Switching To Gilenya® (Fingolimod) From Standard Interferon Offers Sustained Freedom From Disease Activity For People With Relapsing Remitting MS

Two new analyses from the pivotal Phase III TRANSFORMS study presented at the European Neurological Society (ENS) have shown early and sustained improvements in disease activity in patients who were switched from an interferon to Gilenya® (fingolimod). Improvements were seen within 12 months of the switch and were sustained up to 4.5 years, confirming the long term effectiveness of once daily pill fingolimod.1,2 The analyses showed that fingolimod was effective across key measures of disease activity-free status (defined as a combination of no relapses, no 3-month disability progression and no MRI activity) and brain volume loss.1,2 

Dr Martin Duddy, Consultant Neurologist who leads an MS service based at The Royal Victoria Infirmary, Newcastle commented, "The goal of management in MS is to identify and treat the disease quickly, so that we can give people the best possible outcomes. The new data show that in the year after you switch to the once a day fingolimod pill, you are 50% more likely to be free from measurable disease activity compared to staying on the interferon injections. We can see the effectiveness of the fingolimod tablets sustained over the 4.5 years of the study." 

Fingolimod has been approved for use in the NHS since March 2012. These new data support the NICE guidance for fingolimod, which states that it is suitable for patients with the relapsing remitting form of the disease remaining highly active despite treatment with one year's duration of interferon injection prior to switching treatment to fingolimod.3 

Analysis one: the relationship between early disease activity and long term clinical outcomes1 The first new analysis evaluated the association between measures of disease activity (defined as relapses, 3-month disability progression or MRI activity) in the first year of therapy and long-term clinical outcomes. 

After switching from interferon to fingolimod, the proportion of patients who were disease activity free increased by almost 50% (from 44.3% to 66.0%) between the end of years one and two respectively. Patients who were disease activity free in year one were most likely to remain clinically disease activity-free (defined as no relapses and no 6-month disability progression) till the end of the extension study (up to 4.5 years). 

The authors of analysis one concluded that switching from an interferon to fingolimod resulted in favourable long term clinical disease activity free outcomes. 

Analysis two: Long term efficacy of fingolimod in patients previously treated with an interferon beta-1a

A separate post-hoc analysis showed that treatment with fingolimod resulted in an annualised relapse rate (ARR) reduction in patients who had prior disease activity despite treatment with an interferon treatment.2 

In patients who were switched from interferon to fingolimod after one year, the ARR was reduced by more than 50% (from between 0.33-0.37 ARR on interferon to 0.14-0.16 ARR on fingolimod treatment) and remained low to the end of the study (up to 4.5 years).2 

In addition, further analysis showed that, irrespective of prior treatment and disease activity, brain volume loss was significantly reduced (by about 50%, from between -0.40 to -0.43 on interferon to -0.21 to -0.28 on fingolimod), after one year in patients taking fingolimod compared to those taking interferon and this low rate was sustained until the end of the study.2 Similarly, a slowing / decrease in the rate of brain volume loss was observed in patients that switched from interferon to fingolimod after one year2. Fingolimod is the only approved MS treatment shown to consistently reduce brain volume loss across studies with a significant effect seen as early as six months.4-6 A low rate of brain volume loss with fingolimod was sustained for up to four years in Phase III studies and for up to seven years in patients completing a Phase II study. 7,8 A recent paper identified that brain volume loss in MS occurs early and predicts long-term disability.9 

The authors of analysis two concluded that treatment with fingolimod resulted in positive outcomes which were sustained up to 4.5 years for patients with high disease activity despite prior treatment with interferon beta-1a (IFN).2 

Conclusion

The new analyses confirm the relationship between early disease activity and long term clinical outcomes, and highlight the importance of early and effective treatment decisions.1,2