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Long-term follow up of alemtuzumab-treated patients: a retrospective study in a Belgian tertiary care center

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Abstract

Background

Pivotal studies have reported a significant proportion of patients achieving no evidence of disease activity (NEDA) after 2 cycles of treatment with alemtuzumab (ATZ), that can be maintained for several years. Long-term real-world evidence regarding ATZ as well as subsequent treatment trajectories is still scarce.

Objective

To analyze the effectiveness and safety of ATZ-treated patients in a tertiary care Belgian center.

Methods

A retrospective cohort study including 32 patients treated with ATZ between 2015 and 2021 was performed.

Results

32 patients received 2 ATZ courses with a mean follow-up (FU) duration of 5.6 years (range: 2.25–8.2). 21.75% patients were treatment naïve. 40.5% were previously treated with natalizumab or fingolimod. NEDA-3 was achieved in 61.3–85% of patients, with failure mostly attributed to recurrence of radiological disease activity. During FU, annualized relapse rates remained very low (0.06–0.14), disability improvement occurred in up to 40.5%, whereas disability worsening occurred in up to 13.5%. Retreatment risk was associated with younger age (< 45 years old, Odds Ratio 8.0, p = 0.02) and a higher number of previous DMTs (Hazard ratio 2.7, 95%CI 1.3–7.4, p = 0.02). Safety in our cohort was consistent with the known profile of ATZ. At the end of FU, 65.6% patients remained untreated after 2 or 3 courses of ATZ, while the remaining switched to anti-CD20 therapy or cladribine.

Conclusion

ATZ is a high efficacy therapy for active MS, providing long-term remission in a significant proportion of patients. Retreatment was more frequent in younger patients or patients having failed a higher number of previous DMTs.

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Data availability

The data that support the findings of this study are available from the corresponding author upon request. Data are located in controlled access data storage at the Cliniques Universitaires Saint-Luc.

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Funding

The authors did not receive funding for the submitted work.

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Authors and Affiliations

  1. Department of Neurology, Cliniques Universitaires Saint-Luc (Neurology), UCLouvain, Brussels, Belgium

    Vincent van Pesch & Souraya El Sankari

  2. Carol Davila University of Medicine and Pharmacy, Bucharest, Romania

    Andreea-Raluca Hanganu

  3. Neurology Department, Fundeni Clinical Institute, Bucharest, Romania

    Andreea-Raluca Hanganu

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  1. Vincent van Pesch
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  3. Souraya El Sankari
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Contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Andreea Florea and Vincent van Pesch. The first draft of the manuscript was written by Andreea Florea and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Vincent van Pesch.

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Conflict of interests

Prof. van Pesch received travel grants from Merck Healthcare KGaA (Darmstadt, Germany), Biogen, Sanofi, Bristol Meyer Squibb, Almirall and Roche. His institution has received research grants and consultancy fees from Roche, Biogen, Sanofi, Merck Healthcare KGaA (Darmstadt, Germany), Bristol Meyer Squibb, Janssen, Almirall, Novartis Pharma, and Alexion. Prof. El Sankari and Dr. Florea have no relevant financial or non-financial interests to disclose.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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van Pesch, V., Hanganu, AR. & Sankari, S.E. Long-term follow up of alemtuzumab-treated patients: a retrospective study in a Belgian tertiary care center. Acta Neurol Belg (2024). https://doi.org/10.1007/s13760-024-02542-9

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