Contributions
Abstract: EP1647
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Natalizumab (NTZ) is a highly effective disease modifying treatment for relapsing-remitting multiple sclerosis (RRMS) that has been linked with an increased risk of developing Progressive Multifocal Leukoencephalpothy (PML). In most developed countries its use has since been restricted mostly to patients negative to JC virus antibodies or altogether avoided. In Brazil other highly effective therapies are not available in public healthcare, making Natalizumab an important tool to manage MS patients with active and/or aggressive disease. We report a single-center experience in very long-term use and risk management of NTZ.
Objectives: To report efficacy and safety of very long-term use of NTZ in a real-world setting using a strict surveillance protocol.
Methods: We retrospectively analysed charts from our clinic and identified patients who received NTZ for ≥ 48 infusions. We acquired data regarding clinical activity, JCV serostatus and severe infectious complications. All patients followed in our center with a high risk of PML who opt to maintain treatment with NTZ must adhere to a strict monitoring protocol consisting of routine clinical appointments every 3 months and MRI every 3-4 months, to allow for early detection of imaging changes suspect of PML.
Results: We identified 25 patients (84% female) with a median 60 infusions of NTZ (50 - 73). Nineteen (76%) patients were JCV positive, 13 of them with an AI titer ≥ 1.5 (52%). Three patients had a history of previous immunosuppressive drug use (Mitoxantrone, n=2; Cyclophosphamide, n=1), one of them negative for JCV antibiodies. Post-treatment ARR was 0.07. Six patients presented 9 relapses, 3 of them related to discontinuation of treatment. Complete clinical remission was achieved by 76% of patients and there were no severe infectious complications in the entire cohort. Other side effects were rare, mild and well tolerated.
Conclusion: Most patients achieved successful control of disease activity following the start of NTZ treatment. In patients who are willing to accept a risk of PML and intensive clinical and imaging monitoring, it may be viable to continue treatment for a very long time. This strategy is, however, costly and puts a high burden in both the patient and the healthcare provider.
Disclosure: Nothing to disclose.
Abstract: EP1647
Type: Poster Sessions
Abstract Category: Therapy - Long-term treatment monitoring
Introduction: Natalizumab (NTZ) is a highly effective disease modifying treatment for relapsing-remitting multiple sclerosis (RRMS) that has been linked with an increased risk of developing Progressive Multifocal Leukoencephalpothy (PML). In most developed countries its use has since been restricted mostly to patients negative to JC virus antibodies or altogether avoided. In Brazil other highly effective therapies are not available in public healthcare, making Natalizumab an important tool to manage MS patients with active and/or aggressive disease. We report a single-center experience in very long-term use and risk management of NTZ.
Objectives: To report efficacy and safety of very long-term use of NTZ in a real-world setting using a strict surveillance protocol.
Methods: We retrospectively analysed charts from our clinic and identified patients who received NTZ for ≥ 48 infusions. We acquired data regarding clinical activity, JCV serostatus and severe infectious complications. All patients followed in our center with a high risk of PML who opt to maintain treatment with NTZ must adhere to a strict monitoring protocol consisting of routine clinical appointments every 3 months and MRI every 3-4 months, to allow for early detection of imaging changes suspect of PML.
Results: We identified 25 patients (84% female) with a median 60 infusions of NTZ (50 - 73). Nineteen (76%) patients were JCV positive, 13 of them with an AI titer ≥ 1.5 (52%). Three patients had a history of previous immunosuppressive drug use (Mitoxantrone, n=2; Cyclophosphamide, n=1), one of them negative for JCV antibiodies. Post-treatment ARR was 0.07. Six patients presented 9 relapses, 3 of them related to discontinuation of treatment. Complete clinical remission was achieved by 76% of patients and there were no severe infectious complications in the entire cohort. Other side effects were rare, mild and well tolerated.
Conclusion: Most patients achieved successful control of disease activity following the start of NTZ treatment. In patients who are willing to accept a risk of PML and intensive clinical and imaging monitoring, it may be viable to continue treatment for a very long time. This strategy is, however, costly and puts a high burden in both the patient and the healthcare provider.
Disclosure: Nothing to disclose.