A more detailed analysis of the safety of cladribine has just been published. Unfortunately, it is too early to comment on the malignancy risk; this will require long-term follow-up and an active post-marketing surveillance programme.
Cook et al. Mult Scler. 2011 Jan 12. [Epub ahead of print]
Disclaimer: As the principal investigator on this study I have an obvious conflict of interest.
Fatigue is very common in MS and can be attributed to many factors. This paper reviews sleep disturbances in MS and it association with fatigue. In people with significant fatigue sleep hygiene should be on top of the management plan; without a good night’s sleep how can you expect to feel awake and full of energy.
Kaminska et al. J Neurol Sci. 2011 Jan 15. [Epub ahead of print]
Cognitive symptoms and depression are common in people with MS. A recent study shows an association between these symptoms; subjects with cognitive impairment were more likely to report low mood.
Wow! Let’s hope it is not too expensive for the NHS.
24 treatment-naïve RRMS patients participated in a 1 year prospective safety study. There were no differences were identified between the two treatment groups with respect to patient-reported adverse events or laboratory abnormalities. The combination treatment regimen of interferon beta-1a and mycophenolate was well tolerated.
The investigators conclude: “Despite the small sample size, therapeutic trends were observed in favor of combination therapy. An adequately powered controlled trial of mycophenolate in MS appears warranted.”
Remington et al. Ther Adv Neurol Disord. 2010 Jan;3(1):3-13.
I couldn’t agree more with the investigators; given the current dogma concerning the autoimmune pathogenesis of MS, mycophenolate should be given a chance. The problem is that with the imminent launch of several oral therapies, will it be possible to design an affordable trial to test mycophenolate in RRMS? I suspect not!
Mycophenolate is an anti-rejection agent widely used in transplantation. This was a randomised, 6-monthly, study to compare the effectiveness of mycophenolate to interferon beta in 35 untreated patients with RRMS. Not surprisingly there was no difference between mycophenolate and interferon beta therapy treatment groups. The mycophenolate group showed a trend toward a lower accumulation of lesions on MRI, but this was not significant. This study was simply too small to draw any conclusions (underpowered). It should have been appropriately powered to give a definitive answer; the worrying consequence of this study is will anybody be brave enough now to do a definitive trial? Has this study killed a potentially promising oral agent?
Frohman et al. Ther Adv Neurol Disord. 2010 Jan;3(1):15-28.
Is it ethical to do under-powered studies? NO!
Should people with MS who volunteer to participate in treatment trials expect the studies to be appropriately powered? YES!
Walking impairment in patients with multiple sclerosis: exercise training as a treatment option; “exercise training and physical activity might hold significant potential for the management of progressive mobility disability in MS.”
Until recently the cytokines* interleukins 12 and 23 were believed to be very important in driving inflammation in MS. A drug that neutralises these cytokines has failed to have the desired effect on the disease thus questioning the current dogma. As a result of this study most immunologists have changed their thinking about the disease. Although this trial was negative the people with MS who volunteered to participate in this study have made a very valuable contribution to the field. Negative trial results can be as important as positive ones; in this case the results have changed the way we think about the disease.
Vollmer et al. Mult Scler. 2010 Dec 6.
* cytokines is a term immunologists use to describe the protein messages that cell send to each other to communicate; not too dissimilar to the role of hormones!
This review confirms our advice that there is insufficient evidence to support statins (cholesterol lowering drugs) as a treatment for MS.
Wang et al. Cochrane Database Syst Rev. 2010 Dec 8;12:CD008386.
THE AUTHORS’ CONCLUSIONS ARE SELF-EXPLANATORY: “The current level of evidence for the effectiveness of vitamin D supplementation in the management of people with MS is based on a single randomised control trial with potential high risk of bias, which does not at present allow confident decision-making about the use of Vitamin D in MS. Therefore, until further high quality evidence is available, clinicians may wish to consider relevant MS guidelines on vitamin D supplementation when making decisions about the care of people with multiple sclerosis. Adequately powered, multi-centred RCTs with a focus on clinical as well as immunological and MRI outcomes that are meaningful to people with MS, and are able to provide insight into the benefits of Vitamin D in people with MS, are still required.”
Jagannath et al. Cochrane Database Syst Rev. 2010 Dec 8;12:CD008422