Prescribing information

 

How could a step-up in MS therapy help children and adolescents with MS?

 

Some children and adolescents with MS still experience symptoms, despite treatment.

How could their lives change with a step-up in MS therapy?

 

Image of fictional paediatric patient, Josh.

Video summary: PARADIGMS, the largest randomised Phase 3 trial for paediatric patients with RRMS1,3

 

 

Stamp saying ‘85% of children and adolescents in paradigms were relapse free at 2 years of treatment with Gilenya’.

Analysis of total study population. Versus 38.8% IFN β-1A patients free of relapses at 2 years.1

Stamp saying ‘85% of children and adolescents in paradigms were relapse free at 2 years of treatment with Gilenya’.

Post-hoc analysis. Versus 84.7% IFN β-1A patients free from 3-month CDP at 2 years (n=107 in each group; p values were not reported).4

 

82% relative reduction in ARR vs IFN β-1a in children and adolescents at 2 years.1

Bar graph showing  82% relative reduction in ARR vs IFN β-1a in children and adolescents at 2 years. 7. Table showing Any AEs, AE leading to interruption of study drug, AE leading to discontinuation of study drug and Any serious AE for Gilenya.

Adapted from Chitnis T et al. 2018.1
Absolute reduction in ARR at 2 years was 0.55 (absolute values: 0.12 with GILENYA vs 0.67 with IFN β-1a).

 

Safety is consistent with that seen in adults.1

AEs occurring in ≥10% of patients in either treatment arm1

  GILENYA
(n=107) n (%)
IFN β-1a IM
(n=107) n (%)
Any AEs* 95 (88.8) 102 (95.3)
AE leading to interruption of study drug 12 (11.2) 3 (2.8) 
AE leading to discontinuation of study drug 5 (4.7) 3 (2.8)
Any serious AE 18 (16.8) 7 (6.5) 
  GILENYA
(n=107) n (%)
IFN β-1a IM
(n=107) n (%)
Headache 34 (31.8) 32 (29.9)
Viral URTI 23 (21.5) 26 (24.3) 
URTI 17 (15.9) 5 (4.7)
Leucopenia 15 (14.0) 3 (2.8) 
Influenza  12 (11.2) 4 (3.7)
Influenza-like illness  5 (4.7) 40 (37.4)  
Cough  10 (9.3) 12 (11.2)
Chills  1 (0.9) 11 (10.3) 
Pyrexia 8 (7.5) 22 (20.6)

Adapted from Chitnis T et al. 2018.1
*Does not include MS relapses reported as AEs.

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 5.5.1

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.2

AE, adverse event; ARR, annualised relapse rate; CDP, confirmed disability progression; DMT, disease modifying therapy; EDSS, expanded disability status scale; EMA, European Medicines Agency; FDA, Food and Drug Administration; Gd+, gadolinium-enhancing; IFN β-1a, interferon beta-1a; IM, intramuscularly; MRI, magnetic resonance imaging; MS, multiple sclerosis; RES, rapidly evolving severe; RRMS, relapsing-remitting multiple sclerosis; URTI, upper respiratory tract infection.

References     

  1. Chitnis T et al. N Engl J Med 2018;379(11):1017–1027.
  2. GILENYA (fingolimod) Summary of Product Characteristics.
  3. ClinicalTrials.gov. https://www.clinicaltrials.gov/ct2/show/NCT01892722. Accessed September 2020.
  4. Chitnis T et al. Paper presented at the 7th joint ECTRIMS-ACTRIMS Meeting, 25–28 October 2017, Paris, France.
GIL19-C053(1)b November 2020.
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