comparative studies are needed to establish a treatment algorithm in patients with NMOSD and to confirm a major efficacy of RTX respect to other immunosuppressive drugs.
Disclosure: Dr. Sangalli, Dr. Radaelli, Dr. F. Esposito, Dr Pensato, Dr. G. Greco and Dott. Comola have no conflicts of interest relevant to this submission. Dr. Moiola reports speaking fees and/or travel expenses from Merck Serono and from Biogen, outside the submitted work.
Dr. Colombo reports speaking fees and/or travel expenses from Merck Serono and from Teva Pharmaceuticals, outside the submitted work. Prof. Comi has received compensation for consulting services and/or speaking activities from Biogen, Novartis, Teva Pharmaceutical Ind, Sanofi, Genzyme, Merck Serono, Biogen, Bayer, Actelion and Serono Symposia Int. Found, outside the submitted work. Dr. Martinelli reports consultancy, speaking fees and/or travel expenses from Biogen-Dompè SG, Merck Serono, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme Europe, Teva Pharmaceuticals, outside the submitted work.
Abstract: P844
Type: Poster
Abstract Category: Clinical aspects of MS - 2 MS Variants
Introduction: Neuromyelitis Optica Spectrum Disorders (NMOSD) is a severe demyelinating disease antibody-mediated with no approved treatment. Rituximab (RTX) has been proposed as a first-line therapy, but few comparative studies have been published so far. We retrospectively evaluated the effect of RTX treatment respect to cyclophosphamide (CFX) which is one of the main alternative therapy used in these patients.
Methods: Overall among the 70 NMOSD patients followed at our centre, 42 patients received at least one cycle of RTX and 25 patients received at least two cycles of CFX.
Results: No differences in disease severity and clinical characteristics between the two cohorts were observed (table 1). The median treatment duration was 33 and 11 months for the RTX and CFX group respectively. Overall the proportion of relapse free patients was significantly higher in the RTX group (57% vs 20% p< 0.0001). The reduction of the mean ARR was significantly higher in the group of patients receiving RTX (81 vs 43% p< 0,05). In both groups the EDSS was stable or improved in the majority of patients (83% in the group treated with RTX and 72% in the group receiving CFX). Since fourteen patients were treated with RTX after the failure of CFX, subgroup analysis confirming the results were performed.
Conclusion: Our study demonstrated a more efficacy of RTX in NMO patients respect to CFX. Despite the several limitations of the study, our results justify an earlier use of the monoclonal antibody and confirm that RTX can be considered the best treatment option in NMO SD patients. However as the CFX was used at the standard dosage of 800 mg/m2 we cannot exclude a possible better outcome with higher dose of the immunosuppressive drug. More comparative studies are needed to establish a treatment algorithm in patients with NMOSD and to confirm a major efficacy of RTX respect to other immunosuppressive drugs.
Disclosure: Dr. Sangalli, Dr. Radaelli, Dr. F. Esposito, Dr Pensato, Dr. G. Greco and Dott. Comola have no conflicts of interest relevant to this submission. Dr. Moiola reports speaking fees and/or travel expenses from Merck Serono and from Biogen, outside the submitted work.
Dr. Colombo reports speaking fees and/or travel expenses from Merck Serono and from Teva Pharmaceuticals, outside the submitted work. Prof. Comi has received compensation for consulting services and/or speaking activities from Biogen, Novartis, Teva Pharmaceutical Ind, Sanofi, Genzyme, Merck Serono, Biogen, Bayer, Actelion and Serono Symposia Int. Found, outside the submitted work. Dr. Martinelli reports consultancy, speaking fees and/or travel expenses from Biogen-Dompè SG, Merck Serono, Bayer Schering, Novartis, Sanofi-Aventis, Genzyme Europe, Teva Pharmaceuticals, outside the submitted work.