The aim of the study was to evaluate whether Fingolimod [ Gilenya ] ( 0.5 mg and 0.25 mg ) has superior efficacy compared to Glatiramer acetate 20 mg in reducing disease activity over 12 months in patients with relapsing-remitting multiple sclerosis.
Fingolimod 0.5 mg has demonstrated superior efficacy over placebo and Interferon beta-1a in phase 3 trials.
Head-to-head comparisons of the efficacy and safety of disease-modifying therapies are important in informing treatment decisions in clinical practice.
In ASSESS, a phase 3b, randomized, multicenter, rater- and dose-blinded study, eligible patients were randomized to receive once-daily oral Fingolimod 0.5 mg ( N=352 ), 0.25 mg ( N=370 ), or subcutaneous Glatiramer acetate 20 mg ( N=342 ).
Superiority of the Fingolimod doses was tested hierarchically: 0.5 mg versus GA followed by 0.25 mg versus Glatiramer acetate.
The primary endpoint was reduction in annualized relapse rate ( ARR ), and secondary endpoints were MRI measures of disease activity at 12 months.
Safety and tolerability were assessed.
Overall, 859 ( 80.7% ) patients completed the study. Over 12 months, ARRs with Fingolimod 0.5 mg and Glatiramer acetate were 0.153 and 0.258, respectively ( relative reduction [ RR ], 40.7%; p=0.0138 ); Fingolimod 0.25 mg achieved a numerical RR of 14.6% but did not reach statistical significance.
Compared to Glatiramer acetate, Fingolimod 0.5 mg and 0.25 mg has significantly reduced the mean number of new / newly enlarged T2 ( RR, 54.4% and 42.1%,respectively; p less than 0.0001 ) and Gadolinium-enhancing T1 lesions ( RR, 55.6% for both doses; p=0.0167 and p=0.0011, respectively ).
Adverse events reported with both Fingolimod doses were consistent with the known safety profile.
More discontinuations from the study drug were reported with Glatiramer acetate due to injection-related adverse effects, consent withdrawal and unsatisfactory therapeutic effects.
In conclusion, Fingolimod 0.5 mg is the optimal efficacious dose and is the first and only disease-modifying therapy to show superior efficacy in reducing disease activity versus Glatiramer acetate in a controlled head-to-head study.
Safety findings were consistent with the established safety profile of Fingolimod. ( Xagena )
Source: American Academy of Neurology ( AAN ) Annual Meeting, 2019