Treatment studies at ECTRIMS – Day 3
This week, Copenhagen is hosting the 29th meeting of ECTRIMS (European Committee for Treatment and Research in MS), the largest annual gathering of physicians and researchers specialized in MS.
New Avonex formulation appears effective
A new formulation of Avonex (interferon beta-1a) is in development that offers an important advantage of fewer injections. Avonex must be injected once a week. But the new formulation needs to be injected only every 2 or 4 weeks.
The effectiveness of this new drug is being studied in the two-year ADVANCE trial and results at one year are now available (Calabresi and colleagues. ECTRIMS 2013; abstract P514). Over 1,500 people in the trial received either a placebo or one of two dose schedules of new-formulation Avonex (either every 2 weeks or every 4 weeks).
The frequency of relapses was reduced 36% when taken every two weeks and 27% when taken every four weeks compared to placebo. More frequent dosing was also better at reducing the number of MRI lesions and the risk of disability progression. The proportion of people who were disease activity-free (i.e. no relapses, no new MRI lesions, no disability progression) with the drug at one year was 34% when taken every two weeks, 22% when taken every four weeks, and 15% for placebo.
Tecfidera and Aspirin: the pros and cons
A common symptom among people who take Tecfidera (BG-12) is flushing (redness, itching, burning), which may be unpleasant enough for some to stop taking the drug. In the phase III DEFINE trial, about one-third of people taking Tecfidera experienced flushing (Gold and colleagues. N Engl J Med 2012;367:1098-1107).
Researchers in the U.S. have examined whether taking an Aspirin (acetylsalicylic acid, or ASA) beforehand will make this nuisance side effect more tolerable (O’Gorman and colleagues. ECTRIMS 2013; abstract P651). Over the course of the first month, 86-98% of people taking Tecfidera experienced flushing. Flushing was a little less common (72%) and less severe if people took an Aspirin thirty minutes before Tecfidera.
However, there was a trade-off. About 80% of people taking Tecfidera suffered from gastrointestinal problems, such as nausea/vomiting, stomach pain, diarrhea and bloating. While Aspirin didn’t seem to worsen these symptoms, people were more likely to stop taking the Tecfidera/Aspirin combination.
It should be noted that taking one Aspirin tablet (325 mg) 30 minutes before Tecfidera is suggested in the product monograph – but taking Aspirin for more than four days in a row is not recommended (Tecfidera Product Monograph, Biogen Idec Canada, March 23, 2013). In its review of the drug, the FDA found little evidence that taking Aspirin beforehand is an effective way of managing flushing (Center for Drug Evaluation and Research. Tecfidera Summary Review, February 11, 2013).
Long-term results for new oral therapies
Three oral therapies are now available (in some countries) to treat MS and ongoing studies are determining their effectiveness and safety over the longer term. The most recent results are:
– Gilenya (fingolimod): The LONGTERMS study is an extension of two phase III studies of Gilenya (FREEDOMS and TRANSFORMS) (Kappos and colleagues. ECTRIMS 2013; abstract P1052). After a median of 4-5 years, people on Gilenya have shown consistently low relapse rates and about 68-70% have experienced no relapses. Disability scores haven’t changed over the past five years. About 90% of people do not require the use of a cane (EDSS 6.0).
– Tecfidera (BG-12): ENDORSE is an extension of the two phase III trials (DEFINE and CONFIRM) of Tecfidera (Gold and colleagues. ECTRIMS 2013; abstract P538). The annual relapse rate remains low among those still taking the drug. About 69% of people have experienced no relapses during three years of treatment with Tecfidera.
– Aubagio (teriflunomide): An extension of the phase III TEMSO study has been ongoing for eight years (Freedman and colleagues. ECTRIMS 2013; abstract P544). Relapse rates have remained low. The most common adverse effects include diarrhea, hair thinning and influenza. The drug appears to be well tolerated. However, about 1 in 5 people have experienced a serious adverse effect, most commonly liver function abnormalities.
These results suggest that all three oral therapies are effective in the medium term. However, it should be noted that a limitation of all extension studies is that people from the original trial often drop out (for many reasons). If they’ve dropped out because they haven’t responded to the drug, this can skew the results and make a drug’s effectiveness look better than it is.
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