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Alemtuzumab efficacy and safety data of over 9 years

Presented by
Dr T. Ziemssen, Dr J. Jones, Prof. P. Vermersch
EAN 2020
Phase 3, CARE-MS
Alemtuzumab improved outcomes versus subcutaneous interferon (SC IFN)Ī²-1a over 2 years in multiple sclerosis (MS) patients with highly active disease from CARE-MS and extension studies. Efficacy was maintained up to 9 years [1]. Safety data of alemtuzumab was also presented, notably acute adverse events (AEs) during infusion and in the days following, as well as AEs occurring after lymphocyte repopulation.

Alemtuzumab efficacy and safety over 9 years were reported in patients that were previously treated with disease-modifying treatment and with highly active disease at baseline of the core CARE-MS I/II trials. In the first 2 years, annualised relapse rate was decreased with alemtuzumab versus SC IFNĪ²-1a and remained low in years 3-9 (0.16, 0.17, and 0.25, respectively, according to definition). Through year 9, 49%-59% of patients with highly active disease achieved 6-month confirmed disability improvement and 55%-64% remained free of 6-month confirmed disability worsening. Median cumulative brain volume change ranged from -0.64% to -1.80%. Safety in patients with highly active disease was similar to that in the overall study population, including serious AEs (39.8%-47.8% vs 44.8%).

Over 9 years in pooled CARE-MS alemtuzumab treated patients (n=811), AEs occurring after lymphocyte repopulation (18-36 months post treatment) included [2]:

  • thyroid disorders (47.6%);
  • immune thrombocytopenia (2.7%);
  • autoimmune nephropathies (0.4%);
  • acute acalculous cholecystitis (0.4%).

Among 25,292 patients treated with alemtuzumab in the postmarketing setting, there were also rare cases of autoimmune hepatitis (10.7/ 10,000) and haemophagocytic lymphohistiocytosis (2.7/10,000). Notable acute AEs temporally associated with alemtuzumab in the pooled CARE-MS studies (n=811) were predominantly infusion-associated reactions and serious infections, with a respective incidence of 90% and 3% [3]. Additional postmarketing events of interest (n=25,292) included haemorrhagic stroke/pulmonary alveolar haemorrhage (7.1/10,000 patients treated), other stroke (0.8/10,000), myocardial infarction (2.0/10,000), and cervicocephalic arterial dissection (1.6/10,000). Some patients who experienced myocardial infarction were aged <40 years and had no risk factors for ischaemic heart disease; some cases had temporarily abnormal blood pressure and/or heart rate during infusion.

  1. Ziemssen T, et al. Abstract EPR3107, EAN 2020.
  2. Jones J, et al. Abstract EPR2127, EAN 2020.
  3. Vermersch P, et al. Abstract EPR3097, EAN 2020.

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