THURSDAY, Dec. 5, 2013 (HealthDay News) -- For individuals with clinically isolated syndromes (CIS), a first demyelinative episode that often precedes multiple sclerosis (MS), Bacille Calmette-Guérin (BCG) vaccination correlates with reduced development of gadolinium-enhancing lesions, according to a study published online Dec. 4 in Neurology.
Giovanni Ristori, M.D., Ph.D., from the University of Rome, and colleagues randomized 73 patients with CIS to receive BCG (33 participants) or placebo (40 participants). Participants underwent monthly monitoring with brain magnetic resonance imaging for six scans. Participants were then treated with intramuscular interferon-β-1a for 12 months; from 18 months, they were treated with disease-modifying therapies (DMT) prescribed by neurologists in an open-label extension phase lasting up to 60 months.
The researchers found that the number of cumulative lesions was significantly lower in the vaccinated group during the first six months, with relative risks of 0.541 (P = 0.03) for gadolinium-enhancing lesions; 0.364 (P = 0.001) for new and enlarging T2-hyperintense lesions; and 0.149 (P = 0.001) for new T1-hypointense lesions. In the BCG group the number of total T1-hypointense lesions was significantly lower at six, 12, and 18 months. The cumulative probability of clinically definite MS was significantly lower at 60 months in the BCG + DMT arm (hazard ratio, 0.52; P < 0.05), and more vaccinated individuals remained free from DMT (odds ratio, 0.20; P = 0.04).
"Early BCG may benefit CIS and affect its long-term course," the authors write.
Several authors report financial ties to the pharmaceutical industry.
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