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.

Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis / Spelman, T.; Mekhael, L.; Burke, T.; Butzkueven, H.; Hodgkinson, S.; Havrdova, E.; Horakova, D.; Duquette, P.; Izquierdo, G.; Grand'Maison, F.; Grammond, P.; Barnett, M.; Lechner Scott, J.; Alroughani, R.; Trojano, M.; Lugaresi, A.; Granella, Franco; Pucci, E.; Vucic, S.. - In: EUROPEAN JOURNAL OF NEUROLOGY. - ISSN 1351-5101. - 23:4(2016), pp. 729-736. [10.1111/ene.12929]

Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis

GRANELLA, Franco;
2016

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.
Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis / Spelman, T.; Mekhael, L.; Burke, T.; Butzkueven, H.; Hodgkinson, S.; Havrdova, E.; Horakova, D.; Duquette, P.; Izquierdo, G.; Grand'Maison, F.; Grammond, P.; Barnett, M.; Lechner Scott, J.; Alroughani, R.; Trojano, M.; Lugaresi, A.; Granella, Franco; Pucci, E.; Vucic, S.. - In: EUROPEAN JOURNAL OF NEUROLOGY. - ISSN 1351-5101. - 23:4(2016), pp. 729-736. [10.1111/ene.12929]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2810054
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