Neurology Xagena
ENDORSE is an ongoing, 5-year, dose-blind extension of the phase 3 DEFINE and CONFIRM studies evaluating the efficacy and safety of delayed-release Dimethyl fumarate ( DMF ) in relapsing-remitting multiple sclerosis ( RRMS ).
A 2-year interim analysis of clinical efficacy data from ENDORSE was presented.
Patients randomized to delayed-release Dimethyl fumarate 240mg twice ( BID ) or three times daily ( TID ) in DEFINE / CONFIRM continued the same dosing regimen in ENDORSE. Placebo ( DEFINE / CONFIRM ) and Glatiramer acetate ( CONFIRM ) patients were randomized 1:1 to delayed-release Dimethyl fumarate BID or TID.
Efficacy was analyzed ( June 12, 2013 cutoff ) according to treatment arm in parent/extension study: BID/BID, TID/TID, Placebo/BID, Placebo/TID, Glatiramer/BID, Glatiramer/TID.
Of 2,079 patients completing DEFINE / CONFIRM, 1,736 were dosed in ENDORSE ( n=501 [ BID/BID ], 502 [ TID/TID ], 249 [ Placebo/BID ], 248 [ Placebo/TID ], 118 [ Glatiramer/BID ], and 118 [ Glatiramer/TID ] ).
Adjusted annualized relapse rate ( ARR ) during Year 1 and Year 2 ( DEFINE / CONFIRM ) and Year 3 and Year 4 ( ENDORSE ) were: 0.202, 0.163, 0.138, and 0.142 for BID/BID, and 0.239, 0.123, 0.167, and 0.198 for TID/TID.
ARR in Year 4 ( second year of delayed-release Dimethyl fumarate treatment ) was 0.126 for Placebo/BID, 0.138 for Placebo/TID, 0.128 for Glatiramer/BID, and 0.184 for Glatiramer/TID.
Disability progression remained low among patients continuing delayed-release Dimethyl fumarate treatment.
In conclusion, delayed-release Dimethyl fumarate was associated with low relapse rates and disability progression in continuously treated patients and patients who switched from Placebo or Glatiramer. ( Xagena )
Gold R et al, European Neurological Society ( ENS ) Congress, 2014
XagenaMedicine_2014
