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Off-label rituximab in patients with secondary progressive multiple sclerosis
Y. Naegelin1, P.R. Naegelin1, L. Kappos1,2, T. Derfuss1,2
1Neurology, Departments of Medicine, Biomedicine, Clinical Research and Biomedical Engineering, 2Laboratory of Clinical Neuroimmunology, Department of Biomedicine, University Hospital Basel, Basel, Switzerland
Background: Rituximab (RTX) is a monoclonal antibody against the B-cell-specific surface protein CD 20. Based on considerations about the role of B cells in the progressive phase of disease RTX might be an option in secondary progressive MS (SPMS).
Objective: To evaluate the course of disease after initiation of treatment with RTX in a local cohort of patients with SPMS.
Methods: Patients with active and/or rapidly progressive SPMS were treated off label with RTX and were included in this retrospective analysis if RTX had been given at least once and follow-up was at least one year. RTX was given in intervals of 6-12 months (m, once or twice 1'000mg intravenously within two weeks), based on the individual decision of the treating neurologist considering clinical course and CD-19-lymphocyte counts. Baseline (BL) was defined as the date of first rituximab infusion. Treatment duration was calculated to be 12 months after one infusion of RTX. Treatment Intensity (TI) was defined to be the total of administered RTX in mg divided by the duration of treatment in months. Standardized Neurostatus assessments (EDSS) were analysed on a yearly interval before BL and thereafter until a maximum of 12 m after last RTX dose.
Results: 36 patients (19 females) treated in our center before May 2014 with RTX were included into this analysis. Mean (min-max) age at BL was 49.6 years (y, 23-71), disease duration (DD) was 17.9 y (3-40), EDSS 2 y before BL was 5.9 (2.5-7.5), at BL 6.4 (3.0-8.5), last EDSS under treatment or up to 1 year after having stopped treatment was 6.6 (3.5-8.5). Mean follow-up was 3.1 y (1-7). Mean TI was 168.4 mg/month (83.3-250). Worsening of EDSS occurred in 14 patients (38.9%). 6 patients (16.67%) reached confirmed progression during follow-up.
In two patients (5.6%) treatment with RTX was stopped due to adverse events (microcytoclastic vasculitis, focal herpes zoster).
Conclusions: RTX treatment was generally well tolerated in this cohort of patients with active and/or rapidly progressing SPMS. Fewer patients than expected reached confirmed progression
Y. Naegelin1, P.R. Naegelin1, L. Kappos1,2, T. Derfuss1,2
1Neurology, Departments of Medicine, Biomedicine, Clinical Research and Biomedical Engineering, 2Laboratory of Clinical Neuroimmunology, Department of Biomedicine, University Hospital Basel, Basel, Switzerland
Background: Rituximab (RTX) is a monoclonal antibody against the B-cell-specific surface protein CD 20. Based on considerations about the role of B cells in the progressive phase of disease RTX might be an option in secondary progressive MS (SPMS).
Objective: To evaluate the course of disease after initiation of treatment with RTX in a local cohort of patients with SPMS.
Methods: Patients with active and/or rapidly progressive SPMS were treated off label with RTX and were included in this retrospective analysis if RTX had been given at least once and follow-up was at least one year. RTX was given in intervals of 6-12 months (m, once or twice 1'000mg intravenously within two weeks), based on the individual decision of the treating neurologist considering clinical course and CD-19-lymphocyte counts. Baseline (BL) was defined as the date of first rituximab infusion. Treatment duration was calculated to be 12 months after one infusion of RTX. Treatment Intensity (TI) was defined to be the total of administered RTX in mg divided by the duration of treatment in months. Standardized Neurostatus assessments (EDSS) were analysed on a yearly interval before BL and thereafter until a maximum of 12 m after last RTX dose.
Results: 36 patients (19 females) treated in our center before May 2014 with RTX were included into this analysis. Mean (min-max) age at BL was 49.6 years (y, 23-71), disease duration (DD) was 17.9 y (3-40), EDSS 2 y before BL was 5.9 (2.5-7.5), at BL 6.4 (3.0-8.5), last EDSS under treatment or up to 1 year after having stopped treatment was 6.6 (3.5-8.5). Mean follow-up was 3.1 y (1-7). Mean TI was 168.4 mg/month (83.3-250). Worsening of EDSS occurred in 14 patients (38.9%). 6 patients (16.67%) reached confirmed progression during follow-up.
In two patients (5.6%) treatment with RTX was stopped due to adverse events (microcytoclastic vasculitis, focal herpes zoster).
Conclusions: RTX treatment was generally well tolerated in this cohort of patients with active and/or rapidly progressing SPMS. Fewer patients than expected reached confirmed progression