New information on oral therapies for multiple sclerosis – ECTRIMS 2015
European Committee for Treatment and Research in MS (ECTRIMS) – 31st Congress – Barcelona, Spain, October 7-10, 2015 – Three oral medications are now available to treat multiple sclerosis, and numerous researchers have examined their effectiveness and safety. The following is a summary of some of the studies presented at ECTRIMS 2015.
Aubagio: A good proportion of people who take Aubagio can expect to experience no relapses, no new inflammatory activity on their MRI, and no progression of their disability, according to the results of two analyses. Once people had been on treatment for six months (after which the medication is fully effective), about 28% of people had no noticeable disease activity over the next 18 months (Chan and colleagues. ECTRIMS 2015; abstract 1037). Over the longer-term term, over 40% of people experienced no relapses, worsening disability or MRI activity (Wolinsky and colleagues. ECTRIMS 2015; abstract P1047).
How do you know if you’re responding to treatment? One way is to count the number of relapses and MRI lesions (called a Rio score) (Sormani and colleagues. Mult Scler 2013;19:605-612). As you might expect, people with few lesions and no relapses – both indicating that disease activity is well suppressed – do better in terms of disability over the longer term. Using this measure of treatment response, an estimated 79% of people starting treatment with Aubagio will respond to the medication (Sormani and colleagues. ECTRIMS 2015; abstract P1131). Responders were more likely to be free of disability – an effect that became apparent within the first few months of starting the medication, and which was still apparent 5-6 years later.
One concern that people can have with Aubagio is hair thinning, which affects about 8% of people (Freedman and colleagues. ECTRIMS 2015; abstract EP1460). A study at nine MS centres in the U.S. found that when hair thinning occurs, it typically begins about 2-3 months after you start taking Aubagio (Travis and colleagues. ECTRIMS 2015; abstract P1113). The problem was mild in a majority of cases, and the hair loss wasn’t permanent. The hair will regrow at the start of the next hair cycle. The study found that at the follow-up visit, about 80% of people said that the problem was greatly improved or resolved. Only a couple of people stopped or interrupted treatment because of hair thinning.
Tecfidera: A long-term study (called ENDORSE) of people enrolled in clinical trials of Tecfidera reported that relapse rates remain very low over a six-year period of treatment (Hutchinson and colleagues. ECTRIMS 2015; abstract P543). Disability levels were stable from years 3-5, and most people had no new inflammatory lesions on their MRI (Arnold and colleagues. ECTRIMS 2015; abstract 566).
One problem that has emerged with Tecfidera over the last year is progressive multifocal leukoencephalopathy (PML), a potentially fatal brain infection. PML has plagued Tysabri users (about 600 cases to date, including over 100 deaths), but fortunately the PML risk appears to be much lower with Tecfidera. One theory is that persistently low white blood cell (WBC) counts are associated with PML risk; of particular importance are lymphocytes, a type of WBC that protect against infection. In clinical trials of Tecfidera, about 7% of people experienced a severe problem with low WBC counts (Fox and colleagues. ECTRIMS 2015; abstract P606), which is generally managed by either reducing the drug or stopping it altogether. Several MS centres in the U.S. and Scotland reported their experience with WBC/lymphocyte counts and Tecfidera. In general, it appears that the problem is somewhat more common in the real world compared to the world of clinical trials – about 6-13% of people had persistently low blood cell counts (Romba and colleagues. ECTRIMS 2015; abstract P1130; Smoot and colleagues. Abstract P610; MacDougall and colleagues. Abstract P624). The people at highest risk of developing this problem are typically older, those with worse disability, and people with lower blood cell counts before they start treatment.
Gilenya: Low lymphocyte counts are also seen with Gilenya, but the situation is a little different because that is the normal way that the drug works in MS. Gilenya sequesters lymphocytes in the lymph nodes so they aren’t free to cause inflammation in the brain. Low lymphocyte counts may contribute to the PML risk with Gilenya (three cases have been reported thus far), but this isn’t known for sure. In fact, a long-term safety analysis of people taking Gilenya for up to seven years found that a low blood cell count didn’t appear to be associated with an increased risk of infections of any kind (Cohen and colleagues. ECTRIMS 2015; abstract P591). So this issue will need more study. As with Tecfidera, the PML risk with Gilenya appears to be very low.
Still, low lymphocyte counts are a concern to some, so a small Italian study looked at whether taking Gilenya every other day (rather than every day) had less of an impact on blood cell counts (Merlini and colleagues. ECTRIMS 2015; P1183). It did – but 1 in 4 had a relapse, suggesting that the lower dose wasn’t as effective in controlling their MS. This underscores the importance of taking Gilenya every day.
People who start Gilenya appear to be satisfied with their treatment judging by the number who keep taking the medication. Among people enrolling in the Gilenya patient support program in Canada, about 77% were still taking their medication two years later (Lapierre and colleagues. ECTRIMS 2015; abstract P529). This compares favourably to what has been seen with the injectable medications (interferons and Copaxone): a study in Ontario found that a majority of people stopped their treatment within 2-3 years (Wong and colleagues. Can J Neurol Sci 2011;38:429-433).
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