Mindfulness-Based Interventions Found to Improve Quality of Life in MS Patients
In a randomized intention-to-treat analysis published in the journal Neurology on September 28, 2010, researchers found that mindfulness-based interventions (MBI) improve the health-related quality of life (HRQOL) of multiple sclerosis (MS) patients significantly more than usual care.
The study randomized 150 patients with MS to either the experiment group or the control group and studied them from February 2007 to March 2009. Patients allocated to the experiment group received MBI, which included personal intake interviews to establish rapport, 8 weekly 2.5-hour classes in mindfulness practices, one 7-hour session at week 6, daily homework assignments, and a post-intervention interview. Patient-reported outcomes were measured at baseline, at post-intervention interview, and at a 6-month follow-up. These outcomes included HRQOL and depression, fatigue, and anxiety. Using statistical analysis, the researchers found that all patient-reported outcomes were significantly improved in the MBI group compared with the usual care group.
The authors note that while diseasemodifying therapies have an immense effect on delaying progression of disease, HRQOL is still low in the MS population, and the results of this study may prove very useful. “Such positive response may reflect a strong desire among patients for treatments complementary to medical management, to enhance coping with consequences of MS.”
JCV Serostatus Testing May Decrease Risk of PML
Researchers from Biogen Idec, the manufacturer of natalizumab (Tysabri), have developed an enzyme-linked immunosorbent assay that can detect antibodies for JC polyomavirus (JCV). The virus is responsible for progressive multifocal leukoencephalopathy (PML), a serious opportunistic infection of the brain that can result in death. The risk of developing PML is increased drastically in patients receiving natalizumab.
The utility of the assay is still up for debate, and numerous studies evaluating its use have been published in the September 2010 issue of the Annals of Neurology, along with an editorial that further analyzes its benefit. In one study, funded by Biogen Idec, it was found that in 831 MS patients treated with natalizumab, 53.6% tested positive for anti-JCV antibodies, in contrast to other studies that have shown a much higher percentage of the natalizumab-treated population exposed to JCV. The prognostic robustness of this assay is evident in the fact that of the 17 patients who were diagnosed with PML, 100% of them tested positive for anti-JCV antibodies.
Published in the same issue of the Annals of Neurology, an editorial written by Kenneth Tyler, MD, of the University of Colorado School of Medicine, states that the utility of this new assay, in comparison with older blood or urine tests, cannot be overstated. Older tests were not as selective for JCV and “cross-reactivity between antibodies directed against JCV and other human polyomaviruses including BK, KI, WU, and Merkel cell polyomaviruses” was far too cumbersome.
A sensitive and specific test for anti-JCV antibodies will be able to better stratify MS patients by risk for contracting PML when given natalizumab, and a more educated decision to treat with natalizumab can be made. Even with the promising results of the assay, more clinical trials are still underway to assess its use before it is broadly applied to the MS population.
Fast Fact: The farther an individual lives from the equator, the higher the incidence of multiple sclerosis.
Albuterol Added to Glatiramer Acetate Shows Benefit
In a move toward another potential oral therapy option for MS, a study published in the September 2010 issue of the Archives of Neurology demonstrated improved clinical outcomes when oral albuterol is combined with subcutaneous glatiramer acetate. Noting the hypothesis that MS is an autoimmune disease mediated by interleukin 12 (IL-12), the researchers theorized that a treatment that reportedly decreases IL-12 expression in monocytes in healthy individuals, albuterol, may modify MS disease.
The double-blind study randomized 44 subjects with relapsing-remitting MS to receive glatiramer acetate 20 mg subcutaneously plus albuterol 4 mg orally once daily or glatiramer acetate plus placebo. The subjects were followed for 2 years. The primary end point was change in Multiple Sclerosis Functional Composite (MSFC) and MRI; immunologic and other clinical markers were used as secondary end points. At 6 months, subjects receiving glatiramer acetate plus albuterol had a significantly greater MSFC compared with subjects receiving glatiramer acetate plus placebo. No significant treatment effect was observed at 2 years.
Because there was early significant improvement but no significant improvement in MSFC at 2 years, the authors suggest that “the addition of albuterol to glatiramer acetate therapy at the time of treatment initiation may accelerate clinical response.” Despite the promising results, more definitive studies are still needed until albuterol therapy is recommended as a disease-modifying drug.