Trial of fingolimod vs. interferon beta-1a in pediatric MS
Recognizing the need for more randomized trial data on multiple sclerosis (MS) interventions in the pediatric population, researchers launched the PARADIGMS study.
Recognizing the need for more randomized trial data on multiple sclerosis (MS) interventions in the pediatric population, researchers launched the PARADIGMS study. The Phase III investigation compared outcomes in 107 relapsing patients aged 10–17 years who were treated with oral fingolimod and 108 who were treated with intramuscular interferon beta-1a for a period of up to 2 years. The children experienced a mean 2.4 relapses in the 2 years prior to the study, but the annualized relapse rate after treatment was reduced to 0.12 with fingolimod and to 0.67 with interferon beta-1a. Moreover, the annualized rate of new or newly enlarged lesions on MRI—a secondary endpoint—was lower with fingolimod than with interferon beta-1a. There were fewer adverse events in the fingolimod group; however, more of them were serious in nature compared with the interferon beta-1a group. In light of the findings, the researchers say longer trials are warranted to gauge the durability and safety of fingolimod in pediatric MS.