Prescribing information

 

Efficacy outcomes with GILENYA in patients with RRMS aged 10–17 years.

Relapse rate reductions are also shown in children and adolescents2

GILENYA treatment resulted in an 82% relative reduction in ARR vs IFN β-1a at 2 years in children and adolescents2

Bar chart showing the annualised relapse rate of paediatric patients in the PARADIGMS trial.

Adapted from Chitnis T, et al. 2018.2

Absolute reduction in ARR at 2 years was 0.55 (absolute values: 0.12 with GILENYA vs 0.67 with IFN β-1a).

The landmark PARADIGMS paediatric study2

Largest randomised Phase 3 trial for paediatric patients with RRMS2,3

 Infographic about the PARADIGMS trial. The trial included 107 patients treated with GILENYA, and 107 treated with interferon-beta-1a. The trial was run at 80 sites across 25 countries. The 2-year double-blind active-comparator phase is complete. The 5-year open-label extension is ongoing.

Key inclusion criteria2

Patients with RRMS aged 10-17 years at randomisation who had an EDSS score of 0 to 5.5 and:

  • ≥1 MS relapse in the year preceding screening, or
  • ≥2 MS relapses in the 2 years preceding screening, or
  • Evidence of ≥1 Gd+ T1 lesion on MRI within 6 months before randomisation

 

Key endpoints2

  • Primary: ARR
  • Secondary: Annualised rate of number of new/newly enlarged T2 lesions on MRI
  • Other secondary: Relapse-free patients, Gd+ T1 lesions on MRI, safety

 

Additional clinical and MRI observations2

  • Reduction in 3-month confirmed disability progression
  • Reduction in brain atrophy vs IFN β-1a
Video summary of the landmark PARADIGMS trial
 

ARR: annualised relapse rate; EDSS: Expanded Disability Status Scale; Gd+: gadolinium enhancing; IFN β-1a: interferon beta-1a; IM: intramuscularly; MRI: magnetic resonance imaging; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis.

PARADIGMS: PARADIGMS is a flexible duration (up to 2 years), double-blind, randomised, multicentre trial to evaluate the safety and efficacy of oral GILENYA compared to injectable IFN β-1a in children and adolescents with a confirmed diagnosis of RRMS, followed by a 5-year open-label extension phase. PARADIGMS is being carried out at 80 centres in 25 countries, and was designed in agreement with the EMA, FDA and the International Pediatric Multiple Sclerosis Study Group. The study enrolled 215 children and adolescents (aged 10 to less than 18 years) with RRMS and an EDSS score between 0 and 5.5.2

Indication: GILENYA is indicated as a single disease modifying therapy in highly active RRMS for the following groups of adult patients and paediatric patients aged 10 years and older: patients with highly active disease despite a full and adequate course of treatment with ≥1 disease modifying therapy, or patients with RES RRMS defined by ≥2 disabling relapses in 1 year, and with 1 or more Gd+ lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.1

References

  1. GILENYA (fingolimod) Summary of Product Characteristics.
  2. Chitnis T, et al. N Engl J Med 2018;379(11):1017-1027.
  3. ClinicalTrials.gov. Accessed December 2018.
  4. ClinicalTrials.gov. NCT01892722 (PARADIGMS).
GIL19-C053a March 2020.
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