AAN report on status of MS drug trials – PART II

As the AAN conferences continues, so too do the updates on current and new treatments for MS. Here are some more highlights:

Efficacy and safety of alemtuzumab maintained after 4 years despite most patients not requiring additional treatment

Alemtuzumab was recently approved as a treatment for relapsing-remitting MS in Canada. It is a monoclonal antibody administered via intravenous infusion and has a dosing profile that is quite unique to the MS treatment repertoire: for the first treatment course, individuals receive one infusion of 12 mg alemtuzumab per day for five days. One year later, individuals receive one infusion per day for three days.  Two pivotal phase III clinical trials for alemtuzumab in people with relapsing-remitting MS showed encouraging efficacy and safety results. Researchers have been observing individuals from these trials over time to assess the long term durability of the drug. The extension study enrolled 349 alemtuzumab-treated patients. At four years post-treatment, researchers noted that 73% of individuals treated in the first clinical trial did not require another round of alemtuzumab treatment beyond the initial two courses. As well, approximately 70% of treated patients were free of new lesions and MRI activity in years three and four, and rates of brain volume loss were reduced.

First data from long term follow up of people taking peginterferon beta-1a

Beta interferons are an approved treatment for RRMS. They work by reducing the immune response and inflammation in the central nervous system. Peginterferon beta-1a is an adaptation of interferon beta-1a. The modification allows the drug to exist in the body longer. Currently, peginterferon beta-1a is an approved MS treatment in certain countries, but is still under review by Health Canada. In a phase III clinical trial called ADVANCE, peginterferon beta-1a dosed at 125 μg every two weeks showed improvements as early as 12 weeks, with a 34% reduction in relapse rate compared to placebo. There was also a 36% reduction in people who relapsed compared to placebo. The first results of the extension phase of the study – called ATTAIN – were reported at AAN. They showed that the frequency of adverse events decreased in year 3 of treatment, with most common events being injection-site reactions and flu-like symptoms (adverse events were similar among those who received the treatment every 2 weeks versus every 4 weeks).

Two year data for emerging treatment daclizumab HYP

Daclizumab high-yield process (HYP) is a newly patented version of a drug that is commonly used to prevent rejection in organ transplantation. Daclizumab HYP prevents activation and growth of immune cells, and is administered once a month via under-the-skin injections. Results of a phase III clinical trial for daclizumab HYP – called DECIDE – demonstrated that treatment with daclizumab HYP resulted in a 45% reduction in relapse rate versus treatment with interferon beta-1a, and a 41% reduction in the proportion of people who experienced relapses. There was also a 54% reduction in the number of active lesions on MRI, and risk of disability progression was reduced by 27%. Adverse events were minor and manageable, with Infections and skin and liver-related effects more commonly seen in people treated with daclizumab HYP versus interferon beta-1a.

Leave a Reply

Your email address will not be published. Required fields are marked *