Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS (Articolo in rivista)

Type
Label
  • Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS (Articolo in rivista) (literal)
Anno
  • 2014-01-01T00:00:00+01:00 (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#doi
  • 10.1212/01.wnl.0000438216.93319.ab (literal)
Alternative label
  • 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. (2014)
    Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS
    in Neurology
    (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#autori
  • 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. (literal)
Pagina inizio
  • 41 (literal)
Pagina fine
  • 48 (literal)
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  • http://www.scopus.com/inward/record.url?eid=2-s2.0-84892183623&partnerID=q2rCbXpz (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#numeroVolume
  • 82 (literal)
Rivista
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#numeroFascicolo
  • 1 (literal)
Note
  • Scopu (literal)
Http://www.cnr.it/ontology/cnr/pubblicazioni.owl#affiliazioni
  • Center for Experimental Neurological Therapies, Azienda Ospedaliera S Camillo-Forlanini, Rome, Italy; S. Andrea Hospital-site, Neurosciences, Mental Health, and Sensory Organs (NESMOS) Department, Department of Neurology and Psychiatry, Rome, Italy; 'Sapienza' University of Rome, Department of Neurological Sciences, Azienda Ospedaliera S Camillo-Forlanini, Rome, Italy; MSCenter, Fondazione don Carlo Gnocchi, IRCCS, Milan, Italy; Neuroradiology Unit, Fondazione don Carlo Gnocchi, IRCCS, Milan, Italy; Department of Neurological Sciences, CNR, Naples, Italy; Federico II University, Biostructure and Bioimaging Institute, CNR, Naples, Italy; National Centre of Epidemiology, National Institute of Health, Rome, Italy (literal)
Titolo
  • Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS (literal)
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-?-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 1 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). © 2013 American Academy of Neurology. (literal)
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