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Vision in a Phase 3 Trial of Natalizumab for Multiple Sclerosis: Relation to Disability and Quality of Life

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Title Journal of Neuro-Ophthalmology, March 2015, Volume 35, Issue 1
Date 2015-03
Language eng
Format application/pdf
Type Text
Publication Type Journal Article
Collection Neuro-Ophthalmology Virtual Education Library: Journal of Neuro-Ophthalmology Archives: https://novel.utah.edu/jno/
Publisher Lippincott, Williams & Wilkins
Holding Institution Spencer S. Eccles Health Sciences Library, University of Utah
Rights Management © North American Neuro-Ophthalmology Society
ARK ark:/87278/s6b311f8
Setname ehsl_novel_jno
ID 227699
Reference URL https://collections.lib.utah.edu/ark:/87278/s6b311f8

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Title Vision in a Phase 3 Trial of Natalizumab for Multiple Sclerosis: Relation to Disability and Quality of Life
Creator Salim Chahin; Laura J Balcer; Deborah M Miller; Annie Zhang; Steven L Galetta
Affiliation Department of Neurology (SC), University of Pennsylvania, Philadelphia, Pennsylvania; Departments of Neurology and Population Health (LJB), New York University School of Medicine, New York, New York; Department of Neurology (DBM), Cleveland Clinic Foundation, Cleveland, Ohio; Biogen Idec Inc (AZ), Weston, Massachusetts; and Department of Neurology (SLG), New York University School of Medicine, New York, New York.
Abstract BACKGROUND: Low-contrast visual acuity (LCVA), a sensitive measure of visual function in multiple sclerosis (MS), demonstrated treatment effects as a secondary outcome measure in the Phase 3 trial of natalizumab, AFFIRM. In these posttrial analyses, we studied the relation of visual function to quality of life (QOL), magnetic resonance imaging (MRI) measures, and Expanded Disability Status Scale (EDSS) scores. METHODS: At baseline and at 52 and 104 weeks in AFFIRM, patients underwent binocular testing of LCVA (1.25% and 2.5% contrast) and high-contrast visual acuity (HCVA). Vision-specific QOL was assessed by the Impact of Visual Impairment Scale (IVIS), whereas the SF-36 Health Survey and Visual Analog Scale were administered as generic QOL measures and the EDSS as a measure of neurologic impairment. RESULTS: Among QOL measures, IVIS scores showed the most significant correlations with visual dysfunction at all time points in the trial (r= -0.25 to -0.45, P < 0.0001 for LCVA and HCVA). Higher MRI T1- and T2-lesion volumes were also associated with worse vision scores at all time points (P < 0.0001). Clinically meaningful worsening (progression) of LCVA was noted in substantial proportions of patients in AFFIRM and was prevalent even among those without EDSS progression over 2 years (21.9% with LCVA progression at 2.5% contrast; 26.2% at 1.25% contrast). HCVA worsened in only 3.7% of patients without EDSS progression. CONCLUSIONS: Loss of visual function, particularly as measured by LCVA, was common in AFFIRM, occurring in >20% of patients. Both LCVA and HCVA scores reflect vision-specific aspects of QOL, but LCVA provides information about disability progression not entirely captured by the EDSS. Vision represents a key dimension of outcome assessment for MS and adds valuable information on disability and QOL that can be useful to clinicians.
Subject Adolescent; Adult; Antibodies, Monoclonal, Humanized; Cross-Sectional Studies; Disability Evaluation; Disabled Persons; Female; Humans; Magnetic Resonance Imaging; Male; Middle Older people; Multiple Sclerosis; Natalizumab; Quality of Life; Time Factors; Treatment Outcome; Vision Disorders; Visual Acuity; Visual Analog Scale; Young Adult
OCR Text Show
Format application/pdf
Publication Type Journal Article
Collection Neuro-Ophthalmology Virtual Education Library: Journal of Neuro-Ophthalmology Archives: https://novel.utah.edu/jno/
Publisher Lippincott, Williams & Wilkins
Holding Institution Spencer S. Eccles Health Sciences Library, University of Utah
Rights Management © North American Neuro-Ophthalmology Society
Setname ehsl_novel_jno
ID 227670
Reference URL https://collections.lib.utah.edu/ark:/87278/s6b311f8/227670
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