Treatment with Tecfidera Improves Long-term Outcomes in Multiple Sclerosis Patients

The Current Study

A recent, post-hoc study showed that over half of newly diagnosed patients treated with Tecfidera did not relapse or progress for 6 years, according to a study presented at the 68^th annual meeting of the American Academy of Neurology.

These findings reinforce data from previous parent studies that showed early treatment with this drug can improve long-term clinical outcomes in patients.

Real-world data from a claims database also suggest that Tecfidera is associated with lower annualized relapse rates relative to multiple disease modifying therapies.

“The MS treatment landscape has expanded rapidly in recent years, giving physicians and patients options for various stages of disease. Beyond clinical findings, real-world data provide important insights into patients’ experiences outside of clinical trials,” said Kate Dawson, MD, vice president, Biogen US Medical. “These data show Tecfidera consistently delivers strong and sustained efficacy in newly diagnosed patients both in a real-world and clinical setting, further supporting the value it offers patients and affirming the advantages of early treatment with Tecfidera in decreasing clinical disease activity.”

In the current study, analyses from Phase 3 DEFINE, CONFRIM, and ENDORSE studies showed Tecfidera shows efficacy regarding relapse and disability measures in newly diagnosed patients.

The study enrolled participants who were newly diagnosed with MS within 1 year of enrolling in DEFINE or CONFIRM, patients who are treatment-naïve, or patients who only received treatment with corticosteroids alone.

Researchers found that patients who received Tecfidera at the beginning of DEFINE and CONFIRM maintained positive effects opposed to patients that switched to Tecfidera treatment in ENDORSE after taking placebo for 2 years in the other studies (56.3% versus 50.6%).

According to the study, Tecfidera was associated with lower ARR of MS relapse in relation to other MS treatments, such as glatiramer acetate, interferon β, teriflunomide, and fingolimod.

Study authors note that Tecfidera and fingolimod had similar results.

After 1 year, the unadjusted ARR rates from the baseline were: Tecfidera (-0.14; p<0.0001); interferon β (-0.03); glatiramer acetate (+0.03); teriflunomide (-0.04); fingolimod (-0.12; p=0.0016).

To understand the safety profile of Tecfidera, data presented at American Academy of Neurology explored the treatment’s effects on lymphocyte profiles.

The data reinforces the importance of absolute lymphocyte counts (ALC) monitoring and supports the long-term safety profile of Tecfidera, the study concluded.

DEFINE Trial

This was a 2-year, randomized, multi-center, double-blind, placebo-controlled, dose-comparison phase 3 clinical trial. More than 1200 patients with remitting multiple sclerosis (RRMS) were evaluated. The main purpose of this study was to determine whether Tecfidera was effective in reducing relapses in patients after 2 years.

CONFIRM Trial

This was a 2-year, randomized, multi-center, placebo-controlled, double-blind, dose-comparison phase 3 clinical trial. More than 1400 patients with RRMS were studied. The main purpose of this study was to determine whether Tecfidera was effective in reducing replaces in patients after two years.

ENDORSE Trial

This is an ongoing dose-blinded study that enrolled 1738 patients who completed either the DEFINE or CONFIRM studies.

Patients who received 2 years of Tecfidera in either of the aforementioned studies continued the same dose. Patients who previously received a placebo were randomized 1:1.

These patients will be followed for up to 8 years in order to evaluate the long-term safety of TECFIDERA.