Consistent real-world efficacy and safety up to 13 years in ENDORSE study1

The longest clinical follow-up of DMF exposure to date

In the ENDORSE long-term extension study

45% reduction in ARR over 10 years of DMF treatment (0.20 Year 1 vs 0.11 Years 9-10)

  • Relapse rates in newly diagnosed patients were consistent with the overall patient population
  • Rates of confirmed disability worsening (CDW) remained low over 10 years in the DMF/DMF population (72%)

56% reduction in ARR maintained to Year 10 in overall population of patients who switched from placebo

  • 64% reduction in ARR maintained to Year 10 in newly diagnosed placebo-switched patients, 0.25 (Years 0-2) vs 0.09 (Years 3-10)
  • Rates of CDW remained low over 10 years in the PBO/DMF population (73%)

Stability analysis: Relapse

  • 63% of patients were relapse-free in subsequent years (up to 12 years)

Stability analysis: Progression

Study was funded by Biogen.

Safety results were consistent with pivotal trials, with no new safety concerns after up to 13 years of observation

Most common AEs in ENDORSE

The majority of AEs were mild to moderate, and overall incidence and type were otherwise consistent to those reported in the pivotal trials

  • AEs were generally similar across treatment groups and the newly diagnosed population

Low incidence of infections, serious infections, or malignancy in any treatment subgroup

Patient-year=the last date in study minus the date of first exposure to DMF plus 1, divided by 365.25. Incidence was calculated as the number of patients with specific adverse events divided by the total patient-years of follow-up. Prolonged severe lymphopenia: <0.5 × 109/L for ≥6 months; prolonged moderate lymphopenia: ≥0.5 to <0.8 × 109/L for ≥6 months; mild lymphopenia: <LLN at any time. LLN: lower limit of normal (0.91 × 109/L).

  • Incidence of infection and malignancy was low regardless of level of lymphopenia
    • Malignancy incidence in ENDORSE (459 per 100,000 person-years) was consistent with the background rate of the general US population (442 per 100,000 person-years)

More than half (59%) of patients maintained absolute lymphocyte counts (ALC) above the lower limit of normal up to 13 years (LLN; 0.91 x 109/L)

ALC Over Time

Mean ALC decreased over the first 48 weeks and remained generally stable for up to 13 years

Study was funded by Biogen.

Baseline characteristics of patients who completed ENDORSE were similar to those who discontinued at any time over the course of the study

Baseline demographics of patients who completed or discontinued ENDORSE


Age, sex, and ethnicity are at ENDORSE baseline. EDSS score, number of relapses within the previous 12 months, and time since most recent pre-study relapse are at Study 1/Study 2 baseline.

Study was funded by Biogen.

Study was funded by Biogen.