• Douglas L Arnold, Brenda Banwell, Amit Bar-Or, Angelo Ghezzi, Benjamin M Greenberg, Emmanuelle Waubant, Gavin Giovannoni, Jerry S Wolinsky, Jutta Gärtner, Kevin Rostásy, Lauren Krupp, Marc Tardieu, Wolfgang Brück, Tracy E Stites, Gregory L Pearce, Dieter A Häring, Martin Merschhemke, Tanuja Chitnis, and PARADIGMS Study Investigators.
• Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada douglas.arnold@mcgill.ca.
• J. Neurol. Neurosurg. Psychiatr. 2020 May 1; 91 (5): 483-492.

ObjectivePARADIGMS demonstrated superior efficacy and comparable safety of fingolimod versus interferon β-1a (IFN β-1a) in paediatric-onset multiple sclerosis (PoMS). This study aimed to report all predefined MRI outcomes from this study.MethodsPatients with multiple sclerosis (MS) (aged 10-<18 years) were randomised to once-daily oral fingolimod (n=107) or once-weekly intramuscular IFN β-1a (n=108) in this flexible duration study. MRI was performed at baseline and every 6 months for up to 2 years or end of the study (EOS) in case of early treatment discontinuation/completion. Key MRI endpoints included the annualised rate of formation of new/newly enlarging T2 lesions, gadolinium-enhancing (Gd+) T1 lesions, new T1 hypointense lesions and combined unique active (CUA) lesions (6 months onward), changes in T2 and Gd+ T1 lesion volumes and annualised rate of brain atrophy (ARBA).ResultsOf the randomised patients, 107 each were treated with fingolimod and IFN β-1a for up to 2 years. Fingolimod reduced the annualised rate of formation of new/newly enlarging T2 lesions (52.6%, p<0.001), number of Gd+ T1 lesions per scan (66.0%, p<0.001), annualised rate of new T1 hypointense lesions (62.8%, p<0.001) and CUA lesions per scan (60.7%, p<0.001) versus IFN β-1a at EOS. The percent increases from baseline in T2 (18.4% vs 32.4%, p<0.001) and Gd+ T1 (-72.3% vs 4.9%, p=0.001) lesion volumes and ARBA (-0.48% vs -0.80%, p=0.014) were lower with fingolimod versus IFN β-1a, the latter partially due to accelerated atrophy in the IFN β-1a group.ConclusionFingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

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