Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab

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Title Initial Impairment and Recovery of Vision-Related Functioning in Participants With Acute Optic Neuritis From the RENEW Trial of Opicinumab
Creator Jennifer Petrillo; Laura Balcer; Steven Galetta; Yi Chai; Lei Xu; Diego Cadavid
Affiliation Department of Value and Access (JP), Biostatistics (YC, LX), and Clinical Development (DC), Biogen, Cambridge, Massachusetts; and Departments of Neurology, Population Health, and Ophthalmology (LB and SG), New York University School of Medicine, New York, New York
Abstract Background: Leucine-rich repeat and immunoglobulin domain-containing Nogo receptor-interacting protein 1 (LINGO-1) is a key suppressor of oligodendrocyte differentiation and axonal remyelination and regeneration. This analysis evaluated the potential benefit of opicinumab, a human monoclonal antibody against LINGO-1, vs placebo on exploratory clinical endpoints of patient-reported vision-related functioning and high-contrast visual acuity (HCVA) in RENEW participants with acute optic neuritis (AON). Methods: Participants were randomized to 100 mg/kg opicinumab intravenous or placebo every 4 weeks (6 infusions). Assessments were conducted in the per-protocol (PP) population and included: 25-item National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25), 10-item Neuro-Ophthalmic Supplement (NOS-10), and HCVA. Results: The opicinumab group (n = 33) had worse mean (SD) baseline patient-reported vision-related functioning scores vs placebo (n = 36): NEI-VFQ-25 composite, 75.5 (17.6) vs 79.0 (16.6); NOS-10 composite, 63.6 (19.8) vs 69.8 (21.2), respectively. By Week 24, the placebo and opicinumab groups experienced substantial mean improvements from baseline (NEI-VFQ-25 composite, 15.17 vs 13.51 [difference (95% CI): -1.66 (-5.11 to 1.78)]; NOS-10 composite, 17.40 vs 16.04 [difference (95% CI): -1.35 (-7.38 to 4.67)]). Between-treatment differences in mean change from baseline were not significantly different at any time point. Analysis of covariance-adjusted mean recovery from baseline in HCVA at Week 24 for the affected eyes was 11.8 and 8.7 letters for placebo and opicinumab, respectively (P = 0.202). Conclusions: Most participants in the RENEW PP population demonstrated substantial recovery from baseline in patient-reported vision-related functioning and HCVA, regardless of treatment and structural damage. Average scores after recovery remained lower than those of published disease-free control groups. These results provide important information on visual function recovery in patients with AON, as measured by NEI-VFQ-25 and NOS-10.
Subject Acute Disease; Adolescent; Adult; Antibodies, Monoclonal / pharmacokinetics; Antibodies, Monoclonal / therapeutic use; Double-Blind Method; Female; Humans; Infusions, Intravenous; Male; Membrane Proteins / immunology; Middle Aged; Multiple Sclerosis / drug therapy; Multiple Sclerosis / physiopathology; Nerve Tissue Proteins / immunology; Optic Neuritis / drug therapy; Optic Neuritis / physiopathology; Quality of Life; Recovery of Function / physiology; Sickness Impact Profile; Surveys and Questionnaires; Visual Acuity / physiology; Visually Impaired Persons; Young Adult
OCR Text Show
Date 2019-06
Language eng
Format application/pdf
Type Text
Publication Type Journal Article
Source Journal of Neuro-Ophthalmology, June 2019, Volume 39, Issue 2
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/s6t20t68
Setname ehsl_novel_jno
ID 1595798
Reference URL https://collections.lib.utah.edu/ark:/87278/s6t20t68
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