Oxford, UK– 16 September 2016 – Sanofi Genzyme, the specialty care global business unit of Sanofi, today announced six-year investigational data from the extension study of Lemtrada® (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS). These results have been presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London.
“The Lemtrada data being presented at ECTRIMS from the ongoing extension study illustrate that more than half of patients experienced sustained effects of treatment on disease activity, despite receiving their last treatment course five years previously,”1-5 said Professor Alasdair Coles, Department of Clinical Neurosciences, University of Cambridge. “It is very promising to see these consistent effects over time across relapse, disability and MRI measures.”
In RRMS patients treated with alemtuzumab in the CARE-MS Phase III pivotal studies, the effects observed in the two-year trials were maintained through four additional years in the extension study. More than 90 percent of the patients (349 (95%) CARE-MS I and 393 (93%) CARE-MS II) who were treated with alemtuzumab in the CARE-MS trials enrolled in the extension. These patients were eligible to receive additional treatment with alemtuzumab in the extension if they experienced at least one relapse or at least two new or enlarging brain or spinal cord lesions.1-5
After the initial two courses of treatment in the CARE-MS trials, which were given at month zero and at month 12, 64 percent of alemtuzumab patients from CARE-MS I and 55 percent from CARE-MS II did not receive additional alemtuzumab treatment during the following five years, through month 72.1-5
The low annualised relapse rates observed in patients who received alemtuzumab in the Phase III studies CARE-MS I (0.16) and CARE-MS II (0.28) remained consistent throughout the extension (0.12 and 0.15 at year six).1,5
Through year six, 77 percent (248 patients) and 72 percent of patients (219 patients) who received alemtuzumab in CARE-MS I and CARE-MS II, respectively, did not experience worsening of six-month confirmed disability as measured by the Expanded Disability Status Scale (EDSS).1,5
Through year six, 34 percent (126 patients) and 43 percent (119 patients) of patients who had disability before receiving alemtuzumab in CARE-MS I and CARE-MS II, respectively, had improvement in EDSS score confirmed over at least six months as compared with pre-treatment baseline.1,5
Through year six, patients who received alemtuzumab in CARE-MS I and II experienced a slowing of brain atrophy as measured by brain parenchymal fraction on magnetic resonance imaging (MRI). In years three through six, the median yearly brain volume loss was -0.20 percent or less, which was lower than that observed in the alemtuzumab-treated patients during the two-year pivotal studies (CARE-MS I: -0.59 percent in year one; -0.25 percent in year two; CARE-MS II: -0.48 percent in year one; -0.22 percent in year two).3
In each of years three, four, five and six, most patients had no evidence of MRI disease activity, defined as no new gadolinium-enhancing T1 lesions and no new or enlarging T2 lesions (CARE-MS I: Y3 72 percent n=326 patients, Y4 70 percent n=324 patients, Y5 70 percent n=319 patients, Y6 66 percent n=304 patients; CARE-MS II: Y3 68 percent n=361 patients, Y4 70 percent n=336 patients, Y5 68 percent n=326 patients, Y6 69 percent n=304 patients).2,3
Through year six, the yearly incidence of most adverse events during the extension study was comparable or reduced compared with the pivotal studies.1 The frequency of thyroid adverse events was highest in year three and declined thereafter.1
The Phase III trials of alemtuzumab were randomised, rater-blinded, two-year pivotal studies comparing treatment with alemtuzumab 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. The protocol called for alemtuzumab to be 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, 12 months later.
More than 100,000 people in the UK have Multiple Sclerosis (MS)6, with around 85 percent diagnosed with RRMS.7
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About Lemtrada (alemtuzumab)
Lemtrada (alemtuzumab) is a humanised monoclonal antibody therapy which selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has transient impact on other immune cells. The reduction in the level of circulating T and B cells by alemtuzumab and subsequent repopulation may reduce the potential for relapse. It can also help to slow down or reverse some of the signs and symptoms of MS.8 Patients treated with Lemtrada had reduced annualised relapse rate compared to patients treated with subcutaneous interferon beta-1a injected three times per week, and treatment experienced patients were less likely to experience accumulation of their disability with Lemtrada compared with subcutaneous interferon beta-1a. Lemtrada is administered in two short treatment courses. The first treatment course includes one infusion per day for five days (course one). A year later a second course is administered one infusion per day for three days (course two).8
Lemtrada has been in clinical development for MS for more than 10 years and is supported by an extensive multicentre, multi-country clinical programme.9,10,11 Lemtrada was developed as part of research at the University of Cambridge and more than 1,500 patients participated in Lemtrada clinical trials, of which nearly 900 received Lemtrada.9,10,11
EU Indication and Usage
Lemtrada was granted EU marketing authorisation in September 2013 to treat adult patients with active RRMS defined by clinical or imaging features.12
Sanofi Genzyme has introduced a risk management plan to ensure that Lemtrada is used as safely as possible. Based on this plan, safety information has been included in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet for Lemtrada, including the appropriate precautions to be followed by healthcare professionals and patients.
For full prescribing information about Lemtrada, the Summary of Product Characteristics can be found here: http://www.medicines.org.uk/emc/medicine/28917/SPC/LEMTRADA+12+mg+concentrate+for+solution+for+infusion/
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1 Coles et al. Alemtuzumab Provides Durable Improvements in Clinical Outcomes in Treatment-Naive Patients With Active Relapsing-Remitting Multiple Sclerosis Over 6 Years in the Absence of Continuous Treatment (CARE-MS I). Presented at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016, London, UK.
2 Arnold et al. Durable Reduction in MRI Disease Activity With Alemtuzumab in Treatment-Naïve Patients With Active Relapsing-Remitting Multiple Sclerosis: 6-Year Follow-up of the CARE-MS I Study. Presented at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016, London, UK.
3 Traboulsee et al. Alemtuzumab Durably Slows Brain Volume Loss Over 6 years in the Absence of Continuous Treatment in Patients With Active RRMS Who Were Treatment-Naive (CARE-MS I) or Had an Inadequate Response to Prior Therapy (CARE-MS II). Presented at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016, London, UK.
4 Traboulsee et al. Alemtuzumab Suppresses MRI Disease Activity Over 6 Years in Patients With Active Relapsing-Remitting Multiple Sclerosis and an Inadequate Response to Prior Therapy (CARE-MS II). Presented at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016, London, UK.
5 Fox et al. Efficacy of Alemtuzumab Is Durable Over 6 Years in Patients With Active Relapsing-Remitting Multiple Sclerosis and an Inadequate Response to Prior Therapy in the Absence of Continuous Treatment (CARE-MS II). Presented at 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016, London, UK.
6 MS Society. About MS. https://www.mssociety.org.uk/what-is-ms/information-about-ms/about-ms?utm_source=what-is-ms&utm_medium=link&utm_campaign=Landing-page-analysis&utm_content=about-ms. Accessed September 2016.
7 MS Society. Relapsing-Remitting MS (RRMS). https://www.mssociety.org.uk/what-is-ms/types-of-ms/relapsing-remitting-rrms. Accessed September 2016.
8 Patient Information Leaflet (PIL). http://www.medicines.org.uk/emc/medicine/28914 Accessed September 2016.
9 Cohen et al. Alemtuzumab versus interferon beta 1a as first-line treatment for patients with relapsing-remitting multiple sclerosis: a RCT phase III trial. The Lancet 2012; 380: 1069-1078
10 Coles et al. Alemtuzumab for patients with relapsing multiple sclerosis after disease-modifying therapy: a RCT phase III trial. The Lancet 2012; 380: 1829-1839
11 Coles, A.J. Alemtuzumab more effective than interferon b-1a at 5-year follow-up of CAMMS223 Clinical Trial. Neurology 2012; 78: 1069-1078
12 EPAR Summary for the public. Lemtrada (alemtuzumab) European Medicines Agency. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/003718/WC500150523.pdf. Accessed September 2016.
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Last updated on: 22/09/2016
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