Therapeutic Advances in Neurological Disorders (Apr 2021)

Efficacy and safety of alemtuzumab over 6 years: final results of the 4-year CARE-MS extension trial

  • Alasdair J. Coles,
  • Douglas L. Arnold,
  • Ann D. Bass,
  • Aaron L. Boster,
  • D. Alastair S. Compston,
  • Óscar Fernández,
  • Eva Kubala Havrdová,
  • Kunio Nakamura,
  • Anthony Traboulsee,
  • Tjalf Ziemssen,
  • Alan Jacobs,
  • David H. Margolin,
  • Xiaobi Huang,
  • Nadia Daizadeh,
  • Madalina C. Chirieac,
  • Krzysztof W. Selmaj

DOI
https://doi.org/10.1177/1756286420982134
Journal volume & issue
Vol. 14

Abstract

Read online

Background: In the 2-year CARE-MS I and II trials, alemtuzumab 12 mg administered on 5 consecutive days at core study baseline and on 3 consecutive days 12 months later significantly improved outcomes versus subcutaneous interferon beta-1a (SC IFNB-1a) in relapsing–remitting multiple sclerosis patients. Here, we present the final 6-year CARE-MS extension trial results (CAMMS03409), and compare outcomes over 6 years in patients randomized to both treatment groups at core study baseline. Methods: Over a 4-year extension, alemtuzumab patients (alemtuzumab-only) received as-needed additional alemtuzumab (⩾12 months apart) for disease activity after course 2. SC IFNB-1a patients who entered the extension discontinued SC IFNB-1a and received 2 alemtuzumab 12 mg courses (IFN–alemtuzumab), followed by additional, as-needed, alemtuzumab. Results: Through year 6, 63% of CARE-MS I and 50% of CARE-MS II alemtuzumab-only patients received neither additional alemtuzumab nor other disease-modifying therapy, with lasting suppression of disease activity, improved disability, and slowing of brain volume loss (BVL). In CARE-MS I patients (treatment-naive; less disability; shorter disease duration), disease activity and BVL were significantly reduced in IFN–alemtuzumab patients, similar to alemtuzumab-only patients at year 6. Among CARE-MS II patients (inadequate response to prior treatment; more disability; longer disease duration), alemtuzumab significantly improved clinical and magnetic resonance imaging outcomes, including BVL, in IFN–alemtuzumab patients; however, disability outcomes were less favorable versus alemtuzumab-only patients. Safety profiles, including infections and autoimmunities, following alemtuzumab were similar between treatment groups. Conclusion: This study demonstrates the high efficacy of alemtuzumab over 6 years, with a similar safety profile between treatment groups. ClinicalTrials.gov identifiers: NCT00530348; NCT00548405; NCT00930553