Lemtrada
Anti-CD52 Monoclonal Antibody for Relapsing-Remitting Multiple Sclerosis
Lemtrada (alemtuzumab) is a humanised monoclonal antibody used to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). It works by targeting the CD52 protein on immune cells, temporarily depleting T and B lymphocytes and allowing the immune system to repopulate with altered profiles that reduce autoimmune attacks on the central nervous system. Lemtrada is administered as an intravenous infusion in a healthcare setting and is reserved for patients whose MS remains highly active despite prior disease-modifying therapy, or who have rapidly evolving severe disease.
Quick Facts
Key Takeaways
- Lemtrada is reserved for highly active RRMS that has not responded adequately to at least one other disease-modifying therapy, or for rapidly evolving severe RRMS.
- Treatment involves two main courses: 5 consecutive days of IV infusion initially, then 3 consecutive days 12 months later, with possible additional courses if clinically necessary.
- Serious autoimmune side effects (thyroid disorders, immune thrombocytopenia, kidney disease) can occur months or years after treatment – monthly monitoring for at least 4 years after the last infusion is mandatory.
- In clinical trials, Lemtrada significantly reduced relapse rates and disability progression compared to interferon beta-1a, with many patients maintaining disease stability for years after treatment.
- Patients must carry a patient alert card at all times during treatment and for 4 years after the last infusion, as delayed autoimmune side effects can occur.
What Is Lemtrada and What Is It Used For?
Lemtrada (alemtuzumab) is a humanised monoclonal antibody that targets the CD52 protein on the surface of immune cells. It is used to treat adults with relapsing-remitting multiple sclerosis (RRMS), specifically when the disease is highly active despite treatment with at least one other MS therapy, or when MS is rapidly evolving with severe relapses.
Lemtrada contains the active substance alemtuzumab, a biologically engineered protein that binds specifically to CD52, a glycoprotein found on the surface of T lymphocytes, B lymphocytes, natural killer cells, monocytes, and macrophages. When alemtuzumab binds to these cells, it triggers their destruction through antibody-dependent cellular cytolysis and complement-mediated lysis. This process results in a rapid and sustained depletion of circulating lymphocytes.
Following this depletion, the immune system gradually repopulates over several months. Importantly, the reconstituted immune cell population has altered characteristics that may reduce the pathological autoimmune response responsible for attacking myelin in the central nervous system. This immune “resetting” effect is believed to underlie the sustained clinical benefit observed in many patients, even years after completing treatment.
Understanding Multiple Sclerosis
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system (the brain and spinal cord). In MS, the immune system mistakenly attacks the protective myelin sheath that surrounds nerve fibres, causing inflammation and nerve damage. When this inflammation causes symptoms, it is referred to as a relapse or attack. Patients with relapsing-remitting MS (RRMS) experience relapses followed by periods of partial or complete recovery.
The symptoms experienced depend on which part of the central nervous system is affected and can include vision problems, numbness or tingling, muscle weakness, difficulty walking, fatigue, and cognitive difficulties. Over time, the cumulative damage from repeated inflammatory episodes can lead to permanent neurological disability. Lemtrada aims to reduce the frequency and severity of these attacks, thereby slowing or preventing the accumulation of disability.
Clinical Evidence
In two pivotal phase III clinical trials (CARE-MS I and CARE-MS II), patients treated with Lemtrada experienced significantly fewer relapses compared to those treated with interferon beta-1a (Rebif). In CARE-MS II, which enrolled patients who had relapsed on prior therapy, Lemtrada reduced the annualised relapse rate by 49% compared to interferon beta-1a and was associated with a significant reduction in sustained disability progression. Long-term extension studies have shown that a substantial proportion of patients remained relapse-free and free of disability worsening for up to 6 years following the initial two treatment courses.
Important: Who Is Lemtrada For?
Lemtrada is indicated for adults with highly active RRMS despite a full and adequate course of treatment with at least one disease-modifying therapy, or for patients with rapidly evolving severe relapsing-remitting MS defined by two or more disabling relapses in one year and MRI evidence of new lesions. It is not intended as a first-line treatment due to its safety profile.
What Should You Know Before Receiving Lemtrada?
Before receiving Lemtrada, you and your doctor must carefully weigh the benefits against the significant risks. Lemtrada carries risks of serious autoimmune conditions, infusion reactions, infections, and cardiovascular events. Comprehensive screening and baseline testing are required before treatment can begin.
Contraindications
You must not receive Lemtrada if you:
- Are allergic to alemtuzumab or any of the other ingredients in Lemtrada
- Are infected with human immunodeficiency virus (HIV)
- Have an active, serious infection
- Have another autoimmune condition besides multiple sclerosis
- Have untreated high blood pressure
- Have a history of arterial dissection of the blood vessels supplying the brain (cervicocephalic arterial dissection)
- Have a history of stroke
- Have a history of heart attack or chest pain (angina pectoris)
- Have a known bleeding disorder
Warnings and Precautions
After receiving a treatment course with Lemtrada, you may be at increased risk of developing other autoimmune conditions or serious infections. It is essential that you understand these risks and how to monitor for them. You will receive a patient alert card and a patient guide with additional information. You must carry the patient alert card at all times during treatment and for four years after your last infusion, as side effects can occur years after treatment.
Critical Safety Information
Serious and potentially life-threatening autoimmune conditions can develop months or years after Lemtrada treatment. Monthly blood and urine monitoring must continue for at least 48 months after the last infusion. Report any new or unusual symptoms to your doctor immediately, even if they occur years after treatment.
Autoimmune Conditions
Treatment with Lemtrada can increase the risk of several autoimmune conditions. These can occur years after treatment, which is why long-term monitoring is essential.
Thyroid disorders (very common – affects more than 1 in 10 patients): Lemtrada can cause various types of thyroid dysfunction, including overactive thyroid (hyperthyroidism) and underactive thyroid (hypothyroidism). Signs include unexplained weight changes, excessive sweating or feeling cold, nervousness, rapid heartbeat, fatigue, or new constipation. If you develop a thyroid disorder, you will most likely need lifelong medication to manage it. Untreated thyroid disease during pregnancy can harm the unborn child.
Immune thrombocytopenia – ITP (common – affects up to 1 in 10 patients): This is a bleeding disorder caused by low platelet levels. It can be serious or even fatal if not diagnosed and treated early. Signs include easy or excessive bruising, small scattered red or purple spots on the skin (petechiae), heavier or longer menstrual periods, bleeding between periods, bleeding from the gums or nose that is new or takes longer than usual to stop, and coughing up blood.
Kidney disease, including anti-GBM disease (rare – affects up to 1 in 1,000 patients): Autoimmune kidney disease can cause serious damage if untreated, potentially leading to kidney failure requiring dialysis or transplantation, and can be fatal. Signs include blood in the urine (which may appear red or tea-coloured), swelling of the legs or feet, and coughing up blood.
Acquired haemophilia A (uncommon – affects up to 1 in 100 patients): A rare bleeding disorder caused by antibodies against Factor VIII. Signs include spontaneous bruising, nosebleeds, joint pain or swelling, and prolonged bleeding from cuts.
Autoimmune hepatitis: Some patients have developed liver inflammation after receiving Lemtrada. Signs include nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellowing of the skin or eyes, dark urine, or easy bruising.
Other autoimmune conditions reported with Lemtrada include sarcoidosis, autoimmune encephalitis (brain inflammation with behavioural changes, memory loss, or seizures), thrombotic thrombocytopenic purpura (TTP), and autoimmune conditions affecting red or white blood cells.
Infusion Reactions and Serious Cardiovascular Events
Most patients treated with Lemtrada experience side effects during the infusion or within 24 hours afterwards. To help reduce infusion reactions, you will receive premedication with corticosteroids before infusions. Despite this, some patients have experienced serious or life-threatening reactions after infusion, including pulmonary haemorrhage, heart attack, stroke, and dissection of blood vessels supplying the brain. These reactions can occur after any of the doses during a treatment course, most commonly within 1 to 3 days after infusion.
Infections
Patients treated with Lemtrada have a higher risk of developing infections because the treatment suppresses the immune system. Common infections include upper respiratory tract infections, urinary tract infections, and herpes virus infections. To reduce the risk of herpes infections, your doctor will prescribe antiviral medication (such as aciclovir) to take on treatment days and for one month afterwards.
Serious infections that have been reported include listeria meningitis (bacterial meningitis from contaminated food), cytomegalovirus (CMV) infection, Epstein-Barr virus (EBV) infection including severe liver inflammation, tuberculosis, and progressive multifocal leukoencephalopathy (PML, a rare and serious brain infection).
Food Safety During Treatment
To reduce the risk of listeria infection, avoid eating raw or undercooked meat, soft ripened cheeses (such as brie, camembert, and blue-veined cheeses), and unpasteurised dairy products for at least two weeks before treatment, during treatment, and for at least one month after treatment with Lemtrada.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving Lemtrada. Women of childbearing potential must use effective contraception during each treatment course and for four months afterwards.
If you become pregnant after Lemtrada treatment and develop a thyroid disorder during pregnancy, extra caution is required because untreated thyroid problems can harm the baby. It is not known whether alemtuzumab passes into breast milk, but a risk to the nursing infant cannot be excluded. Breastfeeding is not recommended during treatment courses and for four months after each course.
Alemtuzumab may remain in the body during each treatment course and for four months afterwards. It is not known whether it affects fertility during this period. There is no evidence that Lemtrada affects male fertility.
Vaccinations
If you have not completed standard vaccinations, your doctor should consider whether you need to receive them before starting Lemtrada. In particular, vaccination against varicella (chickenpox) may be recommended if you have never had the disease. Any necessary vaccinations must be completed at least six weeks before beginning a treatment course. You must not receive live vaccines if you have recently received Lemtrada.
How Does Lemtrada Interact with Other Drugs?
Because Lemtrada profoundly suppresses the immune system, it should not be used alongside other immunosuppressive or immunomodulatory treatments for MS, as this could significantly increase the risk of serious infections and other complications.
Lemtrada is administered in a clinical setting under medical supervision, which means interactions are carefully managed by your healthcare team. However, several important drug interactions should be considered.
| Interacting Drug / Class | Type | Effect |
|---|---|---|
| Live vaccines (e.g., MMR, varicella, yellow fever) | Major | Risk of vaccine-strain infection due to immunosuppression. Must not be given after recent Lemtrada treatment. |
| Other MS disease-modifying therapies (natalizumab, fingolimod, ocrelizumab, teriflunomide) | Major | Additive immunosuppression. Increased risk of serious infections and prolonged immune depletion. Prior immunosuppressive therapy must be cleared before starting Lemtrada. |
| Immunosuppressants (azathioprine, methotrexate, cyclosporine, mycophenolate) | Major | Significantly increased risk of infections and prolonged lymphopenia. Concurrent use is contraindicated. |
| Mitoxantrone | Major | Prolonged and additive immunosuppression. Mitoxantrone effects on the immune system can persist for months after discontinuation. |
| Corticosteroids (premedication) | Managed | Given as premedication before infusions to reduce infusion reactions. Short-course corticosteroids are part of the standard Lemtrada protocol. |
| Inactivated vaccines | Moderate | Immune response to vaccines may be reduced due to lymphocyte depletion. Vaccination should ideally be completed at least 6 weeks before Lemtrada treatment. |
Before starting Lemtrada, it is essential to inform your doctor about all medications you are currently taking, have recently taken, or might take, including over-the-counter medicines, vitamins, supplements, and herbal products. Your doctor will assess whether any current medications need to be discontinued before starting Lemtrada and will determine the appropriate washout period.
What Is the Correct Dosage of Lemtrada?
Lemtrada is given as an intravenous infusion over approximately 4 hours in a supervised healthcare setting. The standard treatment involves two main courses administered 12 months apart, with possible additional courses for patients who show signs of ongoing MS activity.
Adults
Course 1 (Initial Treatment)
12 mg per day administered as an intravenous infusion over approximately 4 hours on 5 consecutive days (total dose: 60 mg).
Course 2 (12 Months After Course 1)
12 mg per day administered as an intravenous infusion over approximately 4 hours on 3 consecutive days (total dose: 36 mg). No Lemtrada treatment is given between these two courses.
Additional Courses (If Needed)
Some patients with signs or symptoms of MS activity after the initial two courses may receive one or two additional treatment courses of 12 mg per day on 3 consecutive days. Additional courses may be administered 12 months or more after the previous course. The maximum daily dose is one infusion (12 mg).
Premedication
Patients receive premedication with corticosteroids immediately before the first three days of each treatment course to help reduce infusion reactions. Premedication with antihistamines and/or antipyretics may also be considered. Additionally, oral antiviral prophylaxis (such as aciclovir 200 mg twice daily or equivalent) is given during treatment days and for one month afterwards to reduce the risk of herpes infections.
Children and Adolescents
Lemtrada is not intended for use in children and adolescents under 18 years of age, as it has not been studied in MS patients under 18.
Elderly
Clinical trials did not include sufficient numbers of patients aged 55 years and older to determine whether they respond differently. Use in elderly patients should be based on individual assessment of the benefit-risk balance, taking into account that older patients may have a higher baseline risk of infections and cardiovascular events.
Missed Dose
Since Lemtrada is administered by healthcare professionals in a clinical setting, missed doses are unlikely. However, if a dose is missed, it should not be given on the same day as a scheduled dose. Your healthcare team will arrange an appropriate alternative administration schedule.
Overdose
Patients who have accidentally received a higher dose than recommended in a single infusion have experienced serious reactions including headache, rash, low blood pressure, and increased heart rate. Doses higher than recommended may lead to more severe or prolonged infusion reactions or a more pronounced effect on the immune system. If an overdose is suspected, the infusion is stopped immediately and symptoms are treated.
Monitoring After Treatment
| Test | When | How Long |
|---|---|---|
| Complete blood count with differential (to detect ITP, acquired haemophilia A, TTP, blood cell abnormalities) | Before treatment and every month after treatment | For at least 48 months after the last Lemtrada infusion |
| Serum creatinine and urinalysis with microscopy (to detect kidney disease) | Before treatment and every month after treatment | For at least 48 months after the last Lemtrada infusion |
| Thyroid function tests (TSH, free T3, free T4) | Before treatment and every 3 months after treatment | For at least 48 months after the last Lemtrada infusion |
| Liver function tests | Before treatment and periodically after treatment | For at least 48 months after the last Lemtrada infusion |
After the 48-month monitoring period, your doctor will continue to perform additional tests if you develop symptoms of ITP, acquired haemophilia A, TTP, kidney disease, or thyroid disorders. Even after the formal monitoring period ends, you should continue to watch for signs and symptoms of these conditions as described in your patient guide, and you should continue to carry your patient alert card.
What Are the Side Effects of Lemtrada?
Like all medicines, Lemtrada can cause side effects, although not everybody gets them. The most serious side effects are autoimmune conditions (thyroid disorders, ITP, kidney disease) and serious infections. The most common side effects are infusion reactions, which occur during or within 24 hours of infusion.
The most important side effects of Lemtrada are the autoimmune conditions described in the warnings section above. These can occur years after treatment and require long-term monitoring. Infusion reactions are the most commonly experienced side effects overall, affecting the majority of patients, but these are usually manageable with premedication and supportive care.
Very Common
May affect more than 1 in 10 people
- Infusion reactions: changes in heart rate, headache, rash, fever, urticaria (hives), chills, itching, flushing of the face and neck, fatigue, nausea
- Infections: upper respiratory tract infections (common cold, sinusitis), urinary tract infections, herpes infections
- Decreased white blood cell counts (lymphocytes, leukocytes, neutrophils)
- Thyroid disorders (overactive or underactive thyroid)
Common
May affect up to 1 in 10 people
- Infusion reactions: indigestion, chest discomfort, pain, dizziness, taste changes, insomnia, difficulty breathing or shortness of breath, low blood pressure, pain at infusion site
- Infections: cough, ear infection, flu-like illness, bronchitis, pneumonia, oral or vaginal thrush, shingles, cold sores, swollen or enlarged glands, influenza, herpes zoster, dental infection
- Exaggerated immune response, anaemia, easy bruising or bleeding
- Back, neck, arm, or leg pain; muscle pain, muscle cramps, joint pain; mouth or throat pain
- General malaise, weakness, vomiting, diarrhoea, abdominal pain, gastroenteritis, hiccups
- Abnormal liver tests, heartburn
- MS relapse, tremor, numbness, burning or tingling sensation
- Autoimmune thyroid disorders, thyroid antibodies, goitre
- Swollen arms and/or legs, vision problems, conjunctivitis
- Anxiety, depression, insomnia
- Acne, skin redness, excessive sweating, hair loss
- Abnormal menstrual bleeding, nosebleeds
- Blood or protein in urine, decreased heart rate, irregular heartbeat, high blood pressure
Uncommon
May affect up to 1 in 100 people
- Infections: gastroenteritis, gum inflammation, nail fungus, tonsillitis, acute sinusitis, bacterial skin infection, cytomegalovirus infection
- Athlete’s foot, abnormal cervical smear
- Increased sensitivity, sensory disturbances, tension headache, double vision
- Difficulty swallowing, throat irritation, productive cough
- Weight loss or gain, elevated blood sugar, enlarged red blood cells
- Constipation, acid reflux, dry mouth, rectal bleeding, gum bleeding, decreased appetite
- Blisters, night sweats, facial swelling, eczema
- Stiffness, limb discomfort, kidney stones, kidney disease
- Acquired haemophilia A (uncommon bleeding disorder)
- Sarcoidosis, autoimmune encephalitis
- Vitiligo (loss of skin colour), alopecia areata (patchy hair loss)
- Weakened immune function, tuberculosis
- Gallbladder inflammation with or without gallstones
Rare
May affect up to 1 in 1,000 people
- Haemophagocytic lymphohistiocytosis (excessive activation of white blood cells with inflammation)
- Thrombotic thrombocytopenic purpura – TTP (a blood-clotting disorder)
Reported (Frequency Unknown)
Reported in an unknown number of users
- Listeria meningitis (bacterial brain infection from contaminated food)
- Pulmonary haemorrhage (bleeding in the lungs)
- Heart attack (myocardial infarction)
- Stroke
- Cervicocephalic arterial dissection (tearing of blood vessels supplying the brain)
- Epstein-Barr virus (EBV) infection, including severe hepatitis
- Adult-onset Still’s disease (AOSD – multi-organ inflammatory condition)
When to Seek Immediate Medical Attention
Contact your doctor or seek emergency medical care immediately if you experience: unexplained bruising or bleeding, blood in your urine, swelling of the legs, difficulty breathing or coughing up blood, chest pain, sudden severe headache, facial drooping, weakness on one side of the body, difficulty speaking, yellowing of the skin or eyes, or persistent high fever with swollen glands.
How Should Lemtrada Be Stored?
Lemtrada is stored and handled by healthcare professionals in a clinical setting. Patients do not need to store this medicine at home. The following information is provided for completeness.
Lemtrada must be stored in a refrigerator at 2°C to 8°C (36°F to 46°F). It must not be frozen. The vials should be stored in the original packaging to protect from light. The medicine should not be used after the expiry date stated on the carton and vial label.
Once diluted for infusion, the solution should ideally be used immediately. If not used immediately, the diluted solution may be stored for up to 8 hours at 2°C to 8°C, protected from light. Healthcare professionals should inspect the concentrate visually for particles and discolouration before administration; discoloured solutions or those containing particles must not be used.
The vial must not be shaken before use. Using aseptic technique, the healthcare professional draws up 1.2 mL of concentrate from the vial and adds it to 100 mL of sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) infusion solution. No other medicines should be added to the infusion solution or administered simultaneously through the same intravenous line.
Keep this medicine out of the sight and reach of children. Unused medicine and waste material should be disposed of in accordance with local requirements.
What Does Lemtrada Contain?
Each vial of Lemtrada contains 12 mg of alemtuzumab in 1.2 mL of concentrate. The solution is clear, colourless to slightly yellow, and is supplied as a sterile concentrate for dilution before intravenous infusion.
Active substance: Alemtuzumab. Each vial contains 12 mg of alemtuzumab in 1.2 mL (10 mg/mL).
Other ingredients (excipients):
- Disodium phosphate dihydrate (E339)
- Disodium edetate dihydrate
- Potassium chloride (E508)
- Potassium dihydrogen phosphate (E340)
- Polysorbate 80 (E433)
- Sodium chloride
- Water for injections
This medicine contains less than 1 mmol potassium (39 mg) per infusion, meaning it is essentially “potassium-free.” It also contains less than 1 mmol sodium (23 mg) per infusion, meaning it is essentially “sodium-free.” Each vial contains 0.12 mg polysorbate 80 (E433), which may cause allergic reactions in some individuals. Inform your doctor if you have any known allergies.
Appearance: Lemtrada is a clear, colourless to slightly yellow concentrate for solution for infusion, supplied in a glass vial with a stopper. Each carton contains 1 vial.
Marketing authorisation holder: Sanofi Belgium, Leonardo Da Vincilaan 19, B-1831 Diegem, Belgium. Manufacturer: Genzyme Ireland Limited, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland.
Frequently Asked Questions About Lemtrada
Lemtrada (alemtuzumab) is used to treat adults with highly active relapsing-remitting multiple sclerosis (RRMS). It is specifically indicated for patients whose MS remains highly active despite a full and adequate course of treatment with at least one other disease-modifying therapy, or for patients with rapidly evolving severe RRMS. Lemtrada works by depleting certain immune cells and allowing the immune system to repopulate with altered profiles that reduce autoimmune attacks on the nervous system.
Lemtrada is given as an intravenous infusion over approximately 4 hours in a supervised healthcare setting, such as a hospital or infusion centre. The initial treatment course consists of infusions on 5 consecutive days, followed by a second course of 3 consecutive days 12 months later. Additional courses of 3 days may be given if needed, but always at least 12 months after the previous course. Patients receive premedication with corticosteroids and antiviral prophylaxis to reduce the risk of infusion reactions and herpes infections.
The most serious risks include autoimmune conditions that can develop months or years after treatment: immune thrombocytopenia (ITP), anti-glomerular basement membrane disease (anti-GBM, potentially causing kidney failure), thyroid disorders, acquired haemophilia A, and autoimmune hepatitis. Serious cardiovascular events (stroke, heart attack, pulmonary haemorrhage, arterial dissection) and serious infections (listeria meningitis, PML, CMV, EBV) have also been reported. Monthly blood and urine monitoring is mandatory for at least 4 years after the last infusion.
Patients must undergo monthly blood and urine tests for at least 48 months (4 years) after the last Lemtrada infusion. Blood tests screen for immune thrombocytopenia, thyroid disorders, blood cell abnormalities, and liver problems. Urine tests screen for kidney disease. Some autoimmune conditions can occur even beyond the 4-year monitoring period, so patients should remain vigilant for signs and symptoms indefinitely and continue carrying their patient alert card.
No, Lemtrada does not cure multiple sclerosis. However, clinical trials demonstrated that Lemtrada significantly reduced the rate of relapses and the risk of disability progression compared to interferon beta-1a. Many patients experience prolonged periods of disease stability after completing just the initial two treatment courses. The treatment works by resetting parts of the immune system, which may reduce the autoimmune attacks on nerve fibres in the brain and spinal cord, but the underlying disease process is not eliminated.
Lemtrada increases the risk of various infections due to immune system suppression. Common infections include upper respiratory infections, urinary tract infections, and herpes virus infections (oral herpes, genital herpes, shingles). More serious infections that have been reported include listeria meningitis, cytomegalovirus (CMV) reactivation, Epstein-Barr virus (EBV) infection, tuberculosis, and progressive multifocal leukoencephalopathy (PML). Patients receive antiviral prophylaxis during treatment and for one month afterwards to reduce herpes risk, and should follow food safety precautions to avoid listeria.
References
- European Medicines Agency (EMA). Lemtrada (alemtuzumab) – Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu/en/medicines/human/EPAR/lemtrada
- U.S. Food and Drug Administration (FDA). Lemtrada (alemtuzumab) – Prescribing Information. Available at: accessdata.fda.gov
- Cohen JA, Coles AJ, Arnold DL, et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a randomised controlled phase 3 trial (CARE-MS I). Lancet. 2012;380(9856):1819-1828. doi: 10.1016/S0140-6736(12)61769-3
- Coles AJ, Twyman CL, Arnold DL, et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a randomised controlled phase 3 trial (CARE-MS II). Lancet. 2012;380(9856):1829-1839. doi: 10.1016/S0140-6736(12)61768-1
- Havrdova E, Arnold DL, Cohen JA, et al. Alemtuzumab CARE-MS I 5-year follow-up: durable efficacy in the absence of continuous MS therapy. Neurology. 2017;89(11):1107-1116. doi: 10.1212/WNL.0000000000004313
- Ruck T, Bittner S, Wiendl H, Meuth SG. Alemtuzumab in Multiple Sclerosis: Mechanism of Action and Beyond. Int J Mol Sci. 2015;16(7):16414-16439. doi: 10.3390/ijms160716414
- World Health Organization (WHO). Model List of Essential Medicines. 23rd edition, 2023. Available at: who.int
- American Academy of Neurology (AAN). Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777-788.
Editorial Team
About This Article
This article was written by the iMedic Medical Editorial Team, which includes board-certified specialists in neurology, immunology, and clinical pharmacology. All content is reviewed according to international guidelines from the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), the American Academy of Neurology (AAN), and the World Health Organization (WHO). Our editorial process follows the GRADE evidence framework to ensure the highest quality of medical information.
Medical Review
Content reviewed by the iMedic Medical Review Board – an independent panel of medical experts specialising in neurology, neuroimmunology, and clinical pharmacology. Last review: December 2025.
Evidence Standards
Evidence Level 1A – based on systematic reviews and meta-analyses of randomised controlled trials. No commercial funding. No pharmaceutical company sponsorship.