Gilenya – How Well It Works

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Two large randomized, double-blind, controlled studies were used to evaluate the effectiveness of Gilenya in people with MS. The first study, called FREEDOMS (short for FTY720 Research Evaluating Effects of Daily Oral Therapy in MS), was a placebo-controlled study comparing two dosage levels of Gilenya. The second study, called TRANSFORMS (short for Trial Assessing Injectable Interferon vs. FTY720 Oral in RRMS), was an active-control study in which Gilenya was compared with the interferon beta medication Avonex.

Both studies included people with relapsing remitting MS (RRMS) who had had at least 2 relapses within the 2 years before the study started or 1 relapse in the year before the study started with evidence of certain level of disability as measured by the Expanded Disability Status Scale (EDSS).

 

Gilenya Results of FREEDOM Study

FREEDOM was a 2-year placebo-controlled study. People who participated in this study had received no interferon beta medication or glatiramer acetate (Copaxone) for at least 3 months before the study and had not received natalizumab (Tysabri) for at least 6 months before the start of the study. The primary efficacy outcome (the key measurement designed to show the effectiveness of the medication) was annual rate of relapse in persons taking Gilenya compared with placebo. Magnetic resonance imaging (MRI) was used to measure brain lesions at the beginning of the study, before Gilenya was given, and at month 6, 12, and 24 of the study.

People who participated in FREEDOM were randomized (assigned randomly or by chance) to receive one of two different dosages of Gilenya (425 people received 0.5 mg and 429 people received 1.25 mg) or placebo (418 received placebo).

Results from FREEDOM: Gilenya versus placebo

Gilenya 0.5 mg

Placebo

P-value

Clinical endpoints

Annual rate of relapse 0.18 0.40 <0.001
Patients without relapse (%) 70% 46% <0.001
Hazard ratio of disability progression 0.70 0.02

MRI endpoints

Mean (median) number new or newly enlarged lesions over 2 years 2.5 (0) 9.8 (5.0) <0.001
Mean (median) number lesions at 2 years 0.2 (0) 1.1 (0) <0.001

 
Gilenya resulted in a significantly lower annual rate of relapses (54% lower) and a significant delay in progression of disability (30% lower) compared with placebo. The graph below shows the difference in time to 3-month disability progression between Gilenya and placebo. Gilenya also resulted in fewer new or newly enlarged brain lesions as seen by MRI compared with placebo.

 

Gilenya Results of TRANSFORMS Study

TRANSFORMS was a 1-year active-controlled study, in which Gilenya was compared with the interferon beta medication Avonex. Gilenya resulted in significantly fewer relapses than Avonex (a 52% reduction). However, there was no difference between Gilenya and Avonex in how well the two drugs slowed the progression of disability. Gilenya resulted in a significantly greater reduction in disease activity as measured by MRI, including reductions in new and newly enlarging brain lesions and brain lesion activity, compared with Avonex.

Results from TRANSFORMS: Gilenya versus Avonex

Gilenya 0.5 mg (N=429)

Avonex 30 μg (N=431)

P-value

Clinical endpoints

Annual rate of relapse 0.16 0.33 <0.001
Patients without relapse (%) 83% 70% <0.001
Hazard ratio of disability progression 0.71 0.21

MRI endpoints

Mean (median) number new or newly enlarged lesions over 1 year 1.6 (0) 2.6 (1.0) 0.002
Mean (median) number lesions at 1 year 0.2 (0) 0.5 (0) <0.001