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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.

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FIND EVENTS
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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

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 comparator 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 in 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