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New Investigational Data on Six-Year Efficacy of Sanofi Genzyme's Lemtrada® (alemtuzumab) in Multiple Sclerosis Patients Who Experienced Relapse Between Treatment Courses To Be Presented at AANSanofi Genzyme, the specialty care global business unit of Sanofi, announced today positive new six-year investigational data from a post-hoc analysis of the extension study of Lemtrada® (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS). These data will be presented at the 69th American Academy of Neurology (AAN) Annual Meeting. Lemtrada is administered as two annual treatment courses, with the first treatment course administered via intravenous infusion on five consecutive days, and the second course administered on three consecutive days, twelve months later. The majority of patients treated with Lemtrada (76%; n=330) in the Phase III pivotal study CARE-MS II did not relapse between their first and second courses of Lemtrada; 24% (n=105) of Lemtrada-treated patients in CARE-MS II relapsed between courses. Clinical and MRI outcomes in the Lemtrada-treated patients who relapsed between courses markedly improved after their second course. Through six years, the clinical and MRI results observed in these patients were similar to those in the patients who did not relapse between courses:
Retreatment data for both groups of patients is as follows:
Consistent with the CARE-MS I and II full cohorts, through year six the most frequent adverse events (AEs) observed with Lemtrada were infusion-associated reactions; other AEs of interest included autoimmune AEs. "Relapses are not uncommon following the initiation of disease-modifying therapies for relapsing MS. Approximately 25% to 45% of RMS patients treated with DMTs experience relapses in the first year or two of treatment,1,2" said Barry Singer, M.D., Director of The MS Center for Innovations in Care, Missouri Baptist Medical Center, St. Louis, MO. "The new Lemtrada data being presented at AAN suggest that occurrence of relapses in patients after receiving their initial course but before receiving their second course is not an indicator of lack of response to the treatment, and support the importance of administering the full two-course regimen. The 24% of Lemtrada-treated patients in CARE-MS II who relapsed between their first and second courses experienced a marked improvement in clinical and MRI disease activity at year 2, which was maintained through six years. The results observed in these patients through six years were similar to those observed in the 76% of patients who were relapse-free between courses one and two." The Phase III trials of Lemtrada were randomized, open-label, rater-blinded, two-year pivotal studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had an inadequate response to another therapy (CARE-MS II). Active disease was defined as at least two relapses in the previous two years and at least one in the previous year. More than 90 percent of the patients who were treated with Lemtrada in the CARE-MS trials enrolled in the extension study. These patients were eligible to receive additional treatment with Lemtrada during the extension if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions. They were eligible to receive treatment with another DMT during the extension at the investigator's discretion. In clinical trials, serious side effects associated with Lemtrada included infusion reactions, autoimmune disorders (such as thyroid disease, autoimmune cytopenias, and nephropathies), infections and pneumonitis. Lemtrada may cause an increased risk of malignancies. Risk management programs incorporating education and monitoring help support early detection and management of key identified and potential risks. The most common side effects of Lemtrada are rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, urticaria, pruritus, thyroid gland disorders, fungal infection, arthralgia, pain in extremity, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting. (See Important Safety Information below.)
About Lemtrada® (alemtuzumab) The precise mechanism by which alemtuzumab exerts its therapeutic effects in MS is unknown. Alemtuzumab is a monoclonal antibody that targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Lemtrada depletes circulating T and B lymphocytes after each treatment course. Lymphocyte counts then increase over time with a reconstitution of the lymphocyte population that varies for the different lymphocyte subtypes. Sanofi Genzyme holds the worldwide rights to alemtuzumab and has responsibility for its development and commercialization in multiple sclerosis. Bayer Healthcare receives contingent payments based on global sales revenue.
Lemtrada® (alemtuzumab) U.S. Indication Do not receive LEMTRADA if you are infected with human immunodeficiency virus (HIV). 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 thrombocytopenia, which is when reduced platelet counts in your blood cause severe bleeding that, if not treated, may cause life-threatening problems. Call your healthcare provider right away if you have any of the following symptoms: easy bruising; bleeding from a cut that is hard to stop; 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 can, if untreated, lead to severe kidney damage, kidney failure that needs dialysis, a kidney transplant, or death. Call your healthcare provider right away if you have any of the following symptoms: blood in the urine (red or tea-colored urine); swelling of legs or feet; 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 healthcare provider 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:
To lower your chances of getting a serious infusion reaction, your healthcare provider 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 after they happen. 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 healthcare provider if you have the following symptoms that may be a sign of thyroid cancer:
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. Thyroid problems: Some patients taking LEMTRADA may get an overactive thyroid (hyperthyroidism) or an underactive thyroid (hypothyroidism). Call your healthcare provider if you have any of these symptoms:
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:
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: • Herpes viral infections. Some people taking LEMTRADA have an increased chance of getting herpes viral infections. Take any medicines as prescribed by your healthcare provider to reduce your chances of getting these infections. • Tuberculosis. Your healthcare provider 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 healthcare provider right away if you have symptoms of a serious infection such as fever or swollen glands. Talk to your healthcare provider before you get vaccinations after receiving LEMTRADA. Certain vaccinations may increase your chances of getting infections. Swelling of lung tissue (pneumonitis): Some people have had swelling of the lung tissue while receiving LEMTRADA. Call your healthcare provider right away if you have the following symptoms:
Before receiving LEMTRADA, tell your healthcare provider if you:
• are taking a medicine called Campath® (alemtuzumab) Tell your healthcare provider 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 healthcare provider 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:
Tell your healthcare provider 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. You are encouraged to report side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088 Please see full U.S. Prescribing Information, including boxed WARNING and Medication Guide.
About Sanofi Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn more at www.sanofigenzyme.com. Sanofi® is a registered trademark of Sanofi. Genzyme® and Lemtrada® are registered trademarks of Genzyme Corporation. All rights reserved. 1 Schwid SR, Panitch HS. Clinical Therapeutics 2007; 29:2031-48. 2 PolmanCP, O'Connor PW, Havrdova E, et al. New England Journal of Medicine 2006; 354:899-910 3 Company data on file
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