the LEMTRADA
clinical
studies
LEMTRADA was studied to assess
Relapses
Disability
LEMTRADA was studied in 2 two-year clinical trials against Rebif® (interferon beta-1a) 44 mcg, an interferon that is commonly prescribed for relapsing MS.
Patients were treated with LEMTRADA for 2 years and were then invited to continue in an Extension Study for an additional 4 years, for a total of 6 years.
people in the 2-year study (Study 1) with 426 taking LEMTRADA and 202 taking Rebif
people treated with LEMTRADA (387) entered the Study 1 Extension
of people treated with LEMTRADA (332) that began Study 1 remained through Year 6
LEMTRADA was studied in people who had a relapse on an MS therapy. The study included patients who had experienced at least 2 relapses during the 2 years prior to the trial, and at least 1 relapse during the year prior to the trial.
In addition, participants in Study 1 had to have relapsed on interferon beta or glatiramer acetate and had Expanded Disability Status Scale (EDSS) scores of 5 or less.
WHO ENTERED THE STUDY 1 CLINICAL TRIAL?
| AVG. AGE | 35 |
| GENDER | 66 F%/34% M |
| AVG. YEARS WITH MS | 4.5 |
| AVG. RELAPSES IN PRIOR YEAR | 1.7 |
| AVG. EDSS | 2.7 |
EDSS measures disability progression in people with MS on a scale of 0 to 10, where 0 represents no disability.
Types of information collected
Primary
Information that the study set out to do, learn, or prove based on the expected effects of the drug.
Secondary
Information that adds support and understanding to primary information.
Tertiary
Tertiary or exploratory information may provide additional learnings about clinically important events that may be more closely examined in later studies.
- No definitive conclusions about treatment effects with LEMTRADA or Rebif can be drawn from tertiary information.
Is it possible for Lemtrada to reduce relapses?
The annual relapse rate was 0.26 for LEMTRADA vs 0.52 for Rebif.
who took LEMTRADA were living relapse-free at 2 years vs nearly 1 out of 2 people who took Rebif.
The annual percentage of people in the Extension Study who took LEMTRADA and were living relapse-free ranged from
Is it possible for LEMTRADA to slow disability progression?
13% of patients who took LEMTRADA experienced confirmed disability progression compared with 21% of those who took Rebif.
A separate study in patients showed no statistically significant difference in confirmed disability progression between LEMTRADA and Rebif.
Confirmed disability progression was defined as at least a 1-point increase (1.5 for patients starting at 0) on the Expanded Disability Status Scale (EDSS) that lasts for 6 months.
who took LEMTRADA had no confirmed disability progression vs 79% of patients who took Rebif.
who were in the Extension Study had no confirmed disability progression.
These results were not tested for statistical significance. No definitive conclusions about treatment effects of LEMTRADA or Rebif can be drawn from these tertiary data from the LEMTRADA clinical trials.
At year 2, 85% of patients who took LEMTRADA had stabilized or improved disability vs 75% of people who took Rebif.
| LEMTRADA | Rebif | |
| 28.8% | Improved Disability | 16.0% |
| 55.9% | Stabilized Disability | 58.9% |
| 15.3% | Worsened Disability | 25.1% |
At year 6, 77% of patients who took LEMTRADA had stabilized or improved disability.
| LEMTRADA | ||
| 23.6% | Improved Disability | |
| 53.7% | Stabilized Disability | |
| 22.7% | Worsened Disability |
IMPROVED DISABILITY
1-point or greater decrease in EDSS score.
STABILIZED DISABILITY
+ or more - half-point or less change in EDSS score.
WORSENED DISABILITY
1-point or greater increase in EDSS score.