AAN REPORT 3: New information from MS treatment trials
American Academy of Neurology highlights
MS drug trials were the day’s main highlights at the American Academy of Neurology’s annual meeting. Here is a summary of the treatment studies.
- CombiRx study comparing Avonex or Copaxone versus the combination of Avonex + Copaxone (Lublin and colleagues. AAN 2013; abstract P04.121). After an average of 4 years on treatment, about 30% of people showed disability progression (defined as a 1-point increase or more in their EDSS score). About the same number showed improvement in disability (defined as a 1-point decrease in EDSS score). There was no advantage in taking both drugs compared to either Avonex or Copaxone on its own.
- GALA study of twice the usual dose of Copaxone (40 mg) taken three times a week instead of daily (Rieckmann and colleagues. AAN 2013; abstract P07.090). This schedule did reduce disease activity compared with a placebo. However, only 23.3% were disease activity-free (no relapses, EDSS progression or MRI lesions) after one year on this regimen. In comparison, twice that number can be disease activity-free with Tysabri or Gilenya.
- Gilenya studies focused on the effect of the drug on progression of disability in MS. An analysis of people in two of the phase III studies (called FREEDOMS and TRANSFORMS) found that their risk of disability progression was over 50% lower with oral Gilenya compared to placebo (Bergvall and colleagues. AAN 2013; abstracts P04.128 and P07.108). An interesting finding was that with Gilenya, disability was twice as likely to improve over the course of a year. A separate analysis of three phase III trials (including FREEDOMS II) showed that the rate of brain shrinkage (or atrophy) was reduced by about one-third in people on Gilenya compared to those on placebo or Avonex (Cohen and colleagues. AAN 2013; abstract S51.006).
- TOWER study of oral Aubagio (teriflunomide) (Miller and colleagues. AAN 2013; abstract S01.004; Moses and colleagues. AAN 2013; abstract S41.006). This study showed that the higher dose of Aubagio reduced relapse rates by 36% and disability progression by 31%. Relapses were reduced by 22% with the lower dose and there was no significant effect on disability. The most common side effects with teriflunomide were headache, abnormal liver function tests, thinning hair, diarrhea and nausea. An analysis of different subgroups found that the impact of the higher dose of Aubagio on progression was more pronounced in people with initially more active disease.
- DEFINE and CONFIRM studies of BG-12. Three reports looked at the combined results of the two phase III trials that examined two dosing schedules (twice or three times a day) of oral BG-12. Overall, BG-12 reduced relapse rates by about 50% compared to placebo. The drug’s effectiveness was slightly less (41-47% reduction in relapses) in the subgroup of people with more relapses when they started treatment (Bar-Or and colleagues. AAN 2013; abstract P07.095). The relapse rate reduction was 27-44% in people from North America. The impact of therapy was greater in people from Eastern Europe, which was probably due to the fact that a majority of Eastern Europeans had never received an MS medication before (Kita and colleagues. AAN 2013; abstract P07.091). Overall, 26-28% of people treated with BG-12 were free of disease activity (no relapses, EDSS progression or MRI lesions) compared to 15% in the placebo group (Havrdova and colleagues. AAN 2013; abstract P07.106).
- ALLEGRO trial of oral laquinimod (Comi and colleagues. AAN 2013; abstract S41.004). Following the initial two-year study, participants could enroll in an ongoing extension of the study during which everyone (including the placebo group) would receive laquinimod. One year into the extension, people taking laquinimod for a longer period appear to have a lower risk of disability progression, underscoring the importance of starting treatment as early as possible.
- CARE MS-II trial of alemtuzumab versus Rebif in people who didn’t respond adequately to a prior MS treatment (Twyman and colleagues. AAN 2013; abstract P07.098). In the initial study, the infusion drug alemtuzumab reduced the relapse rate by 49% compared to what was seen with Rebif. This effect was evident in the first year of starting alemtuzumab. The drug was also effective in people with severe relapses. At one year, 44% of people taking alemtuzumab were disease activity-free (no relapses, EDSS progression or MRI lesions) compared to 27% in the Rebif group (Hartung et al. AAN 2013; abstract P07.093). After two years, the proportion who were disease activity-free was 32% with alemtuzumab and about 14% with Rebif.
- SELECT study of daclizumab. The SELECT study compared two doses of the infusion drug daclizumab given once a month to a placebo. Daclizumab, a new drug in development, was effective in people with highly active MS as well as in the overall study population, producing a 50% reduction in the relapse rate in both groups (Mehta and colleagues. AAN 2013; abstract P07.113). Daclizumab was also effective in reducing the number of new MRI lesions and appeared to make lesions less damaging to the brain (Radue and colleagues. AAN 2013; abstract P07.094). After one year of treatment, 39% of people were disease activity-free (no relapses, no EDSS progression, no MRI lesions) with daclizumab compared to 11% on placebo (Havrdova and colleagues. AAN 2013; abstract P07.105).
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