Consistent control of disease activity with fingolimod versus IFN β-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. Issue 1 (29th August 2019)

• Record Type: Journal Article
• Authors: Deiva, Kumaran; Huppke, Peter; Banwell, Brenda; Chitnis, Tanuja; Gärtner, Jutta; Krupp, Lauren; Waubant, Emmanuelle; Stites, Tracy; Pearce, Gregory Lewis; Merschhemke, Martin
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 91:Issue 1(2020)
• Page Start: 58
• Page End: 66
• Publication Date: 2019-08-29
• Subjects: fingolimod -- paediatric multiple sclerosis -- disability progression -- PARADIGMS -- gilenya; Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2019-321124
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Background: In PARADIG MS, a double-blind phase III trial in 215 paediatric patients with multiple sclerosis (MS) (10 to <18 years), fingolimod administered for up to 2 years significantly reduced the annualised relapse rate (ARR) and rate of new/newly enlarged T2 (n/neT2) lesions compared with interferon (IFN) β-1a. Objectives: To investigate (1) differences between treatment groups across subpopulations (treatment-naïve, younger/prepubertal patients); (2) disability progression. Methods: ARRs at 10, 11 and 12 years were estimated based on predefined modelling extrapolations. Changes in Expanded Disability Status Scale (EDSS), and in 3 month (3M) and 6 month (6M) confirmed disability progression (CDP) were evaluated post hoc. Results: In the treatment-naïve subpopulation, fingolimod reduced ARR and n/neT2 lesions by 85.8% and 53.4%, respectively versus INF β-1a (both p<0.001), compared with 81.9% and 52.6% in the overall population. Model-based ARR reductions in younger patients (≤12 years) were 91.9%–94.6%. Twice as many IFN β-1a-treated than fingolimod-treated patients had worse EDSS scores at study end (20.6% vs 10.5%, p=0.043). Risk reductions in 3M-CDP and 6M-CDP were 77.2% (p=0.007) and 80.2% (p=0.040), respectively. Conclusions: Fingolimod in paediatric MS was associated with consistent control of disease activity versus IFN β-1a (including treatment-naïve and younger patients) and resulted in less disability progression for up to 2 years. Trial registration number: NCT01892722 .