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January 07, 2014; 82 (1) Article

Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS

Giovanni Ristori, Silvia Romano, Stefania Cannoni, Andrea Visconti, Emanuele Tinelli, Laura Mendozzi, Pietro Cecconi, Roberta Lanzillo, Mario Quarantelli, Carla Buttinelli, Claudio Gasperini, Marco Frontoni, Giulia Coarelli, Domenico Caputo, Vincenzo Bresciamorra, Nicola Vanacore, Carlo Pozzilli, Marco Salvetti
First published December 4, 2013, DOI: https://doi.org/10.1212/01.wnl.0000438216.93319.ab
Giovanni Ristori
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.
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Silvia Romano
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.
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Stefania Cannoni
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.
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Andrea Visconti
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.
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Emanuele Tinelli
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.
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Laura Mendozzi
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.
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Pietro Cecconi
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.
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Roberta Lanzillo
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.
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Mario Quarantelli
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.
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Carla Buttinelli
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.
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Claudio Gasperini
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.
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Marco Frontoni
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.
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Giulia Coarelli
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.
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Domenico Caputo
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.
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Vincenzo Bresciamorra
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.
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Nicola Vanacore
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.
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Carlo Pozzilli
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.
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Marco Salvetti
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.
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Citation
Effects of Bacille Calmette-Guérin after the first demyelinating event in the CNS
Giovanni Ristori, Silvia Romano, Stefania Cannoni, Andrea Visconti, Emanuele Tinelli, Laura Mendozzi, Pietro Cecconi, Roberta Lanzillo, Mario Quarantelli, Carla Buttinelli, Claudio Gasperini, Marco Frontoni, Giulia Coarelli, Domenico Caputo, Vincenzo Bresciamorra, Nicola Vanacore, Carlo Pozzilli, Marco Salvetti
Neurology Jan 2014, 82 (1) 41-48; DOI: 10.1212/01.wnl.0000438216.93319.ab

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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).

GLOSSARY

BCG=
Bacille Calmette-Guérin;
CDMS=
clinically definite multiple sclerosis;
CI=
confidence interval;
CIS=
clinically isolated syndrome;
CSE=
conventional spin-echo;
DMT=
disease-modifying therapy;
EDSS=
Expanded Disability Status Scale;
Gd=
gadolinium;
IFN=
interferon;
MS=
multiple sclerosis;
RR=
relative risk;
T1W=
T1-weighted;
T2W=
T2-weighted;
TE=
echo time;
TR=
repetition time

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Editorial, page 15

  • Supplemental data at www.neurology.org

  • Received December 27, 2012.
  • Accepted in final form August 28, 2013.
  • © 2013 American Academy of Neurology
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Letters: Rapid online correspondence

  • Effects of Bacille Calmette-Gu?rin after the first demyelinating event in the CNS
    • Robert Lisak, Neurology, Wayne State University Medicalrlisak@med.wayne.edu
    Submitted February 24, 2014
  • The cost effective way to increase effectiveness of immuno-modulation
    • Kah Fang Khoo, Consultant Physician, Tanjung Medical Centrefangpenang@gmail.com
    Submitted February 24, 2014
  • BCG and EBV status
    • Giovanni Ristori, Researcher, Center for Experimental Neurological Therapies, S. Andrea Hospital-site, Neurosciences, Mental Healtgiovanni.ristori@uniroma1.it
    • Giovanni Ristori, Rome, Italy; Silvia Romano, Rome, Italy; Giulia Coarelli, Rome, Italy; Maria Chiara Buscarinu, Rome, Italy; Marco Salvetti, Rome, Italy
    Submitted February 19, 2014
  • BCG vaccination may restore normal Notch signaling, which is disrupted in MS, possibly due to infection by Epstein-Barr virus causing auto-immunity
    • Steven R Brenner, Physician, St. Louis University Dept. Neurology and Psychiatry, retired.SBren20979@aol.com
    Submitted January 28, 2014
  • BCG: to vaccinate may be better.
    • Giovanni Ristori, researcher, Center for Experimental Neurological Therapies, S. Andrea Hospital-site, Neurosciences, Mental Healtgiovanni.ristori@uniroma1.it
    • Silvia Romano, Rome, Italy; Giulia Coarelli, Rome, Italy; Maria Chiara Buscarinu, Rome, Italy; Marco Salvetti, Rome, Italy
    Submitted January 22, 2014
  • BCG: to vaccinate or not?
    • Nitin K. Sethi, Assistant Professor of Neurology, New York-Presbyterian Hospital, Weill Cornell Medical Center 525 East 68th Street, New York, NY 1006sethinitinmd@hotmail.com
    • Nitin K Sethi, New York, NY
    Submitted January 09, 2014
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