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Effect of fingolimod on MRI outcomes in patients with paediatric-onset multiple sclerosis: results from the phase 3
Douglas L Arnold1,2, Brenda Banwell3, Amit Bar-Or4,5
1Montreal Neurological Institute, McGill University, Montreal, Quebec, Canada douglas.arnold@mcgill.ca.
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.
Insights
Fingolimod demonstrated superior efficacy in reducing MRI activity and brain atrophy compared to interferon β-1a in children with multiple sclerosis. This study confirms fingolimod
Area of Science:
- Neurology
- Immunology
- Radiology
Background:
- Paediatric-onset multiple sclerosis (PoMS) requires effective treatment strategies.
- Previous studies indicated fingolimod's potential benefits in PoMS.
- MRI is crucial for monitoring disease activity and progression in MS.
Purpose of the Study:
- To report all predefined MRI outcomes from the PARADIGMS study comparing fingolimod and interferon β-1a in PoMS.
- To assess the efficacy of fingolimod versus interferon β-1a on key MRI markers of disease activity and brain atrophy.
Main Methods:
- Randomized trial of oral fingolimod versus intramuscular interferon β-1a in patients aged 10-18 years with PoMS.
- MRI assessments conducted at baseline and every 6 months for up to 2 years.
- Key MRI endpoints included T2 lesions, gadolinium-enhancing T1 lesions, T1 hypointense lesions, combined unique active lesions, lesion volumes, and annualized brain atrophy rate (ARBA).
Main Results:
- Fingolimod significantly reduced the formation of new/enlarging T2 lesions, Gd+ T1 lesions, new T1 hypointense lesions, and CUA lesions compared to interferon β-1a.
- Fingolimod showed lower increases in T2 and Gd+ T1 lesion volumes.
- Fingolimod demonstrated a significantly lower annualized rate of brain atrophy (ARBA) compared to interferon β-1a.
Conclusions:
- Fingolimod significantly reduced MRI-assessed disease activity in children with PoMS over 2 years.
- Fingolimod also significantly reduced brain atrophy compared to interferon β-1a in this population.
- These findings support fingolimod's efficacy in managing PoMS.
