T Spelman1,2, L Mekhael3, T Burke3, H Butzkueven1,2, S Hodgkinson4, E Havrdova5, D Horakova5, P Duquette6, G Izquierdo7, F Grand'Maison8, P Grammond9, M Barnett10, J Lechner-Scott11, R Alroughani12, M Trojano13, A Lugaresi14, F Granella15, E Pucci16, S Vucic3. 1. Department of Neurology, Royal Melbourne Hospital, Parkville, Vic., Australia. 2. Department of Medicine (RMH), University of Melbourne, Parkville, Vic., Australia. 3. Westmead Hospital, Sydney, NSW, Australia. 4. Liverpool Hospital, Sydney, NSW, Australia. 5. Charles University, Prague, Czech Republic. 6. Hôpital Notre Dame, Montreal, QC, Canada. 7. Hospital Universitario Virgen Macarena, Sevilla, Spain. 8. Neuro Rive-Sud, Hôpital Charles LeMoyne, Quebec, QC, Canada. 9. Center de réadaptation déficience physique Chaudière-Appalache, Levis, QC, Canada. 10. Brain and Mind Research Institute, Sydney, NSW, Australia. 11. John Hunter Hospital, Newcastle, NSW, Australia. 12. Amiri Hospital, Kuwait City, Kuwait. 13. Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy. 14. MS Center, Department of Neuroscience, Imaging and Clinical Sciences, University 'G. d'Annunzio', Chieti, Italy. 15. Department of Neurosciences, University of Parma, Parma, Italy. 16. Neurology Unit, ASUR Marche - AV3, Macerata, Italy.
Abstract
BACKGROUND AND PURPOSE: Early relapse outcomes in long-term stable patients switching from interferon β/glatiramer acetate (IFNβ/GA) to oral therapy are unknown. OBJECTIVE: The objective of this study was to compare early relapse and progression in multiple sclerosis (MS) patients switching to oral therapy following a period of stable disease on IFNβ/GA, relative to a propensity-matched comparator of patients remaining on IFNβ/GA. METHODS: The MSBase cohort study is a global, longitudinal registry for MS. Time to first 6-month relapse in previously stable MS patients switching from platform injectables ('switchers') to oral agents were compared with propensity-matched patients remaining on IFNβ/GA ('stayers') using a Cox marginal model. RESULTS: Three-hundred and ninety-six switchers were successfully matched to 396 stayers on a 1:1 basis. There was no difference in the proportion of patients recording at least one relapse in the first 1-6 months by treatment arm (7.3% switchers, 6.6% stayers; P = 0.675). The mean annualized relapse rate (P = 0.493) and the rate of first 6-month relapse by treatment arm (hazard ratio 1.22, 95% confidence interval 0.70, 2.11) were also comparable. There was no difference in the rate of disability progression by treatment arm (hazard ratio 1.43, 95% confidence interval 0.63, 3.26). CONCLUSION: This is the first study to compare early relapse switch probability in the period immediately following switch to oral treatment in a population previously stable on injectable therapy. There was no evidence of disease reactivation within the first 6 months of switching to oral therapy.
BACKGROUND AND PURPOSE: Early relapse outcomes in long-term stable patients switching from interferon β/glatiramer acetate (IFNβ/GA) to oral therapy are unknown. OBJECTIVE: The objective of this study was to compare early relapse and progression in multiple sclerosis (MS) patients switching to oral therapy following a period of stable disease on IFNβ/GA, relative to a propensity-matched comparator of patients remaining on IFNβ/GA. METHODS: The MSBase cohort study is a global, longitudinal registry for MS. Time to first 6-month relapse in previously stable MSpatients switching from platform injectables ('switchers') to oral agents were compared with propensity-matched patients remaining on IFNβ/GA ('stayers') using a Cox marginal model. RESULTS: Three-hundred and ninety-six switchers were successfully matched to 396 stayers on a 1:1 basis. There was no difference in the proportion of patients recording at least one relapse in the first 1-6 months by treatment arm (7.3% switchers, 6.6% stayers; P = 0.675). The mean annualized relapse rate (P = 0.493) and the rate of first 6-month relapse by treatment arm (hazard ratio 1.22, 95% confidence interval 0.70, 2.11) were also comparable. There was no difference in the rate of disability progression by treatment arm (hazard ratio 1.43, 95% confidence interval 0.63, 3.26). CONCLUSION: This is the first study to compare early relapse switch probability in the period immediately following switch to oral treatment in a population previously stable on injectable therapy. There was no evidence of disease reactivation within the first 6 months of switching to oral therapy.
Authors: Maria Trojano; Mar Tintore; Xavier Montalban; Jan Hillert; Tomas Kalincik; Pietro Iaffaldano; Tim Spelman; Maria Pia Sormani; Helmut Butzkueven Journal: Nat Rev Neurol Date: 2017-01-13 Impact factor: 42.937