Contributions
Abstract: EP1616
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Rituximab, a chimeric monoclonal anti-CD20 B-cell depleting agent has shown promising results in the treatment of multiple sclerosis (MS). Since the publication of the first randomized controlled trials in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Primary-Progressive Multiple Sclerosis (PPMS) it has been used off-label in heterogeneous cohorts of MS patients.
Objective: To evaluate the efficacy and safety of rituximab given off-label to Cypriot patients with MS.
Methods: Clinical data for 30 MS patients (16 male, 14 female) treated with off-label rituximab at the Cyprus Institute of Neurology and Genetics were retrospectively collected and reviewed. Outcome data (relapse rate and EDSS progression) as well as adverse effects were recorded.
Results: Out of the 30 patients included in this study 10 were diagnosed with RRMS (mean age at diagnosis 23.8±6.3), 17 with Secondary Progressive MS (32.2±5.6) and 3 with PPMS (42±27.7). The median (range) EDSS pre-treatment was 4.5 (2.5-7.5), 6 (3.5-8) and 6(5-8) for RRMS, SPMS and PPMS patients respectively. Before rituximab initiation, 2 patients were treatment naive, 7 were treated with natalizumab, 6 with interferons, 11 with fingolimod and 4 with other immunosuppresive therapies. Patients were treated with 500 or 1000 mg rituximab IV every 6 months following an initial dose of 2000 mg subdivided into two infusions given within a 2-week interval. Seventeen out of the thirty patients included in this study have recently commenced rituximab infusions (< 12 months) and hence have a very short follow up period. The median (range) follow up period for the remaining 12 patients is 18 (13-63) months. Only one patient with SPMS discontinued treatment due to disease progression.Rituximab infusions were generally well tolerated; there were only six grade 3 or 4 adverse events recorded, including respiratory tract infections, cytopenias and drug-induced psoriasis. Following rituximab administration, all patients with RRMS (with a follow-up period of >12 months) remained relapse-free and had a stable or slightly improved EDSS score. Patients with SPMS had a significant reduction in their relapse rate and a stabilization or slight improvement of their EDSS scores.
Conclusion: Our results are in agreement with larger retrospective studies in which it was demonstrated that rituximab was well tolerated and effective in treating RRMS and SPMS patients by reducing relapse rate and stabilizing disease.
Disclosure: Eleni Leonidou:Nothing to disclose
Marios Pantzaris:Nothing to disclose
Kleopas Kleopa:Nothing to disclose
Theodoros Kyriakides:Nothing to disclose
Maria Loizidou:Nothing to disclose
Yiolanda Panayiota Christou:Nothing to disclose
Abstract: EP1616
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Background: Rituximab, a chimeric monoclonal anti-CD20 B-cell depleting agent has shown promising results in the treatment of multiple sclerosis (MS). Since the publication of the first randomized controlled trials in patients with Relapsing-Remitting Multiple Sclerosis (RRMS) and Primary-Progressive Multiple Sclerosis (PPMS) it has been used off-label in heterogeneous cohorts of MS patients.
Objective: To evaluate the efficacy and safety of rituximab given off-label to Cypriot patients with MS.
Methods: Clinical data for 30 MS patients (16 male, 14 female) treated with off-label rituximab at the Cyprus Institute of Neurology and Genetics were retrospectively collected and reviewed. Outcome data (relapse rate and EDSS progression) as well as adverse effects were recorded.
Results: Out of the 30 patients included in this study 10 were diagnosed with RRMS (mean age at diagnosis 23.8±6.3), 17 with Secondary Progressive MS (32.2±5.6) and 3 with PPMS (42±27.7). The median (range) EDSS pre-treatment was 4.5 (2.5-7.5), 6 (3.5-8) and 6(5-8) for RRMS, SPMS and PPMS patients respectively. Before rituximab initiation, 2 patients were treatment naive, 7 were treated with natalizumab, 6 with interferons, 11 with fingolimod and 4 with other immunosuppresive therapies. Patients were treated with 500 or 1000 mg rituximab IV every 6 months following an initial dose of 2000 mg subdivided into two infusions given within a 2-week interval. Seventeen out of the thirty patients included in this study have recently commenced rituximab infusions (< 12 months) and hence have a very short follow up period. The median (range) follow up period for the remaining 12 patients is 18 (13-63) months. Only one patient with SPMS discontinued treatment due to disease progression.Rituximab infusions were generally well tolerated; there were only six grade 3 or 4 adverse events recorded, including respiratory tract infections, cytopenias and drug-induced psoriasis. Following rituximab administration, all patients with RRMS (with a follow-up period of >12 months) remained relapse-free and had a stable or slightly improved EDSS score. Patients with SPMS had a significant reduction in their relapse rate and a stabilization or slight improvement of their EDSS scores.
Conclusion: Our results are in agreement with larger retrospective studies in which it was demonstrated that rituximab was well tolerated and effective in treating RRMS and SPMS patients by reducing relapse rate and stabilizing disease.
Disclosure: Eleni Leonidou:Nothing to disclose
Marios Pantzaris:Nothing to disclose
Kleopas Kleopa:Nothing to disclose
Theodoros Kyriakides:Nothing to disclose
Maria Loizidou:Nothing to disclose
Yiolanda Panayiota Christou:Nothing to disclose