The results from a number of clinical studies of new treatments
for MS were reported. There was one phase III study. Studies in phase III are designed to definitively demonstrate
whether a treatment works or not. There were also numerous phase II studies. Phase II studies are intended to
test safety, find the best dose, and get an idea whether the drug being tested is likely to work.
major report was the results of a phase III placebo-controlled trial of teriflunomide. This is an oral immunosuppressive
drug which is very similar to a drug already in use for rheumatoid arthritis. The relapse rate was reduced by 30%, and
the number of patients with progression of disability also decreased by 30%. The amount of MRI activity decreased by
67%. There were not any worrisome side effects. I think this may end up being a useful treatment if the side effects
remain minor, particularly since most of the more effective drugs have also proven to be more risky. They have 3 other
phase III studies now in progress, some of which combine teriflunomide with one of the other standard treatments.
were a lot of phase II trials reported. There were two studies of different antibodies which eliminate B cells,
similar to rituximab, which is also in testing for MS. They are called ocrelizumab and ofatumumab. Both of them
showed an impressive effect on MRI activity. I would expect their side effects and benefit to be similar to rituximab.
My concern with these agents is that there will be rare, but severe, infections. We are using rituximab for other diseases
similar to MS, and I expect that these anti-B cell antibodies will end up having an important place in MS treatment.
But we will need to wait for the results of further testing.
Another interesting drug is firategrast.
This is an oral medication which is supposed to do the same thing that Tysabri does. The highest dose tested decreased
MRI activity by about 50%. Side effects were minor. The best dose may be higher than the doses they tested, and
I will be interested to see what the long term side effects are.
A study of the combination of a statin (the
medicines for high cholesterol) with interferon resulted in interesting findings. The patients on the combination treatment
did worse than the ones on interferon alone. There have been several studies of this combination, with variable results.