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Natalizumab reduces visual loss in patients with relapsing multiple sclerosis
L J Balcer1, S L Galetta, P A Calabresi
1Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. lbalcer@mail.med.upenn.edu
Neurology
|April 18, 2007
Summary
Natalizumab significantly reduced visual loss in relapsing multiple sclerosis (MS) patients. Low-contrast acuity testing effectively demonstrated treatment effects, proving valuable for future MS visual outcome assessments.
Area of Science:
- Neuroscience
- Ophthalmology
- Clinical Trials
Background:
- Multiple sclerosis (MS) is a chronic neurological disease that can affect vision.
- Assessing visual function is crucial for monitoring MS progression and treatment efficacy.
- Low-contrast letter acuity (LCLA) testing is a potential tool for evaluating subtle visual changes.
Purpose of the Study:
- To evaluate the effect of natalizumab on low-contrast letter acuity in relapsing MS patients.
- To assess the utility of LCLA testing as a measure of visual function in MS clinical trials.
Main Methods:
- Two randomized, double-blind, placebo-controlled phase 3 trials (AFFIRM and SENTINEL) were conducted.
- Natalizumab was administered as monotherapy (AFFIRM) or add-on therapy (SENTINEL).
- Visual acuity was tested at 100% contrast and low contrast (2.5% and 1.25%).
Main Results:
- Natalizumab significantly reduced the risk of clinically significant visual loss at 1.25% contrast by 35% in AFFIRM (p=0.008) and 28% in SENTINEL (p=0.038).
- Mean changes in vision scores from baseline showed significant differences, with worsening observed in non-natalizumab groups.
- LCLA testing demonstrated a clear treatment effect, distinguishing between natalizumab and placebo groups.
Conclusions:
- Natalizumab effectively reduces visual loss in patients with relapsing multiple sclerosis.
- Low-contrast acuity testing is a sensitive and valuable tool for assessing visual outcomes in MS.
- LCLA testing is a strong candidate for incorporation into future multiple sclerosis clinical trials.
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