Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis

Summary

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

Timeline

Start

2013-07-26

Primary completion

2017-07-14

Completion

2030-02-18

Outcome

Met primary endpoint

paper The adjusted annualized relapse rate was 0.12 with fingolimod and 0.67 with interferon beta-1a (absolute difference, 0.55 relapses; relative difference, 82%; P<0.001). PMID 30207920 ↗

registry analysis (superiority test); Fingolimod vs Interferon Beta-1a; p <0.001; Negative binomial regression model NCT01892722 ↗

release “Phase III PARADIGMS study in pediatric MS met its primary endpoint, showing a significant reduction in relapses occur with fingolimod versus interferon beta-1a” novartis.com ↗

Publications

• Deiva K, Huppke P, Banwell B, Chitnis T, Gartner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN beta-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.
• Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostasy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gartner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fingolimod	Small molecule	0.25 mg	Oral
Subject	Fingolimod	Small molecule	0.5 mg	Oral
Comparator	Interferon beta-1a	Protein / enzyme biologic	30 ug	Intramuscular

Indications