TY - JOUR T1 - Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIG<em>MS</em> study JF - Journal of Neurology, Neurosurgery &amp; Psychiatry JO - J Neurol Neurosurg Psychiatry SP - 483 LP - 492 DO - 10.1136/jnnp-2019-322138 VL - 91 IS - 5 AU - Douglas L Arnold AU - Brenda Banwell AU - Amit Bar-Or AU - Angelo Ghezzi AU - Benjamin M Greenberg AU - Emmanuelle Waubant AU - Gavin Giovannoni AU - Jerry S Wolinsky AU - Jutta Gärtner AU - Kevin Rostásy AU - Lauren Krupp AU - Marc Tardieu AU - Wolfgang Brück AU - Tracy E Stites AU - Gregory L Pearce AU - Dieter A Häring AU - Martin Merschhemke AU - Tanuja Chitnis A2 - , Y1 - 2020/05/01 UR - http://jnnp.bmj.com/content/91/5/483.abstract N2 - 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–&lt;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&lt;0.001), number of Gd+ T1 lesions per scan (66.0%, p&lt;0.001), annualised rate of new T1 hypointense lesions (62.8%, p&lt;0.001) and CUA lesions per scan (60.7%, p&lt;0.001) versus IFN β-1a at EOS. The percent increases from baseline in T2 (18.4% vs 32.4%, p&lt;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. ER -