Tanuja Chitnis, MD, spoke about the first-of-its-kind PARADIGMS trial, and pediatric multiple sclerosis, as well as how it differs from the condition in adults.
Tanuja Chitnis, MD, the director of the Partners Pediatric MS Center at Brigham and Women's Hospital: So, it was not recognized - it was not well recognized - in the past that children got multiple sclerosis (MS). Many of these children were diagnosed with other disorders or left untreated for many years. It wasn't until about 2007 when there was the first publication of diagnostic criteria for pediatric MS that it was well recognized, or began to become recognized that children got MS.
[PARADIGMS] is the first study of its kind, and also partly because there weren't clinical trials being done in this population, with mandates from both the US government as well as the EU through something called the Pediatric Research Equity Act, as well as similar acts within Europe, that there was now a mandate for all new drugs to have a pediatric investigation plan or study done.
So there's probably 3 features that I would say are really important to know [about pediatric MS]. One is that children have a highly inflammatory disease. They have 2 to 3 times as many relapses as a typical adult patient will. Second is that they can have significant cognitive issues, and this can translate into difficulties with school as well as later on in life, so it's important to both treat and monitor and support that aspect. That is also a factor that's being studied in these trials so they'll understand, once all of these results are analyzed, whether the drug also affects cognition. And thirdly is that children progress more slowly on the disabilities scale in terms of ambulation disability, but at a younger age could have more disability than an adult patient.