RT Journal Article SR Electronic T1 Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study JF Journal of Neurology, Neurosurgery & Psychiatry JO J Neurol Neurosurg Psychiatry FD BMJ Publishing Group Ltd SP 483 OP 492 DO 10.1136/jnnp-2019-322138 VO 91 IS 5 A1 Arnold, Douglas L A1 Banwell, Brenda A1 Bar-Or, Amit A1 Ghezzi, Angelo A1 Greenberg, Benjamin M A1 Waubant, Emmanuelle A1 Giovannoni, Gavin A1 Wolinsky, Jerry S A1 Gärtner, Jutta A1 Rostásy, Kevin A1 Krupp, Lauren A1 Tardieu, Marc A1 Brück, Wolfgang A1 Stites, Tracy E A1 Pearce, Gregory L A1 Häring, Dieter A A1 Merschhemke, Martin A1 Chitnis, Tanuja A1 YR 2020 UL http://jnnp.bmj.com/content/91/5/483.abstract AB Objective PARADIGMS 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.Methods Patients 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).Results Of 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.Conclusion Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.