shoot BCG and go faster
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Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.
Ristori G,
Romano S,
Cannoni S,
Visconti A,
Tinelli E,
Mendozzi L,
Cecconi P,
Lanzillo R,
Quarantelli M,
Buttinelli C,
Gasperini C,
Frontoni M,
Coarelli G,
Caputo D,
Bresciamorra V,
Vanacore N,
Pozzilli C,
Salvetti M.
Source
From
the Center for Experimental Neurological Therapies (G.R., S.R., S.C.,
A.V., C.B., G.C., M.S.), S. Andrea Hospital-site, Neurosciences, Mental
Health, and Sensory Organs (NESMOS) Department and Department of
Neurology and Psychiatry (E.T., M.F., C.P.), "Sapienza" University of
Rome, Department of Neurological Sciences (C.G.), Azienda Ospedaliera S
Camillo-Forlanini, Rome; MSCenter (L.M., D.C.) and Neuroradiology Unit
(P.C.), Fondazione don Carlo Gnocchi, IRCCS, Milan; Department of
Neurological Sciences (R.L., V.B.), Federico II University, and
Biostructure and Bioimaging Institute (M.Q.), CNR, Naples; and National
Centre of Epidemiology (N.V.), National Institute of Health, Rome,
Italy.
Abstract
OBJECTIVE:
To evaluate Bacille Calmette-Guérin (BCG) effects after clinically isolated syndromes (CIS).
METHODS:
In
a double-blind, placebo-controlled trial, participants were randomly
assigned to receive BCG or placebo and monitored monthly with brain MRI
(6 scans). Both groups then entered a preplanned phase with IM
interferon-β-1a for 12 months. From month 18 onward, the patients took
the disease-modifying therapies (DMTs) that their neurologist considered
indicated in an open-label extension phase lasting up to 60 months.
RESULTS:
Of
82 randomized subjects, 73 completed the study (33 vaccinated and 40
placebo). During the initial 6 months, the number of cumulative lesions
was significantly lower in vaccinated people. The relative risks were
0.541 (95% confidence interval [CI] 0.308-0.956; p = 0.03) for
gadolinium-enhancing lesions (the primary endpoint), 0.364 (95% CI
0.207-0.639; p = 0.001) for new and enlarging T2-hyperintense lesions,
and 0.149 (95% CI 0.046-0.416; p = 0.001) for new T1-hypointense
lesions. The number of total T1-hypointense lesions was lower in the BCG
group at months 6, 12, and 18: mean changes from baseline were -0.09 ±
0.72 vs 0.75 ± 1.81 (p = 0.01), 0.0 ± 0.83 vs 0.88 ± 2.21 (p = 0.08),
and -0.21 ± 1.03 vs 1.00 ± 2.49 (p = 0.02). After 60 months, the
cumulative probability of clinically definite multiple sclerosis was
lower in the BCG + DMT arm (hazard ratio = 0.52, 95% CI 0.27-0.99; p
< 0.05), and more vaccinated people remained DMT-free (odds ratio =
0.20, 95% CI 0.04-0.93; p = 0.04).
CONCLUSIONS:
Early BCG may benefit CIS and affect its long-term course.
CLASSIFICATION OF EVIDENCE:
BCG,
as compared to placebo, was associated with significantly reduced
development of gadolinium-enhancing lesions in people with CIS for a
6-month period before starting immunomodulating therapy (Class I
evidence).
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