Contributions
Abstract: P1233
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Natalizumab has been commercially available for almost a decade, with approximately 140,000 patients exposed and 400,000 patient-years (PYs) of exposure. The large exposure to Natalizumab, especially compared with more recently approved multiple sclerosis (MS) disease-modifying therapies, provides the opportunity to assess postmarketing data for evidence of rare and/or latent events.
Objective: Report the long-term effectiveness and safety of Natalizumab in a French Cohort of relapsing-remitting multiple sclerosis (RRMS) patients.
Methods: This retrospective study enrolled 120 MS patients under Natalizumab treatment in Mulhouse, France, over a period of ten years. Clinical and radiological disease activity was assessed compared to baseline: Expanded Disease Scale Score (EDSS), annualized relapse rate (ARR), no evidence of disease activity (NEDA) defined by absence of relapses, no sustained EDSS progression, and absence of active magnetic resonance imaging (MRI) characterized by new T2 or T1 gadolinium-enhancing lesions. Natalizumab therapy discontinuation and adverse events were recorded for safety and tolerability evaluation.
Results: The detailed study will be presented.
Conclusion: In this French cohort, Natalizumab is effective on ARR reduction, MRI stabilization with 2/3 of patients with NEDA. This clinical practice cohort is consistent with efficacy data from phase 3 trials. The frequency of side effects leading to cessation of treatment, was higher in clinical practice than in clinical trials.
Disclosure: Rahma Beyrouti: nothing to disclose
Sohrab Mostofizadeh: nothing to disclose
Emanuelle Penombre: nothing to disclose
Sylvie Courtois: nothing to disclose
Elie Cohen: nothing to disclose
Abstract: P1233
Type: Poster
Abstract Category: Therapy - disease modifying - Long-term treatment monitoring
Background: Natalizumab has been commercially available for almost a decade, with approximately 140,000 patients exposed and 400,000 patient-years (PYs) of exposure. The large exposure to Natalizumab, especially compared with more recently approved multiple sclerosis (MS) disease-modifying therapies, provides the opportunity to assess postmarketing data for evidence of rare and/or latent events.
Objective: Report the long-term effectiveness and safety of Natalizumab in a French Cohort of relapsing-remitting multiple sclerosis (RRMS) patients.
Methods: This retrospective study enrolled 120 MS patients under Natalizumab treatment in Mulhouse, France, over a period of ten years. Clinical and radiological disease activity was assessed compared to baseline: Expanded Disease Scale Score (EDSS), annualized relapse rate (ARR), no evidence of disease activity (NEDA) defined by absence of relapses, no sustained EDSS progression, and absence of active magnetic resonance imaging (MRI) characterized by new T2 or T1 gadolinium-enhancing lesions. Natalizumab therapy discontinuation and adverse events were recorded for safety and tolerability evaluation.
Results: The detailed study will be presented.
Conclusion: In this French cohort, Natalizumab is effective on ARR reduction, MRI stabilization with 2/3 of patients with NEDA. This clinical practice cohort is consistent with efficacy data from phase 3 trials. The frequency of side effects leading to cessation of treatment, was higher in clinical practice than in clinical trials.
Disclosure: Rahma Beyrouti: nothing to disclose
Sohrab Mostofizadeh: nothing to disclose
Emanuelle Penombre: nothing to disclose
Sylvie Courtois: nothing to disclose
Elie Cohen: nothing to disclose