Neurology. 2014 Jan 7;82(1):41-8. doi: 10.1212/01.wnl.0000438216.93319.ab. Epub 2013 Dec 4.
Effects of Bacille Calmette-Guerin after the first demyelinating event in the CNS.
Ristori G1, 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.
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).Comment in
- BCG vaccine for clinically isolated syndrome and MS: infections and protective immunity. [Neurology. 2014]
- Multiple sclerosis: disease activity is reduced in CIS after BCG vaccination. [Nat Rev Neurol. 2014]
- PMID:
- 24306002
- [PubMed - indexed for MEDLINE]
- PMCID:
- PMC3873620
- [Available on 2015/1/7]
Supplemental Content
- Intramuscular interferon beta-1a therapy initiated during a first demyelinating event in multiple sclerosis. CHAMPS Study Group.[N Engl J Med. 2000]
- United States open-label glatiramer acetate extension trial for relapsing multiple sclerosis: MRI and clinical correlates. Multiple Sclerosis Study Group and the MRI Analysis Center.[Mult Scler. 2001]
- Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial.[Lancet Neurol. 2012]
- Review Mitoxantrone: a review of its use in multiple sclerosis.[CNS Drugs. 2004]
- Review Glatiramer acetate: a review of its use in relapsing-remitting multiple sclerosis and in delaying the onset of clinically definite multiple sclerosis.[Drugs. 2010]
Pope Francis Condemns Legalization of Marijuana
Francis told members of a drug-enforcement conference meeting in Rome on Friday that even limited attempts to legalize recreational drugs “are not only highly questionable from a legislative standpoint, but they fail to produce the desired effects.”
Francis has frequently railed against the “evil” of drug addiction and has met with addicts on several occasions.
Just last month, Uruguay — next door to Francis’ native Argentina — approved selling marijuana cigarettes in pharmacies, and recreational marijuana is legal in the U.S. states of Colorado and Washington.
 |
|
Dear Fellow New Yorker,
As the Legislative session concludes in Albany, we wrap up a very productive week where we accomplished several of our top priorities that will truly make New York a better state. This week, we reached an agreement with legislative leaders on an effective package of bills to combat the state’s growing heroin, opioid and prescription drug abuse epidemic. Heroin abuse is a public health crisis in the state of New York. By introducing tougher laws and new programs to protect all New Yorkers, we are taking an aggressive stance to fight the dangers of drug abuse and help save lives. We also passed legislation to establish a comprehensive medical marijuana program for New York State. Medical marijuana has the capacity to do a lot of good for a lot of people who are in pain and suffering, and are in desperate need of a treatment that will provide some relief. At the same time, medical marijuana is a difficult issue because there are risks to public health and safety that have to be averted. This bill is the right balance, and I commend the members of the Legislature who worked so hard on this measure. These measures build on progress from our fourth, on-time budget passed in March that has set our State on a course of fiscal stability—recognized by all three financial rating agencies. In fact, today Fitch raised New York State's credit rating to its highest level ever, and on Monday, Moody's upgraded our credit rating to its highest level since 1964. We also enacted property tax relief for New York’s homeowners and business tax cuts to create jobs; set a plan in place to transform our schools, which included universal full-day pre-kindergarten; and enacted a series of laws to fight corruption and increase transparency in government. Read the 2014 End of Session Report to learn more about our accomplishments achieved over the last six months. Together, we can lay the foundation for continued success and a stronger, greater New York. Sincerely,  Governor Andrew M. Cuomo |
|
 |
|
PubMed Commons