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Natalizumab improves ambulation in relapsing−remitting multiple sclerosis: results from the prospective TIMER study and a retrospective analysis of AFFIRM
Author(s) -
Voloshy.,
Havrdová E.,
Hutchinson M.,
Nehrych T.,
You X.,
Belachew S.,
Hotermans C.,
Paes D.
Publication year - 2015
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.12618
Subject(s) - natalizumab , multiple sclerosis , medicine , expanded disability status scale , placebo , ambulatory , physical therapy , immunology , pathology , alternative medicine
Background and purpose Impaired ambulation is a prominent disabling symptom of multiple sclerosis and can lead to reduced quality of life. Whether natalizumab, a monoclonal antibody shown to reduce disease activity in relapsing−remitting multiple sclerosis, could impact ambulation performance was examined. Methods A prospective open‐label study, TIMER , was conducted in natalizumab‐naive patients ( n = 215). The timed 25‐foot walk ( T 25 FW ) and timed 100‐m walk ( T 100 MW ) were assessed at baseline and at weeks 24 and 48 of natalizumab therapy, together with E xpanded D isability S tatus S cale scores. The effects of natalizumab on T 25 FW performance were also examined in a retrospective analysis of natalizumab‐treated patients ( n = 627) and placebo control patients ( n = 315) from the AFFIRM study. Results In TIMER , a significant increase from baseline in T 25 FW speed was seen at week 24 ( P = 0.0074) and in T 100 MW speed at weeks 24 and 48 (both P < 0.001). A greater proportion of patients showed clinically meaningful increases (≥20%) in walking speed on the T 100 MW (25%) than on the T 25 FW (13%) at week 48 ( P = 0.032). In AFFIRM , natalizumab increased the proportion of patients with ≥20% confirmed improvement in T 25 FW speed at year 2 by 78% versus placebo ( P = 0.0133). Conclusions Natalizumab increased walking speed in patients with relapsing−remitting multiple sclerosis. The T 100 MW may be more sensitive to changes in ambulation capacity than the T 25 FW , and both tests appear to detect clinically meaningful improvements in ambulatory function.