Fingolimod is the first and only disease-modifying therapy with proven superiority versus Glatiramer acetate in relapsing remitting multiple sclerosis
Full data of the ASSESS study, which has evaluated the efficacy of oral, once-daily Fingolimod ( Gilenya ) at 0.5mg and 0.25mg versus once-daily subcutaneous injections of Glatiramer acetate 20mg in reducing disease activity over 12 months in patients with relapsing remitting multiple sclerosis ( RRMS ).
The results demonstrated Fingolimod 0.5 mg's superior efficacy over Glatiramer acetate 20mg in reducing the annualized relapse rate ( ARR ), a key measure of disease activity, with a 40.7% relative reduction over one year versus the active comparator ( ARR estimates of 0.153 vs 0.258, respectively, ARR ratio: 0.493, p = 0.0138 ).
ASSESS is the first direct head-to-head trial of any disease-modifying therapy versus Glatiramer acetate, a current standard of care often used in first-line treatment, to show superiority in measures of disease activity, such as relapses and brain lesions.
Fingolimod 0.25mg achieved a relative ARR reduction of 14.6% but did not reach statistical significance, thereby suggesting Fingolimod 0.5mg as the superior efficacious dose for this patient population.
The safety of Fingolimod observed in ASSESS across both doses was consistent with the established safety profile of the drug, with overall more discontinuations due to adverse events and unsatisfactory treatment effects reported in patients using Glatiramer acetate.
However, in clinical practice many patients with miltiple sclerosis are still treated with Interferon-beta 1a and Glatiramer acetate despite re-occurrence of disease activity and the availability of higher-efficacy treatments.
This may be an indicator of multiple sclerosis treatment inertia.
Secondary endpoints of ASSESS have examined reduction in disease activity, as measured by magnetic resonance imaging ( MRI ), at 12 months.
Fingolimod 0.5mg and 0.25mg significantly has reduced the mean number of new or newly enlarged T2 brain lesions compared with Glatiramer acetate 20mg ( p less than 0.0001 ).
Additionally, both doses significantly reduced the number of Gadolinium-enhancing T1 brain lesions compared with Glatiramer acetate 20mg ( p = 0.0167 and p = 0.0011, respectively ).
The change in percent brain volume from baseline with Fingolimod 0.5mg was similar to Glatiramer acetate at 12 months ( p = 0.1045 ).
The ASSESS study is a phase IIIb randomized, rater- and dose-blinded study to compare the safety and efficacy of Fingolimod 0.25mg and 0.5mg administered orally once-daily, with Glatiramer acetate 20mg administered via subcutaneous injections once-daily, in patients with RRMS over the course of one year. ( Xagena )
Source: American Academy of Neurology ( AAN ) Annual Meeting, 2019