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For US Healthcare Professionals Sanofi Genzyme

Clinical Study Trial Design

CARE-MS II Core Study:

A 2-year, randomized, open-label, rater-blinded, phase III study that included RMS patients (N=628) with EDSS scores of ≤5.0, who had experienced ≥2 relapses in the previous 2 years, with at least 1 relapse in the prior year and at least 1 relapse while on interferon beta or glatiramer acetate therapy after at least 6 months of treatment.1,2

CARE-MS II Extension Study:

If eligible, LEMTRADA-treated patients from the core study were given the option to remain in the ongoing open-label extension study through 6 years and could receive additional LEMTRADA courses (12 mg dose on 3 consecutive days) at least 12 months after their previous course or other DMT if they had evidence of MS disease activity based on clinical or MRI findings.3,4*

*Extension study criteria for initiating additional courses or other DMT: ≥1 protocol-defined relapse and/or ≥2 new or enlarging T2-hyperintense and/or new Gd-enhancing T1-lesions.4

CARE-MS II1,2
LEMTRADA vs Rebif® (interferon beta-1a)

4-Year Extension3
LEMTRADA-treated patients only

  • start
  • 1 yr
  • 2 yrs
  • 3 yrs
  • 4 yrs
  • 5 yrs
  • 6 yrs

628people in CARE-MS II1,2, with
426 taking LEMTRADA
and 202 taking Rebif1,2

91%of LEMTRADA-treated
patients (387) entered
the 4-Year Extension3

78%of patients (332) that
began CARE-MS II1,2 remained
through Year 63

Clinical Study Results: Efficacy

Proven to Reduce Relapses

The efficacy of LEMTRADA was demonstrated in 2 studies that evaluated LEMTRADA in patients with relapsing-remitting multiple sclerosis (RRMS). 12 mg of LEMTRADA was administered by intravenous infusion once daily over a 5-day course, followed one year later by intravenous infusion once daily over a 3-day course.1

Patients had experienced at least 2 relapses during the 2 years prior to trial entry and at least 1 relapse during the year prior to trial entry.1

LEMTRADA Patients had half as many relapses as Rebif Patients

Patients who took LEMTRADA had half as many relapses as people who took Rebif.

The annual relapse rate (ARR) was 0.26 for LEMTRADA vs 0.52 for Rebif.1

Annualized Relapse Rate (ARR)
at Year 2

49%
Relative
Reduction
in ARR
(P<0.0001)

0.52

2.6

  • 1.0
  • 0.9
  • 0.8
  • 0.7
  • 0.6
  • 0.5
  • 0.4
  • 0.3
  • 0.2
  • 0.1
  • 0
  • Rebif
    44 µg

    (n=202)
  • LEMTRADA
    12 mg

    (n=426)

Reduced ARR at Year 21,2

In the core study, there was a 49% relative reduction in ARR (P<0.0001) in LEMTRADA patients (0.26) vs Rebif (0.52)1,2

Annualized Relapse Rate (ARR)

0.23

0.24

0.20

0.15

  • 1.0
  • 0.9
  • 0.8
  • 0.7
  • 0.6
  • 0.5
  • 0.4
  • 0.3
  • 0.2
  • 0.1
  • 0
  • Year
    No. of patients
  • 3387
  • 4381
  • 5361
  • 6351
LEMTRADA 12 mg

Maintained Reduction Over 4 Years3

Core Study Patients Who Entered 4-Year Extension Study3

Relapses were defined as new or worsening neurologic symptoms attributable to MS, lasting at least 48 hours, without pyrexia, after at least 30 days of clinical stability with an objective change (1 point on 2 functional system scales, or 2 points on 1 functional system scale, or increase in EDSS score) on neurological examination.2

Relapse Free

A greater proportion of LEMTRADA patients were relapse free compared with Rebif in the core clinical study.1,3

65%

of LEMTRADA patients were relapse free at year 2 (n=426) vs 47% with Rebif (n=202) (P<0.0001)1,3

79-87%of LEMTRADA patients in the extension study were relapse free in years 3-63

The Power to Slow Confirmed Disability Progression (CDP)

At year 2, LEMTRADA patients were 42% less likely to have confirmed disability progression vs Rebif. 13% of patients who took LEMTRADA experienced confirmed disability progression compared with 21% of those who took Rebif.1,2

Percent of Patients With
6-month CDP at Year 2

42%
Relative
Risk
Reduction
in CDP
(P=0.0084)

21%

13%

  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
  • Rebif
    44 µg

    (n=131)
  • LEMTRADA
    12 mg

    (n=154)

Relative Reduction in
6-month CDP1,2

87% of LEMTRADA patients did
not have CDP at year 2
(n=426)
vs 79% with Rebif (n=202)1,2

Percent of Patients With
6-month CDP

18%

23%

25%

28%

  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
  • Year
    No. at risk
  • 3316
  • 4281
  • 5266
  • 6215
LEMTRADA 12 mg

72% of LEMTRADA core study patients in the 4-year extension study did not have CDP at year 6 (n=387)3

In a second phase III study, the reduction in risk of CDP was not statistically different between LEMTRADA and Rebif.1

CDP was defined as at least a 1-point increase above baseline EDSS (≥1.5-point increase for patients with baseline EDSS of 0) sustained for 6 months.1

Additional Data

Confirmed Disability Improvement (CDI)

Confirmed Disability Improvement was an exploratory endpoint in the study; therefore, this endpoint was not formally tested for significance. No definitive conclusions about the treatment effect of LEMTRADA or Rebif can be drawn from these results.1

Percent of Patients With
6-month CDI at Year 2

13%

29%

  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
  • Rebif
    44 µg

    (n=107)
  • LEMTRADA
    12 mg

    (n=213)

Confirmed Disability Improvement at Year 2

29% of patients achieved
6-month CDI at year 2
(n=321)
vs 13% with Rebif (n=153)2

Percent of Patients With
6-month CDI

36%

41%

42%

43%

  • 60
  • 50
  • 40
  • 30
  • 20
  • 10
  • 0
  • Year
    No. at risk
  • 3183
  • 4158
  • 5149
  • 6119
LEMTRADA 12 mg

Confirmed Disability Improvement at Year 6

43% of core study patients in the
4-year extension study achieved
6-month CDI at year 6 (n=291)

§CDI was defined as a ≥1-point improvement from baseline that was sustained for 6 months and demonstrated by patients with a baseline EDSS of ≥2.0.4

Percent of patients with disability that was stable, improved, or worsened

Stable, improved, or worsened EDSS was an exploratory endpoint in the study; therefore, this endpoint was not formally tested for significance. No definitive conclusions about the treatment effect of LEMTRADA or Rebif can be drawn from these results.1,2

85% of LEMTRADA patients showed stable or improved disability scores vs 75% of those taking Rebif at year 23

  • LEMTRADA: 55.9% were stable, 28.8% improved disability scores, and 15.3% worsened disability scores (n=413)
  • Rebif: 58.9% were stable, 16.0% improved disability scores, and 25.1% worsened disability scores (n=175)

77% of LEMTRADA core study patients in the 4-year extension study showed stable or improved disability scores at year 63

  • LEMTRADA: 53.7% were stable, 23.6% improved disability scores, and 22.7% worsened disability scores (n=313)

Stable disability was defined as a ≤0.5-point change in EDSS from baseline, improved disability was defined as a ≥1-point decrease in EDSS from baseline, and worsened disability was defined as a ≥1.0-point increase in EDSS from baseline.1,2

Reduction in T2-Lesion Volume

Care-MS II Core Study1,2
Median Percent Change in T2-Lesion
Volume from Baseline in Year 2

-1.2

-1.3

  • 0.0
  • -0.2
  • -0.4
  • -0.6
  • -0.8
  • -1.0
  • -1.2
  • -1.4
  • Rebif
    44 µg

    (n=202)
  • LEMTRADA
    12 mg

    (n=426)
P=0.14, not statistically different between the treatments

Additional MRI data from the
6-year CARE-MS II Core and Extension studies

The number of new or enlarging T2-lesions was an exploratory endpoint in the study; therefore, this endpoint was not formally tested for significance. No definitive conclusions about the treatment of LEMTRADA or Rebif can be drawn from these results.3

76% of LEMTRADA patients were free from new or enlarging T2-lesions in year 2 (n=397) vs 48% with Rebif (n=172)3

  • LEMTRADA: 12% of patients (1 lesion), 7% (2-5 lesions), and 5% (>5 lesions)
  • Rebif: 11% of patients (1 lesion), 23% (2-5 lesions), 19% (>5 lesions)

69% of LEMTRADA patients were free from new or enlarging T2-lesions in year 6 (n=313)3

  • LEMTRADA: 13% of patients (1 lesion), 8% (2-5 lesions), and 9% (>5 lesions)

Clinical Study Patient Characteristics

At entry, the average CARE-MS II patient who previously experienced disease activity while on a prior therapy is represented by the characteristics below1,2:

CARE-MS II Baseline Characteristics

Baseline Characteristics LEMTRADA
(n=426)
Rebif® (interferon beta-1a)
(n=202)
Demographics2
Mean Age 34.8 35.8
Sex - Female (%) 66 65
Disease Activity2
Mean Number of Relapses in Prior Year 1.7 1.5
Mean EDSS 2.7 2.7
Mean Number of Gd+ Lesions 2.3 2.1
Disease Duration2
Mean Disease Duration, Years 4.5 4.7
Relapsing MS Treatment History2
Duration of Prior MS Therapy, Years 2.9 3.0
Patients on 1 Prior MS Therapy (%) 70 75
Patients on ≥2 Prior MS Therapies (%) 30 25

Real-Life Infusion Stories

Watch these LEMTRADA patients describe their treatment days' experiences.

RYAN K.: Everybody’s MS and MS treatment plan is different. And everybody reacts differently to medications.

NICOLE S.: My first week of LEMTRADA, my first actual infusion of it, it was a little crazy. But it just kind of gave that little hope at the end of it.

STEPHANIE B.: My husband took off work. I was only working part time at that point so we took the time off and just considered that our full time job that week.

JZON L.: We initially set up the medications that would be needed beforehand. We got all those in line and then set a date.

RYAN K.: I had to fill out paperwork, you get blood tests, you get a skin examination.

NICOLE S.: It was all day, in the infusion room, and being a patient. Which is not something the nurse in me is very good at.

STEPHANIE B.: Five consecutive days and about seven to eight hours each.

RYAN K.: I started with an IV infusion of steroids and then started the medication.

JZON L.: Hunkered down with the laptop, some music, some movies, a bunch of snacks.

STEPHANIE B.: I liked my infusion nurse. I’ve known him for years. The person next to me that was being infused, I’m chummy with him.

RYAN K.: My reaction was not optimal.

NICOLE S.: Some hives, made me really tired, just kind of didn’t feel great.

RYAN K.: The first day I ended up with shaking, a fever, chills. The nurse was able to get a medication ordered by the doctor. Side effects were taken care of very quickly.

JZON L.: Eight hours later, I walked out feeling pretty much the same as when I walked in.

STEPHANIE B.: I haven’t had any side effects. I know every case is different but for me it works. Couldn’t be happier.

RYAN K.: My infusion reactions that I had, totally worth it. No regrets. No looking back. I would do it again. I’m going to do it again.

INDICATION

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.

IMPORTANT SAFETY INFORMATION

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:

  • Immune thrombocytopenic purpura (ITP), a condition of reduced platelet counts in your blood that can cause severe bleeding that may cause life-threatening problems. Call your healthcare provider (HCP) right away if you have any of the following symptoms: easy bruising, bleeding from a cut that is hard to stop, coughing up blood, heavier menstrual periods than normal, bleeding from your gums or nose that is new or takes longer than usual to stop, small, scattered spots on your skin that are red, pink, or purple.
  • Kidney problems called anti-glomerular basement membrane disease, which, if not treated, can lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your HCP right away if you have any of the following symptoms: swelling of your legs or feet, blood in the urine (red or tea-colored urine), decrease in urine, fatigue, coughing up blood.

It is important for you to have blood and urine tests before you receive, while you are receiving and every month for 4 years or longer, after you receive your last LEMTRADA infusion.

Serious infusion reactions: LEMTRADA can cause serious infusion reactions that may cause death. Serious infusion reactions may happen while you receive, or up to 24 hours or longer after you receive LEMTRADA.

  • You will receive your infusion at a healthcare facility with equipment and staff trained to manage infusion reactions, including serious allergic reactions, and urgent heart or breathing problems. You will be watched while you receive, and for 2 hours or longer after you receive, LEMTRADA. If a serious infusion reaction happens while you are receiving LEMTRADA, your infusion may be stopped.

Tell your HCP right away if you have any of the following symptoms of a serious infusion reaction during the infusion, and after you have left the healthcare facility:

  • swelling in your mouth or throat
  • trouble breathing
  • weakness
  • fast, slow, or irregular heartbeat
  • chest pain
  • rash

To lower your chances of getting a serious infusion reaction, your HCP will give you a medicine called corticosteroids before your first 3 infusions of a treatment course. You may also be given other medicines before or after the infusion to try to reduce your chances of having these reactions or to treat them if they happen.

Stroke and tears in your arteries that supply blood to your brain (carotid and vertebral arteries): Some people have had serious and sometimes deadly strokes and tears in their carotid or vertebral arteries within 3 days of receiving LEMTRADA. Get help right away if you have any of the following symptoms that may be signs of a stroke or tears in your carotid or vertebral arteries: drooping of parts of your face, weakness on one side, sudden severe headache, difficulty with speech, neck pain.

Certain cancers: Receiving LEMTRADA may increase your chance of getting some kinds of cancers, including thyroid cancer, skin cancer (melanoma), and blood cancers called lymphoproliferative disorders and lymphoma. Call your HCP if you have the following symptoms that may be a sign of thyroid cancer: new lump, swelling in your neck, pain in front of neck, trouble swallowing or breathing, hoarseness or other voice changes that do not go away, cough that is not caused by a cold.

Have your skin checked before you start receiving LEMTRADA and each year while you are receiving treatment to monitor for symptoms of skin cancer.

Because of risks of autoimmunity, infusion reactions, and some kinds of cancers, LEMTRADA is only available through a restricted program called the LEMTRADA Risk Evaluation and Mitigation Strategy (REMS) Program.

Do not receive LEMTRADA if you:

  • are allergic to alemtuzumab or to any of the inactive ingredients in LEMTRADA
  • are infected with human immunodeficiency virus (HIV)
  • have an active infection

Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your HCP if you have: excessive sweating, unexplained weight loss, unexplained weight gain, fast heartbeat, eye swelling, nervousness, feeling cold, worsening tiredness, constipation.

Low blood counts (cytopenias): LEMTRADA may cause a decrease in some types of blood cells. Some people with these low blood counts have increased infections. Call your doctor right away if you have symptoms of cytopenias such as: weakness, chest pain, yellowing of the skin or whites of the eyes (jaundice), dark urine, fast heartbeat.

Inflammation of the liver: Call your HCP right away if you have symptoms such as unexplained nausea, stomach pain, tiredness, loss of appetite, yellowing of skin or whites of eyes, or bleeding or bruising more easily than normal.

Hemophagocytic lymphohistiocytosis: LEMTRADA may increase the risk of overactivity of the immune system that can be fatal if not diagnosed and treated early. If you experience symptoms such as fever, swollen glands, or skin rash, contact your HCP right away.

Thrombotic thrombocytopenic purpura (TTP): LEMTRADA may cause blood clotting problems that can be fatal. Call your HCP right away if you experience symptoms such as: purplish spots on skin or in mouth due to bleeding under skin, yellowing of skin or whites of eyes (jaundice), feel tired or weak, very pale skin, fever, fast heart rate or short of breath, headache, speech changes, confusion, vision changes, seizure, low amount of urine or dark or bloody urine, stomach pain, nausea, vomiting, or diarrhea.

Bleeding disorder (acquired hemophilia A): LEMTRADA may cause a bleeding disorder called acquired hemophilia A. Call your HCP right away if you have any of the following symptoms: bruising, nose bleeds, bleeding from a cut that may take longer than usual to stop, painful or swollen joints, blood in urine, dark or bloody stools.

Serious infections: LEMTRADA may cause you to have a serious infection while you receive and after receiving a course of treatment. Serious infections may include:

  • listeria. People who receive LEMTRADA have an increased chance of getting a bacterial infection called listeria, which can lead to significant complications or death. Avoid foods that may be a source of listeria or make sure foods are heated well.
  • herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take medicines as prescribed by your HCP to reduce your chances of getting these infections.
  • tuberculosis. Your HCP should check you for tuberculosis before you receive LEMTRADA.
  • hepatitis. People who are at high risk of, or are carriers of, hepatitis B (HBV) or hepatitis C (HCV) may be at risk of irreversible liver damage.

These are not all the possible infections that could happen while on LEMTRADA. Call your HCP right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your HCP before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections.

Progressive multifocal leukoencephalopathy (PML): A rare brain infection that usually leads to death or severe disability has been reported with LEMTRADA. Symptoms of PML get worse over days to weeks. It is important that you call your doctor right away if you have any new or worsening medical problems that have lasted several days, including problems with thinking, eyesight, strength, balance, weakness on one side of your body, using your arms or legs.

Inflammation of the gallbladder without gallstones (acalculous cholecystitis): LEMTRADA may increase your chance of getting inflammation of the gallbladder without gallstones, a serious medical condition that can be life-threatening. Call your HCP right away if you have stomach pain or discomfort, fever, nausea, or are vomiting.

Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your HCP right away if you have shortness of breath, cough, wheezing, chest pain or tightness, or are coughing up blood.

Before receiving LEMTRADA, tell your HCP if you:

  • have bleeding, thyroid, or kidney problems
  • have a recent history of infection
  • are taking a medicine called Campath® (alemtuzumab)
  • have received a live vaccine in the past 6 weeks before receiving LEMTRADA or plan to receive any live vaccines. Ask your HCP if you are not sure if your vaccine is a live vaccine.
  • are pregnant or plan to become pregnant. LEMTRADA may harm your unborn baby.You should use birth control while receiving LEMTRADA and for 4 months after your course of treatment.
  • are breastfeeding or plan to breastfeed. You and your HCP should decide if you should receive LEMTRADA or breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LEMTRADA and other medicines may affect each other, causing side effects. Especially tell your HCP if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.

The most common side effects of LEMTRADA include:

  • rash
  • headache
  • thyroid problems
  • fever
  • swelling of your nose and throat
  • nausea
  • urinary tract infection
  • feeling tired
  • trouble sleeping
  • upper respiratory infection
  • herpes viral infection
  • hives
  • itching
  • fungal infection
  • joint pain
  • pain in your arms or legs
  • back pain
  • diarrhea
  • sinus infection
  • mouth pain or sore throat
  • tingling sensation
  • dizziness
  • stomach pain
  • sudden redness in face, neck, or chest
  • vomiting

Tell your HCP if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of LEMTRADA.

Please see accompanying full Prescribing Information/Medication Guide, including serious side effects.

INDICATION

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

CONTRAINDICATIONS

LEMTRADA is contraindicated in patients:

WARNINGS AND PRECAUTIONS

Most Common Adverse Reactions

In controlled clinical trials, the most common adverse reactions (incidence ≥10% and >interferon beta-1a) with LEMTRADA vs interferon beta-1a were: rash (53% vs 6%), headache (52% vs 23%), pyrexia (29% vs 9%), nasopharyngitis (25% vs 19%), nausea (21% vs 9%), urinary tract infection (19% vs 8%), fatigue (18% vs 13%), insomnia (16% vs 15%), upper respiratory tract infection (16% vs 13%), herpes viral infection (16% vs 3%), urticaria (16% vs 2%), pruritus (14% vs 2%), thyroid gland disorders (13% vs 3%), fungal infection (13% vs 4%), arthralgia (12% vs 9%), pain in extremity (12% vs 9%), back pain (12% vs 8%), diarrhea (12% vs 6%), sinusitis (11% vs 8%), oropharyngeal pain (11% vs 5%), paresthesia (10% vs 8%), dizziness (10% vs 5%), abdominal pain (10% vs 5%), flushing (10% vs 4%), and vomiting (10% vs 3%).

Use in Specific Populations

Physicians are encouraged to register patients in the pregnancy exposure registry by calling 1-866-758-2990. Antibodies, including anti-CD52 and autoantibodies, may be transferred from the mother to the fetus during pregnancy. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves’ disease has been reported.

Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity and infusion reactions, stroke, and because it may increase the risk of malignancies.

Please see full Prescribing Information, including Boxed WARNING.

References:

  1. LEMTRADA [prescribing information]. Cambridge, MA: Genzyme Corporation.
  2. Coles AJ, Twyman CL, Arnold DL, et al; for CARE-MS II investigators. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial. Lancet. 2012;380(9856):1829-1839. doi:10.1016/S0140‑6736(12)61768-1
  3. Data on file. Genzyme Corporation.
  4. Coles AJ, Cohen JA, Fox EJ, et al; on behalf of CARE-MS II and CAMMS03409 investigators. Alemtuzumab CARE-MS II 5-year follow-up: efficacy and safety findings. Neurology. 2017;89(11):1117-1126. doi:10.1212/WNL.0000000000004354

Indication

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.

Limitations of Use: LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

IMPORTANT SAFETY INFORMATION

WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE AND MALIGNANCIES

  • LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane (anti-GBM) disease. Monitor complete blood counts with differential, serum
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