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The monoclonal antibody has shown continued success up to 8 years in clinical trials.
Barry Singer, MD
The effects of alemtuzumab (Lemtrada, Sanofi) on multiple sclerosis disease activity appear to be continuously occurring through 8 years, according to extension data from a pair of phase III trials.
Presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Berlin, Germany, the data revealed that 71% (n = 252) of patients in CARE-MS I and 64% (n = 260) of patients in CARE-MS II did not experience a worsening of condition, as defined by a ≥1-point increase in Expanded Disability Status Scale (EDSS) score confirmed over 6 months.
Among patients treated with alemtuzumab in the 2-year studies, 290 of 376 (77%) and 300 of 435 (69%) completed 8 years’ worth of long-term follow-up. After being administered their initial 2 courses of the therapy, 56% (n = 197) of patients in the CARE-MS I trial and 44% (n = 172) of patients in the CARE-MS II trial received no further treatment.
“The extension study data being presented at ECTRIMS this year showed the effects of Lemtrada were maintained in patients across clinical and MRI outcomes, including brain volume loss, over 8 years,” Barry Singer, MD, the director of the MS Center for Innovations in Care at Missouri Baptist Medical Center, in St. Louis, said in a statement. “After their initial 2 courses of Lemtrada, approximately half of patients received no additional treatment through 8 years. Almost two-thirds of patients did not experience disability worsening through year 8, providing important insight into the effects of Lemtrada seen over time.”
Additionally, at year 8 in the CARE-MS I and CARE-MS II trials, respectively, 41% (n = 81) and 47% (n = 135) of those treated with alemtuzumab experienced confirmed disability improvement, as defined by a ≥1-point decrease in EDSS score confirmed over 6 months. Notably, this was only assessed in those with baseline EDSS scores of ≥2.
The data showed that annualized relapse rates were 0.18 in CARE-MS I and 0.26 in CARE-MS II over 2 years (P <.0001 for both, compared to subcutaneous interferon ß-1a). These rates remained low over 8 years, registering at 0.15 and 0.18, respectively, at that point.
Brain atrophy, defined as brain volume loss as measured by brain parenchymal fraction on magnetic resonance imaging (MRI), was also shown to be slowed through treatment with alemtuzumab.
From years 3 to 8, yearly brain loss was measured as -0.22% or less and -0.19% or less in CARE-MS I and CARE-MS II, respectively. Both of these measures were lower than what was observed during the course of the studies. CARE-MS I showed brain volume losses of -0.59% and -0.25% in years 1 and 2, respectively, and CARE-MS II showed losses of -0.48% and -0.22% in years 1 and 2, respectively.
Also noted was that in years 2 through 8, the majority of patients (66% to 77% in CARE-MS I; 66% to 76% in CARE-MS II) showed no evidence of MRI-measured disease activity, defined as no new gadolinium-enhancing T1 lesions and no new or enlarging T2 lesions.
The adverse event (AE) profile was also shown to be positive, with a reduced incidence of AEs through year 8 in the extension trial, decreasing over time. In CARE-MS I, the incidence rate was 50.7% in year 8 compared to 93.6% in year 1 and 84% in year 2; Likewise, in CARE-MS II it was 52.6% in year 8 compared to 94.7% in year 1 and 92.6% in year 2.
The frequency of thyroid AEs was the highest in year 3 (CARE-MS I, 15%; CARE-MS II, 17%) and generally declined thereafter. All told, there were 2 deaths in CARE-MS I and 4 deaths in CARE-MS II in year 8.
1. Sanofi Presents 8-Year Data on Lemtrada® (Alemtuzumab) [press release]. Cambridge, MA: Sanofi; Published October 10, 2018. businesswire.com/news/home/20181010005474/en. Accessed October 14, 2018.
2. 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.
3. Coles AJ, Cohen JA, Fox EJ, et al.
Alemtuzumab CARE-MS II 5-year follow-up: Efficacy and safety findings. Neurology. 2017;89(11):1117-1126.