There was a lot of excitement at ECTRIMS this week about the emergence of new treatment approaches for all forms of MS, even progressive.
Earlier blog posts have already covered emerging therapies including stem cells, nervous system repair strategies and rehabilitation and wellness approaches. So this report focuses on results from experimental therapies that are well on their way to being available to people with MS.
Making perhaps the most “buzz” were results presented on studies of the monoclonal antibody ocrelizumab, in relapsing remitting and progressive MS. Ocrelizumab targets a protein that appears on immune B cells during specific stages of their life cycle. B cells make antibodies to help fight infection and perform other functions to stimulate the immune system. Scientists believe ocrelizumab destroys the group of B cells that include those that contribute to MS, but leaves other B cells intact that are fighting infections or are prepared to fight new ones.
A highly anticipated presentation described the results of a clinical trial of ocrelizumab involving 732 people with primary progressive MS. Participants were given either ocrelizumab or inactive placebo by in-vein infusions about every 6 months. Results showed that compared to placebo, ocrelizumab significantly reduced the risk of progression of clinical disability (according to the standard EDSS scale) by 24%, and had other positive outcomes. The main side effects were reactions to the infusions, and the incidence of serious infections was relatively low. (Abstract 228) This is the first large-scale clinical trial to show positive results in people with primary progressive MS. We don't yet know what mechanism might be driving these results in progressive MS, so we are eager to see more information when these results are published. For more information, click here.
In addition results were presented from two phase III trials of ocrelizumab in relapsing MS. In both trials the treatment performed very well against Rebif in people who had never been on any MS therapy as well as those who had tried other therapies. The reported results showed that ocrelizumab reduced the risk of relapse by 46 to 47% compared to Rebif, reduced the risk of disease progression by 40%, and had other positive outcomes. (Abstract 190) The sponsor, Genentech (a member of the Roche Group) stated that it plans to apply for marketing approval from the FDA in early 2016. This was a significant set of results as it identified a new approach to modulating the immune system in MS.
Another intriguing trial result came from a dedicated group of investigators led by Dr. Luanne Metz (University of Calgary) who conducted a Phase III trial of a relatively inexpensive oral antibiotic called minocycline. Minocycline has been on the market for decades and is often prescribed to treat acne, and in addition to its bacteria-killing action, it reduces inflammation.
The trial tested minocycline against placebo in 144 people across Canada who had clinically isolated syndrome (CIS) – which means they have early possible signs of MS but haven’t yet shown enough signs or symptoms to be diagnosed with definite MS. The goal was to determine if minocycline, taken orally at a dose of 100mg twice a day, could reduce the proportion of participants with CIS who converted to MS over a 6-month follow-up period. The secondary objective was to determine whether the effect could last up to two years. Their results showed that over 6 months, those taking twice daily minocycline had a 44.6% reduced risk of developing definite MS, compared to those taking placebo. There were no unexpected side effects reported from the trial outside of the most common that occur in some who take this antibiotic, including potential for diarrhea; dizziness or light-headedness; grey discoloration of the skin or tissue in the mouth or teeth; sun sensitivity and secondary infection due to fungi. (Abstract 227)
These results bring up a lot of questions, such as: What are the longer-term benefits or side effects? Would this help people who already have MS? Would a generic drug like this ever become approved by regulators? Would its price alone influence doctors to prescribe it?
These are only a few of many new approaches being explored to stop the MS process and restore function. If you are interested in these and the many other reports from ECTRIMS, visit the ECTRIMS Website and browse the hundreds of abstracts to get an idea of what solutions are on the horizon for people with MS. One important caveat –everything presented at a meeting such as ECTRIMS is considered preliminary until it has been thoroughly peer-reviewed for publication in a respected journal - so the information shared here is based only on the preliminary information we’ve heard so far.