Alemtuzumab in treatment-naïve patients with aggressive MS

In an observational study of treatment-naïve patients with aggressive MS, alemtuzumab yielded positive efficacy results. No evidence of disease activity (NEDA)-3 was reached by almost 70% after 3 years. The authors stress the importance of rigorously selecting the ideal patients for this treatment modality to achieve a positive risk/benefit ratio.

Alemtuzumab is a powerful anti-CD52 monoclonal antibody for the treatment of active MS. It induces depletion of T- and B-cell populations and a possible immune system 'reset', but also has many possible side effects.

The multicentre, prospective, observational study presented by Dr Lucia Moiola (IRCCS San Raffaele Hospital, Italy) evaluated efficacy and safety of alemtuzumab in treatment-naïve patients with aggressive early MS [1]. Between 2015 and 2019, a total of 133 patients were included. Efficacy data were analysed after the end of the complete therapeutic cycle (2 courses of alemtuzumab). Follow-up data at 24 and 36 months was available for 99/133 and 61/133 subjects, respectively.

At year 2 and year 3, mean annualised relapse rate (ARR) was 0.06 and 0.10, respectively. The reduction in ARR was 94.4% compared with pre-treatment (P<0.0001). The percentage of relapse-free patients at years 2 year 3 was 97% and 82%, respectively. Mean time to first relapse was 27.4 months. Female sex (OR 2.05) and a high ARR (OR 1.21) were significantly associated with relapse risk. After 3 years, 43 of 61 patients (69.4%) reached NEDA-3. Overall, 99 patients (74.4%) reported adverse events: 94 (70.1%) had infusion-associated reactions, 21 (15.8%) thyroid dysfunction, and 13 (9.8%) infections.

Dr Moiola stressed that alemtuzumab yielded more favourable efficacy and safety outcomes in this cohort of treatment-naïve patients with aggressive disease than in other randomised controlled trials and real-world studies. This is likely due to young age, short disease duration, and low disability. She added that a neurologist must know and understand the mechanism of action and adverse events of alemtuzumab to be able to confidently propose it to the right patient.

1. Moiola L, et al. Observational study on real-life experience with alemtuzumab in naïve patients with aggressive Multiple Sclerosis. OPR-191, EAN 2021 Virtual Congress, 19–22 June.

 

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Posted on 18 August 202118 August 2021