TY - JOUR
T1 - Risk of early relapse following the switch from injectables to oral agents for multiple sclerosis
AU - Spelman, T.
AU - Mekhael, L.
AU - Burke, T
AU - Butzkueven, H.
AU - Hodgkinson, Suzanne J
AU - Havrdova, Eva
AU - Horakova, Dana
AU - Duquette, Pierre Pascal
AU - Izquierdo, Guillermo
AU - Grand'Maison, Francois
AU - Grammond, Pierre
AU - Barnett, M.
AU - Lechner-Scott, Jeannette
AU - Alroughani, Raed A
AU - Trojano, Maria
AU - Lugaresi, Alessandra
AU - Granella, Franco
AU - Pucci, Eugenio
AU - Vucic, Steve
AU - on behalf of the MSBase Study Group
PY - 2016/4/1
Y1 - 2016/4/1
N2 - 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.
AB - 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.
KW - Dimethyl fumarate
KW - Fingolimod
KW - Multiple sclerosis
KW - Progression
KW - Relapse
KW - Teriflunomide
KW - Treatment switching
UR - http://www.scopus.com/inward/record.url?scp=84955062203&partnerID=8YFLogxK
U2 - 10.1111/ene.12929
DO - 10.1111/ene.12929
M3 - Article
C2 - 26782663
AN - SCOPUS:84955062203
SN - 1351-5101
VL - 23
SP - 729
EP - 736
JO - European Journal of Neurology
JF - European Journal of Neurology
IS - 4
ER -