Y Naegelin1, M Rasenack2, M Andelova3, S Von Felten4, B Fischer-Barnicol2, M Amann5, M Mehling2, L Kappos2, T Sprenger6, T Derfuss2. 1. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, Basel 4031, Switzerland. Electronic address: Yvonne.naegelin@usb.ch. 2. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, Basel 4031, Switzerland. 3. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, Basel 4031, Switzerland; Medical Image Analysis Center, University Hospital Basel, Marktgasse 8, Basel 4051, Switzerland; Department of Neurology, First Faculty of Medicine, Charles University and General Hospital Prague, Ovocný trh 560/5, Prague 1 116 36, Czech Republic. 4. Clinical Trial Unit, Department of Clinical Research, University Hospital Basel, Schanzenstrasse 55, Basel 4056, Switzerland. 5. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, Basel 4031, Switzerland; Medical Image Analysis Center, University Hospital Basel, Marktgasse 8, Basel 4051, Switzerland; Department of Radiology and Nuclear Medicine, University Hospital Basel, Petersgraben 4, Basel 4031, Switzerland. 6. Neurologic Clinic and Policlinic, Departments of Medicine, Clinical Research, Biomedicine and Biomedical Engineering, University Hospital and University of Basel, Petersgraben 4, Basel 4031, Switzerland; Medical Image Analysis Center, University Hospital Basel, Marktgasse 8, Basel 4051, Switzerland; Department of Neurology, DKD HELIOS Klinik Wiesbaden, Aukammallee 33, 65191 Wiesbaden, Germany.
Abstract
BACKGROUND: There is limited evidence about the optimal length of washout when switching from natalizumab to fingolimod. OBJECTIVE: To study if a washout period of 4 weeks is associated with less disease activity compared to 8 weeks. METHODS: 25 patients with Relapsing Remitting Multiple Sclerosis were included in an open label, prospective study with a follow-up of 108 weeks. The primary endpoint (PE) was defined as "time to first relapse or MRI disease activity up to week 56". In addition, a recurrent event analysis (REA) was performed up to week 108. RESULTS: The PE was not met (HR 0.67, 95% CI [0.22,1.97], p = 0.462). Number of relapses before stopping natalizumab was positively associated with the hazard of relapse (HR 3.91, p = 0.0117, 95% CI [1.36, 11.28]). The REA showed a reduction of the hazard to develop a relapse by 77% (HR 0.23, 95% CI [0.08, 0.69], p = 0.00854) in favor of the cohort with 4 weeks washout. CONCLUSIONS: Our study suggests that switching from natalizumab to fingolimod with a shorter washout of 4 weeks might reduce the risk of disease reactivation after switching.
BACKGROUND: There is limited evidence about the optimal length of washout when switching from natalizumab to fingolimod. OBJECTIVE: To study if a washout period of 4 weeks is associated with less disease activity compared to 8 weeks. METHODS: 25 patients with Relapsing Remitting Multiple Sclerosis were included in an open label, prospective study with a follow-up of 108 weeks. The primary endpoint (PE) was defined as "time to first relapse or MRI disease activity up to week 56". In addition, a recurrent event analysis (REA) was performed up to week 108. RESULTS: The PE was not met (HR 0.67, 95% CI [0.22,1.97], p = 0.462). Number of relapses before stopping natalizumab was positively associated with the hazard of relapse (HR 3.91, p = 0.0117, 95% CI [1.36, 11.28]). The REA showed a reduction of the hazard to develop a relapse by 77% (HR 0.23, 95% CI [0.08, 0.69], p = 0.00854) in favor of the cohort with 4 weeks washout. CONCLUSIONS: Our study suggests that switching from natalizumab to fingolimod with a shorter washout of 4 weeks might reduce the risk of disease reactivation after switching.
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