Today Biogen Idec BIIB announced that five-year results from the
ENDORSE Phase 3 extension study show TECFIDERA^® (dimethyl fumarate) provides
strong and sustained efficacy in a broad range of people living with
relapsing-remitting multiple sclerosis (RRMS). These data will be presented at
the Sixth Triennial Joint Meeting of the Americas Committee for Treatment and
Research in Multiple Sclerosis and the European Committee for Treatment and
Research in Multiple Sclerosis (ACTRIMS-ECTRIMS).
Across all patients in the ENDORSE study who received TECFIDERA, including
some patients who were treated for up to seven and a half years, the safety
profile remained consistent with no new or worsening safety signals.
Additional analyses in patients who were newly diagnosed with multiple
sclerosis (MS) when the parent studies DEFINE and CONFIRM began indicate that
TECFIDERA had a robust long-term effect on MS relapse rates, disability
progression and MRI measures in these patients.
“TECFIDERA continues to provide patients with effective oral treatment for MS
that is supported by a growing body of data reinforcing its benefits and
favorable safety profile,” said Alfred Sandrock, M.D., Ph.D., group senior
vice president and chief medical officer at Biogen Idec. “These new ENDORSE
results provide further insight into the positive impact of using TECFIDERA
early in the course of MS and for long-term treatment of this chronic
disease.”
ENDORSE Clinical Efficacy and MRI Outcomes
ENDORSE is a global, dose-blind extension study evaluating the long-term
safety and efficacy of TECFIDERA (240 mg, dosed twice a day [BID] or three
times a day [TID]). Patients who received up to two years of TECFIDERA in the
pivotal Phase 3 DEFINE and CONFIRM studies continued on the same dose in
ENDORSE. Patients who previously received placebo or glatiramer acetate (GA;
20 mg subcutaneous daily injection; CONFIRM only) in DEFINE and CONFIRM were
randomized 1:1 to TECFIDERA BID or TID.
At five years (two years in DEFINE or CONFIRM and three years in ENDORSE),
interim results show that patients who continued on TECFIDERA BID treatment
experienced sustained clinical efficacy on relapse and disability progression
endpoints as measured by annualized relapse rate (ARR) and 24-week Expanded
Disability Status Scale (EDSS), similar to what was observed after two years
in DEFINE and CONFIRM. These patients also maintained a low frequency of brain
lesions over five years as measured by new or enlarging T2-hyperintense
lesions, new non-enhancing T1-hypointense lesions and gadolinium-enhanced
[Gd+] lesions.
These data will be presented in poster presentations on Thursday, Sept.11 at
3:30 p.m. ET:
* Five-Year Follow-up of Delayed-Release Dimethyl Fumarate in RRMS:
Integrated Clinical Efficacy Data from the DEFINE, CONFIRM, and ENDORSE
Studies (P110)
* Five-Year Follow-up of Delayed-Release Dimethyl Fumarate in
Relapsing-Remitting Multiple Sclerosis: MRI Outcomes from DEFINE, CONFIRM,
and ENDORSE (P059)
Clinical Efficacy in Newly Diagnosed Patients
An analysis of data from ENDORSE evaluated the long-term efficacy of TECFIDERA
in newly diagnosed patients, defined as those diagnosed within one year prior
to enrolling in DEFINE or CONFIRM and either disease modifying treatment-naïve
or previously treated with corticosteroids alone.
Over the five-year observation period, newly diagnosed patients taking
TECFIDERA BID experienced sustained reductions in relapses (measured by ARR
and proportion of patients who relapsed), disability progression (measured by
24-week EDSS) and number of brain lesions. These effects are similar to the
results reported for the overall ENDORSE study population, supporting the
consistent efficacy of TECFIDERA in this subpopulation.
These data will be presented in a poster presentation on Thursday, Sept. 11 at
3:30 p.m. ET:
* Long-Term Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed
Patients With RRMS: An Integrated Analysis of DEFINE, CONFIRM and ENDORSE
(P064)
“As shown in the ENDORSE study, TECFIDERA provides consistent outcomes across
a broad range of relapsing-remitting MS patients, including those who are
newly diagnosed, highlighting its utility in the range of patients we see in
practice,” said Ralf Gold, M.D., professor and chair of the Department of
Neurology at St. Josef-Hospital, Ruhr-University in Bochum, Germany. “The
long-term efficacy of TECFIDERA in reducing key measures of disease activity
and its favorable safety profile help support its role as an important
therapeutic option for people living with MS.”
Effect of TECFIDERA on No Evidence of Disease Activity
Another analysis from ENDORSE evaluated the long-term effects of TECFIDERA on
the emerging measure of No Evidence of Disease Activity (NEDA) over five
years. Patients were assessed annually and were considered to have NEDA if
they had: no relapses, no 24-week confirmed disability progression, no Gd+
lesions, and no new or enlarging T2-hyperintense lesions.
Results over five years show that the proportion of patients achieving NEDA
annually was maintained in patients who continued on TECFIDERA, and was
improved in patients who switched from placebo to treatment with TECFIDERA BID
in the ENDORSE study.
These data will be presented in a platform presentation on Friday, Sept. 12 at
9:00 a.m. ET:
* Long-term Follow-up of the Effect of Delayed-Release Dimethyl Fumarate on
No Evident Disease Activity in Patients with Multiple Sclerosis (FC3.5)
ENDORSE Safety
The safety profile of TECFIDERA observed in ENDORSE was consistent with the
favorable findings reported in the DEFINE and CONFIRM studies. There were no
new or worsening safety findings observed in patients who continued treatment
with TECFIDERA from DEFINE and CONFIRM or in patients who switched to
TECFIDERA therapy after the conclusion of the pivotal studies.
All patients in ENDORSE had received treatment with TECFIDERA for at least
five years if previously on TECFIDERA in DEFINE or CONFIRM, including some
patients who had received TECFIDERA for up to seven and a half years
cumulatively. Patients previously on placebo in DEFINE or CONFIRM had received
TECFIDERA in ENDORSE for at least three years. The most common adverse events
in patients who switched to TECFIDERA from placebo or GA were flushing and
gastrointestinal (GI) events, the incidences of which were generally similar
to what was observed in DEFINE and CONFIRM. In patients continuing on
TECFIDERA therapy, the most common adverse events were MS relapse and
nasopharyngitis (common cold).
In patients continuing on, or new to, TECFIDERA treatment there was no overall
increased risk of serious infections (including opportunistic infections) or
malignancies. There was no overall increased risk of renal dysfunction,
urinary events or hepatic adverse events in any treatment group; and mean
white blood cell and lymphocyte counts remained stable.
These data will be presented in a poster presentation on Thursday, Sept. 11 at
3:30 p.m. ET:
* Long-term Follow-up of the Safety of Delayed-Release Dimethyl Fumarate in
RRMS: Interim Results From the ENDORSE Extension Study (P066)
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