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

Autor: van Pesch V; Department of Neurology, Cliniques Universitaires Saint-Luc (Neurology), UCLouvain, Brussels, Belgium. Vincent.vanpesch@saintluc.uclouvain.be., Hanganu AR; Carol Davila University of Medicine and Pharmacy, Bucharest, Romania.; Neurology Department, Fundeni Clinical Institute, Bucharest, Romania., Sankari SE; Department of Neurology, Cliniques Universitaires Saint-Luc (Neurology), UCLouvain, Brussels, Belgium.
Jazyk: angličtina
Zdroj: Acta neurologica Belgica [Acta Neurol Belg] 2024 Oct; Vol. 124 (5), pp. 1543-1554. Date of Electronic Publication: 2024 Apr 15.
DOI: 10.1007/s13760-024-02542-9
Abstrakt: 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.
Competing Interests: Declarations. 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. Ethics approval: 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.
(© 2024. The Author(s) under exclusive licence to Belgian Neurological Society.)
Databáze: MEDLINE
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