Prescribing information

 

Patient outcomes with GILENYA in pivotal clinical trials.

Using GILENYA earlier in the disease course offers greater ARR reduction2

In a post-hoc analysis of the TRANSFORMS and FREEDOMS studies, GILENYA significantly reduced the ARR by 73% compared to IFN β-1a in patients <3 years after first RRMS symptom, and by 45% compared to IFN β-1a in patients ≥3 years after first RRMS symptom2

Bar chart showing the annualised relapse rate of patients whose first RRMS relapse was less than three years ago, and a bar chart showing anualised relapse rate of patients whose first RRMS relapse was three or more years ago.

Figure adapted from Agius M, et al. 2019.2

Time since first RRMS symptom <3 years: absolute reduction in ARR was 0.233 (absolute values: 0.084 with GILENYA vs 0.317 with IFNβ-1a).
Time since first RRMS symptom ≥3 years: absolute reduction in ARR was 0.221 (absolute values: 0.266 with GILENYA vs 0.487 with IFNβ-1a).

Have confidence in long-term disability progression data in adults3

Mean EDSS score in adults remained stable at ≤3 over 7 years3

 

Line graph showing the mean EDSS score in patients in the TRANSFORMS and pooled FREDOMS studies over 7 years.

Figure adapted from Cohen J, et al. 2015.3

The analysis included all patients who received GILENYA 0.5 mg during the core or extension phases of GILENYA trials, including those who switched from comparator treatment during the respective core studies.

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

TRANSFORMS: TRial Assessing Injectable INterferon vs fingolimod Oral in Relapsing-Remitting MS. TRANSFORMS was a 1-year, randomised, double-blind, double-dummy, active (interferon beta-1a)-controlled study of 1,292 adult patients with RRMS. Patients received either a daily dose of GILENYA or a weekly dose of 30 μg Avonex®.4

TRANSFORMS: Randomised Extension Study: A 1-year extension study of TRANSFORMS.4,5 A total of 1,027 patients entered the extension study and 882 patients completed the full 24 months of treatment. Patients originally randomly assigned to receive GILENYA continued with treatment at the same dose as in the core study, and patients originally assigned to receive interferon β-1a in the core study were randomly reassigned to receive GILENYA 0.5 mg or 1.25 mg.6

LONGTERMS: An open-label, single-arm, extension study evaluating the long-term safety, tolerability and efficacy of GILENYA in adult patients who previously participated in Phase 2, 3 or 3b GILENYA studies (including FREEDOMS, FREEDOMS II and TRANSFORMS).3

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.5

References

  1. Derfuss T, et al. Poster P1215 presented at the 32nd Congress of the ECTRIMS, 14-17 September 2016, London, UK.
  2. Agius M, et al. CNS Neurosci Ther 2014; 20: 446-451.
  3. Cohen JA, et al. Poster P591 presented at the 31st Congress of the ECTRIMS, 7-10 October 2015, Barcelona, Spain.
  4. Cohen JA, et al. N Engl J Med 2010; 362: 402-415.
  5. GILENYA (fingolimod) Summary of Product Characteristics.
  6. Khatri B, et al. Lancet Neurol 2011; 10(6): 520-529. 
GIL19-C053a March 2020.
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