ACTRIMS 2013: New MS Treatment Studies
Some important new research was presented at the Fifth cooperative meeting of the Americas Committee for Treatment and Research in MS (ACTRIMS) and the Consortium of MS Clinics (CMSC), held May 31-June 1, 2013, in Orlando, Florida. The following are some of the highlights from the meeting.
Eye problems in MS (optic neuritis) appear to be worsened by low vitamin D levels, according to a study at the University of Calgary (Burton and colleagues. ACTRIMS/CMSC 2013, abstract P2). Thus far, the study has enrolled 42 people with optic neuritis and most had vitamin D insufficiency. The preliminary results suggest that those with low vitamin D levels have worse swelling in the eye, and subtle swelling can still be detected six months later. Dietary supplements to boost vitamin D levels may help the problem and improve vision difficulties in MS.
Oral vs. injectable
A new analysis suggests that oral Aubagio (teriflunomide) holds its own when stacked up against the injectable MS medications (the interferons and Copaxone) (Cutter and colleagues. ACTRIMS/CMSC 2013, abstract P31). Results from 30 studies were examined. When estimating the impact of treatment on relapses or disability, the higher dose of Aubagio (14 mg per day) was slightly better than Avonex, but no different from Rebif, Betaseron/Extavia or Copaxone. The implication is that Aubagio may be a suitable first-choice alternative to an injectable medication for people starting MS treatment.
Need for monitoring after IV steroids
A short course of IV steroids is often used for a severe relapse, but monitoring is needed afterward to ensure that there are no complications. Two potential issues are blood glucose levels and blood pressure. An MS clinic in New York state looked at 18 people who’d received a course of steroids for their MS over a six-month period (Gottesman and colleagues. ACTRIMS/CMSC 2013, abstract P6). About 1 in 10 people had to stop the steroids because of raised glucose levels or high blood pressure. Changes in glucose or blood pressure were generally small for most people. But extra precautions may be needed for people with other diseases, such as diabetes or heart disease, if they’re scheduled for a course of steroids.
Gilenya safety update
Gilenya (fingolimod) is a potent oral medication that is often used for people with highly active disease or those who don’t respond well enough to an injectable medication. The first dose of the drug can slow the heart rate so a six-hour observation period is needed when treatment is started. A few cardiovascular deaths have been reported in people taking Gilenya. While regulatory authorities did not establish a cause and effect, there have been concerns about the safety of the drug. So a new analysis has looked at the long-term safety of Gilenya among people in clinical trials (Cohen and colleagues. ACTRIMS/CMSC 2013, abstract). About 10% of people taking Gilenya had a serious adverse effect, which was similar to what was seen in people taking a placebo (about 12%). The risk of infections was also similar with Gilenya and placebo. Adverse effects that were more common with Gilenya included high blood pressure (6.5%), abnormal liver function test results (8%), a slowing of the heart rate (1%), and swelling in the eye (called macular edema, 0.4%). Significant heart problems (called second-degree atrioventricular block) occurred in about 1 in a thousand people (0.1%). The researchers concluded that the risk of serious complications with Gilenya is no greater than with a placebo.
Treating secondary-progressive MS
Most people with relapsing-remitting MS will develop secondary-progressive MS (SPMS), in which relapses become less common but there is an ongoing accumulation of disability. Unfortunately, the current MS therapies haven’t been shown to be effective in SPMS once relapses have stopped. One possible treatment is rituximab (Rituxan), which targets B cells (which produce antibodies) as its way of modulating the immune response in MS. A small study looked at 30 people with SPMS treated with rituximab over a two-year period (Perrone and colleagues. ACTRIMS/CMSC 2013, abstract P28). Overall, about one-half of the people didn’t show a worsening in their disability progression and about one-third showed some improvement. A previous study also suggested that rituximab may provide some benefit in SPMS (Rommer and colleagues. CNS Drugs 2011;25:607-613). Unfortunately, rituximab isn’t expected to be released as an MS drug (it’s now used to treat some blood cancers). Two other B cell drugs are in development (ocrelizumab, ofatumumab) but haven’t been studied yet in SPMS.
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