Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS(527 views) 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
Neurology (ISSN: 0028-3878, 1526-632x, 0028-3878linking), 2014 Jan 7; 82(1): 41-48.
Keywords: Bcg Vaccine, Beta1a Interferon, Gadolinium, Placebo, Adult, Article, Brain Damage, Contrast Enhancement, Controlled Study, Demyelinating Disease, Disease Course, Double Blind Procedure, Drug Effect, Expanded Disability Status Scale, Female, Follow Up, Human, Long Term Care, Major Clinical Study, Multiple Sclerosis, Mycobacterium Bovis Bcg, Nuclear Magnetic Resonance Imaging, Nuclear Magnetic Resonance Scanner, Outcome Assessment, Priority Journal, Randomized Controlled Trial, Risk Assessment, Risk Factor, Treatment Duration, Young Adult, Bcg Vaccine Pharmacology Therapeutic Use, Brain Pathology, Demyelinating Diseases Drug Therapy Pathology, Double-Blind Method, Follow-Up Studies, Multiple Sclerosis Drug Therapy Pathology, Treatment Outcome,
Affiliations: *** IBB - CNR ***
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
Federico II University, Biostructure and Bioimaging Institute, CNR, Naples, Italy
National Centre of Epidemiology, National Institute of Health, Rome, Italy
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
and National Centre of Epidemiology (N. V.), National Institute of Health, Rome, Italy.
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Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS
Objective: To evaluate Bacille Calmette-Gu rin (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
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS
No results.
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS