Update on Injectable/infusion 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 injectable and infusion medications for multiple sclerosis.
Tysabri: The Tysabri Observational Program (TOP) is an ongoing program looking at the safety and effectiveness of Tysabri. According to the most recent report, people switching from an injectable or Gilenya do very well, with about 1 in 4 people showing an improvement in disability over 8 years of treatment (Butzkueven and colleagues. AAN 2016; abstract P2.069). Disability worsened in about 1 in 10 people during treatment with Tysabri. However, almost one-half of people on Tysabri stopped taking the drug, primarily because of concerns about progressive multifocal leukoencephalopathy. PML is a potentially fatal brain infection and there is an increasing risk of developing it with cumulative exposure to the drug, so many doctors advise stopping Tysabri after two years.
Updated results were also reported for ASCEND, the phase III trial of Tysabri in people with secondary-progressive MS (Steiner and colleagues. AAN 2016; abstract 9153). On average, people had developed SPMS about 5 years earlier, and most required assistance for walking (EDSS score of 6 or more). Tysabri had no effect on walking ability, but did appear to slow the worsening of upper limb disability (hands and arms).
Lemtrada: Two phase III trials tested Lemtrada in people who had never been treated for their MS (CARE-MS I) or had received other therapies beforehand (CARE-MS II); in both studies, people received either Lemtrada or Rebif, with the Rebif group switching to Lemtrada after two years. Lemtrada was given as two annual treatment courses. In CARE-MS I, 68% of people didn’t require additional medication over the next three years (Limmroth and colleagues. AAN 2016; abstract S51.004). The average number of relapses was 0.16 per year; the level of remained stable in 82% of people, and 1 in 3 showed some improvement in their disability. For the group that switched from Rebif to Lemtrada, the relapse rate was reduced by two-thirds (from 0.39 to 0.11), the level of disability was stable in 81%, and disability improved in 18% (Hartung and colleagues. AAN 2016; abstract P3.104).
In CARE-MS II, 60% of people didn’t need another course of treatment after the initial two courses (Coles and colleagues. AAN 2016; abstract P3.022). The average relapse rate was low (0.21), and 43% showed an improvement in their disability. In years 3-5, 52% of people had no relapses, no progression of their disability, and no new lesions on their MRI. For those switching from Rebif to Lemtrada, the average relapse rate decreased substantially (from 0.54 to 0.14) and 21% showed an improvement in disability (Havrdova and colleagues. AAN 2016; abstract P3.024). Combining the two trial results, 84% of people had no worsening of their disability, 43% had an improvement in their disability, and about 70% had no evidence of MS activity (relapses, disability worsening or new MRI lesions) in years 3-5 (Fox and colleagues. AAN 2016; abstract S51.005).
Ocrelizumab: New results were presented for OPERA I/II, the two phase III trials required for drug approval (ocrelizumab is not yet available). The combined results of the two studies showed that there was a 47% reduction in relapses and a 40% reduction in disability progression with ocrelizumab compared to Rebif (Hauser and colleagues. AAN 2016; abstract S49.003). The proportion experiencing an improvement in disability measures was somewhat low (about 16-21%). The proportion of people with worsening disability was 8-13% compared to 14-20% with Rebif (Comi and colleagues. AAN 2016; abstract S49.08). In the first two years of treatment, 48% of people taking ocrelizumab had no evidence of disease activity (i.e. no relapses, no new MRI lesions and no disability progression), compared to 25-30% taking Rebif (Traboulsee and colleagues. AAN 2016; abstract PL02.004).
Daclizumab: This is a treatment in development and information was provided last year (see Latest news on MS treatments – injection/infusion agents, MSology, May 14, 2015). One issue that emerged from ongoing trials (called DECIDE and SELECT) is skin toxicities, such as severe rash (Selmaj and colleagues. ECTRIMS 2014; abstract P094; Kircik and colleagues. ECTRIMS 2015; abstract P550). An analysis of six studies found that 35% of people taking daclizumab developed skin reactions (Giovannoni et al. ECTRIMS 2015; abstract P554). The most recent report of people in the DECIDE study found that most skin reactions were usually mild-to-moderate in severity and didn’t require treatment (Ford and colleagues. AAN 2016; abstract P2.083). Serious skin problems occurred in about 2%, typically developed about 3-23 months after starting treatment, and lasted up to 8 months despite the use of steroid creams or other treatments.
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