Update on Oral Medications for MS
American Academy of Neurology (AAN) annual meeting, Vancouver, B.C., April 15-21, 2016
The following are some of the results from studies looking at the effectiveness and safety of oral MS medications.
Gilenya: An ongoing study in Germany called PANGAEA reported that few people stop taking Gilenya due to side effects – about 5% in the first year, and 2% in the second year (Ziemssen and colleagues. AAN 2016; abstract P2.077). Common side effects included upper respiratory tract infections (10%) and MS fatigue (3.4%). Almost one-half of people taking Gilenya reported no side effects in the first four years of treatment.
The PREFERMS phase IV trial looked at people taking Gilenya compared to an injectable medication (either an interferon or Copaxone) over a 1-year period (Cree and colleagues. AAN 2016; abstract P3.115). After three months on treatment, people were allowed to switch to the other group. At the end of one year, 81% of people in the Gilenya group were still taking Gilenya, but only 29% in the injectable group were still on an injectable.
The first dose of Gilenya can be associated with changes in heart rate (pulse), blood pressure and heart rhythm, so there’s a potential for the drug to interact with other medications that affect heart function. However, in an analysis of almost 700 people enrolled in the PREFERMS study, first-dose effects were similar in those with and without heart conditions, such as high blood pressure or heart disease (Wynn and colleagues. AAN 2016; abstract P2.065). There were also no added safety issues for people on antidepressants (selective serotonin reuptake inhibitors, or SSRIs); a prior study also reported no added safety issues for people taking an SSRI with Gilenya (Bermel and colleagues. Mult Scler Relat Disord 2015;4:273-280).
Aubagio: When it comes to MS treatment, neurologists generally recommend starting as soon as possible rather than putting off the decision. The reason for this was shown in an analysis of the TOWER trial comparing Aubagio and placebo (O’Connor and colleagues. AAN 2016; abstract P3.021). After the 2-year study was completed, people in the placebo group could switch to Aubagio; those initially assigned to Aubagio continued to take it. So this enabled a comparison between people on Aubagio 14 mg/day for 4 years (earlier treatment) compared to 2 years (delayed treatment). Over the 4-year period, about 26.7% of people starting treatment earlier experienced worsening of their disability compared to 30.2% of those in the delayed-treatment group. Those who delayed treatment did worse initially, as you might expect, but two years later they still hadn’t caught up with respect to disability progression.
An analysis of two phase III trials of Aubagio (TEMSO and TOWER) found that 36% of people taking Aubagio had relapses compared to 49% taking placebo (O’Connor and colleagues. AAN 2016; abstract P3.079). For people having a relapse, there was a lower risk of disability if they were taking Aubagio compared to a placebo (22% vs. 29%). Among those with no relapses, about 90% had no worsening of their disability over the next two years, illustrating the importance of avoiding relapses early in the disease course.
Tecfidera: The RESPOND study is an ongoing phase IV trial of older people (average age 47 years) who didn’t respond to Copaxone and were switched to Tecfidera (Kresa-Reahl and colleagues. AAN 2016; abstract P6.172). People reported that they had less MS fatigue and depression symptoms after switching to the oral drug, and treatment satisfaction increased. However, about half of those who started Tecfidera had stopped taking the medication or had withdrawn from the study by the 6-month mark.
Some people taking Tecfidera can develop low white blood cell counts (called lymphopenia), which may require stopping the medication. While the proportion of people is reported to be about 6% (Wenten and colleagues. AAN 2016; abstract P2.098), a study at one MS centre in the U.S. found that twice as many people – about 13% – developed severe lymphopenia (Romba and colleagues. AAN 2016; abstract P2.101). This underscores the importance of regular blood tests while taking an MS medication.
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