AI Article Synopsis
- The study aimed to evaluate the impact of natalizumab on low-contrast letter acuity in patients with relapsing multiple sclerosis (MS) through two major clinical trials.
- In both the AFFIRM and SENTINEL trials, natalizumab demonstrated a significant reduction in the risk of visual loss at low contrast levels compared to control groups.
- The findings suggest that natalizumab effectively prevents visual decline in MS patients and that low-contrast acuity testing could serve as a valuable measure for assessing visual outcomes in future MS research.
Article Abstract
Objective: To examine the effects of natalizumab on low-contrast letter acuity as a prespecified tertiary endpoint in two randomized clinical trials and to evaluate the usefulness of low-contrast letter acuity testing as a candidate test of visual function in multiple sclerosis (MS).
Methods: AFFIRM and SENTINEL were randomized, double-blind, placebo-controlled, multicenter, phase 3 clinical trials of natalizumab in relapsing MS. Natalizumab was evaluated as monotherapy in AFFIRM and as add-on to interferon beta-1a in SENTINEL. Vision testing was performed at 100% contrast (visual acuity) and low-contrast (2.5% and 1.25%).
Results: The risk of clinically significant visual loss (predefined as a two-line worsening of acuity sustained over 12 weeks) at the lowest contrast level (1.25%) was reduced in the natalizumab treatment arms by 35% in AFFIRM (hazard ratio = 0.65; 95% CI: 0.47 to 0.90; p = 0.008) and by 28% in SENTINEL (hazard ratio = 0.72; 95% CI: 0.54 to 0.98; p = 0.038, Cox proportional hazards models). Mean changes in vision scores from baseline were also significantly different, reflecting worsening in non-natalizumab groups.
Conclusions: Natalizumab reduces visual loss in patients with relapsing multiple sclerosis. Low-contrast acuity testing has the capacity to demonstrate treatment effects and is a strong candidate for assessment of visual outcomes in future multiple sclerosis trials.
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| http://dx.doi.org/10.1212/01.wnl.0000259521.14704.a8 | DOI Listing |
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