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 data1

Switching to GILENYA from interferons resulted in an 86% relative reduction in ARR in adults at 5 years1

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 51

Bar chart showing the annualised relapse rate of patients over 5 years in the PANGAEA trial.

 

Figure adapted from Ziemssen T, et al. 2018.1

Absolute reduction in ARR at 5 years was 1.38 (absolute values: 1.6 at baseline and 0.22 at 5 years).1

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

Switching to GILENYA from oral DMTs offers improved disease control3

GILENYA reduced ARR in adult patients switching from an oral DMT (DMF or teriflunomide), regardless of the number of previous DMTs3

 Bar chart showing annualised relapse rates 1 year prior to the PASSAGE trial in patients treated with 1,2 or at least 3 DMTs, and a bar chart showing annualised relapse rate after 1 year in patients switching to GILENYA from 1, 2, or 3 DMTs.

Figure adapted from Ziemssen T, et al. 2017.3

Absolute reductions vs 1 year prior to switch: 1.29 in the 1 DMT group, 1.40 in the 2 DMTs group, and 1.37 in the ≥3 DMTs group.3

Bar chart showing annualised relapse rates 2 years prior to the PASSAGE trial in patients treated with 1,2 or at least 3 DMTs, and a bar chart showing annualised relapse rate after 2 years in patients switching to GILENYA from 1, 2, or 3 DMTs.

Figure adapted from Ziemssen T, et al. 2017.3

Absolute reductions vs 2 years prior to switch: 0.90 in the 1 DMT group, 0.93 in the 2 DMTs group, and 1.07 in the 3 DMTs group. p values were not reported.3

Switching to GILENYA from another oral DMT offers improved disease control3,4

GILENYA reduced ARR in all adult patients switching from an oral DMT (DMF or teriflunomide)3,4

 Bar chart showing annualised relapse rates at baseline, month 12 and month 24 in all patients in the PANGAEA 2.0 trial who switched to GILENYA from an oral DMT.

Figure adapted from Schulze-Toppho U, et al. 2018.4

The p values were not reported. Absolute reduction in ARR in all patients was 0.96 (absolute values: 1.31 at baseline and 0.35 at month 24).4

Bar chart showing annualised relapse rates at baseline, month 12 and month 24 in patients in the PANGAEA 2.0 trial who switched to GILENYA from an oral DMT and completed 24 months of the trial.

Figure adapted from Schulze-Toppho U, et al. 2018.4

The p values were not reported. Absolute reduction in ARR in month 24 completers was 1.44 (absolute values: 1.70 at baseline and 0.26 at month 24).4

ARR: annualised relapse rate; DMT: disease modifying therapy; 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.5 As of January 2018, 729 patients had completed the 5-year documentation period of GILENYA treatment, including 417 of the 1,936 patients who were previously on interferons.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.5

References

  1. Ziemssen T, et al. Poster P6.393 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
  2. Ziemssen T, et al. Poster P5.365 presented at the 70th AAN Meeting, 21-27 April 2018, Los Angeles, CA, USA.
  3. Ziemssen T, et al. Poster P790 presented at the 7th joint ECTRIMS-ACTRIMS meeting, 25-28 October 2017, Paris, France.
  4. Schulze-Topho U, et al. Poster EP1648 presented at the 34th ECTRIMS Congress, 10-12 October 2018, Berlin, Germany.
  5. GILENYA (fingolimod) Summary of Product Characteristics.
GIL19-C053b March 2020.
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