Research News: Recent study findings and new treatments are featured
Children and Adolescents with MS Experience Significant
Reductions in Relapses with Gilenya® (fingolimod) in Phase III Trial
On September 5, 2017, Novartis announced that its Phase III PARADIGMS study in pediatric MS met its primary endpoint. Comparing individuals treated with Gilenya® (fingolimod), a daily oral medicine approved for relapsing forms of MS, to a control group receiving Avonex® (interferon beta-1a) via weekly injections, study participants in the treatment group experienced a significant reduction in their annual relapse rate. The participants in this study were children and adolescents who had been diagnosed with MS and were between the ages of 10 and 17.
According to the press release from Novartis, “Commonly diagnosed during adolescence, pediatric MS is associated with relapses that are more frequent and often more severe than those seen in adults with MS. Relapses negatively affect mobility, balance and cognitive function, and patients with pediatric MS are more likely to accumulate physical disability at an earlier age than those diagnosed as adults. There is currently no treatment indicated for children and adolescents living with MS, based on randomized, controlled, clinical study data.”
PARADIGMS is the first study to compare two MS therapies, approved for adults, in children and adolescents with MS. Enrolling 215 young participants with MS, PARADIGMS was a double-blind, randomized, multi-center Phase III study with a duration up to two years, followed by a five-year open-label extension phase. Side effects and adverse events were similar to those seen in other clinical trials with adult participants.
PARADIGMS was conducted at 87 sites in more than 25 countries. Results of the Phase III study will be presented at the Joint ECTRIMS-ACTRIMS Meeting, which will be held in Paris, France in late October. While Gilenya is not yet approved for the treatment of pediatric MS, Novartis is continuing its analysis and is looking at next steps needed to submit this indication for approval.
Highlights from the AAN and CMSC 2017 Annual Meetings
Since the publication of the Winter/Spring 2017 issue of The Motivator, one of the online articles that MSAA published was a summary of highlights from the American Academy of Neurology (AAN) Annual Meeting in April 2017 and the Consortium of MS Centers (CMSC) Annual Meeting in May 2017.
Among the many topics was important information on MS medications, including select disease-modifying therapies and symptom-management medications. Other information was provided on a number of wellness issues, from lifestyle factors and wellness programs to mindfulness and nutrition. To view MSAA’s online article, please visit mymsaa.org/aancmsc2017.
Mavenclad® (Cladribine Tablets) Approved by European Commission for the Treatment of Relapsing MS
On August 25, 2017, Merck announced that the 10-milligram dose of Mavenclad® (Cladribine Tablets) had been approved for marketing in 38 European countries, in addition to Norway, Liechtenstein, and Iceland. This is the first approved oral medication for MS that is given via short courses for “highly active relapsing multiple sclerosis.” This “short course” is a maximum of 20 days of oral treatment during a two-year period.
More than 2,700 patients participated in the clinical trials, some of whom were observed for up to 10 years. The Phase III clinical trials included CLARITY, CLARITY EXTENSION, and ORACLE MS. Mavenclad was shown to delay disability progression, reduce annualized relapse rate, and reduce disease activity as shown on magnetic resonance imaging (MRI). Side effects include a reduction in lymphocyte count (these are disease-fighting white blood cells), infections, and a possible increased risk of malignancy.
Although patients are given just two short annual courses of tablets within a period of two years, effectiveness can continue for an additional two years without further treatment and without the need for frequent monitoring. The pharmaceutical company plans to file for regulatory approval in other countries, including the United States.