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On July 3, 2020 Sanofi Genzyme was notified that our Lemtrada Home Phlebotomy Partner, Examination Management Services Inc., (EMSI) has gone out of business. Because of this, unfortunately, all future Lemtrada Home Phlebotomy (lab draw) visits from EMSI have been cancelled. Patient safety is Sanofi Genzyme’s #1 priority and we are working to provide an alternative phlebotomy solution as well as coordinate alternative testing options for your next monthly lab tests. If you have any questions related to this announcement, please contact your healthcare provider or your One to One Nurse at 1-855-557-2483.

MAT-US-2015317

LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

LEMTRADA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Since treatment with LEMTRADA can increase your risk of getting certain conditions and diseases, LEMTRADA is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough. LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS). It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

Learn about
the LEMTRADA
clinical
studies

LEMTRADA was studied to assess

LEMTRADA relapsing multiple sclerosis clinical study relapse information

Relapses

LEMTRADA relapsing MS clinical study disability progression data

Disability

LEMTRADA was studied in two 2-year clinical trials against Rebif® (interferon beta-1a)

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.

 
Additional 4-year Extension Study

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.


The 2-year LEMTRADA study consisted of 628 people

people in the 2-year study (Study 1) with 426 taking LEMTRADA and 202 taking Rebif

9 out of 10 people entered the Study 1 Extension

people treated with LEMTRADA (387) entered the Study 1 Extension

78% of people taking LEMTRADA remained in the study through Year 6

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?

Primary Information in Study 1
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years

The annual relapse rate was 0.26 for LEMTRADA vs 0.52 for Rebif.

Secondary Information in Study 1
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.
2 out of 3 people who took LEMTRADA were relapse-free at Year 2

who took LEMTRADA were living relapse-free at 2 years vs nearly 1 out of 2 people who took Rebif.

 
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.

The annual percentage of people in the Extension Study who took LEMTRADA and were living relapse-free ranged from

The annual percentage of people in the extension study who took LEMTRADA and were free from relapses in Years 3-6 ranged from 79% to 87%

Is it possible for LEMTRADA to slow disability progression?

Primary Information in Study 1
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.
People taking LEMTRADA were 42% less likely to have confirmed disability progression vs Rebif at Year 2

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.

Secondary Information in Study 1
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.
At Year 2, 87% of people who took LEMTRADA had no confirmed disability progression vs 79% of people who took Rebif

who took LEMTRADA had no confirmed disability progression vs 79% of patients who took Rebif.

 
People who took LEMTRADA had half as many relapses as people who took Rebif over 2 years.
At Year 6, 7 out of 10 people had no confirmed disability progression

who were in the Extension Study had no confirmed disability progression.

Tertiary Information in Study 1

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.

Important Safety Information See More

LEMTRADA can cause serious side effects including serious autoimmune problems. Some people receiving LEMTRADA develop a condition where the immune cells in your body attack other cells or organs in the body (autoimmunity), which can be serious and may cause death. Serious autoimmune problems may include: