Fingolimod in children


With all the excitement surrounding COVID-19 news snippets are being missed. Parents may be interested. Fingolimod is more effective than beta-interferon. So from now onneuros get a back bone and make sure the next option is shown not to be worse than fingolimod. For the sake of science process and ease of marketing, we have to stop puttingagents against the low hanging fruit. Based on adults, we know fingolimod is more effective on relapse rate than interferon.

Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3 PARADIGMS study.

Arnold DL, Banwell B, Bar-Or A, Ghezzi A, Greenberg BM, Waubant E, Giovannoni G, Wolinsky JS, Gärtner J, Rostásy K, Krupp L, Tardieu M, Brück W, Stites TE, Pearce GL, Häring DA, Merschhemke M, Chitnis T; PARADIGMS Study Investigators.J Neurol Neurosurg Psychiatry. 2020 Mar 4. pii: jnnp-2019-322138.


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.


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).


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.


Fingolimod significantly reduced MRI activity and ARBA for up to 2 years versus IFN β-1a in PoMS.

COI: multiple

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