MS therapies – long-term results – ECTRIMS 2019
Highlights from the 35th congress of the European Committee for Treatment and Research in MS (ECTRIMS), September 11-13, 2019 – A number of studies have reported on the long-term safety of medications used to treat multiple sclerosis. The results were presented in September at the European Committee for Treatment and Research in MS (ECTRIMS) annual meeting, held this year in Stockholm, Sweden.
Tecfidera: A new study looked at 192 people treated with Tecfidera in the original studies and who continued on therapy for up to 10 years (Gold and colleagues. ECTRIMS 2019; abstract P1397). Overall, 51% of people experienced no relapses and 22% had only one relapse over the 10-year period. Two-thirds of people did not show worsening disability and only 21% developed moderate-to-severe disability. The risk of a serious infection was 1% or less in any given year of treatment and the infection risk did not appear to increase over time.
Tysabri: A study in France looked at 770 people who had been treated with Tysabri for up to 10 years (Bigaut and colleagues. ECTRIMS 2019; abstract P1013). People were typically treated with an interferon or Copaxone for up to 8 years before starting Tysabri. Two-thirds stopped taking Tysabri over the next 10 years. People with disease activity that wasn’t adequately controlled appeared to be have the highest risk of worsening disability. At the 10-year mark, about 22% had developed secondary-progressive MS and 21% required a wheelchair.
Ocrevus: The people with relapsing-remitting MS enrolled in the original trials (called OPERA I and II) of Ocrevus have now been on treatment for 6 years. Throughout that period, relapses have remained rare and about 81% of people have not seen worsening disability (Giovannoni and colleagues. ECTRIMS 2019; abstract 1015). The rate of disability also slowed in people with primary-progressive MS, although most (52%) had experienced worsening disability at the end of 6 years (Wolinsky and colleagues. ECTRIMS 2019; abstract 159). The most common problem with Ocrevus was the risk of infections. The overall rate of infections was about 77% per year, primarily affecting the urinary tract and respiratory tract (Hauser and colleagues. ECTRIMS 2019; abstract P648). Serious infections were much less common (about 4% per year). The risk of cancers (including breast cancer) has remained unchanged with continuous drug exposure (about 1% or less every 4 years).
Lemtrada: CARE-MS II was the trial that demonstrated that Lemtrada was effective in people who had previously been taking another MS medication. That study has now been running for 9 years and thus far, 60% of people have not shown any worsening disability (Comi and colleagues. ECTRIMS 2019; abstract P645). Almost one-half (49%) have seen some degree of improvement in their level of disability. About 1 in 4 people had an infection in Year 9 (3% were serious), and the cumulative rate of thyroid problems over the 9-year period was almost 50% (about 6% were serious). One person had a stroke during treatment.
A 12-year study of people enrolled in the earlier phase II study found that most people needed additional courses of treatment (most often in years 6 and 7) (Fernandez-Fernandez and colleagues. ECTRIMS 2019; abstract P651). Treatment remained effective the longer term – disability levels were stable or slightly improved in 71% of people. There was an ongoing risk of infection (27% had an infection in year 12). The cumulative rate of thyroid problems was 51% by year 12.
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