NASHVILLE—In patients with pediatric-onset multiple sclerosis (MS), fingolimod significantly reduces MRI activity and slows brain volume loss for as long as two years, compared with interferon beta-1a, according to data described at the 2018 CMSC Annual Meeting.μg once weekly) on predefined MRI outcomes in patients with pediatric-onset MS.
Analyzing the PARADIGMS Data
PARADIGMS was a double-blind, double-dummy, active-controlled, parallel-group, multicenter study in which patients participated for as long as two years. The investigators randomized patients with pediatric-onset MS (ages 10 through 17) to oral fingolimod or interferon beta-1a. The dose of fingolimod was adjusted for body weight. MRI was performed at baseline and every six months thereafter until the end of the study core phase. A central reading center analyzed the MRI results. The key MRI outcomes were the number of new or newly enlarged T2 lesions and gadolinium-enhancing T1 lesions, annual rate of brain volume change, number of new T1 hypointense lesions, change in total T2 hyperintense lesion volume, and number of combined unique active lesions.
The researchers randomized 107 participants to oral fingolimod and 108 to interferon beta-1a. At baseline, mean age was about 15. Most patients were female. Mean disease duration was one to two years. The average number of relapses in the year before screening was approximately 1.5. Participants had 2.6 to 3.1 gadolinium-enhancing T1 lesions.
Data Support Fingolimod’s Efficacy in Pediatric MS
At the end of the study, fingolimod significantly reduced the annualized rate of new or newly enlarged T2 lesions by 52.6% and the number of gadolinium-enhancing T1 lesions per scan by 66.0%, compared with interferon beta-1a. The odds ratio of freedom from new or newly enlarged T2 lesions was 4.51 in the fingolimod arm, compared with the interferon beta-1a arm. The odds ratio of freedom from gadolinium-enhancing lesions was 3.0 in the fingolimod arm, compared with the interferon beta-1a arm.
Compared with interferon beta-1a, treatment with fingolimod for as long as two years significantly reduced the annualized rate of brain volume change (least squares mean: −0.48 vs −0.80). Fingolimod reduced the annualized rate of new T1 hypointense lesions by 62.8% and the number of combined unique active lesions per scan by 60.7%, compared with interferon beta-1a. Fingolimod also reduced T2 hyperintense lesion volume, compared with interferon beta-1a (percentage change from baseline: 18.4% vs 32.4%).
“The rate of T2-related atrophy [in pediatric MS] is concerning, and I am particularly interested in looking at the extension study data as they come out, and we’ll see if there is a decrease during longer-term treatment,” said Dr. Chitnis.
“These results, overall, along with the efficacy demonstrated on the clinical relapse rate, support the overall benefit of fingolimod in pediatric patients with MS,” she concluded.