Real-World Study Confirms Efficacy, Target Population for Alemtuzumab in MS

Jan Lycke, MD

Results from a real-world, 5-year, prospective single-center study showed that most patients with relapsing-remitting multiple sclerosis (RRMS) used alemtuzumab (Lemtrada; Sanofi Genzyme) as a second- or third-line treatment, with it displaying similar efficacy to what was observed in previous extension studies.¹

The data, presented at 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 13-15, also showed that despite previously failing a disease-modifying therapy (DMT), 76% of patients had progression-free survival and 33% had a cumulative no evidence of disease activity-3 (NEDA-3) status.

Senior author Jan Lycke, MD, professor of neurology, University of Gothenburg, and colleagues assessed basic characteristics and therapeutic effects on 51 patients with RRMS selected for alemtuzumab at the MS Center between 2014 and 2016. Investigators assessed Expanded Disability Status Scale (EDSS), occurrence of clinical relapses, and cerebral MRI of patients at baseline and months 12, 24, 36, 48, and 60.

During the study, all patients reported receiving at least 1 course of alemtuzumab and most (n = 50) received the second. Sixteen patients had a third course and 2 had a fourth. At each of the timepoints, except for month 36, median EDSS was 1.5 (range, 0-7), compared to a median score of 2 (0-7.5) at baseline. More than half (n = 30; 58%) of the patients were relapse-free at the 60-month mark, correlating to an annualized relapse rate (ARR) of 0.12.

The mean age of the cohort was 36.1 (±7.1) years and most patients (n = 38; 74%) had secondline DMT prior to baseline. As for the rest, 6 patients had firstline DMT and 7 were treatment naïve. Breakthrough disease activity despite DMT use (n = 23) was the most common reasons to switch or initiative treatment with alemtuzumab, followed by positive JC virus antibody test during natalizumab (Tyasbri; Biogen; n = 18) treatment, highly active disease from onset (n = 7), and side effects (n = 3).

Investigators found that 63%, 75%, 76%, 80%, and 75%, of patients had NEDA-3 status in years 1, 2, 3, 4, and 5, respectively. Furthermore, 13 patients had confirmed disability worsening (CDW) and 15 had confirmed disability improvement (CDI). At the 60-month follow-up, cumulative data showed that 17 (33%) patients met NEDA-3 status. Although patients had a mean brain parenchymal fraction of 0.862 (±0.037) at baseline (n = 43), these fractions remained unchanged at follow-up.

Because of their disease activity, 13 (25%) patients decided to switch from alemtuzumab to another DMT. Eight patients chose rituximab (Rituxan; Genentech/Biogen), 2 chose natalizumab, and 3 chose autologous hematopoietic stem cell transplantation.

The results of this study reflected those observed in CARE-MS I (NCT00530348), a 5-year study that evaluated the safety and efficacy of alemtuzumab in treatment-naïve patients with RRMS. Over the course of years 0-5, 79.7% of patients were free of 6-month CDW and 33.4% achieved 6-month CDI. Most patients (6.17%, 60.2%, and 62.4%) had NEDA in years 3, 4, and 5.²

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REFERENCES

1. Sandgren S, Novakova L, Axelsson M, Malmestrom C, Zetterberg H, Lycke J. The effect of alemtuzumab treatment in relapsing remitting multiple sclerosis: real-world data from a 5-year prospective one center study. Presented at ECTRIMS 2021. Abstract P734

2. Havrdova E, Arnold DL, Cohen JA, et al. Alemtuzumab CARE-MS I 5-year follow-up. Neurology. 2017; 89(11):1107-1116. doi:10.1212/WNL.000000000004313