Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study.

Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study.

Publication date: Apr 01, 2020

High-efficacy therapies in multiple sclerosis are traditionally used after unsuccessful treatment with first-line disease modifying therapies. We hypothesised that early commencement of high-efficacy therapy would be associated with reduced long-term disability. We therefore aimed to compare long-term disability outcomes between patients who started high-efficacy therapies within 2 years of disease onset with those who started 4-6 years after disease onset.

In this retrospective international observational study, we obtained data from the MSBase registry and the Swedish MS registry, which prospectively collect patient data that are specific to multiple sclerosis as part of routine clinical care. We identified adult patients (aged ?18 years) with relapsing-remitting multiple sclerosis, with at least 6 years of follow-up since disease onset, and who started the high-efficacy therapy (rituximab, ocrelizumab, mitoxantrone, alemtuzumab, or natalizumab) either 0-2 years (early) or 4-6 years (late) after clinical disease onset. We matched patients in the early and late groups using propensity scores calculated on the basis of their baseline clinical and demographic data. The primary outcome was disability, measured with the Expanded Disability Status Score (EDSS; an ordinal scale of 0-10, with higher scores indicating increased disability), at 6-10 years after disease onset, assessed with a linear mixed-effects model.

We identified 6149 patients in the MSBase registry who had been given high-efficacy therapy, with data collected between Jan 1, 1975, and April 13, 2017, and 2626 patients in the Swedish MS Registry, with data collected between Dec 10, 1997, and Sept 16, 2019. Of whom, 308 in the MSBase registry and 236 in the Swedish MS registry were eligible for inclusion. 277 (51%) of 544 patients commenced therapy early and 267 (49%) commenced therapy late. For the primary analysis, we matched 213 patients in the early treatment group with 253 in the late treatment group. At baseline, the mean EDSS score was 2.2 (SD 1.2) in the early group and 2.1 (SD 1.2) in the late group. Median follow-up time for matched patients was 7.8 years (IQR 6.7-8.9). In the sixth year after disease onset, the mean EDSS score was 2.2 (SD 1.6) in the early group compared with 2.9 (SD 1.8) in the late group (p

He, A., Merkel, B., Brown, J.W.L., Zhovits Ryerson, L., , Kister, Malpas, C.B., Sharmin, S., Horakova, D., Kubala Havrdova, E., Spelman, T., Izquierdo, G., Eichau, S., Trojano, M., Lugaresi, A., Hupperts, R., Sola, P., Ferraro, D., Lycke, J., Grand’Maison, F., Prat, A., Girard, M., Duquette, P., Larochelle, C., Svenningsson, A., Petersen, T., Grammond, P., Granella, F., Pesch, Van, Bergamaschi, R., McGuigan, C., Coles, A., Hillert, J., Piehl, F., Butzkueven, H., Kalincik, T., and group, MSBase study. Timing of high-efficacy therapy for multiple sclerosis: a retrospective observational cohort study. 20519. 2020 Lancet Neurol (19):4.

Concepts Keywords
Alemtuzumab Early treatment
Cohort Study Late
Demographic Specific multiple sclerosis
Disability Health sciences
IQR Monoclonal antibodies
Lancet Medical specialties
Median Multiple sclerosis
Mitoxantrone Autoimmune diseases
Multiple Sclerosis EDSS
Natalizumab Natalizumab
Observational Study Therapy
Rituximab Ocrelizumab
SD 18 Multiple sclerosis research


Type Source Name
disease MESH multiple sclerosis
disease MESH relapsing-remitting multiple sclerosis
drug DRUGBANK Rituximab
drug DRUGBANK Ocrelizumab
drug DRUGBANK Mitoxantrone
drug DRUGBANK Alemtuzumab
drug DRUGBANK Natalizumab

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