Prescribing information

 

Efficacy outcomes with GILENYA in real-world clinical practice.

Relapse rate reductions in adults with RRMS are demonstrated by long-term and real-world data2

Switching from interferons to GILENYA resulted in an 86% relative reduction in ARR in adults at 5 years2

The proportion of patients discontinuing treatment each year due to lack of efficacy or disease progression ranged from 2.7% in year 1 to 3.9% in year 52

 

Figure adapted from Ziemssen T, et al. 2018.2

Absolute reduction in ARR at 5 years was 1.38 (absolute values: 1.6 at baseline and 0.22 at 5 years).2

*Patient numbers available only for baseline, year 1 and year 5. p values were not reported.2

ARR: annualised relapse rate; Gd+: gadolinium enhancing; MRI: magnetic resonance imaging; RES: rapidly evolving severe; RRMS: relapsing remitting multiple sclerosis.

PANGAEA: Post-Authorization Non-interventional German sAfety study of GilEnyA in RRMS patients. PANGAEA is a German registry study that enrolled 4,229 adult patients with RRMS from 374 centres.3 As of January 2018, a total of 726 patients had completed the 5-year documentation period of GILENYA treatment, including 417 of the 1,936 patients who were previously on interferons.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.4

References

  1. Derfuss T, et al. Poster P1215 presented at the 32nd Congress of the ECTRIMS, 14-17 September 2016, London, UK.
  2. Ziemssen T, et al. Poster P6.393 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
  3. Ziemssen T, et al. Poster P5.365 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
  4. GILENYA (fingolimod) Summary of Product Characteristics.
GIL19-C053a March 2020.
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