Sanofi Genzyme
Medication
Guide Prescribing Information,
including serious side effects For Healthcare
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LEMTRADA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, LEMTRADA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if LEMTRADA is safe and effective for use in children under 17 years of age.

Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV).

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  • Prescribing Information

Clinical Study Results

LEMTRADA was studied in two 2-year clinical trials against Rebif® (interferon beta-1a), a commonly used medication for relapsing MS

STUDY 1

A 2-year clinical trial of people who had a relapse on an MS therapy

LEMTRADA: Proven to slow confirmed disability progression in a 2-year study

42% less confirmed disability progression with LEMTRADA vs. Rebif®

People who had a relapse on an MS therapy and switched to LEMTRADA had 42% less confirmed disability progression* at 2 years compared to people receiving Rebif.

87% no disability progression with LEMTRADA vs. Rebif® (79%)

87% of people taking LEMTRADA did not experience confirmed disability progression* at 2 years, compared to 79% taking Rebif.

That means 13% of people taking LEMTRADA experienced confirmed disability progression, compared to 21% taking Rebif.

STUDY 2

A 2-year clinical trial of people who had never been on an MS therapy.

In this study, those taking LEMTRADA had 30% less confirmed disability progression* compared with those taking Rebif, with 8% of LEMTRADA patients and 11% of Rebif patients experiencing confirmed disability progression at 2 years. The difference was not significant.


*Confirmed disability progression is defined as at least 1-point increase (1.5 for patients starting at 0) on the EDSS that lasts for 6 months.

HOW LEMTRADA WAS STUDIED

  • When LEMTRADA was being studied, researchers decided to measure LEMTRADA’s effectiveness and safety against Rebif 44 mcg, a commonly prescribed MS medication. Many other studies use a placebo, or no drug at all
  • This was done in two 2-year clinical trials with a total of 1191 people with relapsing MS that were chosen at random to receive either LEMTRADA or Rebif
  • LEMTRADA was studied in both people who had a relapse on an MS therapy and people who had never been on an MS therapy before
  • Both studies included people 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
  • Participants in Study 1 had to have rated 5.0 or lower on the Expanded Disability Status Scale
    (EDSS), while participants in Study 2 rated 3.0 or lower. EDSS measures disability progression in
    people with MS on a scale of 0 to 10, where 0 represents no disability
  • In addition, participants in Study 1 had to have relapsed on interferon beta or glatiramer acetate
Next Section: LEMTRADA Safety