AAN 2017: Update on MS medications – Oral therapies
American Academy of Neurology annual meeting, Boston MA, 22-28 April 2017
The following is a summary of some of the key results from clinical trials of oral medications for MS presented at AAN 2017.
Aubagio: There were two key trials (called TEMSO and TOWER) of Aubagio in people with relapsing-remitting MS (RRMS), and many of the participants enrolled in a long-term extension to see how well treatment continued to work. In both studies, people in the placebo group were switched to Aubagio for the extension. After five years of treatment, disability didn’t get worse in a majority of cases. For those without serious disability at the start of treatment, 96% of people on Aubagio continued to be free of severe disability (Freedman and colleagues. AAN 2017; abstract P6.341). (Severe disability was defined as an EDSS score of 6, i.e. requiring a cane). In the group newly-diagnosed with MS, 90% did not develop even moderate disability (Oh and colleagues. AAN 2017; abstract P6.339).
Tecfidera: People enrolled in clinical trials of Tecfidera (called DEFINE and CONFIRM) also had the option of entering an extension study, and have now been followed-up for seven years (Gold and colleagues. AAN 2017; abstract P6.352). For the extension, people in the placebo group were switched to Tecfidera. In the subgroup of people who started Tecfidera within a year of being diagnosed with MS, few experienced a relapse over the 7-year period. Disability worsened in 18% on continuous treatment, and in 26% of people who started on placebo and later switched to Tecfidera. During the 7-year observation period, about 55% of people who continued to take Tecfidera were free of relapses and worsening disability. However, a high proportion of people (44%) stopped taking Tecfidera at some point over the 7 years. Most people reportedly didn’t stop treatment because of side effects (Pozzilli and colleagues. AAN 2017; abstract P5.383). The overall rate of serious adverse effects was 14%. Ten percent developed a liver disorder. And 4% developed a serious infection, which included one case of PML (progressive multifocal leukoencephalopathy), a severe brain infection.
Gilenya: PREFERMS was a 1-year study of people taking Gilenya or an injectable medication (Copaxone, Rebif, Avonex, Betaseron). People could switch treatments in the first three months because of efficacy or safety concerns, or after three months for any reason. At the end of one year, 81% of people on Gilenya were still taking it. In contrast, only 34% of people taking one of the interferons (Rebif, Avonex or Betaseron) and 25% of those on Copaxone were still on it (Thomas and colleagues. AAN 2017; abstract P6.369). Most people on Gilenya said they were satisfied (77%); whereas most on an injectable were not (satisfied: 44-48%). Similar results were seen in the subgroup of African-Americans: 81% remained on Gilenya vs. 30% on an injectable, and 81% said they were satisfied with Gilenya vs. 49% of those on an injectable (Cascione and colleagues. AAN 2017; abstract P6.382). In the safety analysis, the rate of infections was similar with Gilenya and the injectables, and was less than 1% per year (Fox and colleagues. AAN 2017; abstract P2.108).
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