AAN 2014 – New MS treatment studies: Part I
The 2014 annual meeting of the American Academy of Neurology featured new research looking at the effectiveness and safety of various MS medications. The following is a wrap-up of some of the noteworthy studies.
Aspirin (acetylsalicylic acid, ASA): Taking ASA every day is unlikely to help MS fatigue, according to a study in the U.S. (Wingerchuk and colleagues. AAN 2014; abstract P7.245). People in the study received 1,300 mg of ASA (4 regular Aspirin tablets) or a placebo for two months, but ASA didn’t have much of an impact on fatigue. The ASA group didn’t have any serious adverse effects, but that much Aspirin over the long term could cause stomach problems in some people.
Copaxone (glatiramer acetate): Less frequent dosing with high-dose Copaxone has been approved in the U.S., enabling people to take a 40-mg dose three times a week rather than 20 mg once-daily (with daily dosing still resulting in a higher cumulative dose). This new regimen was shown to be effective in a one-year study called GALA (Khan and colleagues. Ann Neurol 2013;73:705-713). One year later, two-thirds of people taking Copaxone had experienced no relapses compared to a relapse-free rate of 57% for those on no treatment for a year before switching to Copaxone for the second year (Khan and colleagues. AAN 2014; abstract S31.003). Overall, disability progressed in about 7-8% of people over the two-year period.
A few studies have suggested that people on an interferon can get a bit of added benefit if they also take vitamin D supplements (Soilu-Hanninen and colleagues. J Neurol Neurosurg Psychiatry 2012;83:565-571). But the same may not be true for Copaxone. An examination of medical records found that people on an interferon took longer to have a relapse and had less inflammatory activity on their MRI if they had higher vitamin D levels (Rotstein and colleagues. AAN 2014; abstract I7-1.004). But vitamin D levels had no impact on these measures in people taking Copaxone. Why this difference of effect is open to speculation.
Gilenya (fingolimod): The LONGTERMS study has pooled data from phase II and III studies of Gilenya to look at whether there are safety issues over the longer term (Cohen and colleagues. AAN 2014; abstract P2.210). Over the first four years of treatment, the incidence of most side effects (e.g. infections, respiratory problems, blood pressure changes) goes down. The cancer rate was slightly higher, but was low at about 1%. No new safety signals were seen.
Perhaps the biggest concern with Gilenya is its effects on the heart, which has meant that people need to be observed for six hours after taking the first dose (the heart rate starts to recover after that and is usually back to normal within two weeks). The START study in Germany plans to look at cardiac safety in 7,000 people beginning Gilenya. Thus far, among the first 1,230 people starting Gilenya, less than 1% have experienced a significant slowing of their heart rate (to fewer than 45 beats per minute); the maximum amount that heart rate slowed was 12 beats per minute (Limmroth and colleagues. AAN 2014; abstract P2.197). Less than 2% of people had other heart effects (called second-degree AV block), and most were able to continue on treatment. No one showed significant changes in the electrical activity of the heart. There has been talk in some quarters about whether the 6-hour observation period with Gilenya is needed, but it’s unlikely that this requirement will be dropped anytime soon.
The third of three phase III studies of Gilenya was recently published (Calabresi and colleagues. Lancet Neurol 2014;13:545-556). As with most MS studies (and people with MS themselves), most study participants were Caucasian. But a small proportion (less than 1%) were African-American, so an analysis was done to see if Gilenya was as effective in this group of people (Coyle and colleagues. AAN 2014; abstract P3.156). After two years on the regular dose of Gilenya, the relapse rate was 0.26, which is similar to the 0.21 relapse rate seen for the group as a whole (0.36 for those on placebo). About 17% stopped treatment because of side effects (compared to 11% on placebo), which was higher than expected.
See Part II of this report in the next issue of MSology.
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