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GLANCE: results of a phase 2, randomized, double-blind, placebo-controlled study
A D Goodman1, H Rossman, A Bar-Or
1Department of Neurology, University of Rochester Medical Center, Rochester, NY 14642, USA. andrew_goodman@urmc.rochester.edu
Neurology
|March 4, 2009
Summary
Adding natalizumab (a biologic therapy) to glatiramer acetate (GA) reduced new active lesions in relapsing multiple sclerosis patients. This combination therapy was safe and well-tolerated over six months.
Area of Science:
- Neurology
- Immunology
- Clinical Trials
Background:
- Relapsing multiple sclerosis (MS) is characterized by inflammatory lesions in the central nervous system.
- Glatiramer acetate (GA) is a disease-modifying therapy for MS.
- Natalizumab is an established therapy for MS, targeting immune cell trafficking.
Purpose of the Study:
- To assess the safety and tolerability of combining natalizumab with glatiramer acetate in relapsing MS patients.
- To determine if this combination therapy increases the rate of new active brain lesions compared to GA alone.
Main Methods:
- A phase 2, randomized, double-blind, placebo-controlled trial.
- 110 relapsing MS patients on GA for at least one year received either IV natalizumab 300 mg or placebo every 4 weeks for up to 20 weeks.
- Primary outcome: rate of new active cranial MRI lesions.
Main Results:
- Combination therapy showed a significantly lower mean rate of new active lesions (0.03 vs. 0.11, p=0.031) compared to GA alone.
- Fewer new gadolinium-enhancing lesions and T2-hyperintense lesions were observed with combination therapy.
- Infection and infusion reaction rates were similar; no hypersensitivity reactions occurred. Anti-natalizumab antibodies increased with combination therapy.
Conclusions:
- The combination of natalizumab and glatiramer acetate is safe and well-tolerated in relapsing MS patients for 6 months.
- This combination therapy demonstrates efficacy in reducing MRI-detected disease activity.
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