New results from MS medication studies – ECTRIMS 2016
European Committee for Treatment and Research in MS (ECTRIMS), London UK, September 14-17, 2016 – MS medications have been available for over 20 years but many people are still hesitant about starting treatment. Two new studies have investigated whether medications have any impact on the development of disability. The first looked at over 600 people treated at the Karolinska Institute in Sweden over an median 8-year period (Kavaliunas and colleagues. ECTRIMS 2016; abstract P1222). The researchers found that after a person was diagnosed, for every 1-year delay in starting treatment there was a 6-7% increased risk of developing worsening disability. If a person didn’t start treatment within the first three years, they had a 2-3-fold higher risk of disability compared to those who started treatment within the first year after diagnosis.
The second study looked at over 1000 people treated in the years 2000-2003, when only injectable medications (interferons and Copaxone) were available, compared to those treated in 2008-2011, when MS was being diagnosed earlier (the criteria for diagnosis changed in 2010) and more medication options had become available (Tysabri, Gilenya) (Comi and colleagues. ECTRIMS 2016; abstract P753). People in the later period had fewer relapses and less disability compared to the earlier period. Two success factors emerged: starting treatment earlier, and switching to another medication if the first one didn’t work well enough.
Over a dozen MS medications are now available. The following is a summary of some of the treatment studies presented at ECTRIMS 2016.
Aubagio: Two trials (called TEMSO and TOWER) examined the effectiveness of Aubagio versus a placebo, and people could continue on treatment once the studies were completed. Six years later, few people (6.3%) had developed disability severe enough to require a wheelchair (Lublin and colleagues. ECTRIMS 2016; abstract P691). In the TOPIC trial of early MS, the risk of worsening disability was also low (22%) in people taking Aubagio for up to seven years (Miller and colleagues. ECTRIMS 2016; abstract P690).
Tecfidera: Two trials (DEFINE, CONFIRM) examined Tecfidera in relapsing MS; after the initial 2-year studies, people could continue in a longer-term extension study (called ENDORSE). After an average of 6 years, the annual relapse rate remained low (0.14 relapses/year), and about 84% had not experienced worsening disability during treatment with twice-daily Tecfidera (Gold and colleagues. ECTRIMS 2016; abstract P631).
Flushing is a common side effect of Tecfidera, and many doctors prescribe Aspirin to relieve it.
A study called ASSURE looked at whether Aspirin was effective during twice-daily treatment with Tecfidera (Rog and colleagues. ECTRIMS 2016; abstract P1246). Two Aspirin regimens were used in the first month of taking Tecfidera: 150 mg (about half a tablet) twice-daily, or 75 mg (a quarter-tablet) once-daily. Both Aspirin regimens were modestly effective, but only appeared to improve flushing after 2-3 weeks. The higher dose of Aspirin didn’t appear to be more effective than the lower dose, but stomach upset was more common: most people (55%) reported gastrointestinal problems with the combination of Tecfidera and half a tablet of Aspirin.
Gilenya: A common symptom of MS is cognitive problems (difficulty thinking, planning and remembering). A 3-year study reported that cognition improved during treatment with Gilenya (Ozakbas and colleagues. ECTRIMS 2016; abstract P619). In the group with cognitive impairment at the beginning of the study, about 1 in 3 were no longer impaired after treatment with Gilenya.
Lemtrada: In the CARE-MS II trial, people who had been on other medications received two annual courses of Lemtrada. Over a 6-year period, about 50% haven’t received additional treatment but their MS has remained well-controlled (LaGanke and colleagues. ECTRIMS 2016; abstract P681). About 80% in any given year have no relapses, and about 70% show no inflammatory activity on their brain MRI.
In development: Cladribine is a new therapy being developed for MS. It’s an oral medication that’s taken for a couple of weeks a year. An analysis of two phase III studies (called CLARITY and ONWARD) reported that treatment was very effective: relapses were reduced 57%, and worsening disability was reduced 39% compared to a placebo (Giovannoni and colleagues. ECTRIMS 2016; abstract P643). Cladribine was also effective in the subgroup of people with highly active MS, reducing relapses by 62% and the risk of disability progression by 34%.
- Tecfidera vs. Copaxone or an interferon: In Sweden, a higher proportion of people prescribed Tecfidera were still taking it after a year (72.8%) compared to those prescribed Copaxone (52.6%) or an interferon (52.7%) (Berglund and colleagues. ECTRIMS 2016; abstract P649).
- Aubagio vs. Tecfidera: A mail-in survey in France found that people prescribed Tecfidera were twice as likely to stop treatment in the first six months of therapy compared to those taking Aubagio (Moisset and colleagues. ECTRIMS 2016; abstract P650).
- Gilenya vs. Tecfidera: An MS clinic in the U.S. examined records for over 600 people taking Gilenya or Tecfidera (Vollmer and colleagues. ECTRIMS 2016; abstract P702). Over a 2-year period, people were significantly more likely to stop taking Tecfidera compared to Gilenya. Among those with adverse reactions, stomach problems were the most common reason for stopping treatment – mentioned by 24% of those taking Gilenya, and 81% of those taking Tecfidera.
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