J.E. Rick Paulseth, MD
In patients with clinically isolated syndrome (CIS), does glatiramer acetate delay conversion to clinically definite multiple sclerosis (MS)?
Randomized placebo-controlled trial (early glatiramer acetate treatment in delaying conversion to clinically definite MS in subjects Presenting with a Clinically Isolated Syndrome [PreCISe]). ClinicalTrials.gov NCT00666224.
Blinded (patients, clinicians, data collectors, and outcome assessors).*
Mean 2.3 years (3-y trial was stopped early for apparent benefit).
80 centers in 12 European countries, the USA, Argentina, Australia, and New Zealand.
481 patients 18 to 45 years of age (mean age 31 y, 67% women) who had 1 unifocal neurologic event in the previous 90 days and ≥ 2 cerebral T2 lesions ≥ 6 mm in diameter on brain magnetic resonance imaging. Exclusion criteria included neurologic disease other than MS, use of investigational drugs, use of β-interferon or chronic corticosteroids in ≤ 6 months, relapse before enrollment, and pregnancy or breastfeeding.
Daily subcutaneous injection of glatiramer acetate, 20 mg (n = 243), or placebo (n = 238) for ≤ 3 years.
Conversion to clinically defined MS (appearance of a new, or reappearance of a previously observed, neurologic abnormality in the absence of fever or infection, accompanied by objective neurologic changes) and new T2 lesions.
88% (intention-to-treat analysis).
Glatiramer acetate reduced risk for conversion to MS (Table). Time to conversion in the first 25% of patients was 722 days in the glatiramer acetate group and 336 days in the placebo group. At the last scan, the mean cumulative number of new T2 lesions was 4.2 in the glatiramer acetate group and 9.8 in the placebo group (P < 0.01).
In patients with clinically isolated syndrome, glatiramer acetate delayed conversion to clinically definite multiple sclerosis.
Glatiramer acetate vs placebo to delay progression to multiple sclerosis (MS) in patients with clinically isolated syndrome†
†Abbreviations defined in Glossary. RRR, NNT, and CI calculated from hazard ratio and data in article.
Paulseth JR. Glatiramer acetate delayed conversion to multiple sclerosis in patients with clinically isolated syndrome. Ann Intern Med. ;152:JC1–10. doi: 10.7326/0003-4819-152-2-201001190-02010
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Published: Ann Intern Med. 2010;152(2):JC1-10.
Multiple Sclerosis, Neurology.
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